NCT00749268

AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair: A Prospective, Randomized Comparison to Evaluate the Incidence of Post-operative Pain Associated With Absorbable Fixation (AbsorbaTack) vs Conventional Fixation (ProTack) Following Laparoscopic Hernia Repair

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 216 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess pain that occurs following hernia repair that is related to mesh fixation. The study is designed to see if there is any difference in pain after surgery between absorbable and permanent methods of mesh fixation in inguinal and ventral hernia repair.

Conditions

• Hernia, Inguinal
• Hernia, Ventral

Interventions

Type	Name	Description
DEVICE	AbsorbaTack	Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.
DEVICE	ProTack	Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-12-01
• Completion: 2012-11-01
• First posted: 2008-09-09
• Last updated: 2015-10-05
• Results posted: 2015-10-05

Locations

2 sites across 1 country: United States