[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stoma":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,75,104,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100621354","the-impact-of-two-stage-turnbull-cutait-pull-through-coloanal-anastomosis-on-stoma-free-survival-in-low-rectal-anal-preserving-surgery-100621354",false,"NCT07369531","The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery","The Impact of Two-Stage Turnbull-Cutait Pull-Through Coloanal Anastomosis on Stoma-free Survival in Low Rectal Anal-preserving Surgery: A Multicenter Randomized Controlled Trial (FIAS)","FIAS","Inclusion Criteria:\n\n1. Patients with rectal cancer aged 18-75 years confirmed by pathological biopsy as adenocarcinoma;\n2. Preoperative abdominal contrast-enhanced CT and pulmonary CT (or PET-CT) showed no evidence of distant metastasis;\n3. Preoperative rectal MRI evaluation demonstrated that the tumor was located within 5cm below the anal margin, above the intermuscular groove between the internal and external anal sphincters (anal white line) by 1 cm, and without invasion of the external anal sphincter;\n4. For tumors located above the levator ani hiatus, MRI evaluation showed cT1-3, cN0-1, M0, MRF (-); for tumors located below the levator ani hiatus, MRI evaluation showed cT1-2, cN0-1, M0, MRF (-). For patients who received neoadjuvant therapy, tumors above the levator ani hiatus were downstaged to ycT3NxM0 or below, and tumors below the levator ani hiatus were downstaged to ycT2NxM0 or below;\n5. Preoperative BMI \\\u003C 28 kg\u002Fm²\n6. Patients underwent radical laparoscopic\u002Frobot-assisted total mesorectal excision (TME) or transanal total mesorectal excision (TaTME).\n\nExclusion Criteria:\n\n1. Patients diagnosed with concurrent primary malignant tumors in any other organ or multiple distant colorectal cancers;\n2. History of previous open surgery (non-minimally invasive procedures);\n3. Failure to undergo preoperative rectal MRI evaluation and chest\u002Fabdominal imaging assessment, resulting in incomplete clinical staging of the tumor;\n4. Pregnant patients or those with concurrent inflammatory bowel disease;\n5. Preoperative patients with complete intestinal obstruction or requiring emergency surgery;\n6. Preoperative anticipated multivisceral resection or intraoperative required combined organ resection is indicated.;\n7. Recent treatment for other malignancies;\n8. Low rectal cancer classified as type IV in the Bordeaux classification system;\n9. Intraoperatively confirmed distant metastatic disease\n10. Preoperative pathological types of signet ring cell carcinoma, mucinous adenocarcinoma, anaplastic carcinoma, or poorly differentiated carcinoma.\n\nWithdrawal Criteria\n\n1. Patients who refuse surgical intervention after randomization.\n2. Patients who undergo an abdominoperineal resection (APR) following randomization.\n3. Patients who request voluntary withdrawal from the trial at any time throughout the study period.","ALL","18 Years","75 Years",{"count":21,"type":22},520,"ESTIMATED","INTERVENTIONAL",[25],"NA","The goal of this clinical trial is to explore the difference in 3-year stoma-free survival between the Turnbull-Cutait delayed coloanal anastomosis (TCA) surgery and the low anterior resection combined with protective stoma (LAR) surgery in patients with low rectal cancer, as well as the differences in anal function, surgical complications, and survival outcomes within 1 year after surgery. The main questions it aims to answer are:\n\n1. Is TCA surgery superior to LAR surgery in improving the 3-year stoma-free survival of patients with low rectal cancer?\n2. Are there differences in postoperative anal function (assessed by LARS score and Wexner score), quality of life (assessed by EORTC QLQ-CR29 questionnaire), surgical complications, pathological outcomes, and long-term survival (disease-free survival, time to recurrence, overall survival) between the two surgical methods? Researchers will compare the TCA group and the LAR group to see if TCA surgery can reduce the permanent stoma rate, improve postoperative anal function and quality of life, and ensure surgical safety and favorable tumor-related outcomes compared with LAR surgery.\n\nParticipants will:\n\n1. Be randomly assigned to either the TCA group or the LAR group in a 1:1 ratio.\n2. Receive the corresponding surgical intervention.\n3. Complete regular follow-ups at 1 month, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months, 30 months, and 36 after the first surgery.