Hernia, Inguinal Clinical Trial
Official title:
Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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