Study Comparing Total Extraperitoneal Patch "TEP" Versus Lichtenstein According Chronic Pain (TEP-LICH)

Skane University Hospital

Status: Completed

Conditions: Sexual Dysfunction; Chronic Pain

Treatments: Procedure: Lichtenstein; Procedure: Total Extraperitoneal repair (TEP)

Study type: Interventional

Funder types: Other

Identifiers

NCT00803985

596/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 416 patients

Sex: Male

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• men between 30-75 years of age
• ASA class I-II
• primary unilateral inguinal hernia

Exclusion criteria

• lower midline incision below linea arcuate
• large scrotal hernia
• previously or current abuse,mental disease
• obesity BMI > 35
• another simultaneous operation
• nonreducible hernia
• severe pain in the groin without nonrelated to hernia
• contraindications to general anesthesia
• need of language translator
• liver cirrhosis or ascites
• spread cancer disease
• previously irradiation in the area
• lack of operations indication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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416 participants in 2 patient groups

Lichtenstein

Active Comparator group

Description:

Open operation with onlay light weight polypropylene mesh

Treatment:

Procedure: Total Extraperitoneal repair (TEP)

Total Extraperitoneal repair (TEP)

Active Comparator group

Description:

Laparoscopic operation with preperitoneal nonfixated mesh

Treatment:

Procedure: Lichtenstein