NCT00905320

Hernia Repair With or Without Sutures

Sutures or No Sutures (SONS)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.

Detailed description

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.

Conditions

• Hernia

Interventions

Type	Name	Description
PROCEDURE	Metallic Fasteners and Sutures	Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.
PROCEDURE	Metallic Fasteners Alone	Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.

Timeline

• Start date: 2009-09-01
• Primary completion: 2016-11-21
• Completion: 2018-11-21
• First posted: 2009-05-20
• Last updated: 2021-04-20

Locations

1 site across 1 country: United States