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

University Hospital Basel

Status: Completed

Conditions: Inguinal Hernia

Treatments: Drug: non-steroidal anti-inflammatory drug; Procedure: Lichtenstein's operation; Procedure: Mesh Plug Repair; Drug: Paracetamol; Drug: Opiate

Study type: Interventional

Funder types: Other

Identifiers

NCT01637818

R59

Details and patient eligibility

About

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.

Enrollment: 594 patients

Sex: All

Ages: 39+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

594 participants in 2 patient groups

Lichtenstein's Operation

Other group

Treatment:

Drug: Opiate

Drug: non-steroidal anti-inflammatory drug

Drug: Paracetamol

Procedure: Lichtenstein's operation

Mesh Plug Repair

Other group

Treatment:

Drug: Opiate

Procedure: Mesh Plug Repair

Drug: non-steroidal anti-inflammatory drug

Drug: Paracetamol