Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 12:35 PM
Study NCT ID:
NCT02870192
Status:
UNKNOWN
Last Update Posted:
2016-08-17
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-12', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-12', 'lastUpdatePostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intra-operative complications', 'timeFrame': '30 days postoperative', 'description': 'All complications occur during the operation and discovered and managed during the operation or passed undiscovered and discovered postoperative during the same admission or require readmission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rectal Prolapse'], 'conditions': ['Rectal Prolapse']}, 'descriptionModule': {'briefSummary': 'Outcomes of laparoscopic ventral mesh rectopexy are well known, but data on intra-operative adverse events is scant. A multicenter pool-analysis of prospectively collected database on 1384 patients with internal/external rectal prolapse toke place. Overall 72 (5%) patients experienced complications, 41 discovered and managed intraoperatively, 22 postoperative complications, and 9 required readmission. Despite accepted lower rate of morbidity, these results come from four well equipped European centers by four surgeons practiced at least 200 LVMR.', 'detailedDescription': 'Multicenter pooled-analysis of LVMR for internal/external rectal prolapse. All events occurred and discovered intra-operatively or passed undiagnosed and appeared within 30-days postoperatively (same admission/readmission) will included, with classification according to the Clavien-Dindo classification.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients underwent laparoscopic ventral mesh rectopexy for internal and external rectal prolapse\n\nExclusion Criteria:\n\n* other condition than rectal prolapse'}, 'identificationModule': {'nctId': 'NCT02870192', 'briefTitle': 'Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy', 'organization': {'class': 'OTHER', 'fullName': 'University of Rome Tor Vergata'}, 'officialTitle': 'Intra-operative Adverse Events During Laparoscopic Ventral Mesh Rectopexy', 'orgStudyIdInfo': {'id': '91/12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rectal Prolapse', 'description': 'Patients with rectal prolapse, who will underwent laparoscopic ventral mesh rectopexy. The implemented mesh may be synthetic or biological.', 'interventionNames': ['Procedure: Laparoscopic ventral mesh rectopexy']}], 'interventions': [{'name': 'Laparoscopic ventral mesh rectopexy', 'type': 'PROCEDURE', 'description': 'Laparoscopic opening of the Daglous pouch, dissection till reach the levator ani muscle, mesh implementation and fixation, closure of the daglous. The mesh implemented may be synthetic or biological mesh.', 'armGroupLabels': ['Rectal Prolapse']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mostafa Shalaby, MD, MSc', 'role': 'CONTACT', 'email': 'shalaby-mostafa@hotmail.com', 'phone': '0039329353441'}, {'name': 'Pierpaolo Sileri, MD, PhD', 'role': 'CONTACT', 'email': 'piersileri@yahoo.com'}], 'overallOfficials': [{'name': 'Pierpaolo Sileri, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Rome Tor Vergata'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rome Tor Vergata', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Pierpaolo Sileri', 'investigatorAffiliation': 'University of Rome Tor Vergata'}}}}