[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637489":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":46,"responsibleParty":80,"collaborators":84,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":99,"eligibilityCriteria":100,"healthyVolunteers":95,"sex":101,"minAge":102,"maxAge":103,"enrollmentInfo":104,"targetDuration":27,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":114,"overallStatus":49,"whyStopped":27,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"Tongji Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Somatostatin Plus Clear Liquid Diet Without Diverting Stoma","EXPERIMENTAL","Participants in this arm will undergo ultra-low anterior resection without prophylactic diverting stoma. After surgery, they will receive somatostatin plus a clear liquid diet for 7 days, along with routine postoperative care.",[13,14],"Drug: Somatostatin","Other: Clear Liquid Diet",{"label":16,"type":17,"description":18,"interventionNames":19},"Prophylactic Diverting Stoma","ACTIVE_COMPARATOR","Participants in this arm will undergo ultra-low anterior resection with prophylactic diverting stoma and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary.",[20],"Procedure: Prophylactic Diverting Stoma",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Somatostatin","Participants in the experimental arm will receive somatostatin 3 mg diluted in 50 mL of 0.9% sodium chloride by intravenous infusion pump at 4.1 mL\u002Fhour every 12 hours for 7 days after surgery, as part of the postoperative no-stoma management strategy.",[9],null,{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Clear Liquid Diet","Participants in the experimental arm will receive a clear liquid diet after recovery of bowel gas passage, as part of the 7-day postoperative no-stoma management strategy. Parenteral nutrition may be provided according to clinical needs.",[9],{"type":33,"name":16,"description":34,"armGroupLabels":35,"otherNames":27},"PROCEDURE","Participants in the control arm will undergo prophylactic diverting stoma creation during ultra-low anterior resection and will receive standard postoperative care. Somatostatin will not be routinely used unless clinically necessary.",[16],[37,42],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Antian Lu","CONTACT","+8613208585786","lat0061@163.com",{"name":43,"role":39,"phone":44,"phoneExt":27,"email":45},"Senyan Lai","+86 8366 3000 67933","laisenyan@163.com",[47,62,72],{"facility":48,"status":49,"city":50,"state":51,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Ezhou Central Hospital","RECRUITING","Ezhou","Hubei","China","CN",{"type":55,"coordinates":56},"Point",[57,58],114.88655,30.39607,{"lat":58,"lon":57},[61],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"facility":63,"status":49,"city":64,"state":51,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology","Wuhan",{"type":55,"coordinates":66},[67,68],114.26667,30.58333,{"lat":68,"lon":67},[71],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"facility":73,"status":74,"city":64,"state":51,"zip":27,"country":52,"countryCode":53,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Wuhan No. 6 Hospital","NOT_YET_RECRUITING",{"type":55,"coordinates":76},[67,68],{"lat":68,"lon":67},[79],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Lai Senyan","Principal Investigator; Associate Chief Physician, Department of Gastrointestinal Surgery",[85,86,88,91],{"name":48,"class":6},{"name":87,"class":6},"Shanxi Bethune Hospital",{"name":89,"class":90},"Taihe Hospital affiliated to Hubei University of Medicine","UNKNOWN",{"name":92,"class":6},"Sixth Hospital of Wuhan, Affiliated Hospital of Jianghan University","100637489","somatostatin-plus-clear-liquid-diet-versus-diverting-stoma-in-patients-with-rectal-cancer-undergoing-ultra-low-anterior-resection-100637489",false,"NCT07605611","Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Rectal Cancer Undergoing Ultra-Low Anterior Resection","A Multicenter, Randomized Clinical Study of Somatostatin Plus Clear Liquid Diet Versus Diverting Stoma in Patients With Low and Mid Rectal Cancer Undergoing Ultra-Low Anterior Resection","SC-Stoma","Inclusion Criteria:\n\n1. Adults aged 18 to 75 years\n2. Patients with stage I to III rectal malignancy who are scheduled to undergo low anterior resection at a participating gastrointestinal surgery center\n3. The lower edge of the tumor is 8 cm or less from the dentate line, or 10 cm or less from the anal verge, based on preoperative colonoscopy, imaging, or digital rectal examination\n4. The planned anastomosis is expected to be 2 cm or less from the dentate line, or 4 cm or less from the anal verge\n5. Patients have two or more risk factors for anastomotic leakage as assessed by the study team\n6. American Society of Anesthesiologists physical status classification is grade 3 or lower\n7. Body mass index is less than 30 kg\u002Fm²\n8. The patient, or the patient's legally authorized representative, is willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Has another colorectal malignant tumor at the same time\n2. The final anastomosis after surgery is more than 2 cm from the dentate line, or more than 4 cm from the anal verge\n3. Has metastatic disease before surgery\n4. Is pregnant\n5. Has a mental illness or addictive disorder that would prevent participation in the clinical trial\n6. Requires emergency surgery\n7. Has inflammatory bowel disease\n8. Is allergic to somatostatin or is unable to tolerate somatostatin\n9. For participants assigned to the no-stoma group, the surgeon decides that a stoma is required\n10. Has received neoadjuvant drug therapy less than 2 weeks before surgery, or radiotherapy less than 8 weeks before surgery\n11. Has any other condition that makes it impossible to follow the study protocol","ALL","18 Years","75 Years",{"count":105,"type":106},72,"ESTIMATED","INTERVENTIONAL",[109],"NA","The goal of this clinical trial is to learn if somatostatin plus a clear liquid diet can help prevent severe leakage after rectal cancer surgery in adults with low or mid rectal cancer who are scheduled to have ultra-low anterior resection. These patients have a higher risk of leakage where the bowel is joined together after surgery.\n\nThe main questions it aims to answer are:\n\nDoes somatostatin plus a clear liquid diet prevent severe leakage within 1 month after surgery about as well as a prophylactic diverting stoma?\n\nWhat medical problems, bowel function problems, recovery outcomes, and quality of life outcomes do participants have after surgery and during follow-up?\n\nResearchers will compare somatostatin plus a clear liquid diet without a diverting stoma to prophylactic diverting stoma to see if the somatostatin plus clear liquid diet regimen can provide similar protection against severe leakage while reducing the need for stoma creation.\n\nParticipants will:\n\nHave rectal cancer surgery with the bowel joined very close to the anus\n\nBe randomly assigned to receive either somatostatin plus a clear liquid diet for 7 days after surgery without a diverting stoma, or a prophylactic diverting stoma\n\nHave follow-up assessments of leakage, postoperative complications, bowel function, recovery quality, and quality of life\n\nComplete follow-up visits or assessments for up to 3 years after surgery",[112,113],"Rectal Cancer","Anastomotic Leakage",[115,116,117,118,119,120,24,121,122,123],"Rectal cancer","Ultra-low anterior resection","Anastomotic leakage","Severe anastomotic leakage","Diverting stoma","Prophylactic stoma","Clear liquid diet","Bowel function","Quality of life","2026-05-22",{"date":126,"type":127},"2026-05-26","ACTUAL",{"date":129,"type":127},"2025-11-17",{"date":131,"type":106},"2030-06-30",{"name":5,"class":6},3]