Chronic Pain After Inguinal Hernia Repair

Chronic Pain Clinical Trial

— GRIP-ME  

Official title:

A Multicenter Prospective Randomized Trial on Chronic Pain After Inguinal Hernia Repair Using a Selfgrip-mesh

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820131
• Other study ID #: EK MUW 613/2007
• Status: Completed
• Phase: Phase 4
• First received: January 8, 2009
• Last updated: December 8, 2014
• Start date: January 2008
• Est. completion date: December 2014

Study information

• Verified date: January 2009
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• selfgrip mesh
inguinal hernia repair using a selfgrip mesh
• lightweight mesh with suture fixation
inguinal hernia repair using a lightweight mesh with suture fixation

Locations

Country	Name	City	State
Austria	LKH Feldkirch, Dept. of Surgery	Feldkirch
Austria	Hospital Barmherzige Schwestern	Linz
Austria	LK Weinviertel Mistelbach, Surgical Department	Mistelbach
Austria	KFJ Hospital, Dept. of Surgery	Vienna
Austria	KH Göttlicher Heiland	Vienna
Austria	Medical University of Vienna, Dept. of Surgery	Vienna
Austria	KH Wiener Neustadt, Surgical Department	Wiener Neustadt

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	chronic pain		3 months, 15 months	No
Secondary	morbidity		3 months, 15 months	No
Secondary	recurrence rate		3 months and 15 months	No
Secondary	quality of life		3 months and 15 months	No