[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rectal-cancer-surgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rectal-cancer-surgery":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,52,86,113,141,167,189,214,243],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100628563","results-of-low-anterior-resections-with-or-without-preventive-stoma-in-nonemergency-department-100628563",false,"NCT07463261","REsults of LOw Anterior Resections With or Without Preventive Stoma in Nonemergency Department","Results of Anastomotic Leak After Low Anterior Resection With or Without Preventive Stoma for Rectal Cancer in Low-risk Patients in Nonemergency Departments (RELOAD): Protocol of Multicenter Randomized Controlled Non-inferiority Trial","RELOAD","Inclusion Criteria:\n\n* Age \\>18 years;\n* Primary rectal cancer staged as cT1-4aN0-3M0 (or ycT0-4aN0-2M0);\n* Histologically confirmed rectal adenocarcinoma based on endoscopic biopsy;\n* Tumor located ≤12 cm from the dentate line (based on endoscopy, digital rectal examination, and\u002For pelvic MRI);\n* Planned radical minimally invasive (laparoscopic\u002Frobot-assisted) intervention with TME and formation of primary colorectal\u002Fcolonanal anastomosis;\n* Adequate hematologic function: hemoglobin ≥100 g\u002FL, leukocytes \\>4 × 10\\^9\u002FL, platelets \\>100 × 10\\^9\u002FL;\n* Adequate renal function: serum creatinine \\\u003C150 µmol\u002FL;\n* Adequate hepatic function: AST\u002FALT \\\u003C100 U\u002FL;\n* Predicted risk of anastomotic leakage ≤10% (AFOR 0-1).\n\nExclusion Criteria:\n\n* Age ≥80 years;\n* Presence of a pre-existing diverting ileostomy or colostomy;\n* Peritumoral abscess or tumor perforation;\n* Distant metastases (M1) identified preoperatively and\u002For intraoperatively;\n* Synchronous or metachronous malignancy;\n* Prior pelvic irradiation for another condition (e.g., cervical or prostate cancer);\n* Evidence of malnutrition (serum albumin \\\u003C34 g\u002FL);\n* Severe uncontrolled comorbid conditions (e.g., acute myocardial infarction, uncontrolled hypertension, decompensated heart failure, immunosuppression, systemic corticosteroid therapy, severe chronic obstructive pulmonary disease, chronic kidney disease stage 4-5), type 1 or type 2 diabetes mellitus, or psychiatric\u002Fneurological disorders impairing the ability to provide informed consent;\n* Tumor invasion into adjacent structures or organs (cT4b) identified preoperatively and\u002For intraoperatively;\n* Predicted risk of anastomotic leakage \\>10% (AFOR 2-6).","ALL","18 Years","70 Years",{"count":21,"type":22},442,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of this multicenter randomized non-inferiority trial is to evaluate the safety of low anterior resection for rectal cancer performed with versus without a diverting stoma in patients with a low predicted risk of colorectal anastomotic leakage.\n\nThe primary objective is to determine whether the rate of anastomotic leakage within 30 days after surgery in the no-stoma group is non-inferior to that in the diverting stoma group.\n\nThe secondary objectives include comparison between groups regarding: Stoma rate at 1 year after surgery; Quality of life at 30 days and 1 year (EORTC QLQ-C30, EORTC QLQ-CR29, and LARS score); Short-term postoperative outcomes, including postoperative day metrics, length of hospital stay, and complications graded according to the Clavien-Dindo classification; Reoperation rates within 30 days and 1 year.\n\nParticipants will include adult patients with mid- or low-rectal adenocarcinoma who are scheduled for radical minimally invasive total mesorectal excision and have a predicted risk of anastomotic leakage \\\u003C10% according to the study risk model.",[28,29,30,31,32],"TME","Rectal Cancer Surgery","Low Rectal Cancer","Middle Rectal Cancer","Local Advanced Rectal Cancer",[34,35,36,37,38],"rectal cancer","preventive stoma","randomized trial","low-risk patients","anastomotic leak","RECRUITING","2026-05-11",{"date":42,"type":43},"2026-05-13","ACTUAL",{"date":45,"type":43},"2026-05-05",{"date":47,"type":22},"2027-06-10",{"name":49,"class":50},"ANO Scientific and Practical Club for the Development of Modern Medical