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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsinki, Finland, 000290
        • Hospital for Children and Adolescents

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Antti I Koivusalo, MDPhD, Hospital for Children and Adolescents,Helsinki,Finland
  • Principal Investigator: Mikko P Pakarinen, MD PhD, Hospital for Children and Adolescents,Helsinki,Finland
  • Principal Investigator: Risto J Rintala, Professor, Hospital for Children and Adolescents,Helsinki,Finland
  • Study Director: Christer Holmberg, Professor, Hospital for Children and Adolescents,Helsinki,Finland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

January 8, 2008

First Submitted That Met QC Criteria

January 16, 2008

First Posted (Estimate)

January 17, 2008

Study Record Updates

Last Update Posted (Estimate)

January 17, 2008

Last Update Submitted That Met QC Criteria

January 16, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • 216L2002
  • T 1040L0007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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