[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colorectal-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colorectal-surgery":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,45,72,106,131,158,184,211,236,257,283,314,342,354,383,419,441,468,490,516,541,570,601,629,653],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100054301","biological-and-clinical-underpinnings-of-postoperative-pain---colorectal-surgery-100054301",false,"NCT07219160","Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery","Biological and Clinical Underpinnings of Postoperative Pain - Colorectal Surgery (BAC-UPP 2 Study)","BAC-UPP 2","Inclusion Criteria:\n\n* Participants scheduled for colorectal cancer surgery\n* Age between 18-65; 3)\n* Understanding verbal and written English\n\nExclusion Criteria:\n\n* Concurrent medical conditions that could confound the interpretation of the data\n* Human immunodeficiency virus positive diagnosis\n* Cardiovascular or pulmonary disease\n* Systemic rheumatoid disease\n* Uncontrolled hypertension (i.e. SBP\u002FDBP of \\> 150\u002F95\n* Current illness accompanied by fever (body temperature \\>38 °C)\n* Any other chronic pain conditions\n* Conditions resulting in altered nerve sensation\n* Hospitalization due to psychiatric illness within the last 6 months\n* Poorly controlled diabetes\n* History of stroke\n* History of seizures\n* Circulatory disorders such AS Raynauds' disease\n* History of drug or alcohol abuse.","ALL","18 Years","89 Years",{"count":22,"type":23},128,"ESTIMATED","OBSERVATIONAL","Persistent pain after colorectal surgery remains a significant clinical challenge that can delay recovery, reduce quality of life, and increase long-term healthcare burden. The goal of this study is to gain a deeper understanding of the biological and clinical factors that influence pain severity after colorectal surgery and contribute to the transition from acute to chronic postoperative pain. Guided by a biopsychosocial framework, this research will address the following aims:\n\n1. The investigators will use standardized experimental pain testing before surgery to evaluate how patients respond to different types of controlled sensory stimuli. These responses may help predict who is more likely to experience severe or prolonged pain after surgery.\n2. The investigators will analyze blood samples collected before and after surgery to measure markers of inflammation and other biological responses. These data will help us explore how the body's immune and hormonal systems relate to pain severity in both the short- and longer-term recovery phases.\n3. The investigators will assess psychological and clinical factors, such as emotional health, coping style, household income, and life stressors, to understand how they contribute to patients' pain experiences throughout recovery.\n4. The investigators will examine whether routinely collected demographic and clinical characteristics can help identify patients at greater risk of experiencing higher levels of pain after surgery. This approach will allow us to better understand which patients may benefit from more tailored perioperative pain management strategies.",[27],"Colorectal Surgery",[29,30,31,32],"colorectal surgery","nociception","acute pain","chronic pain","NOT_YET_RECRUITING","2026-07-10",{"date":36,"type":37},"2026-07-13","ACTUAL",{"date":39,"type":23},"2026-09-01",{"date":41,"type":23},"2030-08",{"name":43,"class":44},"University of Alabama at Birmingham","OTHER",{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":4},"100433980","mechanical-bowel-prep-randomized-study-100433980","NCT04931173","Mechanical Bowel Prep Randomized Study","Is Mechanical Bowel Preparation Necessary to Reduce Surgical Site Infection Following Colon Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* undergoing elective colon surgery for benign or malignant disease\n* over the age of 18 years\n* provides informed consent.\n\nExclusion Criteria:\n\n* known anaphylaxis to neomycin or metronidazole\n* pregnancy or lactation\n* chronic renal failure (serum creatinine \\> 220 umol\u002FL).",{"count":53,"type":23},1062,"INTERVENTIONAL",[56],"NA","Following colon surgery, surgical site infection (SSI) is the most common complication and leads to longer recovery time for patients and increased health care costs. Currently, there is high quality evidence to show that the combination of intravenous antibiotics (IVA), mechanical bowel preparation (MBP) and oral antibiotics (OA) is the most effective bowel preparation to reduce SSI. However, there are no studies comparing IVA+MBP+OA and IVA+OA. This is an important question because if IVA+OA works the same as IVA+MBP+OA, then MBP may be safely omitted as part of the bowel preparation to reduce SSI and patients would avoid the side effects of MBP prior to their surgery. Therefore, the objective is to perform a trial to determine if IVA+OA works the same as IVA+MBP+OA to reduce SSI following colon surgery.",[27],[60,61,62],"Surgical Site Infection","Mechanical Bowel Preparation","Randomized Controlled Trial","2026-06-17",{"date":65,"type":37},"2026-06-22",{"date":67,"type":23},"2026-09",{"date":69,"type":23},"2028-12",{"name":71,"class":44},"Mount Sinai Hospital, Canada",{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":54,"phases":82,"briefSummary":83,"conditions":84,"keywords":91,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":105},"100643351","vacstent-use-for-the-treatment-of-anastomotic-leakage-following-colorectal-surgery-100643351","NCT07631702","VACStent Use for the Treatment of Anastomotic Leakage Following coloREctal Surgery","VACStent Use for the Treatment of Anastomotic Leakage Following Colorectal Surgery: a Multicenter Prospective Efficacy Study","VACURE","Inclusion Criteria:\n\n* AL in the distal sigmoid, upper or mid rectum following a colorectal resection\n* ≥ 18 years old.\n* Signed a written informed consent\n\nExclusion Criteria:\n\n* Anastomosis that is not endoscopically accessible.\n* Contra-indications for VacStent GI therapy: (a) Significant tissue ischemia in the area of the wound cavity, larger than the length of the VacStent GI Colon; (b) Anastomotic defect located \\\u003C4 cm from the dentate line. This is considered a relative contraindication, as very distal placement may cause patient discomfort although not necessarily; (c) Severe coagulopathy; (d) Ileus that does not allow for endoscopic examination.\n* Anastomotic fistula to surrounding organs (vagina, bladder, small bowel)",{"count":81,"type":23},40,[56],"Introduction: Anastomotic leakage (AL) is the most severe complication following colorectal surgery and is associated with significant morbidity and mortality. VacStent therapy is a promising therapeutic approach, combining endoscopic vacuum therapy with mechanical stability of a stent and thereby allowing continued fecal passage. It may enhance anastomotic healing and reduce the need for a diverting ostomy or additional surgical procedures. VACStent Use for the treatment of anastomotic leakage following coloREctal surgery (VACURE) study aims to assess the efficacy and safety of VacStent therapy for colorectal AL.\n\nMethods and analysis: VACURE is a prospective, multicenter efficacy study conducted at ten Dutch hospitals. Forty patients will be included over 18 months. All patients (≥18 years) with AL of the distal sigmoid, upper or mid rectum following colorectal resection will be considered for treatment with the VacStent GI Colon device. Trained endoscopists will perform stent placement, exchanges, and removal. Patients will remain hospitalized and those without diverting ostomy will receive osmotic laxatives and a fiber-free diet during treatment. Anastomotic healing will be confirmed endoscopically and radiologically posttreatment. The primary endpoint is the primary endpoint is the rate of participants that achieve complete anastomotic healing without the need for further interventions (confirmed by radiologic and endoscopic assessment). Secondary endpoints include safety, percentage of functioning anastomoses at 1 year post-treatment, 1-year stoma-free survival, diverting ostomy omission, healing time, number of stents, complications, reinterventions, length of hospitalization, pain scores, functional and quality of life outcomes up to 1 year posttreatment, patient experiences, and cost-effectiveness.",[27,85,86,87,88,89,90],"Anastomotic Leak Rectum","Endoscopy, Digestive System","Vacuum Therapy","Stents","Anastomotic Leakage","Minimal Invasive",[92,93,94,95],"Postoperative Complications","Anastomotic Leak","Vacuum stent","Endoscopic vacuum therapy","2026-06-03",{"date":98,"type":37},"2026-06-08",{"date":100,"type":23},"2026-07-01",{"date":102,"type":23},"2028-10-01",{"name":104,"class":44},"Amsterdam UMC, location VUmc",1,{"id":107,"slug":108,"hasResults":12,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":54,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":127,"leadSponsor":129,"locationsCount":105},"100639146","bilateral-erector-spinae-plane-block-versus-bilateral-oblique-subcostal-transversus-abdominis-plane-block-for-postoperative-analgesia-in-colorectal-surgery-100639146","NCT07602452","Bilateral Erector Spinae Plane Block Versus Bilateral Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Colorectal Surgery","Ultrasound-Guided Bilateral Erector Spinae Plane Block Versus Bilateral Oblique Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Colorectal Surgery: A Prospective Randomized Study.","Inclusion Criteria:\n\n* Age 18 to 75 years old.