Technologies","OTHER",7,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":69,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":85},"100588083","phase-3-improving-functional-outcomes-and-quality-of-life-in-patients-with-rectal-cancer-after-surgery-with-intensified-follow-up--surveillance-100588083","NCT06936774","Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance","Improving Functional Outcomes and Quality of Life in Patients With Rectal Cancer After Surgery With Intensified Follow-up & Surveillance - a Randomized Controlled Trial (iRECOVER)","iRECOVER","Inclusion Criteria:\n\n* patients older than 18 years\n* patients with rectal cancer in the middle and lower third of the rectum in stages I to IV who underwent LAR with TME and protective ileostomy\n* able to give informed consent as documented by signature\n\nExclusion Criteria:\n\n* dementia or other psychiatric disorder that would prevent the patients from answering the questionnaires and experiencing sustainable training effects\n* impossibility of stoma reversal due to persistent anastomotic leak and\u002For local recurrence",{"count":61,"type":22},140,[63],"PHASE3","The goal of this clinical study is to gain further insights into the treatment of patients with Low Anterior Resection Syndrome (LARS) symptoms after rectal resection. The main question is: Can LARS symptoms and quality of life be improved by implementing an intensified follow-up program? Researchers will compare the results of the intervention group with the results of a control group in which patients do not receive an intensified follow-up program to determine whether the intervention works. Participants will undergo an intensified follow-up program which consists of several follow-up visits and medical treatment, pelvic floor muscle training and gynaecological and urological co-treatment in case of LARS symptoms and urinary or sexual complaints.",[66,29,67,68],"LARS - Low Anterior Resection Syndrome","Rectal Cancer","Quality of Life (QOL)",[70,71,72,73,74,75],"LARS","Low Anterior Resection Syndrome","Intensified follow-up","Rectal cancer","Rectal resection","Low anterior resection","2026-04-30",{"date":78,"type":43},"2026-05-06",{"date":80,"type":43},"2025-12-01",{"date":82,"type":22},"2028-07-01",{"name":84,"class":50},"University Hospital, Basel, Switzerland",5,{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100632326","intraoperative-rectal-lavage-to-prevent-local-recurrence-after-laparoscopic-mid-to-low-rectal-cancer-resection-a-multicenter-randomized-trial-100632326","NCT07512232","Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial","Laparoscopic Rectal Irrigation for the Prevention of Local Recurrence After Radical Resection of Mid-to-Low Rectal Cancer: A Prospective, Multicenter, Randomized, Open-label, Parallel-controlled Clinical Study","TOWER-2","Inclusion Criteria:\n\n* Age between 18 and 75 years old.\n* Pathologically confirmed rectal adenocarcinoma.\n* Mid-to-low rectal cancer with the tumor lower margin located ≤10 cm from the anal verge.\n* Underwent laparoscopic radical resection for rectal cancer with sphincter preservation.\n* Without concomitant multiple primary malignancies.\n* Adequate organ function.\n* Patients or their family members were able to understand the study protocol, willing to participate in this study, and provided written informed consent.\n\nExclusion Criteria:\n\n* Concomitant other malignancies or a history of prior malignancies.\n* Abdominal perineal resection (Miles' operation) or Hartmann's procedure.\n* Failure to open the peritoneal reflection during surgery.\n* History of previous pelvic floor surgery.\n* Emergency surgery due to bowel obstruction.\n* Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or other severe comorbidities that render the patient unable to tolerate the procedure.\n* History of severe psychiatric disorders.\n* Pregnant or lactating women.\n* Any other clinical or laboratory conditions considered unsuitable for participation in the trial by the investigators.","75 Years",{"count":96,"type":22},1598,[25],"Brief Summaries Trial Purpose The primary objective of this prospective, randomized, multicenter, open-label, parallel-controlled clinical trial is to evaluate whether intraoperative rectal irrigation during laparoscopic radical resection of low-to-mid rectal cancer reduces postoperative local recurrence rates compared to no irrigation. Secondary objectives include assessing overall survival, incidence of postoperative complications (e.g., anastomotic leakage, stenosis), and quality of life at 6 months (EORTC QLQ-C30 scale).