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

Not Applicable

Completed

• Conditions: Inguinal Hernia
• Interventions: Procedure: Hernia repair

• Registration Number: NCT00597194
• Lead Sponsor: Hospital for Children and Adolescents, Finland

Brief Summary

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

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.

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2007-12
• Study First Submitted: 2008-01-08
• Study First Submitted QC: 2008-01-16
• Last Update Submitted: 2008-01-16
• Study First Posted: 2008-01-17
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LH	Hernia repair	Laparoscopic herniorraphy (LH) for inguinal hernia
OH	Hernia repair	Inguinal hernia operated using a classic open herniotomy(OH)

Primary Outcome Measures

Name	Time	Method
recovery after inguinal hernia surgery = time to restore normal activities after surgery	one week

Secondary Outcome Measures

Name	Time	Method
degree of postoperative pain	3 days
duration of surgery and hospital stay	1 day
long term surgical result	2 years

Trial Locations

Locations (1)

Hospital for Children and Adolescents; 🇫🇮 Helsinki, Finland