Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:26 AM
Study NCT ID:
NCT00905320
Status:
COMPLETED
Last Update Posted:
2021-04-20
First Post:
2009-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hernia Repair With or Without Sutures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006547', 'term': 'Hernia'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013537', 'term': 'Sutures'}], 'ancestors': [{'id': 'D053831', 'term': 'Surgical Fixation Devices'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2018-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-19', 'studyFirstSubmitDate': '2009-05-18', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2021-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-op Pain', 'timeFrame': '12 Weeks', 'description': 'Short-Form McGill Pain Questionnaire (SFMP)'}], 'secondaryOutcomes': [{'measure': 'Hernia recurrence', 'timeFrame': '2 Years', 'description': 'CT Scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hernia repair'], 'conditions': ['Hernia']}, 'descriptionModule': {'briefSummary': 'This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.', 'detailedDescription': 'This is a randomized study in which subjects will undergo one or two currently accepted techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.\n\nPain will be assessed through week 12, and hernia recurrence will be assessed for 2 years after surgery. Subjects will complete pain questionnaires at baseline, each day during hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life questionnaires will be completed at baseline, at discharge from hospital, and during follow-up visits at 2, 6, and 12 weeks after discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDemographics:\n\n* Age ≥ 18 years old\n* If female, negative pregnancy test\n\nPre-Operative Findings:\n\n* Presence of an abdominal hernia associated with previous surgical incision\n* Midline ventral\\\\incisional hernia demonstrated either on physical examination by investigators or radiologic imaging tests.\n* CT scan, MRI, Ultrasound\n* No evidence of incarceration, strangulation\n* Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)\n* Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter\n\nExclusion Criteria:\n\nPre-Operative History:\n\n* Severe medical co-morbidities that prevent safe performance of laparoscopic surgery including coronary artery disease, obstructive pulmonary disease, etc.\n* History of the following:\n\n * Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)\n * Chronic use (defined as greater than 3 months) of narcotic analgesic for pain other than from the hernia that is intended to be repaired\n* Allergy to products used in hernia repair including surgical mesh\n* Any abdominal ventral incisional hernia previously repaired with permanent synthetic mesh placed inside the peritoneal cavity\n* Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of the abdominal musculature and fascia)\n* Presence of simultaneous intra-abdominal infection\n* Simultaneous presence of a bowel obstruction\n* History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.\n\nIntra-operative Findings:\n\n* Simultaneous performance of another surgical procedure during hernia repair other than acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)\n* Intra-operative identification of full thickness injury to intestine (i.e. enterotomy), liver, bladder, etc.'}, 'identificationModule': {'nctId': 'NCT00905320', 'acronym': 'SONS', 'briefTitle': 'Hernia Repair With or Without Sutures', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Sutures or No Sutures (SONS)', 'orgStudyIdInfo': {'id': '0803-15'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Metallic Fasteners and Sutures', 'description': 'Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures', 'interventionNames': ['Procedure: Metallic Fasteners and Sutures']}, {'type': 'EXPERIMENTAL', 'label': 'Metallic Fasteners Alone', 'description': 'Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone', 'interventionNames': ['Procedure: Metallic Fasteners Alone']}], 'interventions': [{'name': 'Metallic Fasteners and Sutures', 'type': 'PROCEDURE', 'otherNames': ['Metallic fasteners and sutures.'], 'description': 'Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.', 'armGroupLabels': ['Metallic Fasteners and Sutures']}, {'name': 'Metallic Fasteners Alone', 'type': 'PROCEDURE', 'otherNames': ['Metallic fasteners alone for mesh fixation'], 'description': 'Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.', 'armGroupLabels': ['Metallic Fasteners Alone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}], 'overallOfficials': [{'name': 'Don Selzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indiana University Department of Surgery'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Don Selzer', 'investigatorAffiliation': 'Indiana University'}}}}