\n\nParticipants Will:\n\n* Undergo laparoscopic radical resection with or without rectal irrigation (based on randomization);\n* Follow standardized Enhanced Recovery After Surgery (ERAS) protocols postoperatively;\n* Attend scheduled follow-ups at 3, 6, 12, 24, 36, and 60 months post-surgery, including clinical evaluations, imaging (CT\u002FMRI), laboratory tests (CEA), and questionnaire assessments;\n* Maintain a symptom diary and record rescue inhaler usage (if applicable).",[100,29],"Middle and Low Rectal Cancer",[34,102],"rectal Lavage","2026-03-30",{"date":105,"type":43},"2026-04-06",{"date":107,"type":43},"2025-06-01",{"date":109,"type":22},"2028-05-31",{"name":111,"class":50},"Sun Yat-sen University",1,{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":94,"enrollmentInfo":120,"targetDuration":4,"studyType":23,"phases":122,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":140},"100625936","coloseal-icd-system-anastomotic-protection-pivotal-study-100625936","NCT07429110","ColoSeal™ ICD System Anastomotic Protection Pivotal Study","Inclusion Criteria:\n\n1. Subject is 22-75 years of age at screening and is diagnosed with rectal cancer.\n2. Subject is determined to be 'robust' as assessed via the Clinical Frailty Scale (CFS; score 1-3), the Mini-Cog (score ≥3) and either the Short Physical Performance Battery (SPPB; score ≥10) or Timed Up and Go (TUG; score \\\u003C12 seconds). This inclusion applies to subjects aged 71-75 only.\n3. Subject is scheduled for elective sphincter sparing resection, either open, laparoscopic or robotic with mesorectal excision (either abdominal or transanal approach).\n4. Subject requires the creation of a stapled anastomosis maximally 10 cm from the anal verge, and minimally with sufficient distance from the anal verge to accommodate use of an anastomotic stapler.\n5. Subject has been informed of the study's nature, agrees to its provisions, and has provided written informed consent, which has been approved by the appropriate Ethics Committee (EC) or Institutional Review Board (IRB).\n6. Subject must have a designated (lay or professional) caregiver available in the in-home setting while the ICD System is in use.\n7. Subject should live within ≤ 75 miles (120 km) of their study investigator's facility. If outside of this range, subjects must be willing to stay in accommodations ≤ 75 miles (120 km) of the investigator's facility for 1-day post-study device removal.\n8. Subject must be willing and able to comply with protocol requirements, including study follow-up visits.\n\nExclusion Criteria:\n\nPreoperative:\n\n1. Subject at the time of baseline screening is not planned to have ostomy reversal prior to 6 months post-index procedure.\n2. Subject with a life expectancy \\\u003C 1 year due to condition other than rectal cancer.\n3. Subject with American Society of Anesthesiologists (ASA) classification \\> 3.\n4. Subject has a systemic infection at the time of surgery or requiring systemic antimicrobial therapy up to 1 week before surgery.\n5. Subject had major surgical or interventional procedure within 30 days before the index procedure or planned major surgical or interventional procedure within 30 days after the index procedure.\n6. Subject has received systemic chemotherapy or radiation to the pelvis within 30 days before the planned procedure.\n7. Subject has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis, diffuse descending colon diverticulosis (i.e., diverticula at potential planned fixation site), diverticulitis, or inflammatory bowel disease in the descending colon.\n8. Subject has an anatomic abnormality (e.g., polyp, diverticula, vascular malformation) or bowel damage at or within 5 cm of the target device anchor site that could interfere with safe device function.\n9. Subject has a diagnosis of coagulopathy (INR≥1.5), thrombocytopenia (platelet count \\\u003C150,000\u002FμL), or immune suppression (CD4+ T-cell count \\\u003C500 cells\u002Fmm³).