Clinical Trial: Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Waitemata District Health Board

Current Primary Outcome: Hernia recurrence rates at 2 years post surgery.

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Complication rates.
  • Duration of procedure.
  • Cost of equipment use.
  • Rate of conversion to open procedure
  • Length of hospital stay.
  • Time to return to work and usual activities.
  • Pain scores and analgesic use.


Original Secondary Outcome: Same as current

Information By: Waitemata District Health Board

Dates:
Date Received: April 5, 2006
Date Started: April 2006
Date Completion: May 2010
Last Updated: February 2, 2009
Last Verified: February 2009