AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Phase 4

Completed

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
B	ProTack	-
A	AbsorbaTack	-

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	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".
Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events	One year

Secondary Outcome Measures

Name	Time	Method
Hernia Recurrence	Discharge, 1 Month, 6 Month, 1 year
Quality of Life	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.

Locations (2): Greenville Hospital System
🇺🇸
Greenville, South Carolina, United States
University Hospitals at Case Medical Center
🇺🇸
Cleveland, Ohio, United States