\n10. Subject has a condition resulting in significant cognitive impairment and\u002For functional decline, such as dementia or advanced Parkinsons disease.\n11. Subject has a BMI ≥ 40.\n12. Subject is scheduled for a concurrent major surgical procedure during the index procedure (e.g., liver resection).\n13. Subject has been taking regular systemic steroid medication in the last 6 months prior to the index procedure.\n14. Subject is taking anticoagulants, antimetabolites or antiplatelet agents (Note: low-dose aspirin therapy is permitted) within 7 days of the index procedure.\n15. Subject has undergone a prior pelvic anastomosis.\n16. Subject has fecal incontinence, involvement of the sphincter by neoplastic disease, or evidence of extensive local disease in the pelvis seen on pre-operative imaging.\n17. Subject is diabetic with hemoglobin A1c \\> 8.0% (64 mmol\u002Fmol).\n18. Serum albumin of \\\u003C 3.0 g\u002FdL.\n19. Serum prealbumin of \\\u003C15mg\u002FdL.\n20. Subject has a known allergy to any component of the device.\n21. Subject has a known allergy to iodine or iodine-based contrast unless the subject can be adequately premedicated before the leak test.\n22. Subject has unresolved alcohol or drug abuse, in the investigator's opinion.\n23. Subject is pregnant or planning to become pregnant (female subjects of childbearing potential must have a negative urinary pregnancy test ≤ 7 days before the surgical procedure).\n24. Subject is unable or unwilling to provide informed consent.\n25. Subject is currently participating in an investigational drug or another device study that clinically interferes with the current study endpoints.\n\n    Intraoperative:\n26. Subject is not planned to receive an ostomy placement at the time of the index procedure.\n27. Subject's left colon (bowel) preparation on the day of surgery is deemed inadequate for ICD Device placement, as determined by the investigator.\n28. Subject requires an end-to-end or side-to-end anastomosis smaller than 31 mm in diameter or greater than 10cm from the anal verge.\n29. Subject failed intraoperative leak test.\n30. Subject has any condition or abnormality which, in the opinion of the investigator, may jeopardize subject safety or the quality of the study data.","22 Years",{"count":121,"type":22},250,[25],"The purpose of this clinical investigation is to evaluate the safety of the ColoSeal ICD System by evaluating its effectiveness in reducing the stoma creation rate and by comparing the rate of major complications to current standard of care for rectal cancer surgery with a diverting ostomy.",[29],[67,126,127,128],"Diverting Ostomy","Stoma","Anastomosis","NOT_YET_RECRUITING","2026-02-18",{"date":132,"type":43},"2026-02-24",{"date":134,"type":22},"2026-04",{"date":136,"type":22},"2028-02",{"name":138,"class":139},"Averto Medical, Inc.","INDUSTRY",2,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":151,"phases":4,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":165,"locationsCount":112},"100620486","postoperative-outcomes-of-single-stapled-anastomosis-combined-with-transanal-natural-orifice-specimen-extraction-100620486","NCT07358247","Postoperative Outcomes of Single-stapled Anastomosis Combined With Transanal Natural Orifice Specimen Extraction","Postoperative Outcomes of Transanal Transection and Single-stapled Technique Combined With Transanal Natural Orifice Specimen Extraction: a Single-center Retrospective Cohort Study","NOSE","Inclusion Criteria:\n\n* Adult patients aged more than 18 years old at the time of surgery\n* Patients with a histological diagnosis of rectal adenocarcinoma\n* Patients who underwent surgery between January 2017 and January 2023\n* Patients with a low rectal tumor meeting the Low Rectal Cancer Development Programme (LOREC) criteria\n\nExclusion Criteria:\n\n* Patients who underwent non-restorative procedures (including abdominoperineal resection or Hartmann's procedures).\n* Patients who underwent immediate or delayed coloanal anastomosis.\n* Patients who underwent open surgery.\n* Patients who underwent unplanned conversion from minimally invasive to open approach.