Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

Study Overview
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Brief Summary
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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 Description
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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.

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

Conditions
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Hernia, Inguinal

Intervention / Treatment
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* Procedure: method of hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male <60yrs with primary inguinal hernia Exclusion Criteria: Recurrent hernia Bilateral hernia Non-reducible/obstructed hernia Previous lower abdominal surgery/radiotherapy

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: method of hernia repair|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hernia recurrence rates at 2 years post surgery. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia, Inguinal, Groin, Laparoscopic, Open, Abdominal wall