Chronic Pain After Inguinal Hernia Repair

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00820131

Acronym

GRIP-ME

Enrollment

250

Registered

2009-01-09

Start date

2008-01-31

Completion date

2014-12-31

Last updated

2014-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Inguinal Hernia

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.

Interventions

PROCEDUREselfgrip mesh

inguinal hernia repair using a selfgrip mesh

PROCEDURElightweight mesh with suture fixation

inguinal hernia repair using a lightweight mesh with suture fixation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
chronic pain	3 months, 15 months

Secondary

Measure	Time frame
morbidity	3 months, 15 months
recurrence rate	3 months and 15 months
quality of life	3 months and 15 months

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026