\n* Both sexes.\n* American Society of Anesthesiologists (ASA) physical status II-III.\n* Scheduled for open colorectal surgery under general anesthesia.\n\nExclusion Criteria:\n\n* History of opioid abuse.\n* Chronic opioid consumption.\n* Body mass index (BMI) ≥ 35 kg\u002Fm2.\n* Severe cardiac insufficiency, defined as New York Heart Association (NYHA) class III or IV heart failure.\n* Renal failure, defined as an estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n* Hepatic encephalopathy.\n* Having a skin infection at or near the puncture site.\n* Coagulopathy, defined as platelet count \\\u003C 100,000\u002Fmm³, INR \\> 1.5, or use of anticoagulant therapy that could not be withheld.\n* Allergy to drugs used in the study.\n* History of previous or recurrent laparoscopic cholecystectomy procedures.","75 Years",{"count":115,"type":23},50,[56],"This study aims to compare the ultrasound-guided bilateral erector spinae plane block (ESPB) and oblique subcostal transverse abdominal plane block (OSTAPB) for postoperative analgesia in colorectal surgery.",[119,120,121,27],"Bilateral Erector Spinae Plane Block","Bilateral Oblique Subcostal Transversus Abdominis Plane Block","Postoperative Analgesia","RECRUITING","2026-05-21",{"date":125,"type":37},"2026-05-22",{"date":123,"type":37},{"date":128,"type":23},"2026-12-01",{"name":130,"class":44},"Cairo University",{"id":132,"slug":133,"hasResults":12,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":54,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":105},"100637116","nutritional-supplementation-to-improve-colorectal-cancer-surgery-100637116","NCT07599501","Nutritional Supplementation to Improve Colorectal Cancer Surgery","Perioperative Nutritional Supplementation to Prevent Postoperative Complications and Improve Postoperative Outcomes After Colorectal Cancer Surgery: a Single-center Unblinded Randomized Controlled Trial","NUTRICOLOR","Inclusion criteria\n\n* Participants aged more than 18 years old.\n* Histological diagnosis of colorectal adenocarcinoma.\n* Participants scheduled for elective minimally invasive colorectal resection.\n* Participants with a preoperative MUST score equal to or below 2. Exclusion criteria\n* Any condition that, in the opinion of the investigator, may interfere with the study procedures.\n* Emergent surgery.\n* Planned open surgery. Participants undergoing unplanned surgical conversion (from minimally invasive to open) will be withdrawn from the study.\n* Any concomitant surgery unrelated to the primitive colorectal cancer (for example, concomitant liver metastasis resection).\n* Participants with preoperative MUST score \\> 2.\n* Pregnant or breastfeeding participants. Women of childbearing potential must agree to use a reliable contraceptive method. Otherwise, a pregnancy urine test must be performed at each study visit to exclude a potential pregnancy.",{"count":140,"type":23},190,[56],"This study aims to explore the effectiveness of perioperative Oral Nutritional Supplementation (ONS) combined with an optimized, tailored diet in reducing the risk of postoperative complications and improving the nutritional status of colorectal cancer patients scheduled for curative colorectal resection.",[144,27],"Colorectal Cancer",[146,147,148],"Colorectal cancer","Colorectal surgery","Oral Nutritional Supplementation","2026-05-13",{"date":151,"type":37},"2026-05-20",{"date":153,"type":23},"2026-09-30",{"date":155,"type":23},"2028-02-28",{"name":157,"class":44},"Istituto Clinico Humanitas",{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":4,"eligibilityCriteria":164,"healthyVolunteers":12,"sex":18,"minAge":165,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":54,"phases":168,"briefSummary":169,"conditions":170,"keywords":173,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":105},"100573880","optimizing-care-transition-process-for-older-colorectal-surgery-patients-100573880","NCT06752031","Optimizing Care Transition Process for Older Colorectal Surgery Patients","Optimization of Care and Recovery in Older Colorectal Surgery Patients: A Hybrid Effectiveness-Implementation Pilot Study Protocol","Inclusion Criteria:\n\n* Adult patients (\\>65 years old)\n* Scheduled to undergo an elective colorectal surgery procedure\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Emergent, non-elective colorectal procedures\n* Non-English Speaking","65 Years",{"count":167,"type":23},30,[56],"The goal of this study to test if a care transition intervention designed for older colorectal surgery patients would improve outcomes after discharge. It will assess the feasibility of the intervention.",[27,171,172],"Care Transition","Older Adults (65 Years and Older)",[147,174,175],"Care transition","Older adults","2026-05-08",{"date":149,"type":37},{"date":179,"type":37},"2025-10-30",{"date":181,"type":23},"2027-12",{"name":183,"class":44},"Massachusetts General Hospital",{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":192,"targetDuration":194,"studyType":24,"phases":4,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":4},"100634566","the-hugo-ras-colorectal-collaborative-100634566","NCT07541352","The Hugo RAS Colorectal Collaborative","The Hugo RAS Colorectal Collaborative (HRCC): An International Study to Advance Minimally Invasive Surgery","HRCC","Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Scheduled to undergo any type of colorectal surgery (elective or emergent) where the Hugo RAS system is planned to be used\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n-Patients unable to provide informed consent",{"count":193,"type":23},2000,"3 Years","The Hugo RAS Colorectal Collaborative (HRCC) is an international, multicenter dataset of patients undergoing colorectal surgery using the Hugo RAS system. The registry aims to analyze short and long-term outcomes to provide real-world evidence on the safety and effectiveness of the system.",[27,197,198],"Robotic Surgery","ColoRectal Cancer and Inflammatory Bowel Disease",[146,200,201],"IBD","Robotic surgery","2026-04-20",{"date":204,"type":37},"2026-04-22",{"date":206,"type":23},"2026-04",{"date":208,"type":23},"2029-06",{"name":210,"class":44},"IRCCS Azienda Ospedaliero-Universitaria di Bologna",{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":219,"targetDuration":4,"studyType":54,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":226,"lastUpdatePostDateStruct":227,"startDateStruct":229,"completionDateStruct":231,"leadSponsor":233,"locationsCount":105},"100582617","efficacy-and-safety-of-colorectal-anastomotic-leak-testing-100582617","NCT06865638","Efficacy and Safety of Colorectal Anastomotic Leak Testing","A Comparative Study of Clinical Outcomes Between Leak Testing and No Leak Testing for Anastomosis in Colorectal Cancer Surgery: a Multicenter, Stratified Randomized Controlled Trial.","Inclusion Criteria:\n\n1. Patients diagnosed with colorectal cancer by pathology and scheduled for surgical treatment who meet the surgical indications.\n2. Aged between 18 and 85 years.\n3. American Society of Anesthesiologists (ASA) physical status classification is I - III.\n4. The patient or his\u002Fher legal representative can understand and sign the informed consent form and is willing to cooperate throughout the study process.\n\nExclusion Criteria:\n\n1. Patients with preoperatively diagnosed anastomotic leak or other severe abdominal infections.\n2. Patients with severe cardiovascular and cerebrovascular diseases (such as recent myocardial infarction, unstable angina pectoris, severe heart failure, acute cerebral infarction, etc.) who cannot tolerate surgery and related tests.\n3. Patients with severely impaired liver and kidney function (liver function Child - Pugh classification C or above, creatinine clearance rate \\\u003C 30 ml\u002Fmin).\n4. Patients with coagulation disorders (such as platelet count \\\u003C 50×10⁹\u002FL, international normalized ratio (INR) \\> 1.5, etc.) that cannot be corrected or are receiving anticoagulant therapy that cannot be adjusted.\n5. Patients with a history of abdominal radiotherapy or multiple abdominal surgeries and severe abdominal adhesions that may affect the operation and detection procedures.\n6. Patients with other malignant tumors who are receiving active anti-tumor treatment such as radiotherapy and chemotherapy.