Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery

This study has been completed.

Sponsor:

Information provided by:

Institute of Child Health

ClinicalTrials.gov Identifier:

NCT00231543

First received: October 3, 2005

Last updated: October 11, 2006

Last verified: October 2005

History of Changes

Tracking Information

First Received Date ^ICMJE

October 3, 2005

Last Updated Date

October 11, 2006

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

resting energy expenditure

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00231543 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

whole body protein turnover
indices of inflammatory response
pro and anti inflammatory cytokines
free radical production
post operative pain

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

Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery

Official Title ^ICMJE

Not Provided

Brief Summary

The aim of this trial was to characterise the intra and post operative metabolic, endocrine and inflammatory response to laparoscopic fundoplication in children. We are testing the hypothesis that laparoscopic fundoplication is associated with a lack of hypermetabolism and catabolism and blunting of the endocrine/inflammatory stress response

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Condition ^ICMJE

Gastro-Oesophageal Reflux

Intervention ^ICMJE

Procedure: Laparoscopic fundoplication
Procedure: open Nissen fundoplication

Study Arm (s)

Not Provided

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

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

infants and children with gastro-oesophageal reflux

Exclusion Criteria:

septic shock, multi-organ dysfunction syndrome, cardiac, renal or congenital metabolic abnormalities

Gender

Both

Ages

1 Month to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT Number ^ICMJE

NCT00231543

Other Study ID Numbers ^ICMJE

99SG92

Has Data Monitoring Committee

Not Provided

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Institute of Child Health

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Agostino Pierro, Prof

Institute of Child Health

Information Provided By

Institute of Child Health

Verification Date

October 2005

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

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