Gastro-Oesophageal Reflux Clinical Trial
NCT number | NCT00231543 |
Other study ID # | 99SG92 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | October 3, 2005 |
Last updated | October 11, 2006 |
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 |
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
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Great Ormond Street Hospital and the Institute of Child health | London |
Lead Sponsor | Collaborator |
---|---|
Institute of Child Health |
United Kingdom,
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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