Hernia Repair With or Without Sutures (SONS)
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|ClinicalTrials.gov Identifier: NCT00905320|
Recruitment Status : Recruiting
First Posted : May 20, 2009
Last Update Posted : August 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|Hernia||Procedure: Metallic Fasteners and Sutures Procedure: Metallic Fasteners Alone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Sutures or No Sutures (SONS)|
|Study Start Date :||September 2009|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||August 2021|
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
- Pain [ Time Frame: 12 Weeks ]Short-Form McGill Pain Questionnaire (SFMP)
- Hernia recurrence [ Time Frame: 2 Years ]CT Scan
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905320
|Contact: Don Selzer, MDemail@example.com|
|Contact: Maryanne Bowyer-Cherry, RNfirstname.lastname@example.org|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator: Don Selzer, MD|
|Principal Investigator:||Don Selzer, MD||Indiana University Department of Surgery|