AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Hernia, Ventral, Hernia, Inguinal

Intervention / Treatment
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* Device: AbsorbaTack
* Device: ProTack


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Device: AbsorbaTack<br>* 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.<br>|
| Active Comparator: B<br> | Device: ProTack<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hernia