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

Primary Purpose

Gastro-Oesophageal Reflux

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Laparoscopic fundoplication
open Nissen fundoplication
Sponsored by
Institute of Child Health
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastro-Oesophageal Reflux

Eligibility Criteria

1 Month - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: infants and children with gastro-oesophageal reflux Exclusion Criteria: septic shock, multi-organ dysfunction syndrome, cardiac, renal or congenital metabolic abnormalities

Sites / Locations

  • Great Ormond Street Hospital and the Institute of Child health

Outcomes

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

Full Information

First Posted
October 3, 2005
Last Updated
October 11, 2006
Sponsor
Institute of Child Health
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1. Study Identification

Unique Protocol Identification Number
NCT00231543
Brief Title
Laparoscopy in Children: Does it Decrease the Metabolic, Endocrine and Inflammatory Stress Response to Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Institute of Child Health

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-Oesophageal Reflux

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laparoscopic fundoplication
Intervention Type
Procedure
Intervention Name(s)
open Nissen fundoplication
Primary Outcome Measure Information:
Title
resting energy expenditure
Secondary Outcome Measure Information:
Title
whole body protein turnover
Title
indices of inflammatory response
Title
pro and anti inflammatory cytokines
Title
free radical production
Title
post operative pain

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: infants and children with gastro-oesophageal reflux Exclusion Criteria: septic shock, multi-organ dysfunction syndrome, cardiac, renal or congenital metabolic abnormalities
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agostino Pierro, Prof
Organizational Affiliation
Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Great Ormond Street Hospital and the Institute of Child health
City
London
ZIP/Postal Code
WC1N 1EH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
21725231
Citation
McHoney M, Wade AM, Eaton S, Howard RF, Kiely EM, Drake DP, Curry JI, Pierro A. Clinical outcome of a randomized controlled blinded trial of open versus laparoscopic Nissen fundoplication in infants and children. Ann Surg. 2011 Aug;254(2):209-16. doi: 10.1097/SLA.0b013e318226727f.
Results Reference
derived
PubMed Identifier
20400097
Citation
McHoney M, Eaton S, Wade A, Carnielli V, Kiely E, Drake D, Curry J, Pierro A. Effect of laparoscopy and laparotomy on energy and protein metabolism in children: a randomized controlled trial. J Pediatr. 2010 Sep;157(3):439-44, 444.e2. doi: 10.1016/j.jpeds.2010.02.067. Epub 2010 Apr 18.
Results Reference
derived

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

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