[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ileostomy---stoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ileostomy---stoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,71,100,122,144,177,201,233,263,293],{"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":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100527002","digestibility-of-different-plant-based-proteins-in-humans-with-ileostomy-100527002",false,"NCT06142084","Digestibility of Different Plant-based Proteins in Humans With Ileostomy","True Ileal Digestibility of Different Plant-based Proteins in a Human Ileostomy Model","PAN-Prodig","Inclusion Criteria:\n\n* Age: 18 - 75 years\n* Body mass index: 18.5 - 30 kg\u002Fm2\n* (double-loop) Ileostomy with an intact small bowel\n* Signed informed consent\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Ileostomy \\\u003C 3 months before the study\n* Any clinically significant present or past disease\u002Fcondition other than colon cancer which in the investigator's opinion could interfere with the results of the trial\n* Any clinically significant present or past medication which in the investigator's opinion could interfere with the results of the trial","ALL","18 Years","75 Years",{"count":5,"type":21},"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this interventional study is to learn about the digestibility of different plant-based proteins in adults (age 18-75) with an ileostomy.\n\nThe main questions the study aims to answer are:\n\n1. How does the digestibility of proteins in the small intestine differ between different plant-based proteins?\n2. Which proteins and amino acids are not digested or absorbed in the small intestine and are available for further metabolic processes in the large intestine?\n3. How do metabolites in the collected content of the ileostomy bag differ after consuming different plant-based proteins?\n4. Can the in vivo results be compared to results from existing in vitro models?\n\nParticipants will consume five different protein meals (oat protein - high bioavailable, oat protein - low bioavailable, pea protein - high bioavailable, pea protein low bioavailable, protein-free meal) on five different study days in a random order. Five hours after consuming the test meals ileostomy bags will be collected and the content will be analysed to answer the above mentioned research questions.",[27],"Ileostomy - Stoma",[29,30,31],"Protein","Plant-based","Digestibility","RECRUITING","2026-06-22",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":21},"2026-09",{"date":40,"type":21},"2028-12",{"name":42,"class":43},"Örebro University, Sweden","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":54,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":4},"100637362","cp384---ostomy-care-oc-pro-panel-plan-100637362","NCT07589907","CP384 - Ostomy Care (OC) PRO Panel Plan","384 PRO Panel","Inclusion Criteria:\n\n* 18 years of age or above\n* full legal capacity\n* willing and able to complete online questionnaires\n* have either an ileostomy, a colostomy, or a urostomy\n\nExclusion Criteria:\n\n* Cannot have a scheduled stoma reversal surgery\n* Cannot have more than one stoma",{"count":53,"type":21},1000,"5 Years","OBSERVATIONAL","The aim is to create an electronic patient reported outcome (e-PRO) based registry, specifically for subjects living with a stoma (ileostomy, colostomy or urostomy).",[58,27,59],"Ostomy","Urostomy","NOT_YET_RECRUITING","2026-05-11",{"date":63,"type":36},"2026-05-15",{"date":65,"type":21},"2026-06-01",{"date":67,"type":21},"2032-10-31",{"name":69,"class":70},"Coloplast A\u002FS","INDUSTRY",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100628661","effects-of-stoma-education-on-patients-100628661","NCT07464548","Effects of Stoma Education on Patients","Determining the Effects of Stoma Education on Patients' Self-Efficacy, Body Image, and Stoma Adherence","Stoma","Inclusion Criteria:\n\n* Adults who have undergone colostomy or ileostomy surgery.\n* Willingness to participate voluntarily in the study.\n* Elective surgery patients.\n* No diagnosed psychological disorders.\n\nExclusion Criteria:\n\n* Emergency surgery cases.\n* Patients with cognitive impairment or psychiatric disorders preventing participation.\n* Patients unwilling to participate or unable to comply with study follow-ups.","90 Years",{"count":81,"type":21},100,[24],"tomas are classified according to the anatomical region in which they are created and the surgical technique used. Stomas that open into the large intestine are called colostomies, those that open into the small intestine are called ileostomies, and the creation of an anastomosis of the ureters to the abdominal wall is called a urostomy. Stomas are commonly used in the treatment of gastrointestinal diseases. Ileostomy and colostomy are the most frequently encountered types of stomas. While colorectal cancer is the primary reason for intestinal stoma creation, inflammatory bowel diseases, penetrating abdominal injuries, congenital