\n* Patients with a concomitant diagnosis of Inflammatory Bowel Disease (IBD).",{"count":150,"type":22},190,"OBSERVATIONAL","Natural Orifice Specimen Extraction (NOSE) eliminates the need for additional abdominal incisions in minimally invasive colorectal procedures, potentially reducing the risk of wound complications and postoperative pain. In the context of restorative Total Mesorectal Excision (TME), single-stapling (SS) techniques facilitate NOSE through transanal rectal transection, as opposed to the conventional double-stapling technique. This study aims to explore the potential advantages of NOSE combined with SS anastomosis compared to conventional abdominal extraction in minimally invasive restorative TME.",[154,29],"Rectal Cancer Patients",[156,157,73,158],"Single-stapled anastomosis","Natural orifice specimen extraction","Wound complications","2026-01-13",{"date":161,"type":43},"2026-01-22",{"date":163,"type":22},"2026-01-31",{"date":76,"type":22},{"name":166,"class":50},"Istituto Clinico Humanitas",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":4,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":174,"minAge":4,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":177,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":4},"100607532","comparison-of-different-surgical-approaches-in-female-rectal-cancer-100607532","NCT07189780","Comparison of Different Surgical Approaches in Female Rectal Cancer.","Impact of Two Different Anterior Rectal Wall Mobilization Techniques on Postoperative Outcomes in Female Patients With Mid-low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n1. Pathologically confirmed rectal adenocarcinoma.\n2. Female patients scheduled to undergo laparoscopic total mesorectal excision (TME).\n3. Body mass index (BMI) ≤ 30 kg\u002Fm².\n4. Tumors with the distal margin located ≤ 10 cm from the anal verge.\n5. Absence of distant metastases (e.g., to the liver, lungs, or other organs).\n\nExclusion Criteria:\n\n1. Presence of severe pre-existing comorbidities (e.g., significant hepatic, renal, cardiac, pulmonary, or coagulation dysfunction).\n2. History of malignancy in other organs.\n3. Patients requiring emergency surgery due to conditions such as acute perforation or obstruction.\n4. Intraoperative findings of tumor invasion into adjacent organs necessitating multivisceral resection or palliative resection.\n5. Previous history of anorectal or rectal surgery. 6Preoperative magnetic resonance imaging (MRI) indicating invasion of the anterior rectal wall.","FEMALE",{"count":176,"type":22},200,[25],"Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects.\n\nIn our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion.\n\nSince our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.",[29],"2025-09-17",{"date":182,"type":43},"2025-09-24",{"date":184,"type":22},"2025-10-01",{"date":186,"type":22},"2030-08-01",{"name":188,"class":50},"First Affiliated Hospital of Wenzhou Medical University",{"id":190,"slug":191,"hasResults":11,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":195,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":23,"phases":199,"briefSummary":200,"conditions":201,"keywords":203,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":112},"100595680","walking-and-sitting-difficulties-after-rectal-cancer-surgery-100595680","NCT07035600","Walking and Sitting Difficulties After Rectal Cancer Surgery","WASA - Walking and Sitting Difficulties After APE","WASA","Inclusion Criteria:\n\n* Patients with rectal cancer to be treated with\u002Fwithout neoadjuvant (chemo)radiation and abdominoperineal excision with or without mesh (APE\u002FELAPE) Informed consent Able to read and understand Swedish or Danish\n\nExclusion Criteria:\n\n* Patients with rectal cancer to be operated by extended abdominoperineal excision (ELAPE) requiring musculocutaneous or muscular flaps to be operated by Hartmann's procedure to be operated by anterior resection (low or high) participation in other randomized trials in conflict with the protocol and endpoints of the WASA trial Not understanding Swedish or Danish Patients reporting habit of physical activity exceeding the WHO-recommendations (150 min + two strength sessions) at baseline.",{"count":198,"type":22},300,[25],"Earlier studies have shown that many patients (up to 30%) who have had a major surgery for rectal cancer, called a rectum amputation (where the entire rectum and anus are removed and the person gets a permanent stoma), still have trouble sitting and walking three years after the surgery. These problems are then seen as long-term or chronic.