Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2026-01-07 @ 11:30 AM
Study NCT ID:
NCT03766061
Status:
COMPLETED
Last Update Posted:
2019-02-01
First Post:
2018-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-30', 'studyFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients presenting with recurrence of hernia', 'timeFrame': '8 months', 'description': 'Recurrence (defined as appearance of swelling in operative site with positive cough impulse) of hernia after surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain from score 1 to 10', 'timeFrame': '3 days', 'description': 'Postoperative pain measured with visual analog score after surgery with 1 being the minimum and 10 being the maximum'}, {'measure': 'Hospital Stay duration in days', 'timeFrame': '1 week', 'description': 'hospital stay (duration of patient from surgery to discharge) after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Paraumbilical Hernia']}, 'descriptionModule': {'briefSummary': 'It is a randomized controlled trial in which we are comparing onlay mesh hernioplasty with sublay mesh hernioplasty for paraumbilical hernia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients of both sexes and age 20 years and above with paraumblical hernia Defect size 3 to 6cm in greatest diameter\n\nExclusion Criteria:\n\n* defect size less than 3cm or greater than 6 cm in greatest diameter Obstructed or strangulated hernia Uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT03766061', 'briefTitle': 'Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Hospital, Lahore'}, 'officialTitle': 'Onlay Mesh Hernioplasty Vs Sublay Mesh Hernioplasty for Paraumbilical Hernia Repair', 'orgStudyIdInfo': {'id': 's8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Onlay Mesh Hernioplasty', 'description': 'In this group patients with paraumbilical hernia are treated with onlay mesh hernioplasty in which we placed mesh on the anterior rectus sheath', 'interventionNames': ['Procedure: Onlay mesh Hernioplasty']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sublay Mesh Hernioplasty', 'description': 'In this group patients with paraumbilical hernia are treated with sublay mesh hernioplasty in which we placed mesh in the retromuscular space', 'interventionNames': ['Procedure: Sublay Mesh Hernioplasty']}], 'interventions': [{'name': 'Onlay mesh Hernioplasty', 'type': 'PROCEDURE', 'description': 'Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath', 'armGroupLabels': ['Onlay Mesh Hernioplasty']}, {'name': 'Sublay Mesh Hernioplasty', 'type': 'PROCEDURE', 'description': 'Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space', 'armGroupLabels': ['Sublay Mesh Hernioplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services hospital', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'Mahmmood Ayyaz, mbbs, fcps', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Services Hospital, Lahore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Services Hospital, Lahore', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Dr. SamiUllah', 'investigatorAffiliation': 'Services Hospital, Lahore'}}}}