NCT00803985

Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain

A Randomised Controlled Trial Comparing Total Extra-Peritoneal (TEP) to Lichtenstein Inguinal Hernia Repair Concerning Physical Sequelae and Quality of Life at One and Three Years - the TEPLICH Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 416 (actual)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: Male
• Age: 30 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to se if there is a difference regarding chronic pain and sexual dysfunction one and tree years after laparoscopic un fixated preperitoneal mesh versus gold standard open fixated on lay mesh in inguinal hernia surgery. Long term cross-sectional follow-up comparing different instruments for measurement of chronic pain.

Detailed description

Prospective randomized study comparing total extraperitoneal patch TEP versus open onlay mesh according to Lichtenstein in primary unilateral inguinal hernias in men between 30 to 75 years of age. Non fixated polypropylene mesh is used in the TEP operation and fixated light weight polypropylene mesh is used in the Lichtenstein procedure. The aim is to study chronical pain and sexual dysfunction. Clinical examination according nerve function, hernia status and genital findings are performed together with a questionnaire including SF36, Inguinal Pain Questionnaire(IPQ), sexual function are registered preoperatively, one and tree years postoperatively. Cross-sectional follow-up in median 7.5 years using enquiries for comparison of different pain instruments to evaluate the effect of chronic pain on physical activity.

Conditions

• Chronic Pain
• Sexual Dysfunction

Interventions

Type	Name	Description
PROCEDURE	Total Extraperitoneal repair (TEP)	Operation for primary inguinal hernias i men
PROCEDURE	Lichtenstein	Operation for primary inguinal hernias i men

Timeline

• Start date: 2008-04-01
• Primary completion: 2017-03-01
• Completion: 2018-03-01
• First posted: 2008-12-08
• Last updated: 2018-12-20

Locations

1 site across 1 country: Sweden