anomalies, obstructions due to diverticular disease, ischemic colitis, radiation injury, sigmoid colon volvulus, and fecal incontinence are also among the indications for stoma creation. Despite advances in surgical techniques, complications are commonly seen in individuals with stomas. Incorrect stoma placement, the use of inappropriate bags and adapter systems, and a lack of knowledge and skills among patients and caregivers play a significant role in the development of complications. Depending on these conditions, patients may encounter problems such as edema, bleeding, ischemia, and mucocutaneous dehiscence in the early postoperative period. These complications negatively affect not only physical health but also the individual's social life, psychological state, and overall quality of life. Symptoms such as peristomal skin problems, uncontrolled gas release, fecal incontinence, and pain can hinder participants' adaptation to daily life and lead to social isolation. Nursing care and patient education are of great importance in managing these problems faced by individuals with stomas. The nursing process requires a comprehensive approach extending from the pre-operative period to the post-discharge phase. In this process, individualized education programs addressing fundamental issues such as nutrition, elimination, sexuality, social participation, and privacy should be implemented to improve quality of life, develop self-care skills, and prevent complications. In this context, the investigators have planned this study to determine the effects of the education provided to patients on stoma adaptation, body image, and self-efficacy.",[85,27,86,87,88,89],"Colostomy - Stoma","Patient Education","Body Image","Self Efficacy","Adjustment","2026-04-15",{"date":92,"type":36},"2026-04-17",{"date":94,"type":36},"2026-03-10",{"date":96,"type":21},"2026-08-10",{"name":98,"class":43},"Ataturk University",2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":4},"100624760","a-single-centre-open-prospective-pilot-clinical-study-to-assess-the-safety-and-performance-of-the-ties-transcutaneous-implant-system-in-patients-requiring-a-permanent-ileostomy-or-colostomy-100624760","NCT07413822","A Single-centre Open, Prospective, Pilot Clinical Study to Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy","To Assess the Safety and Performance of the TIES® Transcutaneous Implant System in Patients Requiring a Permanent Ileostomy or Colostomy","TIES IV","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Patients requiring a permanent ileostomy or colostomy\n* Planned for stoma revision surgery with implantation of the TIES® system\n* Ability to understand the study procedures and comply with follow-up visits\n* Willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Age below 18 years or above 75 years\n* Temporary stoma or planned stoma reversal\n* Active abdominal or peristomal infection at the time of surgery\n* Severe uncontrolled systemic illness that may increase surgical risk\n* Known allergy or hypersensitivity to device materials\n* Pregnancy or lactation\n* Participation in another interventional clinical study within the last 30 days\n* Any condition which, in the opinion of the investigator, makes the patient unsuitable for the study",{"count":109,"type":21},10,[24],"This is a single-centre, prospective, open-label pilot clinical study designed to evaluate the safety and performance of the TIES® (Transcutaneous Implant Evacuation System) in adult patients requiring a permanent ileostomy or colostomy. Eligible patients will undergo surgical implantation of the TIES® Port as part of stoma revision. Participants will be followed for 16 weeks post-implantation to assess device safety, tissue ingrowth and healing, performance, durability, and impact on quality of life. Safety will be evaluated through monitoring of adverse events, while performance and usability will be assessed using structured questionnaires and clinical assessments. Quality of life will be measured using the validated Stoma-QoL questionnaire. The study aims to generate clinical evidence on the feasibility and safety of the TIES® system as an alternative to conventional stoma management.",[27,85],"2026-02-13",{"date":115,"type":36},"2026-02-17",{"date":117,"type":21},"2026-03-01",{"date":119,"type":21},"2028-05-30",{"name":121,"class":43},"Asian Institute of Gastroenterology, India",{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":129,"enrollmentInfo":130,"targetDuration":4,"studyType":22,"phases":132,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":44},"100572793","the-effect-of-preoperative-stoma-simulation-on-anxiety-and-postoperative-adaptation-100572793","NCT06737887","The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation","The Effect of Preoperative Stoma Simulation on Anxiety and Postoperative Adaptation: A Randomised Controlled Trial","Inclusion Criteria:\n\n* All patients who are planned for elective stoma surgery,\n* Are between the ages of 18-65,\n* Can speak Turkish,\n* Can read and write,\n* Are conscious,\n* Are willing to participate in the study will be included.