Chronic Pain After Inguinal Hernia Repair

NCT00820131 | Completed Phase 4

• 1 other identifier: EK MUW 613/2007
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 7

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. 1.open anterior mesh repair using conventional Lichtenstein technique (sutures for mesh-fixation)
2. 2.open anterior mesh repair using a selfgrip mesh (polylactic-acid gripping system for mesh fixation)

Conditions

Inguinal Hernia; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• chronic pain

  3 months, 15 months

Secondary Outcomes (3)

• morbidity

  3 months, 15 months

• recurrence rate

  3 months and 15 months

• quality of life

  3 months and 15 months

Study Arms (2)

1

EXPERIMENTAL

Procedure: selfgrip mesh

2

ACTIVE COMPARATOR

Procedure: lightweight mesh with suture fixation

Interventions

selfgrip mesh PROCEDURE

inguinal hernia repair using a selfgrip mesh

1

lightweight mesh with suture fixation PROCEDURE

inguinal hernia repair using a lightweight mesh with suture fixation

2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary unilateral inguinal hernia
• years and older

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (7)

LKH Feldkirch, Dept. of Surgery

Feldkirch, Austria

Location

Hospital Barmherzige Schwestern

Linz, Austria

Location

LK Weinviertel Mistelbach, Surgical Department

Mistelbach, Austria

Location

KH Göttlicher Heiland

Vienna, 1170, Austria

Location

KFJ Hospital, Dept. of Surgery

Vienna, Austria

Location

Medical University of Vienna, Dept. of Surgery

Vienna, Austria

Location

KH Wiener Neustadt, Surgical Department

Wiener Neustadt, Austria

Location

MeSH Terms

Conditions

Hernia, Inguinal; Chronic Pain

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Gerhard Prager, MD

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 8, 2009
• First Posted: January 9, 2009
• Study Start: January 1, 2008
• Primary Completion: January 1, 2013
• Study Completion: December 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2009-01

Locations

AU (7)