AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Medtronic

Status and phase

Completed

Phase 4

Conditions

Hernia, Inguinal

Hernia, Ventral

Treatments

Device: ProTack

Device: AbsorbaTack

Study type

Interventional

Funder types

Industry

Identifiers

NCT00749268

AS08011

Details and patient eligibility

About

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.

Enrollment

216 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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