AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

NCT ID: NCT00749268

Last Updated: 2015-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2012-11-30

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.

Conditions

Hernia, Inguinal; Hernia, Ventral

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

Group Type: ACTIVE_COMPARATOR

AbsorbaTack

Intervention Type: DEVICE

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.

B

Group Type: ACTIVE_COMPARATOR

ProTack

Intervention Type: DEVICE

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.

Interventions

AbsorbaTack

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.

Intervention Type: DEVICE

ProTack

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

M Rosen

Role: PRINCIPAL_INVESTIGATOR

Case Medical Center, University Hospitals of Cleveland, Cleveland, OH, USA

Locations

University Hospitals at Case Medical Center

Cleveland, Ohio, United States

Greenville Hospital System

Greenville, South Carolina, United States

Countries

United States

Other Identifiers

AS08011

Identifier Type: -

Identifier Source: org_study_id