[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Qufora A\u002FS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"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":4},"100629357","outcome-research-in-bowel-irrigation-techniques-for-the-treatment-of-chronic-constipation-andor-faecal-incontinence-100629357",false,"NCT07473622","Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and\u002For Faecal Incontinence","Outcome Research in Bowel Irrigation Techniques: A Novel Self-retaining Catheter Compared With a Conventional Balloon Catheter for the Treatment of Chronic Constipation and\u002For Faecal Incontinence, a Real-world Randomised Explorative Investigation.","ORBIT-1","Inclusion Criteria:\n\n* Faecal incontinence (FI), chronic constipation (CC) or co-existing FI\u002FCC, all of heterogenous origin\n* Positive Rome IV criteria for functional constipation and\u002For positive Rome IV criteria for faecal incontinence\n* 18 years or older\n* Ability to understand written and spoken English (due to questionnaire validity)\n* Ability to understand and provide written, informed consent prior to any investigation-specific procedures\n\nExclusion Criteria:\n\n* Prior use of transanal irrigation\n* Neurogenic bowel dysfunction\n* Low anterior resection syndrome (this group will be excluded due to the possibility of being randomised to a balloon catheter).\n* Previous rectal and\u002For anal surgery (except minor rectal or anal surgery such as haemorrhoid procedures, anal fissure surgery, drainage of a perianal\u002Frectal abscess, or other rectal or anal surgeries deemed minor by the investigator)\n* Physical disability that affects the ability to independently use the irrigation device\n* Intermittent use of opioids inducing chronic constipation\n* Patulous anus\n* Participation in research conflicting with the current investigation\n* Physical or mental conditions affecting the ability to comply with the clinical investigation plan\n* Pregnancy or plans to become pregnant during the investigation period","ALL","18 Years",{"count":20,"type":21},66,"ESTIMATED","INTERVENTIONAL",[24],"NA","This clinical investigation is a post-market, exploratory, randomised, parallel, open-label investigation comparing two UKCA\u002FCE-marked transanal irrigation products for the management of faecal incontinence and\u002For chronic constipation of heterogenous origin. The aim of this investigation is to assess outcomes in a real-world clinical setting, by following the typical clinical routine, with randomisation and more frequent visits\u002Fphone calls as the only difference from typical clinical procedure.\n\nDuring 4-week training period, participants will trained by nurse specialists on how to use the device to which they were randomised to and will be instructed to irrigate once per day. For the remainder of the investigation, participants will be advised to continue irrigation once daily (or a minimum of 3 times a week). Participants will be followed up via phone call or in-person visit up to 52 weeks.",[27,28],"Faecal Incontinence","Chronic Constipation","NOT_YET_RECRUITING","2026-03-10",{"date":32,"type":33},"2026-03-16","ACTUAL",{"date":35,"type":21},"2026-08-01",{"date":37,"type":21},"2028-02",{"name":39,"class":40},"Qufora A\u002FS","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":56,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100587035","a-randomised-clinical-investigation-to-assess-efficacy-of-low-volume-transanal-irrigation-by-qufora-irrisedo-minigo-versus-conservative-treatment-for-low-anterior-resection-syndrome-patients-100587035","NCT06923150","A Randomised Clinical Investigation to Assess Efficacy of Low Volume Transanal Irrigation by Qufora® IrriSedo MiniGo Versus Conservative Treatment for Low Anterior Resection Syndrome Patients","MINIGO","Inclusion Criteria:\n\n1. Adult aged from 18 years\n2. Patients electively treated for rectal cancer with a low anterior resection\n3. Between 3 and 18 months after the conservative colorectal surgery or 3 and 18 months after the stoma reversal if applicable\n4. LARS score \\>= 25 (minor or major LARS) (Emmertsen and Laurberg 2012) AND LARS definition as consensus with at least one symptom that results in at least one consequence (Keane et al. 2020)\n5. Adult for whom previous conservative treatments were started for at least a month\n6. Mental and physical capability of the patient to handle the MiniGo by himself.\n7. Check of the anastomosis (no signs of leakage or clinical relevant stenosis) and absence of local recurrence by Rectal digital examination of the anastomosis, any other exam used in the current practice\n8. Patient affiliated to the health social security system\n\nExclusion Criteria:\n\n1. Contra-indication to use TAI\n2. Former use of TAI (post colo-rectal surgery)\n3. Clinically relevant stenosis\n4. Current metastatic disease or local recurrence\n5. Ongoing chemotherapy\n6. Postoperative radiotherapy for rectal cancer\n7. History of diarrhoeal disease\n8. Inflammatory bowel disease\n9. Dementia\n10. Spinal cord injury, multiple sclerosis, Parkinson's disease or other significant disease assessed to be a contributory cause to LARS symptoms.\n11. Patient with cancer recurrence\n12. Patient with a life expectancy \\\u003C 1 year\n13. Participating to another clinical trial for the treatment of LARS symptom\n14. Ongoing pelvic floor rehabilitation\u002Fbiofeedback\n15. Pregnancy or intention to become pregnant during the trial period\n16. Inability and unwillingness to give informed consent",{"count":49,"type":21},78,"OBSERVATIONAL","The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.",[53,54,55],"Gastroenterology","LARS - Low Anterior Resection Syndrome","Rectal Cancer",[57,58,59,60],"LARS","Transanal Irrigation","Minigo","rectal cancer","RECRUITING","2025-04-03",{"date":64,"type":33},"2025-04-11",{"date":66,"type":33},"2024-06-18",{"date":68,"type":21},"2026-12",{"name":39,"class":40},9,""]