[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stoma-ileostomy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stoma-ileostomy":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,68,92,114,139],{"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":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100566046","protective-ileostomy-versus-protective-colostomy-in-anterior-rectal-resection-100566046",false,"NCT06650085","Protective Ileostomy Versus Protective Colostomy in Anterior Rectal Resection","PROtective ileoStomy Versus ProtectivE Colostomy in Anterior Rectal resectIon - a Multicenter, Open-label, Randomized conTrolled studY (PROSPERITY)","PROSPERITY","Inclusion Criteria: Patients undergoing anterior resection (resection of the rectum and colorectal or coloanal anastomosis) due to a rectal tumour and a protective stoma is planned.\n\nThe exclusion criteria are: (1) patient already having a stoma (or another stoma made during surgery), (2) technical inability to create ileo- or colostomy (e.g. previous bowel resection, anatomical factors), (3) age \\\u003C18 years, (4) inadequate ability to co-operate.","ALL","18 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"NA","Loop ileostomy and loop colostomy are both used as protective stomas after anterior resection. There is a lack of evidence on the superiority of loop ileostomy versus loop colostomy. This is a multicenter, open-label, superiority, individually randomized controlled trial including patients undergoing anterior rectal resection with primary anastomosis and a protective stoma. Patients scheduled for anterior rectal resection are randomized 1:1 to loop ileostomy or loop colostomy intraoperatively. Primary outcome is cumulative stoma-related adverse events within 60 days post-primary surgery (scored using Comprehensive Complication Index (CCI)).",[27,28],"Stoma Colostomy","Stoma Ileostomy","RECRUITING","2026-06-05",{"date":32,"type":33},"2026-06-09","ACTUAL",{"date":35,"type":33},"2025-10-06",{"date":37,"type":21},"2033-10",{"name":39,"class":40},"Helsinki University Central Hospital","OTHER",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":54,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100638650","outcomes-of-midline-stoma-100638650","NCT07616830","Outcomes of Midline Stoma","Outcomes of Midline Stoma: A Prospective Study.","Inclusion Criteria:\n\n* Patients who will undergo temporary stoma (ileostomy\u002Fcolostomy) through midline incision.\n\nExclusion Criteria:\n\n* Patients with jejunostomy.\n* Patients with severe sepsis.",{"count":50,"type":21},30,[24],"* Ileostomy or colostomy is a common surgical procedure used for diverting the lower gastrointestinal content away from distal pathology or anastomotic insufficiency. Once the distal problem has been fixed, the plan is to reverse the stoma. However, the reversal of a stoma is associated with complications, including anastomotic leaks, wound infection, and incisional hernias which can reach up to 33-50%.\n* The ideal site for a stoma on the abdominal wall depends on several factors, including the patient's anatomy, the type of stoma (colostomy or ileostomy), operative findings, and the patient's preferences. Stomas have traditionally been fashioned through the rectus muscle, away from the midline of the abdomen, and below the umbilicus.\n* Management of a stoma placed at the center of a long midline laparotomy wound is challenging with the risk of faecal contamination of midline incision. However in many scenarios, the surgeon is left without options rather than to exteriorize the bowel loop through the midline. Moreover, advantages of midline stoma may include:\n\n  1. Easy to create and save operative time.\n  2. Minimize destruction of the anterior abdominal wall (less tissue injury).\n  3. Eliminate the long-term risk of incisional hernia at the site of previous stoma.\n\nOnly, few reports assess the outcomes of midline ostomy as a temporary stoma",[27,28],[55,56,57],"stoma","incisional hernia","midline incision","2026-05-23",{"date":60,"type":33},"2026-06-01",{"date":62,"type":33},"2025-06-15",{"date":64,"type":21},"2026-09",{"name":66,"class":40},"Assiut University",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":22,"phases":77,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":67},"100551551","phase-1-pilot-study-of-preoperative-intestinal-training-using-antegrade-ileostomy-infusion-100551551","NCT06461559","Pilot Study of Preoperative Intestinal Training Using Antegrade Ileostomy Infusion","Inclusion Criteria:\n\n* Has a diverting loop ileostomy\n* undergoing evaluation for stoma takedown\n\nExclusion Criteria:\n\n* unable to perform consent\n* unable to perform stoma infusion","80 Years",{"count":76,"type":21},20,[78,79],"PHASE1","PHASE2","This research study is being conducted to study the effect of infusing your contents from your ostomy bag back into your intestine to re-train them prior to the ostomy takedown operation, which is a surgery to reverse your ostomy to put your intestine back together. Because your intestine past the ostomy hasn't seen any intestinal content for several weeks to months before the takedown operation, it is no longer used to handling the daily work of processing intestinal content and will take time to recover its normal function after surgery. We hope to speed up this process by training them before your planned surgery.",[28,82],"Ileostomy; Complications","2025-12-11",{"date":85,"type":33},"2025-12-15",{"date":87,"type":33},"2024-08-01",{"date":89,"type":21},"2026-05-01",{"name":91,"class":40},"University of