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OpenTrials
Completed

NCT Number: NCT00231543

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

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

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Key information

Conditions

Gastro-oesophageal Reflux Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

1 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Great Ormond Street Hospital and the Institute of Child health

London, WC1N 1EH, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • infants and children with gastro-oesophageal reflux

Exclusion criteria

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

Treatment and study plan

Laparoscopic fundoplication

Procedure

open Nissen fundoplication

Procedure

Primary outcomes

  1. resting energy expenditure

Secondary outcomes

  1. whole body protein turnover

  2. indices of inflammatory response

  3. pro and anti inflammatory cytokines

  4. free radical production

  5. post operative pain

Sponsors and collaborators

Lead sponsor

Institute of Child Health

Other

Registry information

Important dates

First posted
Oct 4, 2005
Registry last updated
Oct 12, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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