[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646049":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":24,"responsibleParty":31,"collaborators":24,"id":35,"slug":36,"hasResults":37,"nctId":38,"briefTitle":39,"officialTitle":40,"acronym":41,"eligibilityCriteria":42,"healthyVolunteers":37,"sex":43,"minAge":44,"maxAge":24,"enrollmentInfo":45,"targetDuration":24,"studyType":48,"phases":49,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":64,"whyStopped":24,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":24},{"fullName":5,"class":6},"University Hospital of Ferrara","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early TAI-treated group","EXPERIMENTAL","This arm will start trans-anal irrigation within 3 months after stoma closure",[13],"Device: Water-based transanal irrigation system",{"label":15,"type":6,"description":16,"interventionNames":17},"Late TAI-treated group","This arm will begin trans-anal irrigation between three and six months after stoma closure",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Water-based transanal irrigation system","The procedure involves the introduction of water into the rectum and colon via the anus, which stimulates colonic reflex activity and acts as a mechanical bowel washout, thereby facilitating faecal evacuation. The device will deliver a controlled amount of warm water using a catheter - cone or balloon catheter - while sitting on the toilet. Once the desired amount of water has been introduced, the patient will expel the water and bowel contents. The procedure will take approximately 15-30 minutes, depending on the individual patient's response.",[9,15],null,[26],{"name":27,"role":28,"phone":29,"phoneExt":24,"email":30},"Simona Ascanelli Ascanelli, MD, Department of Surgery","CONTACT","+39 348 6909238","simona.ascanelli@unife.it",{"type":32,"investigatorFullName":33,"investigatorTitle":34,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"SPONSOR_INVESTIGATOR","Simona Ascanelli","General Surgeon at University Hospital of Ferrara","100646049","evaluating-the-optimal-timing-of-trans-anal-irrigation-for-low-anterior-resection-syndrome-post-rectal-cancer-surgery-100646049",false,"NCT07696689","Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery","Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery - An Italian Multicentre Randomised Study","EARLY-TAI","Inclusion Criteria:\n\n* Adults aged ≥ 18 years\n* Colorectal resection for rectal cancer with a protective ostomy\n* Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure\n* LARS score \\> 30 (major LARS)\n* Not previously treated with TAI (except for enemas)\n* Completion of training on TAI irrigation by trained medical\u002Fnursing staff\n* Use of only the Peristeen® Plus device for TAI\n* Written informed consent\n\nExclusion Criteria:\n\n* Neurological diseases\n* Psychiatric disorders\n* Refusal to consent to follow-up\n* Current or planned pregnancy\n* Known allergy to latex\n* Presence of contraindications as outlined in the device's Instructions for Use (IFU), such as ischemic colitis, acute inflammatory bowel disease, or acute diverticulitis.","ALL","18 Years",{"count":46,"type":47},250,"ESTIMATED","INTERVENTIONAL",[50],"NA","This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer.\n\nThe main question it aims to answer is:\n\n\"Can starting TAI within three months of stoma closure reduce the number of daily bowel movements in people who have undergone rectal surgery?\" Researchers will compare the outcomes for participants who start TAI within the first three months with those who start after three months, to see if early TAI can reduce the number of daily bowel movements more effectively than starting later.\n\nThe study will also determine whether early TAI can improve typical bowel symptoms, enhance quality of life, and increase satisfaction with treatment as much as when it is performed more than three months after stoma closure.\n\nParticipants will:\n\n* Undergo a preliminary visit to assess their eligibility to participate\n* Undergo training to understand how to use the device correctly\n* Perform regular TAI\n* Undergo four control visits at 1, 3, 6 and 9 months after the start of treatment.",[53],"Low Anterior Resection Syndrome (LARS)",[55,56,57,58,59,60,61,62,63],"LARS","Trans-Anal Irrigation","Rectal Cancer","Low Anterior Resection Syndrome","Constipation","Bowel movements","Fecal incontinence","TAI","Peristeen Plus","NOT_YET_RECRUITING","2026-07-08",{"date":67,"type":68},"2026-07-10","ACTUAL",{"date":70,"type":47},"2026-09",{"date":72,"type":47},"2029-06",{"name":33,"class":6}]