\n7. Patients with mental illness or cognitive impairment who cannot cooperate with the study process and follow-up.","85 Years",{"count":220,"type":23},264,[56],"To evaluate the effectiveness of the gastroscopy, air, and methylene blue (GAM) leak testing in reducing the incidence of postoperative anastomotic complications, especially anastomotic leakage, in patients with colorectal cancer. The primary outcomes included is the incidence of anastomotic complications (mainly anastomotic leak) within 30 days after surgery",[144,224,27,225,89],"Leakage Testing","Complications","2026-03-29",{"date":228,"type":37},"2026-03-31",{"date":230,"type":37},"2024-12-22",{"date":232,"type":23},"2029-04-01",{"name":234,"class":235},"Nanchong Central Hospital","OTHER_GOV",{"id":237,"slug":238,"hasResults":12,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":218,"enrollmentInfo":243,"targetDuration":4,"studyType":54,"phases":245,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":249,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":105},"100608994","pre-emptive-endoscopic-vacuum-therapy-reduces-the-incidence-of-anastomotic-leakage-after-colorectal-cancer-surgery-100608994","NCT07208786","Pre-emptive Endoscopic Vacuum Therapy Reduces the Incidence of Anastomotic Leakage After Colorectal Cancer Surgery","Randomized Clinical Trial on Pre-emptive Endoscopic Vacuum Therapy Versus Conventional Management for the Prevention of Anastomotic Leakage After Colorectal Cancer Surgery","Inclusion Criteria:\n\n1. Pathologically diagnosed with colorectal cancer, planned for radical surgery (right hemicolectomy, left hemicolectomy, or anterior resection of the rectum, etc.).\n2. Age 18-85 years, American Society of Anesthesiologists (ASA) classification I-III.\n3. Anastomosis to be performed in a single stage (meeting anastomotic criteria).\n4. Patient or legal guardian is able to understand and sign the informed consent form and comply with follow-up.\n\nExclusion Criteria:\n\n1. Preexisting anastomotic leakage or severe intra-abdominal infection before surgery.\n2. Complicated by severe cardiovascular or cerebrovascular diseases (e.g., acute myocardial infarction, acute phase of cerebral infarction).\n3. Severe liver or kidney dysfunction (liver function Child-Pugh class C, creatinine clearance \\\u003C30 ml\u002Fmin).\n4. Coagulation disorders (platelets \\\u003C50×10⁹\u002FL, INR \\>1.5) or receiving anticoagulant therapy that cannot be adjusted.\n5. History of abdominal radiotherapy or multiple abdominal surgeries leading to severe intra-abdominal adhesions.\n6. Complicated by other malignant tumors and currently undergoing radiotherapy or chemotherapy.\n7. Psychiatric illness or cognitive impairment preventing compliance with the study.",{"count":244,"type":23},110,[56],"Evaluate the safety and efficacy of postoperative Pre-emptive EVT (PEVT) in reducing the incidence of anastomotic leaks within 30 days after surgery in patients with colorectal cancer. Compare the differences between the PEVT group and the control group in terms of operation time, length of hospital stay, and total medical costs. Analyze the incidence of other postoperative complications in the two groups, such as wound infection, abdominal abscess, and intestinal obstruction. Assess the impact of PEVT on postoperative recovery indicators, including time to first flatus, time to first defecation, and time to ambulation. Observe the occurrence of PEVT-related adverse events, such as device displacement, bleeding, and infection.",[144,27,225,89,248],"Endoscopic Vacuum Therapy","2026-03-28",{"date":251,"type":37},"2026-04-02",{"date":253,"type":37},"2025-09-22",{"date":255,"type":23},"2026-12-30",{"name":234,"class":235},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":54,"phases":266,"briefSummary":267,"conditions":268,"keywords":269,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":105},"100583983","pre-surgical-immunonutritions-effect-on-colorectal-surgery-100583983","NCT06883422","Pre-Surgical Immunonutrition's Effect on Colorectal Surgery","Impact of Pre-surgical Oral Immunonutrition on Plasma Levels of Branched-chain Amino Acids in Elective Colorectal Surgery Patients: a Randomized, Double-blind, Controlled, Clinical Trial","Inclusion Criteria:\n\n* Both sexes\n* Over 18 years of age\n* Scheduled for elective colorectal surgery (Resection and intestinal reconnection)\n* Obtaining patient consent\n\nExclusion Criteria:\n\n* Consumption of nutritional supplements during the 2 weeks prior to patient enrollment\n* Consumption of additional nutritional supplements during the 7 days corresponding to the study intervention period\n* Patients diagnosed with chronic kidney disease\n* Patients diagnosed with hepatic cirrhosis\n* Documented allergy to any of the ingredients in the formulas under evaluation (milk and\u002For soy).",{"count":265,"type":23},126,[56],"Colorectal surgery patients face excessive catabolism, increasing inflammation and immune compromise. The administration of nutritional supplements known as immunonutrition before gastrointestinal surgery has been shown to improve clinical outcomes; however, the mechanisms underlying these benefits remain inconclusive.\n\nThe objective of the study is to evaluate the effect of preoperative nutritional supplementation with an immunonutrient-enriched formula compared to an isocaloric and isoproteic formula on plasma BCAA concentration in patients undergoing elective colorectal surgery. A double-blind, randomized controlled clinical trial will be conducted. Patients will be required to drink the supplement daily for the 7 days preceding the surgical intervention. Patients in both groups will be instructed to maintain their usual food intake. During the study, there will be two patient assessments and a review of medical records to document the outcomes.",[27],[27,270,271,272,273],"Immunonutrition","Enhanced Recovery After Surgery","Preoperative Care","Amino Acids Branched-Chain","2026-03-23",{"date":276,"type":37},"2026-03-27",{"date":278,"type":37},"2023-05-25",{"date":280,"type":23},"2026-12-31",{"name":282,"class":44},"Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran",{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":287,"acronym":288,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":18,"minAge":290,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":54,"phases":293,"briefSummary":294,"conditions":295,"keywords":298,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":313},"100630353","anastomotic-leakage-prevention-by-endovascular-stenting-of-the-superior-mesenteric-artery-100630353","NCT07486570","Anastomotic Leakage Prevention by Endovascular Stenting of the Superior Mesenteric Artery","ALPrES²MA","Inclusion Criteria:\n\n* Age \\>40 years.\n* Patient scheduled for elective colon resection above the recto-sigmoid junction with a primary anastomosis (side-to-side, side-to-end, or end-to-end).\n* Presence of an asymptomatic \\>50% atherosclerotic origin stenosis of the superior mesenteric artery (SMA)\n\nExclusion Criteria:\n\n* All patients with symptomatic chronic or acute mesenteric ischemia (i.e., mesenteric artery stenosis in combination with symptoms as postprandial abdominal pain, fear of eating, altered eating patterns, weight loss, diarrhoea, nausea, or exercise-induced abdominal pain).\n* Presence of a \\>50% stenosis of the celiac artery, regardless of the underlying pathology (i.e., intra-articular atherosclerosis, intra articular thrombus or external compression by the median accurate ligament).\n* Simultaneous performed during the colon resection: a substantial abdominal organ resection, or T4b\u002FT4c colon tumour resection, or a second colon anastomosis or a diverting stoma\n* History of mesenteric revascularization, including endovascular stenting, thrombectomy, or bypass surgery involving any of the mesenteric arteries\n* Patients with a history of heparin induced thrombocytopenia-type 2 due to contraindication for VBX Stent Graft.\n* Patients with a contra-indication for mono antiplatelet therapy with Ascal due to comorbidities, allergy or intolerance.\n* Pregnancy","40 Years",{"count":292,"type":23},360,[56],"Rationale:\n\nAnastomotic leakage (AL) is a severe complication of colon surgery, with an incidence of 2.7-11.9%. It is associated with long-term increased mortality, reduced quality of life, and high healthcare costs due to reoperations and prolonged hospitalization. Among colon cancer patients, 5-year survival rates are 70% for those with AL compared to 81% for those without. A retrospective case-control study identified a \\>50% stenosis of the Superior Mesenteric Artery (SMA) as a significant risk factor, increasing AL odds by six times (OR: 5.9, 95% CI: 2.7-12.6, p \\\u003C .001).\n\nPrimary objective:\n\nThe ALPrES2MA study aims to evaluate whether preventive endovascular stenting of a \\>50% stenosed SMA origin reduces the risk of AL following colon surgery.