California, San Diego",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":98,"targetDuration":100,"studyType":101,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":67},"100558660","prospective-longitudinal-study-of-heylo-for-people-living-with-a-stoma-100558660","NCT06554015","Prospective Longitudinal Study of Heylo™ for People Living With a Stoma","Inclusion Criteria:\n\n1. Are you at least 18 years old? \\[Yes\u002FNo\\]\n2. Do you have an ileostomy or a colostomy? \\[Yes\u002FNo\\]\n3. Have you used Heylo™ for less than seven days? \\[Yes\u002FNo\\]\n\nExclusion Criteria:\n\n1\\) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes\u002FNo\\]",{"count":99,"type":21},100,"1 Year","OBSERVATIONAL","This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.",[28],"2025-08-27",{"date":106,"type":33},"2025-09-04",{"date":108,"type":33},"2024-07-01",{"date":110,"type":21},"2027-07-02",{"name":112,"class":113},"Coloplast A\u002FS","INDUSTRY",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":122,"targetDuration":4,"studyType":101,"phases":4,"briefSummary":124,"conditions":125,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":67},"100603577","impact-on-the-absorption-of-drugs-in-ostomy-patients-100603577","NCT07138326","Impact on the Absorption of Drugs in Ostomy Patients","Beeinflussung Der Resorption Von Arzneimitteln Bei Stoma Patient*Innen","STAR","Planned inclusion criteria:\n\n* Male and female patients aged ≥18 years\n* Belonging to a collective\n* Ileostomy since ≥7d\n* Colostomy since ≥7d The stoma must have been inserted at least 7d ago to ensure that a steady state concentration is achieved.\n* Taking ≥1 of the following active substances since ≥7d:\n\n  * Psychotropic drugs: citalopram, clozapine, duloxetine, escitalopram, melperone, mianserin, milnacipran, mirtazapine, olanzapine, paliperidone, paroxetine, pregabalin, prothipendyl, quetiapine, risperidone, sertraline, trazodone, venlafaxine\n  * NOACs: edoxaban, rivaroxban, apixaban\n\nExclusion Criteria:\n\nInsurmountable language barrier",{"count":123,"type":21},128,"Peroral administration is the preferred way of taking medication. However, the special absorption conditions in ostomy patients are generally not addressed in approval studies and there is also little other literature on this topic. These are usually case reports or studies on individual patients or very small patient collectives.\n\nFor medications with measurable clinical parameters, e.g. blood pressure, blood sugar, etc: Blood pressure, blood sugar, etc., these can be used to draw conclusions about any absorption problems. For medications without the possibility of a direct and objective assessment, the assessment is difficult due to the very low level of evidence. Drug groups without a direct physiological measure are e.g: Psy-chotropic drugs (antipsychotics, antidepressants, anxiolytics) and also the novel oral anticoagulants (NOACs).\n\nThe clinical trial´s results will answer the following questions:\n\n* Are therapeutic blood levels of psychotropic drugs and NOACs achieved in ostomy patients when taken orally in the usual way?\n* Are there differences between the measured levels of ileostomy and colostomy patients? Colostomy and ileostomy patients undergoing inpatient or outpatient treatment at the Klinik Ottakring are ready for inclusion. The blood samples will be obtained during medically indicated and performed blood draws within the scope of medical practice, so that no study-associated risks arise here.\n\nRecorded and evaluated:\n\n* Relevant patient data\n* Plasma levels of the drugs under investigation in ostomy patients. The therapeutic range specified in the respective approval studies serves as the reference value. The results obtained are documented, evaluated and interpreted in an appropriate manner.",[28,126,127,128,129],"Ileostomy - Stoma","Colostomy - Stoma","Absorption","Pharmakokinetic","2025-08-20",{"date":132,"type":33},"2025-08-22",{"date":134,"type":33},"2025-06-18",{"date":136,"type":21},"2026-12-31",{"name":138,"class":40},"WiGeV Klinik Ottakring",{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":151,"conditions":152,"keywords":154,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":4},"100557616","digital-based-home-care-service-for-ostomy-patients-100557616","NCT06540430","Digital Based Home Care Service for Ostomy Patients","Digital Based Home Care Service for Ostomy Patients: Randomized Controlled Trials","Inclusion Criteria:\n\n* Patients aged 19 years or older\n* Patients who have a colostomy or ileostomy after surgery for colon cancer\n* Patients who do not have difficulty using a smartphone\n\nExclusion Criteria:\n\n* Patients younger than 19 years\n* Patients aged 80 years or older\n* Patients who do not know how to use a smartphone\n* Patients with cognitive impairments\n* Patients with pre-existing psychiatric disorders\n* Patients who have undergone emergency surgery\n* Patients who already have stoma-related complications","19 Years","79 Years",{"count":149,"type":21},120,[24],"This study aims to enhance the physical, psychological, and social aspects of stoma care by providing a self-management service via a smartphone application, and to evaluate the impact of this digital-based application on patients' quality of life.",[153,27,28],"Colorectal Neoplasms",[155,156,157],"Stoma","Colorectal neoplasms","Quality of life","NOT_YET_RECRUITING","2024-08-06",{"date":161,"type":33},"2024-08-09",{"date":163,"type":21},"2024-09-01",{"date":165,"type":21},"2026-02-28",{"name":167,"class":40},"Wonju Severance Christian Hospital"]