Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-27 @ 11:25 PM
Study NCT ID:
NCT01022034
Status:
COMPLETED
Last Update Posted:
2009-12-02
First Post:
2009-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pexy Versus Non-pexy for Full Thickness Rectal Prolapse
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012005', 'term': 'Rectal Prolapse'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-01', 'studyFirstSubmitDate': '2009-11-25', 'studyFirstSubmitQcDate': '2009-11-30', 'lastUpdatePostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'long term recurrence of the rectal prolapse', 'timeFrame': 'after 5 years'}]}, 'conditionsModule': {'keywords': ['Rectal prolapse', 'mesh', 'recurrence'], 'conditions': ['Rectal Prolapse']}, 'descriptionModule': {'briefSummary': 'No randomized controlled trial (RCT) has compared no rectopexy to rectopexy for external full-thickness rectal prolapse (FTRP). This study was performed to test the hypothesis that recurrence rates for FTRP following no rectopexy are not inferior to those for rectopexy.\n\nMethod: This is a multicenter randomized non-inferiority trial. Eligible patients were randomized to no rectopexy or rectopexy. The no rectopexy arm was defined as abdominal surgery with rectal mobilization only. The rectopexy arm was defined as abdominal surgery with mobilization and pexy. Sigmoid resection was not randomized and was added in the presence of constipation. The endpoint was recurrence rates defined as presence of external FTRP after surgery. A pre-RCT meta-analysis suggested a sample size of 251 patients based on a 15% expected difference in the 5-year cumulative recurrence rate. Recurrence-free curves will be generated and compared using the Kaplan-Meier method and log-rank test, respectively. A Bonferroni adjustment was used. An adjusted p value of \\<0.01 was considered significant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* informed consent\n* mental ability to understand the procedure\n* age range 18 to 70\n* both sex\n\nExclusion Criteria:\n\n* patients with recurrent rectal prolapse\n* previous pelvic or colorectal surgery\n* previous operation for fecal incontinence\n* Cancer\n* chronic intestinal Inflammatory diseases'}, 'identificationModule': {'nctId': 'NCT01022034', 'acronym': 'Bergamaschi', 'briefTitle': 'Pexy Versus Non-pexy for Full Thickness Rectal Prolapse', 'organization': {'class': 'NETWORK', 'fullName': 'Societa Italiana di Chirurgia ColoRettale'}, 'officialTitle': 'Pexy vs. No Pexy in Abdominal Surgery for Full Thickness Rectal Prolapse in Adults: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Berg.2007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pexy group', 'description': 'This group of patients with full thickness rectal prolapse will receive standard sacral rectopexy with mesh or sutures', 'interventionNames': ['Procedure: sacral rectopexy with sutures or meshes']}, {'type': 'SHAM_COMPARATOR', 'label': 'Non-pexy group', 'description': 'These patients will receive full rectal mobilization from the sacrum but without rectopexy', 'interventionNames': ['Procedure: full rectal mobilization from the sacrum without sacral rectopexy']}], 'interventions': [{'name': 'sacral rectopexy with sutures or meshes', 'type': 'PROCEDURE', 'armGroupLabels': ['Pexy group']}, {'name': 'full rectal mobilization from the sacrum without sacral rectopexy', 'type': 'PROCEDURE', 'armGroupLabels': ['Non-pexy group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11794-3368', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Stony brook University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Societa Italiana di Chirurgia ColoRettale', 'class': 'NETWORK'}, 'responsibleParty': {'oldNameTitle': 'Roberto Bergamaschi MD, PhD, FRCS', 'oldOrganization': 'State Univeristy of New York , Stony Brook'}}}}