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Completed

NCT Number: NCT00492804

Elective Neurectomy During Inguinal Hernia Repair

Chronic inguinal neuralgia is one of the most important complications following inguinal hernia repair.

It may even outweigh the benefit of the operation. Intraoperative neurectomy has been investigated to reduce the incidence of chronic pain.

This study evaluates the effects of elective division of the ilioinguinal, iliohypogastric and genital branch of the genitofemoral nerves on pain and postoperative sensory symptoms after Lichtenstein hernia repair.

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Key information

Conditions

Inguinal Hernia Chronic Pain Hernia Hernia, Abdominal Hernia, Inguinal Hypesthesia Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Somatosensory Disorders

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Department of Surgery, Cantonal Hospital of St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Uni- or bilateral inguinal hernia
  • Karnofsky-index ≥70
  • Informed consent

Exclusion criteria

  • Recurrent inguinal hernia
  • Previous inguinal operation
  • Emergent operation
  • Severe comorbidities

Treatment and study plan

Lichtenstein hernia repair

Procedure

Lichtenstein hernia repair with tension free mesh

Neurectomy

Procedure

Neurectomy

Primary outcomes

  1. Incidence of postoperative pain

    Time frame: up to three years

Secondary outcomes

  1. Incidence of hypesthesia or paraesthesia

    Time frame: one and three years

  2. Recurrence rate

    Time frame: one and three years

  3. Rate of intra- and postoperative complications

    Time frame: one and three years

  4. Quality of life

    Time frame: one and three years

Sponsors and collaborators

Lead sponsor

Cantonal Hospital of St. Gallen

Other

Registry information

Official study title

Effect of Elective Intraoperative Neurectomy on Chronic Pain After Lichtenstein Hernia Repair. A Prospective, Single-blind, Randomized, Controlled Clinical Trial

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Jun 27, 2007
Registry last updated
Jan 28, 2013

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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