\n\nWASA is a randomized multicenter international study that will test a way to reduce these problems. It will start in fall 2025 and go on for 3.5 years. About 300 patients will take part.\n\nThe patients will be randomly divided into two groups. One group will get guided online training twice a week, specially made for their needs. The other group will get information about the World Health Organization's (WHO) general advice on physical activity.\n\nThe idea is that special training during the first year after surgery will reduce problems with walking and sitting. If the hypothesis can be confirmed, it could lead to an easy and low-cost way to help many rectal cancer patients feel and function better.",[154,29,202,67],"Rectal Cancer, Radiotherapy",[73,204],"Rectal cancer complications","2025-06-16",{"date":207,"type":43},"2025-06-25",{"date":209,"type":22},"2025-09-15",{"date":211,"type":22},"2031-04-01",{"name":213,"class":50},"Sahlgrenska University Hospital",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":221,"enrollmentInfo":222,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100591610","effect-of-preserving-the-left-colic-artery-on-proximal-bowel-perfusion-100591610","NCT06982664","Effect of Preserving the Left Colic Artery on Proximal Bowel Perfusion","Effect of Preserving the Left Colic Artery on Proximal Bowel and Anastomotic Blood Perfusion During Radical Resection for Rectal Cancer: A Randomized Controlled Trial Based on Laser Speckle Contrast Imaging","Inclusion Criteria:\n\n1. a confirmed diagnosis based on pathological reports;\n2. patients who had not received any prior treatment;\n\nExclusion Criteria:\n\n1. a history of previous abdominal surgery or neoadjuvant chemotherapy\u002Fradiation affecting bowel perfusion or anastomosis;\n2. patients requiring emergency surgery due to acute complications;\n3. intraoperative findings necessitating a shift to alternative procedures, such as local excision, abdominoperineal resection, Hartmann's operation, or intersphincteric resection.","80 Years",{"count":223,"type":22},143,[25],"Patients with rectal or rectosigmoid cancer undergoing radical resection will be randomly assigned to either high-tie (HT) or low-tie (LT) ligation of the Inferior Mesenteric Artery (IMA). Proximal bowel blood perfusion will be measured using Laser Speckle Contrast Imaging, and the perfusion characteristics will be compared between the two ligation groups.\n\nAdditionally, for participants randomized to the LT group, an embedded prospective cohort sub-study will be performed. This sub-study involves controlled, temporary intraoperative occlusion of the preserved Left Colic Artery (LCA). During this temporary occlusion, LSCI will be used to assess the resulting changes in colonic perfusion, specifically measuring outcomes like the ischemic demarcation line (LOD) retraction distance, to further investigate the functional contribution of the preserved LCA. The overall trial aims to determine the optimal IMA ligation strategy based on objective perfusion data and a deeper understanding of LCA's role.",[29,227,228],"Perfusion Imaging","Anastomosis, Leaking",[230,231,232,233],"rectal caner","Perfusion","Anastomosis leakage","Laser Speckle Contrast Imaging","2025-05-13",{"date":236,"type":43},"2025-05-21",{"date":107,"type":22},{"date":239,"type":22},"2026-06-30",{"name":241,"class":242},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":251,"maxAge":4,"enrollmentInfo":252,"targetDuration":4,"studyType":23,"phases":254,"briefSummary":255,"conditions":256,"keywords":258,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":112},"100577284","transanal-irrigation-for-low-anterior-resection-syndrome-100577284","NCT06796296","Transanal Irrigation for Low Anterior Resection Syndrome","The Safety and Efficacy of Transanal Irrigation in Patients from Low Anterior Resection Syndrome After Rectal Cancer Surgery : a Multicenter Prospective Randomized Controlled Trial (TraLARS Study)","TraLARS","Inclusion Criteria:\n\n* Adults aged 19 years and above.\n* Patients who have undergone low or ultra-low anterior resection surgery for rectal cancer (within 15cm from the anal verge).