\n\nExclusion Criteria:\n\n* Patients with speech or hearing impairments,\n* Those who have had urostomy surgery,\n* Those who have a psychological diagnosis or are taking medication,\n* Those who need intensive care after surgery,\n* Those whose stoma was closed during the study,\n* Those who have complications in the peristomal area,\n* Patients who have had stoma surgery before will be excluded from the study.","65 Years",{"count":131,"type":21},58,[24],"The majority of patients (60-70%) develop high levels of anxiety before surgery. Surgical patients may experience feelings of anxiety due to insufficient information and counseling before surgery and potential changes in the body caused by surgery. Fears include (but are not limited to) not waking up from anesthesia, not being able to return to previous work and family life, and adaptation concerns regarding new processes after surgery. Patients with fear of complications experience preoperative anxiety four times more than other patients. Other factors affecting preoperative anxiety were determined to be waiting for a long time before surgery, not knowing what will happen during surgery, losing control of the body, not receiving sufficient social support, being exposed to medical errors, and encountering undesirable health outcomes after surgery. The changes that will occur in the body and lifestyle after stoma surgery scare patients and cause them to feel anxiety in the pre-operative period. Despite significant developments in stoma care products and the increase in the number of nurses specialized in stoma care in recent years, the majority of patients experience problems with compliance. For this reason, the compliance of stoma patients with stoma life is increasingly the subject of clinical trials and epidemiological studies. In our country, studies conducted to determine the problems experienced by stoma individuals regarding compliance with stoma and social life are limited. Nursing interventions are recommended to reduce patients' anxiety and increase their compliance with stoma after surgery. This study aims to evaluate the effect of stoma simulation performed preoperative surgery on the patient's anxiety level and postoperative stoma compliance.",[85,27],"2026-02-10",{"date":137,"type":36},"2026-02-11",{"date":139,"type":21},"2027-01-02",{"date":141,"type":21},"2028-01-02",{"name":143,"class":43},"Kocaeli University",{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":152,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":44},"100618972","magnesium-in-gastrointestinal-disease-100618972","NCT07338565","Magnesium in Gastrointestinal Disease","Magnesium Status in Patients With Gastrointestinal Disease","MAGIC","Inclusion Criteria:\n\n\\- Age 18 or older, mentally competent, and able to understand Danish.\n\nGroup 1:\n\n\\- Diagnosed with IBD (DK50X, Crohn's disease, or DK51X, ulcerative colitis), ileostomy (DZ932) or bile acid diarrhoea (DSK908B) (Se-HCAT scintigraphy showing residual activity \\\u003C10%).\n\nGroup 2:\n\n\\- Healthy individuals.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding.\n* Use of oral magnesium supplements for more than 2 weeks before inclusion.",true,{"count":154,"type":21},120,"Individuals with gastrointestinal diseases - such as Crohn's disease, ulcerative colitis, ileostomy, or bile acid diarrhoea - are at increased risk of magnesium deficiency. Magnesium is a vital mineral that supports many essential functions in the body, including muscle contraction, nerve signalling, heart rhythm, and bone health. Deficiency may contribute to fatigue, muscle cramps, abnormal heart rhythms, and reduce the quality of life.\n\nThe purpose of this study is to investigate the prevalence of magnesium deficiency in individuals with these conditions and to identify the most accurate and practical methods for assessing magnesium status in clinical care.\n\nAlthough plasma magnesium is commonly used in routine blood tests, it represents only about 1% of the body's total magnesium and may not reflect true magnesium levels within cells or tissues. Hence, this study compares several different ways of measuring magnesium, including:\n\n* Plasma magnesium\n* Magnesium levels in red and white blood cells (PBMC, RBC, and buffy coat)\n* Magnesium levels in muscle tissue (via biopsy)\n* A magnesium retention test, based on how much magnesium is excreted after an infusion\n\nThe study includes four groups:\n\n1. Patients with inflammatory bowel disease.\n2. Patients with an ileostomy.\n3. Patients with bile acid diarrhoea.\n4. Healthy individuals (control group).\n\nAll participants will provide blood and urine samples, and some may undergo optional biopsies of muscle or intestinal tissue. Participants will also complete questionnaires and undergo tests of muscle strength and body composition.