Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

Study Overview
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Brief Summary
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We compare laparoscopic and classic open operation for inguinal hernia in children. Attention is focused on the recovery, surgical result and the duration of the operation and hospital stay.

Detailed Description
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Background and objective : In adults the advantages laparoscopic inguinal hernia are less pain, shorter recovery, shorter sick leave and better cosmetic result. It is not known whether laparoscopic hernia repair produces similar results in children.The objective is to compare the duration of recovery, postoperative pain and long-term surgical results between day case laparoscopic and open inguinal hernia repair in children. Key inclusion criteria: Children included in the study must be aged four months to sixteen years of age and not have undergone any previous surgery. Of male patients those with completely descended testes are accepted. Study type: The study is randomized, single-blinded prospective comparison between laparoscopic and open day case inguinal hernia repair in children. Target sample size: For the assumption that there is a difference of one day in time to restore normal activities after laparoscopic and open hernia repair, target sample size of 100 patients in the laparoscopic and 100 in open repair arm should reach 90% power with p < 0.05. Recruitment status : From 10/ 2002 to 1/2007 89 patients (laparoscopic repair LH 47, open repair OH 42) are recruited. Primary outcome: The time to restore normal activity after surgery . Secondary Outcomes : The degree of postoperative pain, the duration of the operation, sick leave of parents, surgical result 6 months and 2 years after the repair.

Official Title
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Day Case Inguinal Hernia Repair in Children. Is Laparoscopic Approach Justified?

Conditions
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Inguinal Hernia

Intervention / Treatment
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* Procedure: Hernia repair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral inguinal hernia age age > 4 months, <16 years fully descended testes study consent signed Exclusion Criteria: previous abdominal or inguinal surgery testes not fully descended not healthy enough for day surgery age < 4months or >16 years study consent not signed

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 16 Years

Sexes Eligible for Study
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All

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OH<br>Inguinal hernia operated using a classic open herniotomy(OH) | Procedure: Hernia repair<br>* Hernia repair laparoscopically (LH) or by open operation (OH)<br>|
| Active Comparator: LH<br>Laparoscopic herniorraphy (LH) for inguinal hernia | Procedure: Hernia repair<br>* Hernia repair laparoscopically (LH) or by open operation (OH)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery after inguinal hernia surgery = time to restore normal activities after surgery |  | one week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of postoperative pain |  | 3 days | 
| duration of surgery and hospital stay |  | 1 day | 
| long term surgical result |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inguinal hernia, laparoscopic repair, open repair, randomized