[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"enterostomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:enterostomy":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100573849","prospective-study-of-the-methods-and-outcomes-of-chyme-reinstillation-after-small-bowel-surgery-100573849",false,"NCT06751628","Prospective Study of the Methods and Outcomes of CHYME REinstillation After Small Bowel Surgery","CHYMERE","Inclusion Criteria:\n\nHigh-output stoma or enterocutaneous fistula (\\>1500 mL per day or \\>1000 mL per day with impact on hydration and nutritional status) Double enterostomy or enterocutaneous fistula with an anatomical configuration allowing chyme reinfusion (CR) Confirmed patency of the downstream digestive segment through digestive contrast imaging\n\nExclusion Criteria:\n\nStricture or fistula in the downstream digestive segment Patient refusal to use the device Fine motor or cognitive impairments preventing the patient or a caregiver from handling the device","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","High-output enterocutaneous fistulas (HOF) and double enterostomies are severe complications of abdominal surgery or trauma. Double enterostomies are typically created after small bowel resection in fragile patients who cannot tolerate intestinal reconnection. Reconnection is generally performed 3-6 months later, once patients have regained sufficient healing capacity. In contrast, HOFs occur when intestinal anastomosis healing fails, causing digestive secretions to exit through the abdominal wall. HOFs lead to excessive loss of fluids and nutrients, defined as digestive output exceeding 1500 mL per day for two consecutive days. This often results in severe dehydration and intestinal failure.\n\nManaging HOFs is a complex, resource-intensive process requiring multidisciplinary care to compensate for losses and ensure patient survival. These conditions cause significant patient burden, increase healthcare costs, and often necessitate parenteral nutrition (PN). PN is associated with longer hospital stays, higher risks of central line infections, venous thrombosis, and liver complications (de Vries et al., 2021).\n\nInnovative approaches are needed to restore lost digestive fluids and nutrients in HOF patients. Such solutions could mitigate intestinal failure, reduce PN reliance, prevent dehydration and kidney failure, shorten hospital stays, and improve quality of life by enabling home care. Chyme reinfusion (CR) is an established technique for transferring digestive fluids back into the bypassed intestine (Figure 1A). Historically, this procedure relied on bulky peristaltic pumps available only in specialized centers, with fewer than ten centers in France offering the service. CR has shown significant benefits, with over 85% of patients discontinuing PN and improving nutritional status (Bhat et al., 2020).\n\nA novel, portable pump system developed by Insides System allows patients to independently perform CR and manage their care in outpatient settings. A case series of 10 patients demonstrated that the Insides System enabled PN discontinuation, corrected liver and electrolyte imbalances, and allowed most patients to return home with CR (Sharma et al., 2017).\n\nThe CHYMERE study aims to evaluate the effectiveness of chyme reinfusion using a home-compatible device for patients with HOF.",[24],"Enterostomy",[26,27],"Reinstillation","Small bowel surgery","RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-25","ACTUAL",{"date":34,"type":32},"2024-07-14",{"date":36,"type":20},"2030-07-14",{"name":38,"class":39},"Nantes University Hospital","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100321802","mucous-fistula-refeeding-reduces-the-time-from-enterostomy-closure-to-full-enteral-feeds-muc-fire-trial-100321802","NCT03469609","Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (\"MUC-FIRE\" Trial)","A Randomized Multicenter Open-label Controlled Trial to Show That Mucous Fistula Refeeding Reduces the Time From Enterostomy Closure to Full Enteral Feeds (MUCous FIstula REfeeding (\"MUC-FIRE\") Trial)","MUC-FIRE","Inclusion Criteria:\n\n1. Infants \\\u003C 366 days,\n2. Ileostomy \u002F Jejunostomy,\n3. double loop enterostomies and split enterostomies (with mucous fistula)\n4. Signed written informed consent obtained by parents\u002Flegal guardians and willingness of parents\u002Flegal guardians to comply with treatment and follow-up procedures of their child\n\nExclusion Criteria:\n\n1. resection of ileocecal valve,\n2. colostomy,\n3. small bowel atresia,\n4. multiple ostomies (more than just an enterostomy and a mucous fistula),\n5. chromosomal abnormalities (if known at the time of randomization),\n6. Hirschsprung's disease,\n7. participation in another drug-intervention study\n8. Intestinal perforation due to a hemodynamic heart defect","12 Months",{"count":51,"type":20},120,"INTERVENTIONAL",[54],"NA","The primary objective of this study is to demonstrate that mucous fistula refeeding between enterostomy creation and enterostomy closure reduces the time to full enteral feeds after enterostomy closure compared to standard of care.",[24],[58,59,60,61,62,63,64,65,66,67,68,69],"infants","necrotizing enterocolitis (NEC)","focal intestinal perforation (FIP)","enterostomy creation","bowel reanastomosis","enteral feeding","caloric intake","parenteral nutrition","complication rate","reduction of hospital expenses","length of hospital stay","refeeding","2026-04-27",{"date":72,"type":32},"2026-05-01",{"date":74,"type":32},"2018-06-18",{"date":76,"type":20},"2027-12",{"name":78,"class":39},"University of Leipzig",17,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":52,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":40},"100581805","a-study-of-using-the-stoma-self-care-apps-by-patients-with-enterostomy-100581805","NCT06855082","A Study of Using the Stoma Self-care Apps by Patients With Enterostomy","A Study of Using the Stoma Self-care Apps by Patients With Enterostomy on the Integrated Model of Technology Acceptance (TAM) and Task-technology Fit(TTF)","Inclusion Criteria:\n\n* Diagnosed with colorectal cancer or intestinal obstruction or abdominal trauma, those who have received colostomy during this hospitalization\n* Conscious, can communicate in Mandarin or Minnan dialect\n* Have no communication, vision, or hearing impairments,\n* Have smartphones\n\nExclusion Criteria:\n\n* Those who are unable to cooperate due to visual, hearing, cognitive or mental impairments\n* Patients who need colostomy surgery due to non-colorectal cancer, intestinal obstruction, or abdominal trauma\n* Patients diagnosed by a physician as having surgery-related complications and requiring further surgery, such as infection, intestinal Perforation, stoma prolapse, stenosis, necrosis, bleeding, etc. (IV) Those who are unable to learn self-care on the day before discharge due to worsening of their illness.","20 Years",{"count":89,"type":20},50,[54],"This study uses a stoma self-care app, accessed through LINE official account, a communication software commonly used by Chinese people, as an intervention measure to integrate technology acceptance and task technology adaptation models to explore the correlation of each aspect and its impact on self-care ability and quality of life. Whether the factors and task technology adaptability will affect the willingness and usage behavior of enterostomy patients, the research subjects can effectively improve their self-care ability, quality of life, usage willingness, and usage behavior after intervention.",[24],[24,94,95,96],"stoma self-care apps","Technology Acceptance Model","Task Technology Fit Model","2025-05-04",{"date":99,"type":32},"2025-05-07",{"date":101,"type":32},"2025-03-14",{"date":103,"type":20},"2027-01-15",{"name":105,"class":39},"HSIN LING CHEN"]