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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2007-01-31

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.

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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OH

Inguinal hernia operated using a classic open herniotomy(OH)

Group Type ACTIVE_COMPARATOR

Hernia repair

Intervention Type PROCEDURE

Hernia repair laparoscopically (LH) or by open operation (OH)

LH

Laparoscopic herniorraphy (LH) for inguinal hernia

Group Type ACTIVE_COMPARATOR

Hernia repair

Intervention Type PROCEDURE

Hernia repair laparoscopically (LH) or by open operation (OH)

Interventions

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Hernia repair

Hernia repair laparoscopically (LH) or by open operation (OH)

Intervention Type PROCEDURE

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

Minimum Eligible Age

4 Months

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No