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Completed

NCT Number: NCT00820131

Chronic Pain After Inguinal Hernia Repair

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.

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

LKH Feldkirch, Dept. of Surgery, Feldkirch, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

selfgrip mesh

Procedure

inguinal hernia repair using a selfgrip mesh

lightweight mesh with suture fixation

Procedure

inguinal hernia repair using a lightweight mesh with suture fixation

Primary outcomes

  1. chronic pain

    Time frame: 3 months, 15 months

Secondary outcomes

  1. morbidity

    Time frame: 3 months, 15 months

  2. recurrence rate

    Time frame: 3 months and 15 months

  3. quality of life

    Time frame: 3 months and 15 months

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: GRIP-ME

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Jan 9, 2009
Registry last updated
Dec 9, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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