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Completed

NCT Number: NCT00659542

Glubran Mesh Fixation in Lichtenstein Hernioplasty

The purpose of the study is to investigate whether chronic postoperative pain is less frequent and quality of life better when inguinal mesh is fixed by using tissue glue compared to conventional sutures in inguinal hernioplasty.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hannu Paajanen

Kuopio, 1777, Finland

About this study

Repair of inguinal hernia in one of the most frequently performed surgical operation in western world. The technique of choice is currently to support inguinal tissues by using polypropylene mesh. Chronic postoperative pain and discomfort occur in 25-30% of patients after inguinal hernioplasty. Pain might be related to mesh fixation by sutures. This randomized study investigates whether mesh fixation by tissue glue (cyanoacrylate) is better than sutures. The patients are followed 1 year postoperatively. Pain, quality of life, operative parameters (time, cost) and recurrences are reported.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • inguinal hernia
  • adult patient

Exclusion criteria

  • patient not willing
  • multiple recurrences
  • inguinal pain without evidence of hernia
  • femoral hernia
  • large scrotal hernia

Treatment and study plan

cyanoacrylate glue

Procedure

1 ml glue

Other names: Glubran2 synthetic surgical glue

Primary outcomes

  1. postoperative pain

    Time frame: 1 year

Secondary outcomes

  1. hernia recurrence, quality of life

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Collaborators

  • North Karelia Central Hospital
  • Paijat-Hame Hospital District

Registry information

Official study title

Randomized Study of Mesh Fixation With Absorbable Sutures or Glubran Tissue Sealant in Lichtenstein Hernioplasty

Acronym: Cyanoacr

Important dates

Study start
2007
Primary completion
2008
Study completion
2009
First posted
Apr 16, 2008
Registry last updated
Mar 11, 2010

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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