Skip to main content
OpenTrials
Completed

NCT Number: NCT00815698

Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair

The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital, Copenhagen, Copenhaven, Denmark

Loading trial locations.

About this study

Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy males 18-80 years
  • Primary inguinal unilateral hernia

Exclusion criteria

  • Recurrent hernia
  • Bilateral, scrotal or femoral hernia
  • BMI above 35

Treatment and study plan

Suture

Procedure

suture for mesh fixation

Other names: Prolene and Vicryl sutures

no suture

Procedure

no suture for mesh fixation, because we use a self-adhesive mesh

Other names: Progrip mesh

Primary outcomes

  1. Pain, Numbness and Discomfort in the Groin

    Time frame: 12 months after surgery

    The primary endpoint was a combined measure that evaluated the prevalence of symptoms considered moderate or severe. These symptoms included moderate to severe chronic pain and/or numbness and/or groin discomfort at the 12-month visit.

Secondary outcomes

  1. Recurrence

    Time frame: 12 months after surgery

    recurrence means recurrence of the hernia defined as a new lump in the inguinal region diagnosed by a surgeon to be a new inguinal hernia.

Sponsors and collaborators

Lead sponsor

Jacob Rosenberg

Other

Collaborators

  • Bispebjerg Hospital
  • Frederikshavn Hospital
  • Nyborg Hospital
  • University Hospital, Gentofte, Copenhagen

Registry information

Official study title

Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial

Acronym: Dangrip

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Dec 30, 2008
Registry last updated
Mar 23, 2016

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.