\n\nThe findings are expected to enhance the understanding and detection of magnesium deficiency in patients with gastrointestinal diseases and to aid in the development of more effective tools for identifying and treating this common yet often overlooked condition.",[157,158,159,160,27,161,162,163,164,165,166,167],"Colitis Ulcerosa","Colitis Ulcerative","Crohns Disease","Morbus Crohn","Ileostoma","Ileostomies","Bile Acid Diarrhea","Bile Acid Malabsorption","Magnesium Deficiency","Magnesium Level","Magnesium","2026-01-05",{"date":170,"type":36},"2026-01-14",{"date":172,"type":36},"2025-11-03",{"date":174,"type":21},"2027-12-01",{"name":176,"class":43},"University of Aarhus",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":44},"100603577","impact-on-the-absorption-of-drugs-in-ostomy-patients-100603577","NCT07138326","Impact on the Absorption of Drugs in Ostomy Patients","Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen","STAR","Planned inclusion criteria:\n\n* Male and female patients aged ≥18 years\n* Belonging to a collective\n* Ileostomy since ≥7d\n* Colostomy since ≥7d The stoma must have been inserted at least 7d ago to ensure that a steady state concentration is achieved.\n* Taking ≥1 of the following active substances since ≥7d:\n\n  * Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine\n  * NOACs: edoxaban, rivaroxban, apixaban\n\nExclusion Criteria:\n\nInsurmountable language barrier",{"count":186,"type":21},128,"Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives.\n\nFor medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs).\n\nThe clinical trial´s results will answer the following questions:\n\n* Are therapeutic blood levels of psychotropic drugs and NOACs achieved in ostomy patients when taken orally in the usual way?\n* Are there differences between the measured levels of ileostomy and colostomy patients? Colostomy and ileostomy patients undergoing inpatient or outpatient treatment at the Klinik Ottakring are ready for inclusion. The blood samples will be obtained during medically indicated and performed blood draws within the scope of medical practice, so that no study-associated risks arise here.\n\nRecorded and evaluated:\n\n* Relevant patient data\n* Plasma levels of the drugs under investigation in ostomy patients. The therapeutic range specified in the respective approval studies serves as the reference value. The results obtained are documented, evaluated and interpreted in an appropriate manner.",[189,27,85,190,191],"Stoma Ileostomy","Absorption","Pharmakokinetic","2025-08-20",{"date":194,"type":36},"2025-08-22",{"date":196,"type":36},"2025-06-18",{"date":198,"type":21},"2026-12-31",{"name":200,"class":43},"WiGeV Klinik Ottakring",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":152,"sex":17,"minAge":209,"maxAge":210,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":214,"conditions":215,"keywords":220,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":232},"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.","19 Years","80 Years",{"count":212,"type":21},256,[24],"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)",[216,217,218,27,219],"Colorectal Surgery","Colorectal Cancer","Rectal\u002FAnal","Anastomotic Leakage",[216,217,77,221,222],"ileostomy","Anastomotic leakage","2025-06-12",{"date":225,"type":36},"2025-06-13",{"date":227,"type":36},"2023-12-04",{"date":229,"type":21},"2027-03-15",{"name":231,"class":70},"JSR Medical Co., Ltd.",3,{"id":234,"slug":235,"hasResults":11,"nctId":236,"briefTitle":237,"officialTitle":238,"acronym":239,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":241,"targetDuration":243,"studyType":55,"phases":4,"briefSummary":244,"conditions":245,"keywords":247,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":262},"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":242,"type":21},300,"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.",[27,216,246],"Dehydration",[221,248,249,250,251,252],"colorectal cancer","inflammatory bowel disease","dehydration","readmission","colorectal surgery","2025-06-08",{"date":255,"type":36},"2025-06-11",{"date":257,"type":21},"2025-06-01",{"date":259,"type":21},"2026-11-30",{"name":261,"class":43},"Multidisciplinary Italian Study group for STOmas (MISSTO)",7,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":269,"eligibilityCriteria":270,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":271,"enrollmentInfo":272,"targetDuration":4,"studyType":22,"phases":273,"briefSummary":274,"conditions":275,"keywords":278,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":292},"100487562","colectomy-reconstruction-for-ulcerative-colitis-ileorectal-anastomosis-vs-ileal-pouch-anal-anastomosis-in-ulcerative-colitis-100487562","NCT05628701","Colectomy Reconstruction for Ulcerative Colitis, Ileorectal Anastomosis vs Ileal Pouch-Anal Anastomosis in Ulcerative Colitis.","Colectomy Reconstruction for Ulcerative Colitis In Sweden and England: a Multicenter Prospective Comparison Between Ileorectal Anastomosis and Ileal Pouch-Anal Anastomosis After Colectomy in Patients With Ulcerative Colitis.","CRUISE","Inclusion criteria:\n\n* Patients with Ulcerative colitis (UC) aged between 18 and 60\n* Scheduled for or have previously undergone subtotal colectomy and ileostomy.