[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"minimal-invasive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:minimal-invasive":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":23,"briefSummary":25,"conditions":26,"keywords":34,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100643351","vacstent-use-for-the-treatment-of-anastomotic-leakage-following-colorectal-surgery-100643351",false,"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)","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32,33],"Colorectal Surgery","Anastomotic Leak Rectum","Endoscopy, Digestive System","Vacuum Therapy","Stents","Anastomotic Leakage","Minimal Invasive",[35,36,37,38],"Postoperative Complications","Anastomotic Leak","Vacuum stent","Endoscopic vacuum therapy","NOT_YET_RECRUITING","2026-06-03",{"date":42,"type":43},"2026-06-08","ACTUAL",{"date":45,"type":21},"2026-07-01",{"date":47,"type":21},"2028-10-01",{"name":49,"class":50},"Amsterdam UMC, location VUmc","OTHER"]