\n\nSecondary objectives:\n\nClassification of severity of AL, incidence of delayed AL (\\>90 days), Mesenteric Artery Calcification Score (MACS), surgical complications, hospital (re)admissions, Quality of life (including health related quality of life), healthcare and societal costs, cost-effectiveness (expressed as incremental costs per quality-adjusted life year gained), and budget impact. Additionally, the added value of quantitative fluorescence angiography (qFA) in predicting AL during surgery, in hospitals with suitable equipment and experience, will be explored. This will enhance surgeons' capabilities in preventing AL.\n\nStudy design: Nationwide multicentre randomized controlled trail with a 1:1 fashion\n\nStudy population:\n\nPatients, 40 years and over, in the participating hospitals in the Netherlands with a \\>50% SMA origin stenosis scheduled for elective colorectal resection with a primary anastomosis for malignant or benign colorectal pathology.\n\nIntervention:\n\nIntervention group will undergo preventive percutaneous transluminal angioplasty (PTA) and endovascular covered stenting of the SMA, within preferably two weeks prior to the colon resection. Control group will not undergo PTA and endovascular stenting of the \\>50% SMA stenosis prior to the colon resection. Both groups will be treated with a mono antiplatelet therapy, i.e., carbasalate calcium (Ascal ®), for stent patency and atherosclerotic risk reduction. Intervention group has an indication for lifelong mono antiplatelet therapy and control group for at least 12 months\n\nMain study parameters\u002Fendpoints:\n\nThe primary endpoint is the incidence of a clinically relevant AL within 90 days post-surgery. Secondary endpoints include AL classification\u002Fseverity, calcification scores of aortic and mesenteric vessels, stenting complications, stent patency, intra-operative qFA measurements, operative duration, all causes of post-operative complications within 90 days, all reinterventions; surgical (including endovascular) and non-surgical within 90 days, duration of primary postoperative hospital stay and readmission within 12 months, 12 month mortality, patient-reported outcomes on month 0-3-6-12, cost-effectiveness budget impact analysis and stent patency. The total follow-up duration will be a total of 12 months.",[296,27,297],"Mesenteric Vascular Disease","Preventive Intervention",[299,147,300,301,302,303],"Anastomotic leakage","Preventive intervention","Superior Mesenteric Artery Stenosis","Percutaneous transluminal angioplasty","Endovascular stenting","2026-03-17",{"date":306,"type":37},"2026-03-20",{"date":308,"type":37},"2026-02-01",{"date":310,"type":23},"2029-01-01",{"name":312,"class":44},"Medisch Spectrum Twente",10,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":54,"phases":324,"briefSummary":325,"conditions":326,"keywords":328,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100581467","impact-of-ambulatory-continuous-monitoring-using-remote-monitoring-medicine-within-patients-care-pathway-following-colorectal-surgery-contact-greccar-21-100581467","NCT06850688","Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery (CONTACT-GRECCAR 21)","Impact of Ambulatory Continuous Monitoring Using Remote Monitoring Medicine Within Patient's Care Pathway Following Colorectal Surgery - A Multicenter Randomized Study","CONTACT","Inclusion Criteria :\n\n* Man or woman over 18 years old at the time of the J0 visit,\n* Patient who underwent surgery less than 28 days ago, or who is scheduled to undergo colorectal surgery not managed as an outpatient procedure at the investigational center, including resection of at least one colonic or rectal segment and\u002For an anastomosis involving the colon or rectum,\n* At least one of the following two criteria:\n* Anticipated early discharge (within 24 hours following laparoscopic surgery without stoma and without diversion, and within 5 days following laparotomy and\u002For surgery with stoma and\u002For rectal surgery) for a procedure that is not usually managed as an outpatient surgery in routine practice,\n* Estimated risk of hospital readmission greater than 10% according to the nomogram of Tevis et al. \\[15\\], adapted to the postoperative context in digestive surgery (\\>120 points according to this score).\n* Patient affiliated with a health insurance plan,\n* Patient who has signed the study consent form.\n\nExclusion Criteria:\n\n* Discharge to a rehabilitation center requested by the patient,\n* Condition managed on an outpatient basis in routine practice for this type of patient,\n* Patient eligible for home hospitalization services,\n* Suicidal or hetero-aggressive risk in a patient living alone at home\n* Homeless patient,\n* Pregnant or breastfeeding women,\n* Patient under legal guardianship, curatorship, or protected legal status,\n* Patient already enrolled in an interventional postoperative follow-up study.",{"count":323,"type":23},362,[56],"The goal of this Clinical Investigation is to evaluate the effectiveness of implementing the discharge protocol of the remote monitoring platform after colorectal surgery in patients at risk of hospital readmission.\n\nParticipants will be randomized into either the \"30 days of remote monitoring\" group or the \"conventional discharge\" group. The patient returns to the site for their postoperative visit at 30 days and is contacted by phone 90 days after their surgery.",[27,327],"Readmission",[29,329,330,331],"remote monitoring platform","Hospital length of stay","Rehospitalization","2026-03-16",{"date":334,"type":37},"2026-03-19",{"date":336,"type":37},"2025-06-17",{"date":338,"type":23},"2027-05-17",{"name":340,"class":44},"Nantes University Hospital",14,{"id":343,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":344,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":345,"keywords":346,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":353,"locationsCount":4},"100609790",{"count":22,"type":23},[27],[29,30,31,32],"2026-03-11",{"date":349,"type":37},"2026-03-13",{"date":351,"type":23},"2026-05-01",{"date":41,"type":23},{"name":43,"class":44},{"id":355,"slug":356,"hasResults":12,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":362,"targetDuration":4,"studyType":54,"phases":364,"briefSummary":365,"conditions":366,"keywords":370,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":105},"100628665","crp-point-of-care-testing-trajectory-a-predictive-factor-for-anastomotic-leak-in-elective-colorectal-surgery-100628665","NCT07464600","CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery","CRP Point-of-care Testing Trajectory, a Predictive Factor for Anastomotic Leak in Elective Colorectal Surgery? A Key to Early Rehabilitation?","CRP","Inclusion Criteria:\n\n* Patients undergoing elective (non-emergency) colorectal surgery, regardless of the approach (laparotomy, laparoscopy, robotic) and whether there is a protective ileostomy.\n\nExclusion Criteria:\n\n* No anastomosis\n* Urgent surgery\n* Pregnancy or breast-feeding\n* Patients under guardianship or trusteeship\n* Minor patients",{"count":363,"type":23},500,[56],"In colorectal surgery, one of the most feared complications is anastomotic leak (AL). To limit the consequences of AL, it must be diagnosed as early as possible, before it becomes symptomatic. Digestive surgeons use a variety of pre-, per- and post-operative techniques to reduce the rate of anastomotic fistula, but the risk persists, with a rate of 7% reported in the literature. It has been shown that the value of CRP between D1 and D5 correlates with the risk of AL, and that the trajectory between two consecutive days (D1 to D5 post-op) is the most discriminating element in predicting the risk of AF. This assay requires repeated intravenous sampling, which is the opposite of simplifying care. CRP point-of-care testing (POCT) is used in clinical practice, notably in pediatrics and outpatient medicine (in children and adults) to help prescribe probabilistic antibiotic therapy, as the instantaneousness of the result has an impact on patient management. For the diagnosis of AL, CRP POCT assessment could reduce the number of blood samples taken, shorten the time between sampling and medical management in cases of suspected AL, and thus improve the patient's post-operative experience.",[27,367,368,369,93],"Enhanced Recovery","CRP Point-of-care Testing Trajectory","Post-operative Complication",[29,371,372,373,374],"enhanced recovery","CRP point-of-care testing trajectory","post-operative complication","anastomotic leak","2026-03-06",{"date":347,"type":37},{"date":378,"type":37},"2025-09-17",{"date":380,"type":23},"2029-02",{"name":382,"class":44},"Centre Hospitalier Universitaire, Amiens",{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":391,"enrollmentInfo":392,"targetDuration":4,"studyType":54,"phases":394,"briefSummary":395,"conditions":396,"keywords":402,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":415,"leadSponsor":417,"locationsCount":105},"100622848","peripheral-autonomic-block-bap-plus-transversus-abdominis-plane-block-tap-for-postoperative-analgesia-after-minimally-invasive-left-sided-colorectal-resection-baptap-100622848","NCT07388953","Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP)","Peripheral