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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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

Detailed Description

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Conditions

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Gastro-Oesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Laparoscopic fundoplication

Intervention Type PROCEDURE

open Nissen fundoplication

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* infants and children with gastro-oesophageal reflux

Exclusion Criteria

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Agostino Pierro, Prof

Role: PRINCIPAL_INVESTIGATOR

Institute of Child Health

Locations

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Great Ormond Street Hospital and the Institute of Child health

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED

PMID: 21725231 (View on PubMed)

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.