Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery
Sponsor
Institute of Child Health (Other)
Overall Status
Completed
CT.gov ID
NCT00231543
Collaborator
(none)
1
Study Details
Study Description
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 | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Outcome Measures
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 Criteria
Criteria
Ages Eligible for Study:
1 Month
to 16 Years
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00231543
Other Study ID Numbers:
- 99SG92
First Posted:
Oct 4, 2005
Last Update Posted:
Oct 12, 2006
Last Verified:
Oct 1, 2005
Additional relevant MeSH terms: