The Outcome After Lichtenstein Operation vs. ProGrip Patch Repair of Inguinal Hernia

Not Applicable

Completed

• Conditions: Inguinal Hernia; Primary; Unilateral
• Interventions: Device: Open inguinal hernia repair

• Registration Number: NCT01026935
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Status Verified: 2009-12
• Study First Submitted: 2009-12-04
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Primary Completion: 2010-01
• Study Completion: 2011-01
• Last Update Submitted: 2011-07-19
• Last Update Posted: 2011-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 398

Inclusion Criteria

• primary unilateral inguinal hernia

Exclusion Criteria

• not willing to participate
• not capable to understand or fill in the questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sutured mesh	Open inguinal hernia repair	200 patients are randomized to inguinal hernia repair with sutured light weight (38g/m2) polypropylene mesh (Lichtenstein repair)
non-sutured mesh	Open inguinal hernia repair	200 patients are randomized to receive a light weight mesh that adheres to tissues with polylactic micro hooks without sutures

Primary Outcome Measures

Name	Time	Method
postoperative complaints	One year

Secondary Outcome Measures

Name	Time	Method
Recurrence rate	One year

Trial Locations

Locations (2)

HUCH Surgical Hospital, Dept of Surgery; 🇫🇮 Helsinki, Finland

HUCH Jorvi Hospital, department of Surgery; 🇫🇮 Espoo, Finland