\n4. Provide relevant clinical data (perioperative, pathological, follow-up) as required.",[28,29,30,31,32],"Rectal Cancer","Surgical Anastomosis","Survival , Tumor","Anal Function","Stoma",[34,35,36,37],"Turnbull-Cutait anastomosis","Rectal neoplasms","Low anterior resection","Stoma-free survival","RECRUITING","2026-03-21",{"date":41,"type":42},"2026-03-25","ACTUAL",{"date":44,"type":42},"2026-03-18",{"date":46,"type":22},"2031-12-31",{"name":48,"class":49},"The First Hospital of Jilin University","OTHER",2,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100628596","construction-and-evaluation-of-a-flipped-discharge-model-for-stomates-with-colorectal-cancer-100628596","NCT07463690","Construction and Evaluation of a Flipped Discharge Model for Stomates With Colorectal Cancer","Construction and Empirical Study of a \"Flipped\" Discharge Model for Colorectal Cancer Patients With Stoma Based on Response Transformation Theory Research","Inclusion Criteria:\n\n1. Pathologically diagnosed colorectal cancer patients undergoing their first radical surgery with either abdominoperineal resection (Miles) plus permanent colostomy or sphincter-preserving anterior resection (Dixon) plus temporary ileostomy.\n2. Aged 18 years or older.\n3. Possess at least elementary school education and are able to read, communicate, and understand questionnaire content. Voluntarily participate and provide written informed consent.\n4. Postoperative condition is stable without major complications, and patient is conscious.\n5. Meets standard hospital discharge criteria with normally functioning stoma.\n\nExclusion Criteria:\n\n1. History of psychiatric disorders or severe cognitive impairment.\n2. Diagnosis with other concurrent malignancies.",{"count":59,"type":22},200,[25],"This multicenter randomized controlled trial aims to develop and evaluate the effectiveness of a \"Flipped Discharge\" intervention for colorectal cancer patients with a new intestinal stoma. Guided by the Response to Transition Theory, the model addresses the care gap during the vulnerable post-discharge period by shifting critical support from the hospital to the patient's home. Approximately 200 eligible patients will be randomized into either the intervention or standard care control group. The core \"Flipped Discharge\" intervention occurs on the third day post-discharge, delivered either as an in-home visit by a specialist stoma nurse (via an \"Internet + Nursing Service\" platform) or as an intensive, standardized video follow-up with mailed instructional materials. The study's primary outcome is the incidence of stoma-related complications. Secondary outcomes include quality of life, self-care ability, self-efficacy, stoma adaptation, discharge readiness, healthcare costs, and satisfaction. The trial will also explore the mechanisms by which the intervention affects patient outcomes, ultimately seeking to provide evidence for a feasible, patient-centered model to improve care continuity.",[63,32],"Colorectal Cancer","NOT_YET_RECRUITING","2026-03-05",{"date":67,"type":42},"2026-03-11",{"date":69,"type":22},"2026-03-10",{"date":71,"type":22},"2027-12-30",{"name":73,"class":49},"Sun Yat-sen University",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":23,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100620489","mobile-education-and-comfort-in-ostomy-patients-100620489","NCT07358286","MOBILE EDUCATION AND COMFORT IN OSTOMY PATIENTS","THE EFFECT OF KOLCABA'S COMFORT THEORY-BASED MOBILE EDUCATION ON COMFORT LEVELS OF OSTOMY PATIENTS: A RANDOMIZED CONTROLLED TRIAL","STOMA-PLUS","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Patients with a stoma (colostomy or urostomy)\n* Ability to use a smartphone or mobile device\n* Willingness to participate in the study\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Cognitive impairment that prevents understanding of the study procedures\n* Severe psychiatric disorders\n* Inability to use mobile technology\n* Participation in another interventional study during the study period",{"count":84,"type":22},68,[25],"Purpose of the Study\n\nThis study aims to understand whether a mobile education program can improve comfort levels in people living with a stoma. A stoma is a surgical opening created on the abdomen to allow stool or urine to leave the body. Living with a stoma can affect daily life in many ways, including physical comfort, emotional well-being, social life, and the home environment.\n\nThe education program used in this study is based on Kolcaba's Comfort Theory. This theory focuses on comfort as a whole and includes physical, emotional, social, and environmental aspects of a person's life. The study will compare people who receive mobile education with those who receive standard hospital care only.\n\nWho Can Take Part\n\nAdults aged 18 years and older who are scheduled to have colostomy, ileostomy, or urostomy surgery may take part in this study. Participants must be able to communicate in Turkish, read and understand written information, and agree to join the study voluntarily.