Autonomic Block (BAP) Plus Transversus Abdominis Plane Block (TAP) for Postoperative Analgesia After Minimally Invasive Left-Sided Colorectal Resection (BAPTAP): A Randomized, Controlled, Double-Blind Trial","BAPTAP","Inclusion Criteria:\n\n* Elective laparoscopic left-sided colorectal resection\n* ASA physical status I-II\n* Ability to understand the study and sign informed consent\n\nExclusion Criteria:\n\n* Known allergy to study medications (e.g., local anesthetics)\n* Coagulation disorders\n* Pregnancy\n* Inability to understand or provide consent\n* Chronic pain on opioid therapy\n* BMI \\> 35 kg\u002Fm²","80 Years",{"count":393,"type":23},140,[56],"Effective postoperative pain management is essential for enhanced recovery after laparoscopic colorectal surgery. This randomized, controlled, double-blind trial will compare conventional postoperative analgesia (intravenous medications plus surgical wound infiltration) with a locoregional strategy combining a peripheral autonomic block (inferior mesenteric and superior hypogastric plexuses) and a transversus abdominis plane (TAP) block. We hypothesize that the combined strategy (BAPTAP) reduces pain intensity and opioid consumption in the first 48 hours after Left-Sided Colorectal Resection.",[144,27,397,398,399,400,401],"Anesthesia","Autonomic Nerve Block","Transversus Abdominis Plane (TAP) Block","Pain Management","Post Operative Analgesia",[29,403,404,405,406,407,408,409,410],"Postoperative Pain","Peripheral Autonomic Block","Superior Hypogastric Plexus","Inferior Mesenteric Plexus","TAP Block","ERAS","Ropivacaine","Opioid-sparing Analgesia","2026-02-12",{"date":413,"type":37},"2026-02-13",{"date":411,"type":37},{"date":416,"type":23},"2027-07-05",{"name":418,"class":44},"Faculdade de Ciências Médicas de Minas Gerais",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":54,"phases":428,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":440},"100390067","duration-of-urinary-catheterization-100390067","NCT04359069","Duration of Urinary Catheterization","Optimal Duration of Urinary Catheterization After Total Mesorectal Excision","Inclusion Criteria:\n\n* Elective procedures involving total mesorectal excision, including low anterior resection and abdominoperineal resection for rectal cancer as well as proctectomy for inflammatory bowel disease.\n* All approaches (open, laparoscopic and robotic) will be included, as the approaches not differ in the total mesorectal excision technique.\n* Patients who received neoadjuvant chemotherapy and\u002For radiation treatments will be included.\n* Age ≥ 18 years.\n* American Society of Anesthesiologists (ASA) class I-III.\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients undergoing emergent or urgent surgery.\n* Patients undergoing total mesorectal excision in combination with other major surgical procedures on the same day should be excluded from this study.\n* Patients sustaining genitourinary tract injury during the procedure should be excluded postoperatively.\n* History of urinary retention after previous procedure, surgery, or urinary catheter removal.\n* History of urinary retention not being actively treated.\n* Patients requiring prolonged duration or replacement of urinary catheter in the postoperative period for reasons other than urinary retention should be excluded.\n* History of neurogenic bladder.\n* Patients with chronic indwelling Foley catheterization or suprapubic catheterization.\n* History of cystectomy and\u002For any surgically created urinary conduit, including neobladder and ileal conduit.\n* Patients less than 18 years of age should be excluded from this study.\n* Vulnerable patients including incarcerated patients or any patients unable or unwilling to provide informed consent will be excluded from this study.",{"count":427,"type":23},176,[56],"This study is being conducted to determine the length of time a urinary catheter is needed to drain urine from the bladder after colorectal surgery. Urinary retention is a well known complication after pelvic colorectal surgery, and current practice is to continue urinary catheterization for 3- days following pelvic colorectal surgery in an effort to avoid this complication. However, prolonged urinary catheterization is associated with increased risk of urinary tract infections as well as longer hospital stays. The investigators hypothesize that postoperative urinary catheters may be safely removed on postoperative day 1 without increased urinary retention rates. The purpose of this study is to evaluate whether a shorter duration of urinary catheterization (1 day) is non-inferior when compared to standard duration (3 days) in regards to postoperative urinary retention. The investigators plan to perform a prospective, randomized, non-inferiority trial comparing the urinary catheter duration of 1 day and 3 days with the primary endpoint of postoperative urinary retention. Secondary endpoints are urinary tract infection and length of hospital stay. The participants will be randomly assigned to the control group (catheter removal on postoperative day 3) or the experimental group (catheter removal on postoperative day 1).",[27],"2026-02-02",{"date":433,"type":37},"2026-02-05",{"date":435,"type":37},"2020-10-01",{"date":437,"type":23},"2029-01",{"name":439,"class":44},"University of Southern California",2,{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":448,"targetDuration":4,"studyType":54,"phases":450,"briefSummary":451,"conditions":452,"keywords":456,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":459,"lastUpdatePostDateStruct":460,"startDateStruct":462,"completionDateStruct":464,"leadSponsor":466,"locationsCount":105},"100621727","nurse-led-early-mobilization-after-colorectal-surgery-100621727","NCT07374380","Nurse-Led Early Mobilization After Colorectal Surgery","Effect of a Nurse-Led Early Mobilization Protocol on Colorectal Surgery Patients: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Scheduled for elective colorectal surgery (e.g., procedures related to\n* colorectal cancer, diverticulitis, or inflammatory bowel disease \\[IBD\\])\n* Able to ambulate independently preoperatively\n* Medically and cognitively able to participate in a mobilization protocol\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* Undergoing emergency colorectal surgery\n* Patients requiring postoperative intensive care unit (ICU) admission\n* Severe cognitive impairment or psychiatric disorders that may affect participation\n* Musculoskeletal or neurological conditions that impair mobility\n* Inability to understand study instructions due to language or communication barriers",{"count":449,"type":23},80,[56],"This study was designed to evaluate the effectiveness of a nurse-led early mobilization protocol on postoperative recovery outcomes in patients undergoing elective colorectal surgery. The outcomes assessed include walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, incidence of postoperative complications, and length of hospital stay.\n\nResearch Question:\n\nIn patients undergoing colorectal surgery (P), does a nurse-led early mobilization protocol (I), compared with standard mobilization practices (C), improve postoperative recovery outcomes (O), including walking distance, mobility levels, gastrointestinal function (time to first flatus and first defecation), nausea, vomiting, comfort, fatigue, time to initiation of oral intake, patient satisfaction, postoperative complication rates, and length of hospital stay?",[27,453,454,455],"Early Mobilization","Postoperative Care","Postoperative Recovery",[29,457,458],"early mobilization","Nurse-Led Intervention","2026-01-25",{"date":461,"type":37},"2026-01-28",{"date":463,"type":23},"2026-01-05",{"date":465,"type":23},"2026-12-29",{"name":467,"class":44},"Ege University",{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":472,"acronym":473,"eligibilityCriteria":474,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":475,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":477,"conditions":478,"keywords":479,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":481,"lastUpdatePostDateStruct":482,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":440},"100517547","study-of-postoperative-ileus-in-digestive-surgery-100517547","NCT06018961","Study of Postoperative Ileus in Digestive Surgery","IPCID","Inclusion Criteria:\n\n* Patient entering our care sector for surgical management of a pathology affecting the digestive tract:\n* Colorectal cancer\n* Chronic inflammatory bowel disease\n* Colonic diverticulosis.\n\nExclusion Criteria:\n\n* Patient treated for digestive resection with associated resection procedure or to be treated with intraperitoneal chemotherapy.\n* Patient presenting during hospitalization with an ileus secondary to another intra-abdominal complication.