Randomized Multicentre Study Comparing TEP With Lichtenstein Repair for Primary Inguinal Hernia

Uppsala University Hospital

Status: Completed

Conditions: Inguinal Hernia

Treatments: Procedure: Open repair; Procedure: Laparoscopic repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00568269

SMIL II

Ups 144-96

Details and patient eligibility

About

The purpose of this study was to compare the recurrence rate after TEP (laparoscopic method) and Lichtenstein (open method) repair on primary inguinal hernia.

Enrollment: 1,513 patients

Sex: Male

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male
• Age 30-70 years referred to hospital with a primary inguinal hernia.

Exclusion criteria

• Recurrent hernia
• Scrotal or bilateral hernia
• Previous lower abdominal surgery
• Unable to participate in follow up
• ASA more than 3
• Bleeding diathesis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,513 participants in 2 patient groups

Lichtenstein

Active Comparator group

Treatment:

Procedure: Open repair

TEP

Experimental group

Treatment:

Procedure: Laparoscopic repair