\n\nPeople with severe cognitive problems, serious communication difficulties, or major vision or hearing problems will not be included.\n\nWhat Will Happen in the Study\n\nParticipants will be randomly assigned to one of two groups:\n\nMobile Education Group\n\nStandard Care Group\n\nBoth groups will receive routine care provided by the hospital.\n\nParticipants in the mobile education group will also receive access to a mobile application designed specifically for people with a stoma. This application includes:\n\nEasy-to-understand information about stoma care\n\nAnimated educational videos showing step-by-step stoma care practices\n\nGuidance on skin care, pouch changing, and hygiene\n\nInformation on common problems and when to seek medical help\n\nReminders to support daily stoma care routines\n\nThe mobile application can be used on smartphones and does not include diagnosis or treatment. It is for education and support only.\n\nParticipants in the standard care group will receive usual hospital education and care. After the study is completed, they will also be offered the mobile education program.\n\nWhat Participants Will Be Asked to Do\n\nAll participants will be asked to answer questionnaires that measure comfort levels at several time points:\n\nBefore surgery\n\nOne day after surgery\n\nFifteen days after discharge (by phone)\n\nOne month after surgery (during a clinic visit)\n\nParticipants in the mobile education group will be shown how to use the application and may use it as often as they wish. Researchers may contact participants to ask about their experience using the app and to identify any difficulties.\n\nPossible Benefits\n\nParticipants may gain better understanding of stoma care and feel more confident managing daily life with a stoma. The mobile education program may help reduce discomfort, support emotional well-being, and improve overall quality of life.\n\nThe results of this study may help healthcare professionals develop better education tools and support programs for people living with a stoma.\n\nRisks and Safety\n\nThis study does not involve experimental medical treatments. The mobile application provides education only. Personal data will not be collected through the app, and all information will be kept confidential. Participants may leave the study at any time without affecting their medical care.\n\nWhy This Study Is Important\n\nAccess to stoma care education can be limited due to time constraints, staff availability, and hospital resources. Mobile education may provide an easy and accessible way for people to receive reliable information whenever they need it.\n\nThis study will help determine whether a comfort-focused mobile education program can support people living with a stoma and improve their overall comfort and well-being.",[32,88,89],"Ostomy","Mobile Application",[91,92,93,94],"Ostomy Care","Mobile Health","Kolcaba's Comfort Theory","Nursing","2026-01-14",{"date":97,"type":42},"2026-01-22",{"date":99,"type":22},"2026-01",{"date":101,"type":22},"2026-06",{"name":103,"class":49},"Ege University",{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":17,"minAge":18,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":23,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":74},"100618829","the-effect-of-escape-room-simulation-on-nursing-students-knowledge-and-academic-self-efficacy-regarding-stoma-care-100618829","NCT07336706","The Effect of Escape Room Simulation on Nursing Students' Knowledge and Academic Self-Efficacy Regarding Stoma Care","The Effect of Escape Room Simulation on Nursing Students' Knowledge and Academic Self-Efficacy Regarding Stoma Care: A Randomized Controlled Study","Inclusion Criteria:\n\n* Being an undergraduate nursing student\n* Voluntarily agreeing to participate in the study\n\nExclusion Criteria:\n\n* Being a graduate of any health sciences department\n* Having experience with escape room simulation",true,"30 Years",{"count":114,"type":22},60,[25],"This research was planned to determine the effect of escape room simulation on nursing students' knowledge and academic self-efficacy levels regarding stoma care. The research was planned as a randomized controlled trial. This research will be conducted with 60 students of the Nursing Department of Başkent University Faculty of Health Sciences between December 29, 2025 and February 28, 2026. All students who agree to participate in the study will be administered the \"Descriptive Characteristics Form\", the \"Stoma Care and Colostomy Irrigation Knowledge Test (pre-test)\", and the \"Nursing Students Academic Self-Efficacy Scale (pre-test)\". Students will be divided into experimental and control groups using a