Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Mesh Plug Repair; Procedure: Lichtenstein's operation; Drug: Opiate; Drug: Paracetamol; Drug: non-steroidal anti-inflammatory drug

• Registration Number: NCT01637818
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

Long-term follow-up of a randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair based on the following published study "Randomized clinical trial of Lichtenstein's operation versus mesh plug for inguinal hernia repair. Br J Surg. 2007 Jan;94(1):36-41."

Primary endpoints is recurrence.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2012-07
• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-10
• Study First Posted: 2012-07-11
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 594

Inclusion Criteria

• 40 years and older, patients who became 40 in the year of the operation were included (6 patients younger than 40 years were included because of explicit patient's wish).
• provision of written informed consent,
• symptomatic unilateral or bilateral inguinal hernia.

Exclusion Criteria

• presence of a femoral hernia,
• history of hernia repair with mesh,
• type I diabetes,
• presence of local or diffuse infection (urine, skin, lung, sepsis),
• immune deficiency,
• severe medical problems contraindicating safe induction of general anaesthesia or elective surgery,
• pregnancy,
• malignant tumours and
• life expectancy of less than 2 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lichtenstein's Operation	non-steroidal anti-inflammatory drug	-
Mesh Plug Repair	Mesh Plug Repair	-
Mesh Plug Repair	Opiate	-
Lichtenstein's Operation	Lichtenstein's operation	-
Lichtenstein's Operation	Opiate	-
Mesh Plug Repair	non-steroidal anti-inflammatory drug	-
Lichtenstein's Operation	Paracetamol	-
Mesh Plug Repair	Paracetamol	-

Primary Outcome Measures

Name	Time	Method
Recurrence	6 years	Recurrence after hernia operation (Lichtenstein's operatin versus mesh plug)

Secondary Outcome Measures

Name	Time	Method
Reoperation	6 years	Reoperation after inguinal hernia repair (Lichtenstein's operatin versus mesh plug)
Pain	6 years	Pain measurement after inguinal hernia repair by visual analog scale (Lichtenstein's operatin versus mesh plug)
Sensitivity	6 years	Sensitivity after inguinal hernia repair (Lichtenstein's operatin versus mesh plug: 0 = normal, 1 = reduced, 2 = neuralgia

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Basel-Stadt, Switzerland