\n* Patient cared for in an emergency\n* Hepatic resection or other associated metastatic site\n* Multiple digestive resection\n* Colorectal anastomosis less than 7 cm from the anal margin (below the Pouch of Douglas)\n* Patient with American Society of Anesthesiologists physical status (ASA) score \\> 2\n* Patient with an Eastern Cooperative Oncology Group (ECOG) Performance Status Scale \\>2\n* Pregnant or breastfeeding women\n* Patient under a protection regime for adults (guardianship, curators, safeguard of justice)",{"count":476,"type":23},161,"Post-operative ileus is a temporary stoppage of bowel function following surgery. Indeed it can occur in 20% of cases during post-operative follow-up of bowel surgery. The absence of resumption of transit can lead to the implementation of specific treatments such as the placement of a nasogastric tube and drug treatments. To date, the definition of this event is not accepted by everyone and is not based on reproducible evaluation criteria. The main objective of this study is to evaluate a score used to date to define postoperative ileus, the IFEED score, and to compare it to the length of postoperative stay.",[27],[480,147],"Ileus","2025-12-23",{"date":483,"type":37},"2025-12-31",{"date":485,"type":37},"2024-04-24",{"date":487,"type":23},"2026-06-15",{"name":489,"class":44},"University Hospital, Toulouse",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":391,"enrollmentInfo":497,"targetDuration":4,"studyType":54,"phases":499,"briefSummary":500,"conditions":501,"keywords":504,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":507,"lastUpdatePostDateStruct":508,"startDateStruct":510,"completionDateStruct":512,"leadSponsor":514,"locationsCount":4},"100614773","diverting-ileostomy-and-transverse-colostomy-comparative-study-100614773","NCT07283952","Diverting Ileostomy and Transverse Colostomy Comparative Study","Diverting Ileostomy Verses Transverse Colostomy in Colorectal Surgery","Inclusion Criteria:\n\n* • Adults ≥18 years undergoing elective low anterior resection or coloanal anastomosis for benign or malignant colorectal disease.\n\n  * Patients for whom the surgeon has decided that a diverting stoma is required such as emergency resection and anastomosis cases where a covering stoma is indicated.\n  * Ability to provide informed consent.\n\nExclusion Criteria:\n\n* • Patients with pre-existing stoma.\n\n  * Severe comorbidities precluding stoma creation (e.g., advanced renal failure, uncontrolled cardiac disease).\n  * Patients with extensive peritoneal carcinomatosis or unresectable disease.\n  * Pregnant or lactating women.\n  * Inability to comply with follow-up or provide informed consent.",{"count":498,"type":23},36,[56],"Protective diverting stomas are frequently constructed after low anterior resection or colorectal anastomosis to mitigate the consequences of anastomotic leakage, one of the most feared complications in colorectal surgery.\n\nBoth loop ileostomy (LI) and loop transverse colostomy (TC) are accepted methods of diversion. Randomized and observational studies have shown that faecal diversion significantly reduces the clinical severity of leaks and the need for reoperation compared with no diversion.\n\nThe choice between LI and TC remains controversial. Loop ileostomy is technically straightforward and associated with shorter operative time and fewer septic complications at closure. However, it carries specific risks, including high-output stoma, dehydration, electrolyte imbalance, and renal impairment, which may lead to hospital readmissions. Conversely, loop transverse colostomy is associated with fewer fluid and electrolyte issues, but has higher rates of prolapse, skin irritation, and wound complications at closure.\n\nMeta-analyses comparing LI and TC indicate no clear superiority, with each approach demonstrating distinct patterns of morbidity. Some randomized trials have suggested lower major morbidity with LI, while others found no significant difference. Given the heterogeneity of outcomes and limited high-quality, adequately powered trials, further randomized evidence is needed to guide optimal stoma selection in colorectal surgery.",[502,503,27],"Ileostomy","Colostomy",[505,506,27],"Diverting Ileostomy","Transverse Colostomy","2025-12-12",{"date":509,"type":37},"2025-12-16",{"date":511,"type":23},"2026-01-30",{"date":513,"type":23},"2027-11-30",{"name":515,"class":44},"Assiut University",{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":523,"enrollmentInfo":524,"targetDuration":4,"studyType":54,"phases":526,"briefSummary":528,"conditions":529,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":532,"lastUpdatePostDateStruct":533,"startDateStruct":535,"completionDateStruct":537,"leadSponsor":539,"locationsCount":4},"100613844","phase-3-neuromuscular-blocking-agents-on-gastrointestinal-function-following-colorectal-surgery-100613844","NCT07271875","Neuromuscular Blocking Agents on Gastrointestinal Function Following Colorectal Surgery","Effect of Neuromuscular Reversal With Neostigmine\u002FAtropine Versus Sugammadex on Postoperative Gastrointestinal Function Recovery Following Colorectal Surgery","Inclusion Criteria:\n\n* Age ≥ 18 years\n* American Society of Anesthesiologists (ASA) physical status classification I-III\n* Preoperative Mini-Mental State Examination (MMSE) score \\> 23\n* Patients scheduled for elective colorectal surgery under general anesthesia. Disease diagnoses include colorectal cancer, benign polyps, benign strictures, or diverticular disease.\n* Provide informed consent\n\nExclusion Criteria:\n\n* Presence of psychiatric disorders, cognitive impairment, or language communication barriers that may affect assessment compliance.\n* Body Mass Index (BMI) ≥ 35 kg\u002Fm².\n* Severe hepatic dysfunction (Child-Pugh Class C) or renal dysfunction (estimated glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73m² and\u002For receiving renal replacement therapy).\n* Pre-existing severe gastrointestinal dysfunction (e.g., intestinal obstruction, active inflammatory bowel disease, severe constipation\u002Fdiarrhea); receipt of neoadjuvant therapy preoperatively; planned stoma creation surgery; or scheduled for low rectal surgery (e.g., low anterior resection, abdominoperineal resection).\n* History of neuromuscular disorders (e.g., myasthenia gravis) or malignant hyperthermia.\n* History of opioid abuse, or chronic non-surgical pain requiring long-term analgesic therapy.\n* Anticipated difficult airway, or patients planned for postoperative transfer to the intensive care unit (ICU) while intubated.\n* Contraindications to the use of neostigmine, atropine, sugammadex, or rocuronium (e.g., known drug allergy, epilepsy, unstable angina, asthma, glaucoma, uncontrolled malignant arrhythmias especially atrioventricular block, severe cardiac valve stenosis); or current use of medications that may significantly influence the effects of neuromuscular blocking agents (e.g., antibiotics such as tetracyclines, aminoglycosides, polymyxins, and clindamycin; antiepileptic drugs; lithium; certain antidepressants such as sertraline and amitriptyline).\n* Pregnant or lactating women.\n* Current participation in other clinical trials that may interfere with the results of this study.","100 Years",{"count":525,"type":23},560,[527],"PHASE3","This study is a clinical research project conducted at Xijing Hospital to compare the effects of two different neuromuscular blockade reversal strategies on the recovery of gastrointestinal (GI) function after colorectal surgery.\n\nMany patients experience slow recovery of bowel function after colorectal surgery, which can lead to discomfort, nausea, vomiting, and a longer hospital stay. This study investigates whether using one medication (sugammadex) to reverse muscle relaxants used during anesthesia leads to better and faster recovery of gastrointestinal function compared to a traditional combination of medications (neostigmine with atropine).\n\nThe study will include 560 adults scheduled for elective colorectal surgery. Participants will be randomly assigned to one of two groups to receive either:\n\nSugammadex (2 mg\u002Fkg), OR Neostigmine (30 μg\u002Fkg) + Atropine (15 μg\u002Fkg) The assigned study drug will be given by intravenous injection at the end of surgery, once measurements show the muscle relaxant is starting to wear off. The patients, surgeons, outcome assessors, and statisticians will be blinded.\n\nThe main goal is to see if more patients in one group recover their gastrointestinal function within 72 hours after surgery. Gastrointestinal recovery is strictly defined as both being able to tolerate food\u002Fdrinks without significant nausea\u002Fvomiting AND having passed gas or had a bowel movement.\n\nThe study will also compare many other important outcomes between the groups, including:\n\n1. Time to first passage of gas, first bowel movement, and first toleration of food.\n2. Pain scores and opioid pain medication use.\n3. Rates of nausea and vomiting.\n4. Overall quality of recovery and patient satisfaction.\n5. Length of hospital stay and total hospitalization costs.