simple randomization method. Students in the experimental group will be given a lecture on stoma care and irrigation by the researcher. After the training, an escape room simulation will be conducted. Each escape room simulation will be conducted with 6 students, in the form of a pre-information session, an escape room simulation application, and an analysis session. In the pre-information session, the simulation objectives, the purpose of the scenario, the roles within the scenario, and the game rules will be explained, and the escape room and standard patient will be briefly introduced to the students in the meeting room. Then, the students will carry out the scenario and game activity (KAHOOT, Table Game, Card Game, Word Cloud, Crossword Puzzle) with a standard patient in the simulation laboratory prepared as an escape room.\n\nThe researcher will act as a facilitator during the escape room simulation application. During the simulation, if the expected steps are not performed correctly or the game activity is not successfully completed, the team has the right to request hints from the facilitator. Immediately after the escape room simulation is completed, a debriefing session will be held. The debriefing session, lasting approximately 20-30 minutes for each team, will take place in the meeting room located directly opposite the escape room. During the debriefing session, students will be encouraged to express their feelings and thoughts, and feedback will be provided by the researcher. After the debriefing session, and after 1 month the \"Stoma Care and Colostomy Irrigation Knowledge Test (post-test)\" and the \"Nursing Students Academic Self-Efficacy Scale (post-test)\" will be administered.\n\nAll students in the control group will receive instruction on stoma care and irrigation using traditional teaching methods provided by the researcher. After the training is completed, and after 1 month the \"Stoma Care and Colostomy Irrigation Knowledge Test (post-test)\" and the \"Nursing Students Academic Self-Efficacy Scale (post-test)\" will be administered.\n\nData analysis will be performed using the IBM SPSS Statistics 26 software package.\n\nThe main research questions are:\n\nDoes escape room simulation increases nursing students' knowledge levels regarding stoma care? Does escape room simulation increases nursing students' academic self-efficacy regarding stoma care?",[32,118],"ESCAPE ROOM","2026-01-02",{"date":121,"type":42},"2026-01-13",{"date":123,"type":22},"2025-12-29",{"date":125,"type":22},"2026-02-28",{"name":127,"class":49},"Ankara Yildirim Beyazıt University",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":136,"enrollmentInfo":137,"targetDuration":139,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":144,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":74},"100601510","chinese-ostomy-collaboration-group-cocg-clinical-study--siti-classification-100601510","NCT07111429","Chinese Ostomy Collaboration Group (COCG) Clinical Study -SITI Classification","Evaluation of a Modified Clavien-Dindo Classification (COCG) of Stoma Complication in Cancer Patients: a Prospective, Registry-based, Non-randomized Trial (COCG-01 Trial) on Behalf of Chinese Ostomy Collaboration Group","COCG-SITI","Inclusion Criteria:\n\n* Patients with stoma after colorectal cancer resection.\n\nExclusion Criteria:\n\n* Patients who don't want to be studied","80 Years",{"count":138,"type":22},5000,"3 Years","OBSERVATIONAL","Colorectal cancer is an important cancer worldwide, and its incidence is increasing year by year. A large proportion of patients may require diverting stoma or even permanent stoma after surgery. Some of these patients will have a variety of stoma-related complications, which seriously affect the quality of life of patients. At present, the mainstream postoperative complication classification is the traditional CD classification, which is suitable for the classification of most postoperative complications. However, due to the unique anatomical characteristics of patients with stoma, the current CD classification system may not be suitable for the classification of patients with stoma-related complications. Therefore, we plan to establish a registry database of colorectal cancer patients with stoma, explore the attribution and incidence of stoma-related complications, and propose a new improved classification system, the SITI classification, on the existing CD classification, for verification and promotion.",[143,32],"Complication,Postoperative",[145,146],"stoma complications","SITI-CD Classification","2025-08-01",{"date":149,"type":42},"2025-08-08",{"date":151,"type":22},"2025-08-15",{"date":153,"type":22},"2025-12-15",{"name":155,"class":49},"Peking University Cancer Hospital & Institute"]