Ignite Creation Date:
2025-12-24 @ 3:29 PM
Ignite Modification Date:
2026-01-06 @ 8:23 PM
Study NCT ID:
NCT03563092
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2018-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005734', 'term': 'Gangrene'}], 'ancestors': [{'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Open-label, randomized clinical trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-12', 'studyFirstSubmitDate': '2018-05-28', 'studyFirstSubmitQcDate': '2018-06-08', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Factors affecting seroma', 'timeFrame': 'Day 7', 'description': 'To study the various factors associated with seroma like patients demographics, surgeon related factors, etc.'}], 'primaryOutcomes': [{'measure': 'Number of patients developing symptomatic seroma requiring intervention after surgery', 'timeFrame': 'Month 3', 'description': 'The patients developing symptomatic seroma after hernia surgery, assessed by clinical and radiological evaluation, which needs intervention in form of needle aspiration or sac excision.'}], 'secondaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': 'Month 3'}, {'measure': 'Postoperative Pain', 'timeFrame': 'Day 1', 'description': 'Measured by Visual Analogue Pain Scale'}, {'measure': 'Recurrence', 'timeFrame': 'Month 3', 'description': 'Early recurrence of Hernia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Complete Inguinal Hernia', 'Inguinoscrotal Hernia', 'Laparoscopic hernia repair'], 'conditions': ['Inguinal Hernia Without Obstruction or Gangrene']}, 'descriptionModule': {'briefSummary': 'The current study aims to determine whether a use of closed suction drain following laparoscopic inguinal hernia surgery performed for an inguinoscrotal variety can decrease the incidence of symptomatic seroma formation requiring interventions and thus, prevent postoperative morbidity.', 'detailedDescription': 'Patients with laparoscopic inguinal repair, TEP as well as TAPP approach, which matches the inclusion criteria will be randomized intraoperatively, based on a complete assessment of eligibility, just before the mesh placement.\n\nPatients recruited in closed suction drain arm will receive suction drain(14 French sizes) in preperitoneal space via a separate incision. The patients without drain arm, the regular postoperative course will be followed.\n\nThe drain will be removed once the output falls below 50 ml per day. Both groups will be followed up until three months post-surgery.\n\nClinical suspicion of seroma in symptomatic patients will be confirmed by ultrasound. Seroma will be managed conservatively till three weeks in the post-op period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients having an inguinoscrotal hernia (complete type)\n\nExclusion Criteria:\n\nObstructed, incarcerated or strangulated hernia Patients unwilling to participate'}, 'identificationModule': {'nctId': 'NCT03563092', 'acronym': 'SALHS', 'briefTitle': 'Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'GEM Hospital & Research Center'}, 'officialTitle': 'Closed Suction Drain vs no Drain on Symptomatic Seroma Formation After Laparoscopic Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': 'GEMSALHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lap Inguinal Hernia repair with Drain', 'description': 'A (14 French sizes) closed suction drain will be placed in preperitoneal space after laparoscopic inguinal hernia (TEP/TAPP) surgery.', 'interventionNames': ['Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lap Inguinal Hernia repair without Drain', 'description': 'No drain will be placed after laparoscopic inguinal hernia (TEP/TAPP) surgery.', 'interventionNames': ['Procedure: Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery']}], 'interventions': [{'name': 'Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery', 'type': 'PROCEDURE', 'description': 'Standardized minimally invasive approach to inguinal hernia repair', 'armGroupLabels': ['Lap Inguinal Hernia repair with Drain', 'Lap Inguinal Hernia repair without Drain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '641015', 'city': 'Coimbatore', 'state': 'Tamil Nadu', 'country': 'India', 'facility': 'Sandeep C. Sabnis', 'geoPoint': {'lat': 11.00555, 'lon': 76.96612}}], 'overallOfficials': [{'name': 'Chinnusamy Palanivelu, MS,MCh,FRCS,FACS', 'role': 'STUDY_CHAIR', 'affiliation': 'Gem Hospital and Research Center, Coimbatore, India'}, {'name': 'Sandeep C. Sabnis, MS,DNB', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gem Hospital and research center, Coimbatore, India'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'GEM Hospital & Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}