[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bowel-cleansing-prior-to-clinical-procedures\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bowel-cleansing-prior-to-clinical-procedures":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"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":30,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100647829","oral-antibiotics-vs-no-antibiotics-in-pediatric-colorectal-surgery-100647829",false,"NCT07713433","Oral Antibiotics vs. No Antibiotics in Pediatric Colorectal Surgery","Comparison of Outcomes of Pre-operative Oral Antibiotics vs no Antibiotics in Elective Colorectal Surgeries in Children","PEACO","Inclusion Criteria:\n\nChildren with colostomy planned for colostomy closure or pull through procedure for conditions including\n\n1. Anorectal malformation\n2. Hirschsprung's Disease\n3. Perianal Infections\n4. Perineal Trauma\n5. Any other condition requiring diversion colostomy\n\nExclusion Criteria:\n\n1. Children with small bowel stomas\n2. poor general condition (Malnutrition, immunodeficiency)\n3. Previous attempt at repair of colostomy (Reversal\u002FPull through)","ALL","1 Year","15 Years",{"count":21,"type":22},74,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study aims to evaluate whether giving oral antibiotics before elective colorectal surgery can improve recovery and reduce complications in children.\n\nColorectal surgery is commonly performed in children for conditions such as Hirschsprung disease, anorectal malformations, and other bowel disorders. Because the large intestine normally contains many bacteria, these operations carry a higher risk of infection and other postoperative complications. Some surgeons prescribe oral antibiotics before surgery to reduce the number of bacteria in the bowel, while others do not use this approach routinely.\n\nIn this study, children scheduled for elective colorectal surgery will be randomly assigned to one of two groups. One group will receive oral antibiotics before surgery, while the other group will receive standard preparation without oral antibiotics. All children will otherwise receive the same surgical and postoperative care according to hospital guidelines.\n\nResearchers will compare the two groups for important outcomes including surgical site infection, leakage from the bowel connection (anastomotic leak), and length of hospital stay. Additional information regarding recovery and postoperative complications will also be collected.\n\nParticipation in the study will not affect the quality of treatment provided. Parents or guardians may withdraw their child from the study at any time without affecting routine medical care. The results of this research may help determine whether preoperative oral antibiotics should be routinely used in children undergoing elective colorectal surgery and may contribute to improving surgical outcomes and reducing healthcare costs.",[28,29],"Bowel Cleansing Prior to Clinical Procedures","Colorectal Anastomosis",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"pediatric","colorectal","colostomy","duhamel","closure","hirschprung's disease","anorectal malformation","soave pull through","swenson","abdomino-perineal pull through","perineal injury","perineal wounds","ARM","Bowel preparation","oral antibiotics","RECRUITING","2026-07-16",{"date":49,"type":50},"2026-07-20","ACTUAL",{"date":52,"type":50},"2025-01-06",{"date":54,"type":22},"2026-08",{"name":56,"class":57},"Muhammad Zubair Shoukat","OTHER",1,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":23,"phases":70,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100609741","phase-3-a-study-to-investigate-bowel-cleansing-with-plenvu-compared-to-sodium-picosulfate-in-participants-aged-1-to--18-years-of-age-in-preparation-for-colonoscopy-100609741","NCT07218523","A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to \u003C 18 Years of Age in Preparation for Colonoscopy","A Phase 3, Multicentre, Randomised (1:1), Parallel-group, Active-controlled, Central Reader Colonoscopist-blind Study to Evaluate the Bowel Cleansing Efficacy, Safety, Tolerability, Palatability, and Acceptability of PLENVU® as Compared to Sodium Picosulfate in Paediatric Participants From 1 to \u003C 18 Years of Age in Preparation for Colonoscopy (CLARITY)","CLARITY","Inclusion Criteria:\n\n* Participants who require a colonoscopy.\n* Must weigh a minimum of 10 kg, and participants aged 1 to \\\u003C 4 years of age must be above the 10th percentile of weight for age.\n* Must have a negative urine pregnancy test (or serum if a urine pregnancy test cannot be confirmed as negative \\[e.g. three ambiguous results\\]) within 24 hours before the first dose of study intervention.\n* Must use a highly effective method of contraception (failure rate \\\u003C 1% per year) from Day 1 and throughout the Safety Follow-up Period.\n* Must not be breastfeeding.\n* Participant is able to receive regular external feeding without breastfeeding.\n\nExclusion Criteria:\n\n* Has a past history within last 12 months or current episode of severe constipation (requiring repeated use of laxatives\u002Fenema or physical intervention before resolution).\n* Has known or suspected ileus, GI obstruction, gastric retention, bowel perforation, toxic colitis, ischaemic colitis, or megacolon.\n* Has ongoing severe acute inflammatory bowel disease that contraindicates colonoscopy.\n* Participant has history of significant GI surgeries.\n* Has known glucose-6-phosphate dehydrogenase (G6PD) deficiency or phenylketonuria.\n* Participant has a past history within the last 12 months or evidence of any ongoing clinically relevant electrocardiogram (ECG) abnormalities (e.g. arrhythmias).\n* Has a history of uncontrolled hypertension.\n* Participant has regularly used laxatives or colon motility altering drugs in the last month (i.e. more than two times per week) and\u002For has used one or more laxatives within 72 hours prior to administration of the preparation.\n* Has known hypersensitivity or allergic reaction to PEG, ascorbic acid, sodium picosulfate, magnesium oxide, or any other component of the investigational product or comparator.\n* Received or scheduled to receive any vaccines or devices within one week prior to first dose of study intervention.\n* Has a significant neurological disorder or a past history of seizures (excluding simple febrile seizures) or is currently on medication lowering seizure threshold (e.g. tricyclic antidepressants) or has used seizure threshold lowering medication within 14 days prior to administration of the preparation.","17 Years",{"count":69,"type":22},212,[71],"PHASE3","The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are scheduled to undergo a colonoscopy. Colonoscopy is a crucial procedure that helps to diagnose and manage various gastrointestinal (GI) conditions in paediatric patients. An adequate level of bowel preparation and cleansing is essential for effective colonoscopy to allow proper visualisation of the bowel.",[28],[75,76,77,78,79,80,81],"Colonoscopy","Paediatric","Harefield Cleansing Scale","Boston Bowel Preparation Scale","Plenvu","Polyethylene Glycol (PEG)","Bowel Cleansing","2026-05-26",{"date":84,"type":50},"2026-05-27",{"date":86,"type":50},"2025-12-29",{"date":88,"type":22},"2027-01-06",{"name":90,"class":91},"Norgine","INDUSTRY",41]