Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-27 @ 6:13 AM
Study NCT ID:
NCT03765268
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2018-07-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003714', 'term': 'Denervation'}], 'ancestors': [{'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, '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': '2019-02', 'completionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-02', 'studyFirstSubmitDate': '2018-07-13', 'studyFirstSubmitQcDate': '2018-12-04', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of patients developing chronic inguinodynia', 'timeFrame': '3 months', 'description': 'Excruciating Pain measured by visual analog score (with 1 being minimum score and 10 being maximum score) for more than 3 months in inguinal region after open mesh hernioplasty for inguinal hernia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'It is a randomized controlled trial in which we are treating inguinal hernia patients with mesh hernioplasty and either neurectomy of iliohypogastric nerve and ilioinguinal neurectomy or preservation comparing post operative acute or chronic pain'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients male, and age between 20 to 70 years Reducible inguinal hernia\n\nExclusion Criteria:\n\n* Irreducible, obstructed or strangulated hernia uncontrolled diabetes'}, 'identificationModule': {'nctId': 'NCT03765268', 'briefTitle': 'Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Services Hospital, Lahore'}, 'officialTitle': 'Neurectomy Vs Nerve Sparing in Open Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 's9'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Neurectomy', 'description': 'In this group we did mesh hernioplasty of inguinal hernia with neurectomy of iliohypogastric and ilioinguinal nerve', 'interventionNames': ['Procedure: Neurectomy in inguinal hernia repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nerve Sparing', 'description': 'In this group we did mesh hernioplasty of inguinal hernia with preservation of iliohypogastric and ilioinguinal nerve', 'interventionNames': ['Procedure: nerve sparing in inguinal hernia repair']}], 'interventions': [{'name': 'Neurectomy in inguinal hernia repair', 'type': 'PROCEDURE', 'description': 'Mesh hernioplasty of inguinal hernia with neurectomy of ilioinguinal and iliohypogastric nerve', 'armGroupLabels': ['Neurectomy']}, {'name': 'nerve sparing in inguinal hernia repair', 'type': 'PROCEDURE', 'description': 'Mesh hernioplasty of inguinal hernia with sparing of ilioinguinal and iliohypogastric nerve', 'armGroupLabels': ['Nerve Sparing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Services Hospital Lahore', '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'}}}}