Ignite Creation Date:
2025-12-24 @ 5:25 PM
Ignite Modification Date:
2025-12-28 @ 4:27 AM
Study NCT ID:
NCT05599750
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suture Repair vs Mesh Repair for Incisional Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be blinded to intervention. Recurrence on imaging will be assessed by blinded assessors'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2031-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hernia specific quality of life', 'timeFrame': '1 year', 'description': 'Suture repair will be compared to mesh repair for incisional hernias 2-6cm with respect to quality of life using the Hernia-specific Quality of Life (HerQLes) summary score at one year postoperatively. This is reported as a score from 0-100 with higher numbers indicating better quality of life.'}], 'secondaryOutcomes': [{'measure': 'Hernia specific quality of life', 'timeFrame': '5 years', 'description': 'Compare HerQLes summary score at baseline, 30-day, and 2-year follow-up, and 5-year follow up'}, {'measure': 'PROMIS-3a-Pain Intensity scores', 'timeFrame': '5 years', 'description': 'Compare PROMIS-3a-Pain Intensity scores (a validated measure of pain) at baseline, 30-day, 1-year, 2 years, and 5- year follow up. Scores are reported as raw values from 3-15 or as T-scores from 30.7-71.8, with higher numbers indicating more pain.'}, {'measure': 'Recurrence', 'timeFrame': '5 years', 'description': 'Compare composite recurrence using clinical, radiographic exam, and Hernia Recurrence Inventory (HRI) at 1-year, and 2-year, and 5 year follow-up postoperatively'}, {'measure': 'Complications', 'timeFrame': '5 years', 'description': 'Compare all complications at 30-day, 1-year, 2-year, and 5-year follow-up postoperatively. This includes occurrence of surgical site infections, surgical site occurrence requiring intervention, readmissions, hernia related reoperation, or mortality.'}, {'measure': 'Overall quality of life', 'timeFrame': '5 years', 'description': '4\\. Compare Euro-QOL-5D-5L with VAS assessment scores at baseline, 30-day, 1-year, 2 years, and 5-year follow-up.'}, {'measure': 'Cost effectiveness', 'timeFrame': '5 years', 'description': '5\\. Perform a formal cost effectiveness analysis utilizing quality adjusted life years and incremental cost effectiveness ratios.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '41163187', 'type': 'DERIVED', 'citation': 'Maskal SM, Miller BT, Ellis RC, Beffa LRA, Prabhu AS, Rosen MJ, Krpata DM, Huang LC, Petro CC. A modern comparison of suture repair versus mesh repair for incisional hernia: a study protocol for a randomized controlled trial. Trials. 2025 Oct 29;26(1):450. doi: 10.1186/s13063-025-08924-5.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to compare the difference in quality of life at one year postoperatively for patients undergoing incisional hernia repair with mesh versus suture repair using modern techniques.\n\nThe main question it aims to answer are:\n\n• Determine if primary suture repair is non-inferior to mesh repair for incisional hernias 2-6cm with respect to quality of life using the HerQLes summary score at one year postoperatively.', 'detailedDescription': 'This is a patient-blinded randomized control trial comparing incisional hernia repair using synthetic mesh versus suture repair. This is a non-inferiority trial theorizing that suture repair will be non-inferior with respect to quality of life (using the HerQLes survey) at 1 year postoperatively. Patients will be blinded to the intervention, groups will be in parallel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults \\>18 years old.\n* Anticipated hernia defect 2-6cm in width\n* Non-emergent case\n* CDC class I\n* Patients who previously underwent primary ventral hernia repair without the use of mesh\n* Incisional hernia\n\nExclusion Criteria:\n\n* Emergent cases\n* Patients \\< 18 years old\n* Patients who are pregnant\n* Patients who previously underwent a prior ventral hernia repair with mesh at the site of the intended repair. Abdominal mesh in separate locations would be allowed.\n* Ventral hernia \\<2cm or \\> 6 cm in width\n* Primary hernia\n* CDC wound class II-IV'}, 'identificationModule': {'nctId': 'NCT05599750', 'briefTitle': 'Suture Repair vs Mesh Repair for Incisional Hernia', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'A Modern Comparison of Suture Repair With Mesh Repair for Incisional Hernia', 'orgStudyIdInfo': {'id': '22-945'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hernia repair with mesh (Control arm)', 'description': 'Participants will undergo incisional hernia repair with prolene mesh in the retrorectus position with at least 4cm of overlap.', 'interventionNames': ['Procedure: Incisional hernia repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary closure (Intervention arm)', 'description': 'Participants will undergo incisional hernia repair with suture alone using modern surgical techniques.', 'interventionNames': ['Procedure: Incisional hernia repair']}], 'interventions': [{'name': 'Incisional hernia repair', 'type': 'PROCEDURE', 'description': 'Participants will undergo incisional hernia repair', 'armGroupLabels': ['Hernia repair with mesh (Control arm)', 'Primary closure (Intervention arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mazen Al-Mansour, MD', 'role': 'CONTACT', 'email': 'mazen.al-mansour@surgery.ufl.edu'}], 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Sara Maskal, MD', 'role': 'CONTACT', 'email': 'MASKALS2@ccf.org', 'phone': '216-870-5655'}], 'facility': 'Cleveland Clinic Main Campus', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Benjamin Poulose, MD', 'role': 'CONTACT', 'email': 'benjamin.poulose@osumc.edu'}, {'name': 'Kayla Diaz', 'role': 'CONTACT', 'email': 'kayla.diaz@osumc.edu'}, {'name': 'Benjamin Poulose, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Ohio State University Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Richard Pierce, MD, PhD', 'role': 'CONTACT'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'centralContacts': [{'name': 'Clayton Petro, MD', 'role': 'CONTACT', 'email': 'petroc@ccf.org', 'phone': '2169242930'}, {'name': 'Sara Maskal, MD', 'role': 'CONTACT', 'email': 'maskals2@ccf.org', 'phone': '2168705655'}], 'overallOfficials': [{'name': 'Clayton Petro, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clayton Petro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Clayton Petro', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}