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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
  Purpose

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


Condition Intervention
Gastro-Oesophageal Reflux
 Procedure: Laparoscopic fundoplication
Procedure: open Nissen fundoplication

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Child Health:

Primary Outcome Measures:
  • resting energy expenditure

Secondary Outcome Measures:
  • whole body protein turnover
  • indices of inflammatory response
  • pro and anti inflammatory cytokines
  • free radical production
  • post operative pain

  Eligibility

Ages Eligible for Study:   1 Month to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • infants and children with gastro-oesophageal reflux

Exclusion Criteria:

  • septic shock, multi-organ dysfunction syndrome, cardiac, renal or congenital metabolic abnormalities
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00231543

Locations
United Kingdom
Great Ormond Street Hospital and the Institute of Child health
London, United Kingdom, WC1N 1EH
Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Agostino Pierro, Prof Institute of Child Health
  More Information

No publications provided by Institute of Child Health

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00231543     History of Changes
Other Study ID Numbers: 99SG92
Study First Received: October 3, 2005
Last Updated: October 11, 2006
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Esophageal Diseases
Gastroesophageal Reflux
Gastrointestinal Diseases
 Digestive System Diseases
Esophageal Motility Disorders
Deglutition Disorders

ClinicalTrials.gov processed this record on June 17, 2013