Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2026-01-08 @ 9:53 PM
Study NCT ID:
NCT03133533
Status:
WITHDRAWN
Last Update Posted:
2018-06-18
First Post:
2017-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to receive either laparoscopic or robot-assisted repair of inguinal hernia.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'PI on an extended leave of absence.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-14', 'studyFirstSubmitDate': '2017-04-25', 'studyFirstSubmitQcDate': '2017-04-27', 'lastUpdatePostDateStruct': {'date': '2018-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': 'From immediately post-operative until year five following surgical inguinal hernia repair.', 'description': 'Postoperative 30 day complication rates will be recorded prospectively. All complications (including multiple occurrences per patient) will be recorded and graded per the Clavien-Dindo classification system.'}], 'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'Immediate perioperative time', 'description': 'Time from start to finish of procedure, procedure start and stop times as recorded by anesthesia.'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain score', 'timeFrame': 'Until 5 year postoperative', 'description': 'Abdominal pain at rest and on moving (recumbent to the upright position), will be assessed using 0-10 Numeric Pain Rating Scale preoperatively (baseline), and at 24 hours, 30 days, one and five years postoperatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['robot-assisted'], 'conditions': ['Hernia, Inguinal']}, 'descriptionModule': {'briefSummary': 'Randomized trial to compare outcomes of laparoscopic and robot assisted inguinal hernia repair.', 'detailedDescription': 'Inguinal hernia repair is a very common surgical operation. Both laparoscopic and robot-assisted operations are considered acceptable. However, there is no clear indication for a particular approach. No prospective trial has been conducted so far to establish superiority of one approach over the other. The Investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. The Investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. The Investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. The Investigator will compare all variables to establish differences between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* surgeon determined need for inguinal hernia repair\n\nExclusion Criteria:\n\n* \\< 18 years of age\n* \\> 99 years of age\n* medical indication for open repair'}, 'identificationModule': {'nctId': 'NCT03133533', 'briefTitle': 'Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: A Single Institution Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': 'Laparoscopic Versus Robot-assisted Inguinal Hernia Repair: The Immediate, Intermediate, and Long Term Outcome Differences. A Single Institution Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'IRB201601494'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic', 'description': 'laparoscopic inguinal hernia repair', 'interventionNames': ['Procedure: laparoscopic repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'robot-assisted', 'description': 'robot-assisted inguinal hernia repair', 'interventionNames': ['Procedure: robot-assisted repair']}], 'interventions': [{'name': 'laparoscopic repair', 'type': 'PROCEDURE', 'description': 'Surgical inguinal hernia repair using laparoscopic approach.', 'armGroupLabels': ['laparoscopic']}, {'name': 'robot-assisted repair', 'type': 'PROCEDURE', 'description': 'Surgical inguinal hernia repair using robot-assisted approach.', 'armGroupLabels': ['robot-assisted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Michael Latzko, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}