\n* Patients at least 24 months post-surgery without stoma.\n* Patients evaluated with a major LARS score.\n* Patients who comprehend and have the ability to participate in this clinical trial.\n\nExclusion Criteria:\n\n* Patients with recurrent colorectal cancer.\n* Patients with concomitant metastatic colorectal cancer.\n* Patients requiring permanent colostomy.\n* Patients who have undergone postoperative cancer radiation therapy.\n* Patients with underlying conditions not controlled by internal medical treatment.\n* Patients with inflammatory bowel disease (IBD).\n* Patients with symptoms of constipation or diarrhea not controlled by medication.\n* Patients with preoperative symptoms of fecal incontinence.\n* Patients allergic to the investigational drug.\n* Patients deemed unsuitable for clinical trial participation by the principal investigator and study personnel.","19 Years",{"count":253,"type":22},94,[25],"The preservation surgery of the anal sphincter muscle has become the standard procedure in the treatment of rectal cancer and, thanks to advancements in surgical techniques, can now be performed for tumors located closer to the anus. This method allows patients to avoid a permanent artificial anus, maintaining continuity of the intestines and enabling bowel movements through the anus, making it a highly preferred procedure. Furthermore, advancements in various tumor treatments have led to improved long-term survival rates.\n\nPreservation surgery of the anal sphincter muscle is commonly used in the treatment of rectal cancer, resulting in approximately 90% of patients experiencing changes in bowel habits after surgery. These changes include characteristic diarrhea, urgent bowel movements, frequent bowel movements, and fecal incontinence, collectively known as Anterior Resection Syndrome (ARS). Particularly in the case of low rectal cancer, it often manifests as Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, generally persisting in a significant degree for 1-2 years, with some improvement over time. However, for many patients, LARS remains a lifelong challenge, significantly impacting their quality of life. Nighttime symptoms of LARS, in particular, have a profound effect on sleep quality, potentially leading to a decline in overall quality of life.\n\nCurrently, there is no definitive method to completely cure LARS, and the available approaches focus on empirical treatments or short-term symptom control using medications such as loperamide.\n\nLoperamide directly affects the neuromuscular system of the intestine, reducing its motility. This prolongs the time food stays in the intestine, allowing sufficient absorption of moisture and electrolytes, consequently reducing symptoms of diarrhea. Loperamide is available in two forms: loperamide oxide and loperamide hydrochloride. While loperamide oxide products like Arestal® were prescribed by doctors until August 2017, the approval was revoked, leaving loperamide hydrochloride as the only form used domestically. It comes in a single product containing 2 mg of loperamide hydrochloride and a combination product with 0.25 mg of loperamide hydrochloride, a sterilizing agent in the intestine (e.g., acrylonitrile, berberine), and an antispasmodic.\n\nTransanal irrigation (TAI) is a method where patients self-administer water into the rectum through an enema, physically cleansing the anus and rectum. This technique is often used for patients with chronic constipation or fecal incontinence. TAI has proven beneficial, particularly in improving symptoms for patients experiencing bowel dysfunction following sphincter-preserving surgery, especially for those who underwent low anterior resection.\n\nHowever, there is currently no research on the utility and safety of TAI for LARS patients, specifically addressing whether it can improve the nighttime symptoms associated with LARS syndrome and enhance sleep quality. Therefore, this study aims to investigate the impact of TAI on the symptoms of LARS syndrome.",[71,29,257],"Insomnia",[259,260],"Transanal irrigation","Low anterior resection syndrome","2025-01-21",{"date":263,"type":43},"2025-01-28",{"date":265,"type":22},"2025-02-01",{"date":267,"type":22},"2029-12-31",{"name":269,"class":50},"Seoul National University Hospital"]