AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00749268
• Other study ID #: AS08011
• Status: Completed
• Phase: Phase 4
• First received: September 8, 2008
• Last updated: September 9, 2015
• Start date: October 2008
• Est. completion date: November 2012

Study information

• Verified date: September 2015
• Source: Medtronic - MITG
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardFrance: Institutional Ethical CommitteeGermany: Ethics Commission
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: November 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Ventral
• Pain, Postoperative

Intervention

Device:
• 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.
• 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.

Locations

Country	Name	City	State
United States	University Hospitals at Case Medical Center	Cleveland	Ohio
United States	Greenville Hospital System	Greenville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic - MITG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	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".	Discharge, Month 1, Month 6, Month 12	No
Primary	Safety for Laparoscopic Hernia Repair as Measured by Number of Patients Experiencing Device Related Events		One year	Yes
Secondary	Quality of Life	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.	Pre-op, Month 1, Month 6, 1 year	No
Secondary	Hernia Recurrence		Discharge, 1 Month, 6 Month, 1 year	No