Chronic Pain After Inguinal Hernia Repair

Phase 4

Completed

• Conditions: Inguinal Hernia; Chronic Pain
• Interventions: Procedure: lightweight mesh with suture fixation; Procedure: selfgrip mesh

• Registration Number: NCT00820131
• Lead Sponsor: Medical University of Vienna

Brief Summary

Chronic pain after inguinal hernia repair has become a major concern. Although tension-free Lichtenstein technique is used and new lightweight meshes have been developed, still up to 40 % of patients complain of some kind of pain even one year after surgery. The necessity of mesh-fixation using sutures, could be causative. However, current data do not provide evidence whether suture fixation in Lichtenstein repair might be the reason for chronic postoperative pain.

A newly developed selfgrip-mesh enables sutureless fixation of the mesh in open inguinal hernia repair. Hereby a polypropylene mesh is combined with a resorbable polylactic-acid gripping system. Thereby the rate of chronic postoperative pain could be decreased.

Two techniques of inguinal hernia repair will be evaluated:

1. open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)

2. open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)

Postoperative pain will be evaluated by visual analog scale and Mc Gill pain questionaire at the 10th day, as well as 3 and 15 months postoperatively.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Status Verified: 2009-01
• Study First Submitted: 2009-01-08
• Study First Submitted QC: 2009-01-08
• Study First Posted: 2009-01-09
• Primary Completion: 2013-01
• Study Completion: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• primary unilateral inguinal hernia
• 18 years and older

Exclusion Criteria

• bilateral hernia
• recurrent hernia
• incarcerated hernia
• malignant disease within the last 5 years
• not able to understand the questionaire

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	lightweight mesh with suture fixation	-
1	selfgrip mesh	-

Primary Outcome Measures

Name	Time	Method
chronic pain	3 months, 15 months

Secondary Outcome Measures

Name	Time	Method
morbidity	3 months, 15 months
recurrence rate	3 months and 15 months
quality of life	3 months and 15 months

Trial Locations

Locations (7)

LKH Feldkirch, Dept. of Surgery; 🇦🇹 Feldkirch, Austria

KH Wiener Neustadt, Surgical Department; 🇦🇹 Wiener Neustadt, Austria

LK Weinviertel Mistelbach, Surgical Department; 🇦🇹 Mistelbach, Austria

Medical University of Vienna, Dept. of Surgery; 🇦🇹 Vienna, Austria

KH Göttlicher Heiland; 🇦🇹 Vienna, Austria

KFJ Hospital, Dept. of Surgery; 🇦🇹 Vienna, Austria

Hospital Barmherzige Schwestern; 🇦🇹 Linz, Austria