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.

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