[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"anastomotic-complication\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:anastomotic-complication":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":38,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100619934","post-market-study-of-the-signia-circular-stapler-with-tri-staple-technology-in-left-sided-colon-sigmoid-and-rectal-resections-100619934",false,"NCT07351071","Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections","A Prospective, Multicenter, Single-arm, Post Market Study to Evaluate the Safety and Performance of the Signia™ Circular Stapler With Tri-Staple™ Technology in Elective Open or Minimally Invasive Left-sided Colon, Sigmoid, and Rectal Resections (SECURE)","SECURE","Preoperative Inclusion Criteria:\n\n1. Subject is competent and willing to provide documented informed consent to participate in this clinical study\n2. Subject is intended to undergo an elective left sided colon\u002Fcolorectal procedure where a creation of an anastomosis will be completed with the Signia™ circular stapler\n3. Subject is ≥ 18 years of age at time of consent\n\nPreoperative Exclusion Criteria:\n\n1. Subject is unable or unwilling to comply with the study requirements or follow-up schedule\n2. Subject with ASA classification ≥ IV\n3. Subject is pregnant (as determined by standard site practices)\n4. The procedure is an emergency procedure\n5. The procedure is a revision\u002Freoperation for the same indication\n6. The subject has a documented confounding medical condition which in the opinion of the investigator, will not be appropriate for the study, or the subject has an estimated life expectancy of less than 6 months\n7. Subject has participated or plans to participate in an investigational drug or device research study that would interfere with the results of this study\n8. Subject will undergo multiple synchronous colon resections\n9. Subject with a bleeding disorder or is undergoing anticoagulant treatment that has not been reversed (anticoagulant prophylaxis prescribed as part of the surgical protocol is allowed)\n10. Subject has undergone chemotherapy or received biologics within 6 weeks prior to the day of the procedure\n11. Subject has history of chronic corticosteroid use (used greater than 3 months within a year prior to the index procedure)\n12. Subject has chronic immunosuppression therapy (used greater than 3 months within a year prior to the index procedure)\n13. Any subject undergoing an ileal-anal pouch anastomosis surgery\n\nIntraoperative Exclusion Criteria\n\n1. Anastomosis not attempted with the Signia™ circular stapler\n2. Any subject for which the device is intended to be used outside the instructions for use (IFU)","ALL","18 Years",{"count":20,"type":21},137,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.",[27,28,29,30,31,32,33,34,35,36,37],"Colorectal Anastomosis","Left-sided Colon Resection","Anastomotic Leak","Anastomotic Complication","Digestive System Diseases","Gastrointestinal Diseases","Colonic Diseases","Intestinal Diseases","Rectal Diseases","Postoperative Complications","Anastomotic Leaks",[27,28,39,29,40,41,42],"Circular stapler","Rectal cancer","Low anterior resection","Powered stapler","RECRUITING","2026-06-11",{"date":46,"type":47},"2026-06-12","ACTUAL",{"date":49,"type":47},"2025-12-30",{"date":51,"type":21},"2027-02-28",{"name":53,"class":54},"Medtronic - MITG","INDUSTRY",9,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":22,"phases":66,"briefSummary":67,"conditions":68,"keywords":69,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":85},"100505358","the-effect-of-inulin-supplementation-on-colorectal-surgery-outcomes-100505358","NCT05860322","The Effect of Inulin Supplementation on Colorectal Surgery Outcomes","The Effect of Inulin Supplementation on Colonic Healing and Surgical Outcomes Following Colorectal Surgery","INULINE","Inclusion Criteria:\n\n* Patients with a colorectal cancer and who present for elective colorectal surgery\n\nExclusion Criteria:\n\n* Emergency surgery for perforation\u002Fobstruction.\n* Use of antibiotics within 4 weeks prior to surgery (other than usual antibiotic prophylaxis).\n* Presence of preoperative ileostomy or colostomy.\n* Intestinal surgery within 4 weeks prior to colonic surgery.\n* Active asthma.\n* Presence of familial adenomatous polyposis.",{"count":65,"type":21},40,[24],"Colorectal cancer (CRC) is the third most diagnosed cancer in Canada. The most common surgical procedure in patients with CRC is an intestinal resection followed by a reconnection to rejoin the ends of the remaining bowel. Among the postoperative complications, leaking of this intestinal connection is notably feared, affecting up to 20% of patients. These leaks are characterized by impaired intestinal healing and are associated with severe infections and even death.\n\nVarious studies have shown that gut microbiota, the bacteria that live in the digestive tract, plays an essential role in intestinal healing following surgery. These results support the possibility of enhancing intestinal healing through supplements that act as an energy source for gut bacteria. Indeed, animal studies have shown that inulin supplementation, a fiber commonly found in plants, improves intestinal healing following bowel surgery. However, no studies in humans have evaluated its effects on CRC surgery patients.\n\nThis study aims to determine feasibility of a randomized controlled trial that assesses the effects of inulin supplementation before elective colorectal surgery.",[30],[70,71,72,73],"colorectal cancer","inuline","anastomotic leak","anastomotic healing","NOT_YET_RECRUITING","2023-05-05",{"date":77,"type":47},"2023-05-16",{"date":79,"type":21},"2023-08-01",{"date":81,"type":21},"2028-08-01",{"name":83,"class":84},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",1]