Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

Waitemata District Health Board

Status: Unknown

Conditions: Hernia, Inguinal

Treatments: Procedure: method of hernia repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00311935

Hernia repair study

Details and patient eligibility

About

This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group. The overall financial costs of each repair will also be compared.

Full description

Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study. Randomized to open mesh repair or laparoscopic preperitoneal mesh repair. Two surgeons (Dr Rodgers and Dr Hammodat) using a standardized technique. Conversion rates from lap to open will be recorded.

Phone assessment postop day 1, 1 week and at 6 months. Clinic assessment at 4 weeks, 1 year and 2 years.

Primary outcome is hernia recurrence which will be assessed by a research nurse independent of surgeon at each clinic appointment. Assessment to also include assessment of ongoing symptoms such as pain/discomfort, sensory disturbance, and sexual dysfunction.

Quality of life assessment (SF 36 questionnaire) preoperatively and at each assessment.

Pain assessment 4hrs postop and at all other assessments by score 0-10 and measurement of pain relief.

Cost analysis to include the following parameters: theatre equipment costs, theatre time, drug use, hospital stay, time to return to work, time to return to normal activities.

Interim analysis at 2 years of followup by independent Health and Safety committee. Final analysis at 4 years of followup.

Enrollment: 350 estimated patients

Sex: Male

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male <60yrs with primary inguinal hernia

Exclusion criteria

• Recurrent hernia
• Bilateral hernia
• Non-reducible/obstructed hernia
• Previous lower abdominal surgery/radiotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)