Hernia Repair With or Without Sutures (SONS)
|Hernia||Procedure: Metallic Fasteners and Sutures Procedure: Metallic Fasteners Alone|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Sutures or No Sutures (SONS)|
- Pain [ Time Frame: 12 Weeks ]
- Hernia recurrence [ Time Frame: 2 Years ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||August 2021|
|Estimated Primary Completion Date:||August 2019 (Final data collection date for primary outcome measure)|
Active Comparator: Metallic Fasteners and Sutures
Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures
Procedure: Metallic Fasteners and Sutures
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.
Other Name: Metallic fasteners and sutures.
Experimental: Metallic Fasteners Alone
Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone
Procedure: Metallic Fasteners Alone
Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.
Other Name: Metallic fasteners alone for mesh fixation
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.
Pain 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905320
|Contact: Don Selzer, MDfirstname.lastname@example.org|
|Contact: Maryanne Bowyer-Cherry, RNemail@example.com|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator: Don Selzer, MD|
|Principal Investigator:||Don Selzer, MD||Indiana University Department of Surgery|