AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00749268
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : October 5, 2015
Last Update Posted : October 5, 2015
Information provided by (Responsible Party):
Medtronic - MITG

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.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Hernia, Ventral Device: AbsorbaTack Device: ProTack Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2008
Actual Primary Completion Date : December 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

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.

Primary Outcome Measures :
  1. 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".

  2. Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: Pre-op, Month 1, Month 6, 1 year ]

    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.

  2. Hernia Recurrence [ Time Frame: Discharge, 1 Month, 6 Month, 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00749268

United States, Ohio
University Hospitals at Case Medical Center
Cleveland, Ohio, United States, 44194
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Medtronic - MITG
Principal Investigator: M Rosen Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA

Responsible Party: Medtronic - MITG Identifier: NCT00749268     History of Changes
Other Study ID Numbers: AS08011
First Posted: September 9, 2008    Key Record Dates
Results First Posted: October 5, 2015
Last Update Posted: October 5, 2015
Last Verified: September 2015

Keywords provided by Medtronic - MITG:

Additional relevant MeSH terms:
Pain, Postoperative
Hernia, Inguinal
Hernia, Ventral
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Pathological Conditions, Anatomical
Hernia, Abdominal