NCT00231543

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2005

Completed
Last Updated

October 12, 2006

Status Verified

October 1, 2005

First QC Date

October 3, 2005

Last Update Submit

October 11, 2006

Conditions

Gastro-Oesophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • resting energy expenditure

Secondary Outcomes (5)

  • whole body protein turnover

  • indices of inflammatory response

  • pro and anti inflammatory cytokines

  • free radical production

  • post operative pain

Interventions

Laparoscopic fundoplicationPROCEDURE
open Nissen fundoplicationPROCEDURE

Eligibility Criteria

Age1 Month - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • infants and children with gastro-oesophageal reflux

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital and the Institute of Child health

London, WC1N 1EH, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 21725231DERIVED

  • 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.

    PMID: 20400097DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Agostino Pierro, Prof

    Institute of Child Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2005

First Posted

October 4, 2005

Last Updated

October 12, 2006

Record last verified: 2005-10

Locations

GB(1)