[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anastomotic-leak-rectum\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anastomotic-leak-rectum":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,84,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100628925","endoscopic-colorectal-mucosal-evaluation-of-oxygen-tension-100628925",false,"NCT07467980","Endoscopic COlorectal Mucosal Evaluation of Oxygen Tension","Anastomotic Site Mucosal Oxygen Tension and Its Association With Anastomotic Complications","e-COMET","Inclusion Criteria:\n\n* Adult patients (≥18 years).\n* Undergoing a colo-rectal anastomosis.\n* Patients who consent to study participation\n\nExclusion Criteria:\n\n* Patients undergoing a revision surgery.\n* Participants with missing data.\n* Patients who do not undergo intraoperative ICG-FA and StO2 endoscopic imaging promptly after the formation of a viable anastomosis.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","OBSERVATIONAL","Anastomosis refers to the surgical connection between two segments of the bowel, typically performed during colon and rectal surgeries to restore the continuity of the digestive tract after a section has been removed. It is necessary that the ends of the tissue at the anastomotic site are healthy (and capable of healing properly) as this will prevent dreaded complications like anastomotic leaks or strictures which can occur in almost a fifth of patients leading to increased hospital length of stay, costs, and mortality.\n\nCurrently, the most widely used method for assessing tissue viability during anastomosis is indocyanine green fluorescence angiography (ICG-FA). This technique involves injecting a fluorescent dye (indocyanine green) into the bloodstream, which highlights blood flow and tissue perfusion under a special camera. However, ICG-FA has limitations due to allergies and reliability due to the dye's rapid disappearance from the bloodstream. Additionally, the dye cannot be administered repeatedly. This study explores a new method of measuring tissue oxygenation by evaluating mucosal oxygen saturation (StO2) as an alternative to ICG-FA. By evaluating StO2 levels, the research aims to provide a more reliable and repeatable way to assess tissue viability without the drawbacks of using fluorescent dyes. Secondly, any blood supply interruption to the bowel will first lead to mucosal ischemia, which can potentially be reliably captured by measuring mucosal StO2 levels only.\n\nIn this single-center prospective single-arm study, we will evaluate whether mucosal StO2 levels are associated with or can predict anastomotic complications. This study will not involve any intervention that would affect the standard of care.",[25,26],"Anastomotic Leak Rectum","Anastomotic Leak Large Intestine",[28,29,30,31,32,33,34,35],"anastomotic leak","colorectal","endoscopic","oxygen tension","oxygen saturation","mucosal","colon","rectum","RECRUITING","2026-06-08",{"date":39,"type":40},"2026-06-11","ACTUAL",{"date":42,"type":40},"2026-03-16",{"date":44,"type":21},"2028-04",{"name":46,"class":47},"Vanderbilt University Medical Center","OTHER",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":70,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":48},"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":58,"type":21},40,"INTERVENTIONAL",[61],"NA","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.",[64,25,65,66,67,68,69],"Colorectal Surgery","Endoscopy, Digestive System","Vacuum Therapy","Stents","Anastomotic Leakage","Minimal Invasive",[71,72,73,74],"Postoperative Complications","Anastomotic Leak","Vacuum stent","Endoscopic vacuum therapy","NOT_YET_RECRUITING","2026-06-03",{"date":37,"type":40},{"date":79,"type":21},"2026-07-01",{"date":81,"type":21},"2028-10-01",{"name":83,"class":47},"Amsterdam UMC, location VUmc",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":59,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":48},"100583820","impact-of-prior-identification-and-education-of-patients-requiring-a-digestive-stoma-for-fecal-diversion-100583820","NCT06881303","Impact of Prior Identification and Education of Patients Requiring a Digestive Stoma for Fecal Diversion","RESTODIG","Inclusion Criteria:\n\n* Men or women aged 18 and over\n* for whom a fecal diversion stoma is planned on a scheduled or emergency basis\n* affiliated with the French social security system\n\nExclusion Criteria:\n\n* Patient in a period of exclusion from another research protocol at the time of signing the no-objection form,\n* Subjects covered by articles L1121-5 to 1121-8 of the French Public Health Code (minors, adults under guardianship or trusteeship, patients deprived of their liberty, pregnant or breast-feeding women),\n* No digestive stoma or fecal diversion planned\n* Person who does not understand French",{"count":92,"type":21},100,[61],"There are many indications for performing a fecal diversion stoma. In both scheduled and emergency situations, and whatever the context (indication or type of fecal diversion stoma), stomal complications can occur early (10-60%) or late (25%), and may require repeat surgery. The most frequent complications are necrosis, retraction, bleeding, evisceration, occlusion, abscess, hyperflow with hydroelectrolytic consequences, skin lesions, prolapse or eventration. What's more, a temporary stoma can become permanent.