\n* Patients should have sufficient rectal compliance and controllable inflammation in the rectal using topical Mezalasin only.\n\nExclusion criteria\n\n* Rectal inflammation of Mayo Score \\>1\n* Poor sphincter function, perianal disease\n* Uncertainty regarding UC diagnosis P\n* Previous colorectal cancer or severe dysplasia\n* Primary Sclerosing Colitis diagnosis\n* \\>2 year since subtotal colectomy","60 Years",{"count":81,"type":21},[24],"Background There are no prospective trials comparing the two main reconstructive options after colectomy for Ulcerative colitis, ileal pouch anal anastomosis and ileorectal anastomosis. An attempt on a randomized controlled trial has been made but after receiving standardized information patients insisted on choosing operation themselves.\n\nMethods Adult Ulcerative colitis patients subjected to colectomy eligible for both ileal pouch anastomosis and ileorectal anastomosis are asked to participate and after receiving standardized information the get to choose reconstructive method. Patients not declining reconstruction or not considered eligible for both methods will be followed as controls. The CRUISE study is a prospective, non-randomized, multi-center, controlled trial on satisfaction, QoL, function, and complications between ileal pouch anal anastomosis and ileorectal anastomosis.\n\nDiscussion Reconstruction after colectomy is a morbidity-associated as well as a resource-intensive activity with the sole purpose of enhancing function, Quality of Life and patient satisfaction. The aim of this study is to provide the best possible information on the risks and benefits of each reconstructive treatment.",[276,277,27],"Ulcerative Colitis","Inflammatory Bowel Diseases",[279,280,281],"Ulcerative Colitis,","Colectomy","Reconstruction","2022-11-16",{"date":284,"type":36},"2022-11-29",{"date":286,"type":36},"2017-04-04",{"date":288,"type":21},"2029-12-31",{"name":290,"class":291},"Linkoeping University","OTHER_GOV",4,{"id":294,"slug":295,"hasResults":11,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":4,"eligibilityCriteria":299,"healthyVolunteers":11,"sex":300,"minAge":18,"maxAge":79,"enrollmentInfo":301,"targetDuration":4,"studyType":22,"phases":303,"briefSummary":304,"conditions":305,"keywords":307,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":292},"100441390","early-ileostomy-closure-for-rectal-cancer-patients-in-north-america-100441390","NCT05027737","Early Ileostomy Closure for Rectal Cancer Patients in North America","Early Ileostomy Closure Following Restorative Proctectomy for Rectal Cancer Patients: A North American Multicenter Randomized-Controlled Trial (RCT)","Inclusion Criteria:\n\n* Adult (≥18 years-old) patients\n* Underwent restorative proctectomy by a laparoscopic, robotic, transanal total mesorectal excision, or open approach with creation of a diverting loop ileostomy for the treatment of rectal cancer\n* Negative anastomotic \"leak test\" via CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9.\n\nExclusion Criteria:\n\n* Peri-operative immunosuppression (within 6 weeks of surgery date);\n* Age-adjusted Charlson Comorbidity Index \\>6;\n* Other major surgery during the index operation;\n* Any major complications (Clavien Dindo Grade III or greater) following restorative proctectomy;\n* Inability to speak or comprehend English or French and inability to give informed consent.","FEMALE",{"count":302,"type":21},118,[24],"Our preliminary work demonstrates that there is buy-in from both patients and surgeons with regards to early ileostomy closure (EIC) for select rectal cancer patients undergoing restorative proctectomy (RP) and diverting loop ileostomy (DLI). The feedback from leaders in Europe further supports the need for a large scale randomized-controlled trial (RCT) on this subject in North America. Should the results of such a study be favourable, we believe it could support a change in practice that would be beneficial to patients and the health care system alike. Furthermore, our work will help identify which patients and practices are suitable for EIC.\n\nThe goal of our project is to determine whether EIC in rectal cancer patients undergoing RP with a DLI is safe, feasible and beneficial in a North American population. Specifically, our primary objective is to compare the severity of complications between patients undergoing EIC versus traditional (late) closure. Our secondary objectives include assessing the difference in quality of life (QoL), early and late bowel function, and cost of care between these two groups.",[27,306],"Rectal Cancer",[308,309,310,311,312,313],"Early ileostomy closure","Comprehensive complication index","Bowel function","Quality of life","Recovery","Cost","2022-08-22",{"date":316,"type":36},"2022-08-23",{"date":318,"type":36},"2022-02-22",{"date":320,"type":21},"2026-09-01",{"name":322,"class":43},"Jewish General Hospital"]