Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-01-02 @ 3:13 PM
Study NCT ID:
NCT01656369
Status:
COMPLETED
Last Update Posted:
2015-11-23
First Post:
2012-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study Between Delorme Operation With or Without Postanal Repair in Treatment of Complete Rectal Prolapse
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-01', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-20', 'studyFirstSubmitDate': '2012-07-26', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': 'one year postoperative', 'description': 'recurrence rate'}], 'secondaryOutcomes': [{'measure': 'changes of bowel habit', 'timeFrame': 'early postoperative, after 1 year', 'description': 'changes of bowel habit'}, {'measure': 'incontinence', 'timeFrame': '30 day postoperative,and one year postoperative', 'description': 'incontinence'}, {'measure': 'manometric study', 'timeFrame': 'one year postoperative', 'description': 'manometric study (resting pressure, squeezing pressure)'}, {'measure': 'complications', 'timeFrame': '30 day postoperative', 'description': 'stricture, disruption'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Delorme operation,incontinence'], 'conditions': ['Rectal Prolapse']}, 'referencesModule': {'references': [{'pmid': '23187047', 'type': 'DERIVED', 'citation': 'Youssef M, Thabet W, El Nakeeb A, Magdy A, Alla EA, El Nabeey MA, Fouda el Y, Omar W, Farid M. Comparative study between Delorme operation with or without postanal repair and levateroplasty in treatment of complete rectal prolapse. Int J Surg. 2013;11(1):52-8. doi: 10.1016/j.ijsu.2012.11.011. Epub 2012 Nov 24.'}], 'seeAlsoLinks': [{'url': 'http://www.mans.edu.eg/', 'label': 'Mansoura university'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare Delorme operation alone or with post anal repair and levatorplasty for treating complete rectal prolapse.consecutive patients who were treated for complete rectal prolapse at the Colorectal Surgery Unit were eligible for the study.The patients were randomized into two groups: Group I: consisted of patients were subjected to delorme operation only. Group II: consisted of patients were subjected to delorme operation with post anal repair and levatorplasty.', 'detailedDescription': 'Rectal procidentia frequently occurs in older women. Patients usually present with obstructed defecation or fecal incontinence. This study is to compare Delorme operation alone or with post anal repair and levatorplasty for treating complete rectal prolapse. Consecutive patients who were treated for complete rectal prolapse at our Colorectal Surgery Unit were eligible for the study. Exclusion criteria include pregnant female, any patients with previous anal surgery, pudendal nerve neuropathy, anal fistula and sepsis or coagulopathy. All patients underwent clinical evaluation, proctoscopic examination, and sigmoidoscopy. Anorectal physiology studies consisted of anal manometry and measurement of pudendal nerve terminal motor latency (PNTML) to exclude pudendal nerve entrapment syndrome. Patients enrolled in the study were randomized into three groups using the closed envelope method. The envelopes were drawn and opened by a nurse not otherwise engaged in the study in the operating room. The patients were randomized into two groups: Group I: consisted of patients were subjected to delorme operation only. Group II: consisted of patients were subjected to delorme operation with post anal repair and levatorplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '64 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* complete rectal prolapse\n\nExclusion Criteria:\n\n* pregnant female\n* any patients with previous anal surgery\n* pudendal nerve neuropathy\n* anal fistula and sepsis or coagulopathy'}, 'identificationModule': {'nctId': 'NCT01656369', 'briefTitle': 'Comparative Study Between Delorme Operation With or Without Postanal Repair in Treatment of Complete Rectal Prolapse', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Comparative Study Between Delorme Operation With or Without Postanal Repair and Levatorplasty in Treatment of Complete Rectal Prolapse.', 'orgStudyIdInfo': {'id': 'Rectal prolapse'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group I delorme operation only.', 'description': "A circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed. Postoperatively, minimal pain medication was required. Early ambulation was encouraged, and patients' diets were advanced as tolerated.", 'interventionNames': ['Procedure: Group I: delorme operation only.']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'delorme operation with post anal repair', 'description': 'In group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.', 'interventionNames': ['Procedure: delorme operation with post anal repair']}], 'interventions': [{'name': 'Group I: delorme operation only.', 'type': 'PROCEDURE', 'otherNames': ['Group I'], 'description': 'A circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed.', 'armGroupLabels': ['Group I delorme operation only.']}, {'name': 'delorme operation with post anal repair', 'type': 'PROCEDURE', 'otherNames': ['Group II'], 'description': 'In group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.', 'armGroupLabels': ['delorme operation with post anal repair']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Mansurah', 'country': 'Egypt', 'facility': 'Ayman El Nakeeb', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'ayman el nakeeb, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'mansoura university', 'investigatorFullName': 'Ayman El Nakeeb', 'investigatorAffiliation': 'Mansoura University'}}}}