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

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Inguinal; Hernia, Ventral
• Intervention / Treatment: Device: AbsorbaTack; Device: ProTack

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44194
      • University Hospitals at Case Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greenville Hospital System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: A	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.
Active Comparator: B	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	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".	Discharge, Month 1, Month 6, Month 12
Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events		One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Quality of life as measured by the SF-12 which is a multipurpose short form survey with 12 questions. The questions were combined, scored, and weighted to create a scale that provide glimpses into physical functioning and overall health-related-quality of life. The Physical Composite Score was computed using the scores of twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health measured by the scales and 100 indicates the highest level of health.	Pre-op, Month 1, Month 6, 1 year
Hernia Recurrence		Discharge, 1 Month, 6 Month, 1 year

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: M Rosen, Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: September 8, 2008
• First Submitted That Met QC Criteria: September 8, 2008
• First Posted (Estimate): September 9, 2008

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: September 9, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: hernia
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Pain, Postoperative; Hernia; Hernia, Inguinal; Hernia, Ventral
• Other Study ID Numbers: AS08011