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

This study has been completed.

Sponsor:

Information provided by:

Hospital for Children and Adolescents, Finland

ClinicalTrials.gov Identifier:

NCT00597194

First received: January 8, 2008

Last updated: January 16, 2008

Last verified: December 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

January 8, 2008

Last Updated Date

January 16, 2008

Start Date ^ICMJE

October 2002

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

recovery after inguinal hernia surgery = time to restore normal activities after surgery [ Time Frame: one week ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00597194 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

degree of postoperative pain [ Time Frame: 3 days ] [ Designated as safety issue: No ]
duration of surgery and hospital stay [ Time Frame: 1 day ] [ Designated as safety issue: No ]
long term surgical result [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Inguinal Hernia

Intervention ^ICMJE

Procedure: Hernia repair

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

Study Arm (s)

Active Comparator: OH
Inguinal hernia operated using a classic open herniotomy(OH)

Intervention: Procedure: Hernia repair
Active Comparator: LH
Laparoscopic herniorraphy (LH) for inguinal hernia

Intervention: Procedure: Hernia repair

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

89

Completion Date

January 2007

Primary Completion Date

January 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

4 Months to 16 Years

Accepts Healthy Volunteers

No

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Finland

Administrative Information

NCT Number ^ICMJE

NCT00597194

Other Study ID Numbers ^ICMJE

216L2002, T 1040L0007

Has Data Monitoring Committee

No

Responsible Party

Professor Christer Holmberg, Hospital for Children and Adolescents, Helsinki, Finland

Study Sponsor ^ICMJE

Hospital for Children and Adolescents, Finland

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Hospital for Children and Adolescents, Finland

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP