This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by:
Institute of Child Health Identifier:
First received: October 3, 2005
Last updated: October 11, 2006
Last verified: October 2005
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
Primary Purpose: Treatment

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


Ages Eligible for Study:   1 Month to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00231543

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00231543     History of Changes
Other Study ID Numbers: 99SG92
Study First Received: October 3, 2005
Last Updated: October 11, 2006

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases processed this record on September 21, 2017