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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00231543
Other study ID # 99SG92
Secondary ID
Status Completed
Phase N/A
First received October 3, 2005
Last updated October 11, 2006

Study information

Verified date October 2005
Source Institute of Child Health
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Month to 16 Years
Eligibility Inclusion Criteria:

- infants and children with gastro-oesophageal reflux

Exclusion Criteria:

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

Study Design

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


Related Conditions & MeSH terms


Intervention

Procedure:
Laparoscopic fundoplication

open Nissen fundoplication


Locations

Country Name City State
United Kingdom Great Ormond Street Hospital and the Institute of Child health London

Sponsors (1)

Lead Sponsor Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary resting energy expenditure
Secondary whole body protein turnover
Secondary indices of inflammatory response
Secondary pro and anti inflammatory cytokines
Secondary free radical production
Secondary post operative pain
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