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

Medtronic - MITG2 sites in 1 country216 target enrollmentOctober 2008

ConditionsHernia, Inguinal Hernia, Ventral

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hernia, Inguinal
Sponsor: Medtronic - MITG
Enrollment: 216
Locations: 2
Primary Endpoint: Postoperative Pain
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2008

End Date

November 2012

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Medtronic - MITG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Ability and willingness to provide written informed consent and comply with the schedule of protocol assessments
•Age \> 18 years
•Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite reinforcements depending on indication and fixation of reinforcements with helical tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance with recommendations for use

Exclusion Criteria

•Pregnancy
•Patients considered to have greater than reasonable surgical risk associated with general anesthesia and laparoscopic hernia repair
•Known active infection or any major episode of infection requiring hospitalization or treatment with IV antibiotics or oral antibiotics within 30 days prior to screening
•History of alcohol or drug abuse within 6 months prior to screening
•History of chronic pain condition requiring more than 30 days of medical management
•Use of an additional nonresorbable means of fixation (inguinal)
•Patients considered not able to comply with the protocol and follow up schedule
•ASA grade of 4 or above

Outcomes

Primary Outcomes

Postoperative Pain

Time Frame: Discharge, Month 1, Month 6, Month 12

Pain Intensity Numeric Rating Scale (PI-NRS) - change from baseline. Treatments analyzed within inguinal arm and within ventral arm. Scale is 0 - 10 with 0 being "no pain" and 10 being "worst pain imaginable".

Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events

Time Frame: One year