\n6. Occurrence of complications within 30 days after surgery.\n7. The safety of both reversal strategies will be closely monitored throughout the study by recording any adverse events.\n\nThis research aims to provide high-quality evidence to help anesthesiologists and surgeons choose the best method to reverse muscle relaxation, potentially leading to faster recovery, fewer complications, and a better overall experience for patients undergoing colorectal surgery.",[530,531,27],"Postoperative Gastrointestinal Dysfunction (POGD)","Postoperative Ileus","2025-11-26",{"date":534,"type":37},"2025-12-09",{"date":536,"type":23},"2026-01-01",{"date":538,"type":23},"2027-12-31",{"name":540,"class":44},"Xijing Hospital",{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":546,"acronym":547,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":549,"targetDuration":551,"studyType":24,"phases":4,"briefSummary":552,"conditions":553,"keywords":555,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":569},"100527978","low-stable-pressure-pneumoperitoneum-in-colorectal-surgery-cross-study-100527978","NCT06154785","Low Stable Pressure Pneumoperitoneum in Colorectal Surgery (CROSS STUDY)","Low Stable Pressure Pneumoperitoneum in Colorectal Surgery : An Ideal Stage 2b Prospective International Cohort Study (CROSS STUDY)","CROSS","Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Colonic resection (right or left, subtotal or total) performed for benign or malignant pathology\n* Rectal resection with or without stoma for benign or malignant pathology\n* Laparoscopic or robotic procedure\n* Surgery under low stable pressure pneumoperitoneum with AirSeal\n* Patient who benefits by medicare system\n* Oral agreement after reading information letter\n\nExclusion Criteria:\n\n* Laparotomy procedure\n* Associated resection (except appendectomy or liver biopsy)\n* Transverse colectomy\n* Emergency procedure\n* Pelvic sepsis\n* Pregnancy or breast feeding period\n* Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study\n* Persons deprived of liberty or under guardianship",{"count":550,"type":23},300,"30 Days","The objective of this prospective, international cohort is to incorporate the low stable pressure (using Airseal Insufflator) approach and its associated parameters into the early rehabilitation program after colorectal surgery so as to shorten hospitalization up to the ambulatory care and reduce postoperative pain and opioid consumption.",[27,554],"Benign or Malignant Rectal or Colon Tumors",[556,557,558,559],"colorectal pathology","low stable pressure","laparoscopic","length hospital stay","2025-07-31",{"date":562,"type":37},"2025-08-01",{"date":564,"type":37},"2023-12-15",{"date":566,"type":23},"2025-09",{"name":568,"class":44},"Bordeaux Colorectal Institute Academy",18,{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":576,"eligibilityCriteria":577,"healthyVolunteers":578,"sex":18,"minAge":579,"maxAge":391,"enrollmentInfo":580,"targetDuration":4,"studyType":54,"phases":582,"briefSummary":583,"conditions":584,"keywords":587,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":600},"100502783","safety-and-effectiveness-evaluation-of-the-colo-bt-as-an-alternative-treatment-to-the-ileostomy-100502783","NCT05826743","Safety and Effectiveness Evaluation of the COLO-BT as an Alternative Treatment to the Ileostomy","Safety and Effectiveness Evaluations of the COLO-BT™ (Colorectal Balloon Tube) as an Alternative Treatment to the Temporary Ileostomy Following Proctectomy","COLO-BT","Inclusion Criteria:\n\nThe patient must meet all study Inclusion Criteria as outlined below:\n\n* Adult males or females, 19-80 years of age, with signed informed consent\n\n  * Subject whose anastomosis is expected to be located above 4cm from the anus, and at or below 15cm from the anus. (4cm \\\u003C inclusion target ≤ 15cm from the anus).\n\n    ③ Patient must meet all other inclusion criteria to be eligible. While not required, if one or more of the following six risk factors for postoperative anastomotic leakage\\[6,7,8\\] is true, the patient will be considered a high-risk subject:\n\n    \\- Male\n\n    \\- Those with a body mass index of 30 or higher\n\n    \\- Current smoker\n\n    \\- Those who are on medication for diabetes\n\n    \\- Those with clinical stage III or higher malignant tumors\n\n    \\- Those who received chemo\u002Fradiation therapy before surgery\n\n    ④ Those who are willing and able to participate in this clinical study, provide Informed Consent, and are willing to comply with the study procedures and follow up evaluations\n\n    ⑤ Those who have willingness to undertake blood transfusion if required.\n\nExclusion Criteria:\n\nPatients meeting any of the following Exclusion Criteria will not be eligible to participate in the study:\n\n1. Women who are pregnant or breastfeeding\n2. Those who receive emergency surgery\n3. A person who is expected to need intensive medical care after the surgery due to a serious medical condition, with one or more of the following seven factors being true:\n\n   * Patients with abnormal bone marrow function (those with hemoglobin less than 7g\u002Fdl, leukocyte count less than 4000\u002Fmm3, or platelet count less than 100,000\u002Fmm3 even after preoperative corrections)\n   * Patients with severe liver damage or cirrhosis (those whose AST\u002FALT levels are more than three times the normal range or those diagnosed with cirrhosis)\n   * Those with abnormal renal function (those who are on hemodialysis or who have a blood creatinine level of 2.0mg\u002Fdl or more before the surgery)\n   * Those who have undergone cardiac or cerebrovascular stent procedure within the last 6 months\n   * Those who have been diagnosed with pulmonary tuberculosis within the last 6 months or are undergoing drug treatment for pulmonary tuberculosis\n   * Those who continuously administer steroids of 20mg\u002Fday or more within 30 days before the surgery\n   * Patients with ASA (American Society of Anesthesiologists) score of 3 are evaluated by the investigator who determines whether or not patients with ASA score of 3 should be enrolled from the patient safety standpoint. Patients with ASA score higher than 3 are excluded from this study.\n   * Patients who are required to undergo re-intervention to treat the anastomosis following intraoperative positive air leak test (However, patients who underwent complete reconstruction of the anastomosis in the presence of a positive air test, which therefore has made their risk of leak similar to those patients with a negative air leak test.)\n   * Patients who are immune suppressed\n   * Patients with severe diverticulosis\n   * Patients with other colonic wall abnormalities in the likely area of the Outer Balloon and BT BAND application who may be at increased risk for device perforation or migration.\n4. A person who has difficulty in mobility or is unable to communicate in general due to a psychiatric\u002Fneurologic disorder falling under one or more of the following:\n\n   * Those diagnosed with dementia or Alzheimer's disease.\n   * Those who have been diagnosed with schizophrenia or depression or are taking drugs due to this.\n   * A person who has been diagnosed with disability due to intellectual disability.\n5. Patients with intestinal perforation, abscess in the pelvis, or severe inflammation in the pelvis.\n6. Those who have a history of undergoing major surgeries (major bowel resection\u002Fmajor gastrectomy, major hepatectomy) through laparotomy and are likely to have serious adhesions that may affect this surgery.\n7. A patient who underwent a preoperative chemotherapy, but the anastomosis is expected to be located very close to the anus or in the anal canal, thus with a very high risk for complications of the anastomosis, or a patient whom the bowel function is expected to decrease significantly in the future.\n8. Patients who had pre-operative radiotherapy should be excluded.\n9. Patients with inflammatory bowel diseases such as ulcerative colitis, Crohn's disease, intestinal tuberculosis, or autoimmune diseases such as Bechet's disease.\n10. Those who do not consent in writing to the study.\n11. Experienced blood loss (\\>750 cc) within 6 weeks before randomization.\n12. Transfusion during surgery.\n13. Any new sign of ischemia within 6 weeks before randomization.\n14. Diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, intraabdominal infection, ischemic bowel all due to carcinomatosis within 6 weeks before randomization.\n15. Known hypersensitivity or allergy to any of the components required for the procedure.