Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-27 @ 5:45 AM
Study NCT ID:
NCT00691860
Status:
COMPLETED
Last Update Posted:
2015-09-15
First Post:
2008-06-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use of a Mesh to Prevent Parastomal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2008-06-04', 'studyFirstSubmitQcDate': '2008-06-05', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the reduction in the incidence of Parastomal Hernia after the mesh placement', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parastomal hernias', 'Tolerance of lightweight meshes', 'Paracolostomy hernias', 'Peristomal hernias'], 'conditions': ['Parastomal Hernia']}, 'descriptionModule': {'briefSummary': 'Randomized, controlled, prospective study of 54 patients receiving surgery for cancer of the lower third of the rectum with a permanent end colostomy. The aim of the study was to reduce parastomal hernia (PH) occurrence by implanting a lightweight mesh in the sublay position. Patients were followed up a) clinically and b) radiologically by means of abdominal CT. In the clinical follow-up, hernias were observed in four out of 27 patients (14.8%) in the study group and in eleven out of 27 (40.7%) in the control group (p=0.03). The implantation of the mesh reduces the appearance of PH, is well tolerated, and does not increase morbidity'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for permanent end colostomy to treat cancer of the lower third of the rectum,\n* Aged over 18,\n* Charlson comorbidity index below 7\n* Elective surgery\n* Radical surgery\n\nExclusion Criteria:\n\n* Loop colostomies,\n* Emergency surgery,\n* Body mass index above 35 kg/sq.m.,\n* Palliative surgery,\n* Hepatic cirrhosis,\n* Severe COPD (requiring home oxygen treatment),\n* Corticoid treatment'}, 'identificationModule': {'nctId': 'NCT00691860', 'briefTitle': 'Use of a Mesh to Prevent Parastomal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Corporacion Parc Tauli'}, 'officialTitle': 'Randomized, Controlled, Prospective Study of the Use of a Mesh to Prevent Parastomal Hernia', 'orgStudyIdInfo': {'id': 'CSPT-SerraA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients receiving conventional sigmoid end colostomy plus a lightweight mesh Ultrapro®', 'interventionNames': ['Device: Mesh (Ultrapro ®)', 'Procedure: Conventional sigmoid end colostomy']}, {'type': 'OTHER', 'label': '2', 'description': 'Patients receiving conventional sigmoid end colostomy, without mesh', 'interventionNames': ['Procedure: Conventional sigmoid end colostomy']}], 'interventions': [{'name': 'Mesh (Ultrapro ®)', 'type': 'DEVICE', 'otherNames': ['Ultrapro ®'], 'description': 'In the mesh group, the mesh was placed in the sublay position, above the peritoneum and the posterior rectus sheath of the rectus abdominis muscles, with a minimum of 5 cm of mesh around the colostomy', 'armGroupLabels': ['1']}, {'name': 'Conventional sigmoid end colostomy', 'type': 'PROCEDURE', 'description': 'Patients receiving conventional sigmoid end colostomy, without mesh', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Salvador Navarro-Soto, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Corporacio Sanitaria Parc Tauli'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corporacion Parc Tauli', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Xavier Serra-Aracil', 'oldOrganization': 'Corporacio Sanitaria Parc Tauli'}}}}