\n\nThe positioning and fabrication of the digestive stoma for fecal diversion must therefore comply with well-defined criteria to reduce the risk of stomal complications and the difficulties of fitting the stoma, and thus improve the autonomy and therefore the quality of life of the ostomate patient. The guide to good stoma therapy practice recommends that the site of the future stoma should be marked out preoperatively. What's more, the psychological impact of a stoma is such that preoperative and regular postoperative education is essential. This identification and initiation of education is carried out by stoma nurses and\u002For surgeons.\n\nThe impact of preoperative stoma identification and education on stoma complications, quality of life and patient autonomy has been reported in a few comparative series. The impact of preoperative education on quality of life has also been reported.\n\nHowever, despite this \"Evidence Based Medicine\", and the guide to good stoma therapy practice, the identification and education of the future fecal diversion stoma are not always carried out preoperatively. Reasons for this may include lack of time, lack of human resources, in the general context of a shrinking public hospital, or in the current context of distancing and dehumanization of the profession, or lack of conviction on the part of practitioners.\n\nTo this end, the investigators would like to propose a prospective observational study aimed at evaluating the impact of identification and education prior to the performance of a fecal diversion stoma in a programmed situation on the one hand, and an emergency situation on the other.\n\nThe main objective will be to compare quality of life specifically related to the stoma at 30 days postoperatively with the StomaQOL score, between 2 groups of patients:\n\n* unexposed group: no preoperative stoma identification and education\n* exposed group: preoperative stoma identification and education. This comparison will be stratified according to whether surgery is scheduled or emergency surgery.\n\nTotal 100 patients :\n\n* In scheduled surgery: 30 exposed and 30 unexposed patients\n* In emergency surgery: 10 exposed and 30 unexposed patients\n\nTimeline:\n\nInclusion period: 12 months Follow-up period: 12 months Total duration: 24 months",[96,97,25,98,99,100,101,102],"Colorectal Anastomosis","Endometrial","Ulcerative Colitis (Disorder)","Adenomatous Polyposis Coli, Familial","Crohn Disease","Digestive Cancers","Protectomy","2025-11-17",{"date":105,"type":40},"2025-11-18",{"date":107,"type":21},"2026-03-01",{"date":109,"type":21},"2028-03-01",{"name":111,"class":47},"Assistance Publique Hopitaux De Marseille",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},"100554013","routine-endoscopic-evaluation-of-colorectal-anastomoses-for-early-detection-of-anastomotic-leakage-100554013","NCT06493565","Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage","Routine Endoscopic Evaluation of Colorectal Anastomoses for Early Detection of Anastomotic Leakage (REAL-study)","REAL","Inclusion Criteria:\n\n1. ≥ 18 years of age\n2. The participant underwent an open or minimally invasive, sphincter preserving surgery with the construction of a colorectal or coloanal anastomosis ≤15 centimetres from the anorectal junction.\n3. Adequate comprehension of the country specific or English language\n4. Written informed consent\n\nExclusion Criteria:\n\n1\\. Inability to adopt the required positioning for anorectal endoscopic examination (i.e. left lateral position)",{"count":121,"type":21},150,"The objective of this international prospective observational study is to evaluate the implementation of a point-of-care digital rectoscope (LumenEye) into routine care to detect colorectal anastomotic leakage in the early postoperative period.\n\nThe study includes patients undergoing a colorectal resection with colorectal or coloanal anastomosis ≤15 centimeters from the anorectal junction. The participating centers consist of expert colorectal units in various countries.\n\nThe primary endpoint for the study is the time to diagnosis of anastomotic leakage.",[25],[125,126,127,128,129],"Anastomotic leakage","Colorectal cancer","Rectoscopy","Endoscopy","Point-of-care","2024-07-01",{"date":132,"type":40},"2024-07-10",{"date":134,"type":40},"2024-05-01",{"date":136,"type":21},"2026-05",{"name":83,"class":47},5]