AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
| Status: | Completed |
|---|---|
| Conditions: | Post-Surgical Pain, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2008 |
| End Date: | November 2012 |
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.
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
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