\n16. Exclusion criteria not specified above, but the patient is determined to be unsuitable for participation in this clinical study at the judgment of the researcher.",true,"19 Years",{"count":581,"type":23},256,[56],"The purpose of this study is to evaluate the Colorectal Balloon Tube (hereinafter referred to as COLO-BT™) device, a single use, temporary intraluminal bypass device, intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic)",[27,144,585,586,89],"Rectal\u002FAnal","Ileostomy - Stoma",[27,144,588,589,299],"Stoma","ileostomy","2025-06-12",{"date":592,"type":37},"2025-06-13",{"date":594,"type":37},"2023-12-04",{"date":596,"type":23},"2027-03-15",{"name":598,"class":599},"JSR Medical Co., Ltd.","INDUSTRY",3,{"id":602,"slug":603,"hasResults":12,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":609,"targetDuration":610,"studyType":24,"phases":4,"briefSummary":611,"conditions":612,"keywords":614,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":622,"completionDateStruct":624,"leadSponsor":626,"locationsCount":628},"100579463","readmission-and-dehydration-prevention-in-patients-with-elective-ileostomy-100579463","NCT06824623","Readmission and Dehydration Prevention in Patients With Elective Ileostomy","Multicenter Prospective Observational Study to Prevent the Risk of REadmission and DEhydration of Patients With ileoSTOmy in Elective Colorectal Surgery","PREDESTO","Inclusion Criteria:\n\n* All patients with elective ileostomy performed during the study period for benign or malignant colorectal disease\n* Age \\> 18 years\n* Written consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Other ostomy than ileostomy",{"count":550,"type":23},"6 Months","The goal of this prospective observational study is to evaluate the adherence to DRIP score calculation and the application rate of each proposed item to prevent dehydration and readmission in patients undergoing ileostomy creation after elective colorectal resection different Italian colorectal surgical centers.\n\nThe primary endpoint is to verifythe application rate of DRIP score calculation and protocol items.\n\nSecondary endpoints are 30, 90, and 180-day total and dehydration readmission rates.",[586,27,613],"Dehydration",[589,615,616,617,618,29],"colorectal cancer","inflammatory bowel disease","dehydration","readmission","2025-06-08",{"date":621,"type":37},"2025-06-11",{"date":623,"type":23},"2025-06-01",{"date":625,"type":23},"2026-11-30",{"name":627,"class":44},"Multidisciplinary Italian Study group for STOmas (MISSTO)",7,{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":54,"phases":638,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":644,"lastUpdatePostDateStruct":645,"startDateStruct":647,"completionDateStruct":649,"leadSponsor":651,"locationsCount":440},"100590805","reflexology-massage-and-hot-water-foot-bath-for-pain-and-gi-recovery-after-colorectal-surgery-100590805","NCT06972199","Reflexology Massage and Hot Water Foot Bath for Pain and GI Recovery After Colorectal Surgery","The Effect of Reflexology Massage and Hot Water Foot Bath on Pain and Gastrointestinal Functions After Colorectal Surgery","Inclusion Criteria:\n\n* 18 years of age or older,\n* Planning laparoscopic surgery for a malignant tumour in the large intestine,\n* The same method was used for preoperative bowel and GI tract preparation,\n* Postoperative Numerical Proportioning Scale (NRS) score of 3 and above,\n* Verbal and written acceptance to participate in the research.\n\nExclusion Criteria:\n\n* The patient has a temporary or permanent stoma,\n* Having a history of reflexology application before,\n* Open wound, infection, circulatory disorder, lesion, etc. in the areas where reflexology massage or hot water foot bath will be applied,\n* Patient-controlled analgesia in the early postoperative period\n* Having any problem that prevents verbal communication.",{"count":637,"type":23},102,[56],"This study was planned to examine the effect of non-invasive treatment methods that can be applied to alleviate complications involving gastrointestinal system functions such as pain, nausea, vomiting, and absence of gas\u002Ffaecal output after colorectal (colon and rectum) cancer surgery. The two main intervention methods of the study were reflexology massage and hot water foot bath. The effects of these methods on reducing postoperative pain and improving gastrointestinal functions will be investigated. The study was planned as a randomised controlled experimental study to determine the effects of reflexology massage and hot water foot bath on postoperative pain and gastrointestinal functions in colorectal cancer patients undergoing laparoscopic surgery. It is thought that the study will provide evidence for determining the appropriate method to reduce pain and improve gastrointestinal functions in patients undergoing colorectal cancer surgery. The population of the study will consist of colorectal cancer patients who will undergo laparoscopic surgical intervention who are admitted to the General Surgery Clinic of SBU Istanbul Ümraniye Training and Research Hospital.\n\nBased on the percentage measurement values of the methods to be studied in the literature review, G-POWER programme was used for sample calculation with an effect size of 0.4 (Cohen), 95% power and 0.05% margin of error. Cohen\\'s standard effect size was taken as the basis for the effect size. The calculated value is the total value for 3 groups and the total sample size for 3 groups was found as n=102. The number of samples per group was determined as (n)=34. In order to prevent bias in the study, patients who meet the study criteria will be distributed to the experimental and control groups by computerised randomisation programme. Data will be collected by using the Patient Information Form consisting of two parts, Rhodes Nausea, Vomiting and Retching Index and Numerical Proportioning Scale (NRS) developed by the researcher in line with the literature. The data obtained will be evaluated with appropriate statistical methods in the licensed SPSS 21.0 package programme.",[27,641,642,643],"Reflexology","Traditional Chinese Medication (TCM)","Nursing","2025-05-07",{"date":646,"type":37},"2025-05-14",{"date":648,"type":37},"2024-10-30",{"date":650,"type":23},"2026-06-30",{"name":652,"class":44},"Istanbul University - Cerrahpasa",{"id":654,"slug":655,"hasResults":12,"nctId":656,"briefTitle":657,"officialTitle":658,"acronym":659,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":661,"targetDuration":4,"studyType":54,"phases":662,"briefSummary":663,"conditions":664,"keywords":667,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":105},"100556204","evaluating-the-effective-and-safe-use-of-stream-platform-100556204","NCT06522061","Evaluating the Effective and Safe Use of Stream™ Platform","Evaluating the Effective and Safe Use of Stream™ Platform by a Lay User in a Simulated Environment","Home-Stream","Inclusion Criteria:\n\n* Age ≥ 18 years - male or female.\n* Subject\u002FSDM understands and has voluntarily signed and dated Informed Consent Form (ICF).\n* Subject underwent colorectal surgery with anastomosis.\n* Subjects must be willing to comply with trial requirements.\n* Subject has a prophylactic abdominal\u002Fpelvic drain after colorectal surgery.\n\nExclusion Criteria:\n\n* Subjects\u002Fcaregiver is unwilling or unable to comply with the requirements of the protocol.\n* 24 hours or more have passed since the end of the subject's surgery and consent was not attained.\n* The subject had already developed an anastomotic leak at the time of screening and underwent surgery for treatment of the complication.\n* Plans that the subject will be discharged in less than 3 days post-surgery.\n* Subject has reported that they are pregnant.\n* Subject has a permanent end stoma.\n* Subject is delirious.\n* Subject has severe dementia.\n* Subject was involved in the planning and conduct of the clinical investigation.\n* Origin™ is not compatible with the drain used on the subject.\n* Subject and\u002For caregiver is\u002Fare not capable of conducting the calibrations for Stream™ Platform (this can be self-reported or determined by the CRC\u002FHCP\u002Fother research staff).\n* The subject and\u002For caregiver is\u002Fare unable to understand the instructions provided for the management and calibration of Stream™ Platform (this can be self-reported or determined by the CRC\u002Finvestigator\u002Fother research staff).",{"count":7,"type":23},[56],"The study aims to demonstrate the potential for at-home monitoring using Stream™ Platform, through simulated-use testing. Lay users, defined as subjects or nonprofessional caregivers, will be asked to operate Stream™ Platform. Safety, efficacy, and usability data will be collected to ensure that users are able to comply with prescribed device use.\n\nAdditionally, clinical testing will be conducted to identify correlations between measurements from Stream™ Platform and standard laboratory, radiological, and clinical assessments used for leak detection as part of the current standard of care (SOC) that may be skipped if the subject is discharged early.",[665,93,27,666],"User-Centered Design","Artificial Intelligence",[93,666,27,408,668],"Stream Platform","2025-02-26",{"date":671,"type":37},"2025-02-28",{"date":673,"type":23},"2025-03-15",{"date":675,"type":23},"2025-12-30",{"name":677,"class":599},"FluidAI Medical"]