Overview

This trial is active, not recruiting.

Conditions hernia, inguinal, hernia, ventral
Treatments absorbatack, protack
Phase phase 4
Sponsor Covidien
Start date October 2008
End date December 2011
Trial size 371 participants
Trial identifier NCT00749268, AS08011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
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.
(Active Comparator)
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.

Primary Outcomes

Measure
Postoperative Pain
time frame: four time points out to one year
Safety for laparoscopic hernia repair as measured by device related events
time frame: four time points out to one year

Secondary Outcomes

Measure
Quality of life/ time to return to normal activity
time frame: three time points out to one year
Hernia recurrence
time frame: four time points out to one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Trial information was received from ClinicalTrials.gov and was last updated in June 2012.
Information provided to ClinicalTrials.gov by Covidien.