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aparoscopic Thal fundoplication in children: A very long-term follow-up study.

Completed
Conditions
reflux disease
heartburn
10017969
Registration Number
NL-OMON36744
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

All patients, who have undergone laparoscopic Thal fundoplication from 1993 until 1998 for severe GERD and were prospectively included in a longitudinal study on efficacy of ARS. In all patients written consent has to be obtained.

Exclusion Criteria

Inability to undergo investigation (patients in whom medication affecting gastric motility and gastroesophageal reflux cannot be stopped).

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p> Long term success of laparoscopic Thal fundoplication in children with severe<br /><br>GERD:<br /><br>1. Complete symptom relief and normal pH metry<br /><br>2. Complete symptom relief and near-normal pH metry<br /><br>3. Normal pH metry and significant improvement of reflux symptoms (complaints<br /><br>less than mild/monthly) </p><br>
Secondary Outcome Measures
NameTimeMethod
<p>NA</p><br>
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