[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"constipation-by-outlet-obstruction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:constipation-by-outlet-obstruction":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":5},"100431850","defecation-patterns-in-constipated-patients-100431850",false,"NCT04903470","Defecation Patterns in Constipated Patients","Understanding Defecation Patterns Using a Novel Device (Fecobionics) to Improve Treatment of Constipation","Inclusion Criteria: Two groups of subjects will be studied - normal healthy subjects and patients with chronic constipation.\n\nNormal subjects:\n\nInclusion criteria \\*Normal defecation pattern, i.e., bowel movement once every day or other day without excessive straining and sense of complete evacuation.\n\nExclusion Criteria:\n\n* Subjects not willing to consent and undergo the specified tests in this study\n* Pregnant women\n* Subjects with concurrent fecal incontinence and constipation symptoms\n* Chronic diseases\n* Taking medications that affect anorectal function\n* History of anorectal surgery or bowel resection.\n\nConstipation patients:\n\nInclusion Criteria:\n\n* Rome IV diagnostic criteria will be used to diagnose chronic constipation. Patients must have experienced at least two of the following symptoms over the preceding 3 months:\n\n  1. Fewer than three spontaneous bowel movements per week,\n  2. Straining for more than 25% of defecation attempts,\n  3. Lumpy or hard stools for at least 25% of defecation attempts, and\n  4. sensation of anorectal obstruction or blockage.\n\n     \\-\n\n     Exclusion Criteria:\n* Patients not willing to consent and undergo the specified tests in this study\n* pregnant women and patients with concurrent fecal incontinence\n* History of anorectal surgery or bowel resection.",true,"ALL","21 Years","75 Years",{"count":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25],"NA","Chronic constipation (CC) is a common condition that affects up to 25% of the population in North America. It poses a major burden on the healthcare cost. The pathophysiology of this condition is poorly understood and consequently there are inadequate treatments. Current diagnostic tests provide incomplete and often conflicting information. Fecobionics is an electronic simulated stool that has the consistency and shape of normal stool. The device records pressures, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The central hypothesis is that rectal peristalsis is a key component of the defecatory reflex which is not assessed in the current paradigm of diagnostic testing. The novel Fecobionics device will mimic the natural defecation and provide new mechanistic insights into the anorectal physiology and pathophysiology to facilitate the development of new treatments for CC. The Specific Aims are as follows: 1) Study the defecation dynamics in normal control subjects using Fecobionics. The investigators will establish the role of rectal contraction\u002Fperistalsis in the normal evacuation process. 2) Define the defecatory patterns in patients with CC associated with defecatory disorders. The investigators will determine if abnormalities of rectal contraction contribute to the CC. 3) Use a mathematical model of anorectal passage of Fecobionics for enhanced understanding of the normal and abnormal defecatory patterns, including the length-tension properties of the rectum and anal sphincter muscles. The proposal seeks to shift current CC research by providing a stool surrogate for examining the physiologic parameters of defecation reflex using a novel device that will record, pressure, deformability, biomechanics, vectoral and topographic changes in the rectum and anal canal. The noted parameters will be recorded using a wireless Fecobionics device that can examine in detail the mechanistic underpinnings (stress and deformation) of defecation reflex\u002Fprocess in health and disease. The impact of this project is that it assesses a novel, safe, low cost, less invasive, low-risk, radiation-free device in its ability to provide better understanding of evacuation and continence mechanisms and thereby facilitate future development of innovative therapies. The improvement can lead to improvement in diagnostic and therapeutic modalities and reduce healthcare costs associated with anorectal disorders.",[28],"Constipation by Outlet Obstruction",[30,31,32,33,34],"Obstructed defecation","Pelvic floor dysynergia","Paradoxical contraction of the anal sphincter","Anorectal motility","Impedance planimetry of anal sphincter","RECRUITING","2025-10-20",{"date":38,"type":39},"2025-10-21","ACTUAL",{"date":41,"type":39},"2022-12-19",{"date":43,"type":22},"2026-12-30",{"name":45,"class":46},"The California Medical Innovations Institute, Inc.","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100523772","the-revo-study-low-volume-vs-high-volume-rectal-irrigation-100523772","NCT06100055","The ReVo Study: Low-volume vs High-volume Rectal Irrigation","The ReVo Study (REctal Irrigation VOlume Study - 'Low Versus High Volume Irrigation - Optimising Rectal Irrigation Volume in Evacuatory Dysfunction'; A Randomised Controlled Trial)","ReVo","Inclusion Criteria:\n\n* All adult patients over 18 years who have self-reported problematic constipation secondary to evacuation disorders\n* With symptom onset of more than 6 months\n* Symptoms must meet American College of Gastroenterology definition of constipation which is symptoms including unsatisfactory defecation with either infrequent stools, difficulty in passing stool or both for at least previous 3 months (25)\n* All should have tried and failed conservative management (laxatives, life-style modification and bio-feedback)\n* Patients should also have ability and willingness to give informed consent.\n* Patients or carer should be able to use rectal irrigation\n\nExclusion Criteria:\n\nPatients with\n\n* Major colorectal resection surgery, pelvic floor surgery to address defaecatory problems such as posterior vaginal repair, STARR, rectopexy and sacral nerve stimulation within last three months\n* Pregnancy\n* Active rectal bleeding\n* Colorectal cancer\n* Complicated diverticular disease or acute diverticulitis\n* Anal or colorectal stenosis\n* Inflammatory bowel disease\n* Undergoing chemotherapy\n* Ischemic colitis\n* Used rectal irrigation in the past one year","18 Years",{"count":57,"type":22},166,[25],"Rectal irrigation, which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation, is recommended to be considered in patients with chronic constipation, which is refractory to conservative measures such as lifestyle modification, laxatives, nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support.\n\nTwo systems of rectal irrigation are available based on volume delivered, low and high volume. It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology.\n\nTherefore, a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum.\n\nThis trial\u002Fresearch aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum.\n\nThe main questions it aims to answer are:\n\n* if one type of rectal irrigation is superior to the other\n* whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound\n* assess the acceptability and response rates to rectal irrigation.\n\nParticipants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups. This will purely be by chance where the possibility of being in either of the groups will be 50%. They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination. Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms. Lastly they will be provided training on using rectal irrigation (the type they have been assigned to). They will then be asked to commence irrigation at home from the next day.\n\nParticipants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again. This data will then be used to assess any improvement in symptoms after using rectal irrigation. After three months of using rectal irrigation, participation in the trial will come to and end.",[61,62,28,63],"Constipation - Functional","Constipation","Defecation Disorder",[65,66,67,68,69],"chronic constipation","rectal irrigation","evacuation disorders","low-volume rectal irrigation","high-volume rectal irrigation","2024-07-26",{"date":72,"type":39},"2024-07-29",{"date":74,"type":39},"2024-05-10",{"date":76,"type":22},"2025-07",{"name":78,"class":46},"Guy's and St Thomas' NHS Foundation Trust",1]