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OpenTrials
Completed

NCT Number: NCT00749268

AbsorbaTack Evaluation of Postoperative Pain 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.

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Key information

Conditions

Hernia, Inguinal HERNIA, VENTRAL Hernia Hernia, Abdominal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals at Case Medical Center, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AbsorbaTack

Device

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.

ProTack

Device

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

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Sep 9, 2008
Registry last updated
Oct 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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