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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00231543
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : October 12, 2006
Information provided by:
Institute of Child Health

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

Condition or disease Intervention/treatment
Gastro-Oesophageal Reflux Procedure: Laparoscopic fundoplication Procedure: open Nissen fundoplication

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment

Primary Outcome Measures :
  1. resting energy expenditure

Secondary Outcome Measures :
  1. whole body protein turnover
  2. indices of inflammatory response
  3. pro and anti inflammatory cytokines
  4. free radical production
  5. post operative pain

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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