Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-02-28 @ 9:09 PM
Study NCT ID:
NCT04117633
Status:
COMPLETED
Last Update Posted:
2019-10-08
First Post:
2019-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012005', 'term': 'Rectal Prolapse'}], 'ancestors': [{'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}, {'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The study included two equal groups. one group underwent laparoscopic mesh rectopexy and the other underwent suture rectopexy.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2018-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-06', 'studyFirstSubmitDate': '2019-09-28', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Signs of improvement', 'timeFrame': '12 weeks', 'description': 'No recurrence of Rectal Prolapse'}], 'secondaryOutcomes': [{'measure': 'Signs of improvement', 'timeFrame': '30 weeks', 'description': 'Improvement of Fecal Incontinence score(Rintala score)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal Prolapse', 'Laparoscopy', 'Mesh', 'Rectopexy', 'pediatrics'], 'conditions': ['Rectal Prolapse']}, 'descriptionModule': {'briefSummary': 'Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group Results:', 'detailedDescription': 'Purpose: to compare Laparoscopic mesh rectopexy with laparoscopic suture rectopexy Patient and Methods: The prospective study was conducted at Pediatric Surgery Department, Al-Azhar university hospitals, Cairo, Egypt . The operative time, recurrence rate, post-operative constipation, and effect on fecal incontinence, were reported and evaluated for each group'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nChildren with persistant complete Rectal Prolapse.\n\n* Failure of conservative treatment.\n* more than 2 attacks of prolapse requiring manual reduction.\n\nExclusion Criteria:\n\n* Sever constipation\n* Previous abdominal or pelvic surgery with extensive adhesions.\n* Cases older than 12ys,\n* Patients with rectal polyp'}, 'identificationModule': {'nctId': 'NCT04117633', 'briefTitle': 'Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Laparoscopic Suture Versus Mesh Rectopexy for the Treatment of Persistent Complete Rectal Prolapse in Children : A Comparative Randomized Study', 'orgStudyIdInfo': {'id': 'Azh-Ped-Surg-70712018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mesh Rectopexy', 'description': 'Using Laparoscopy', 'interventionNames': ['Device: Laparoscopy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Suture Rectopexy', 'description': 'Using Laparoscopy', 'interventionNames': ['Device: Laparoscopy']}], 'interventions': [{'name': 'Laparoscopy', 'type': 'DEVICE', 'description': 'Laparoscopic Procedures for Rectopexy', 'armGroupLabels': ['Mesh Rectopexy', 'Suture Rectopexy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'abdelaziz yehya', 'investigatorAffiliation': 'Al-Azhar University'}}}}