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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00231543
Enrollment
Unknown
Registered
2005-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2006-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastro-Oesophageal Reflux

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

Interventions

PROCEDURELaparoscopic fundoplication
PROCEDUREopen Nissen fundoplication

Sponsors

Institute of Child Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
1 Months to 16 Years
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

Design outcomes

Primary

MeasureTime frame
resting energy expenditure—

Secondary

MeasureTime frame
whole body protein turnover—
indices of inflammatory response—
pro and anti inflammatory cytokines—
free radical production—
post operative pain—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026