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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00259961
Other study ID # 05SG29
Secondary ID
Status Completed
Phase N/A
First received November 30, 2005
Last updated December 22, 2006
Est. completion date December 2006

Study information

Verified date December 2006
Source Institute of Child Health
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

Long-term results following laparoscopic and open Nissen fundoplication for gastro-oesophageal reflux will be objectively assessed in a selected population of patients already included in a randomized controlled trial comparing the two different techniques. The presence of postoperative symptoms will be evaluated by an independent clinician using an objective questionnaire. The recurrence of gastro-oesophageal reflux will be studied by 24-hours pH study. Furthermore the presence of gastric motility disorders will be studied by electrogastrography and 13C-octanoic acid breath test.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 3 Years to 20 Years
Eligibility Inclusion Criteria: All patients with gastro - oesophagal reflux -

Exclusion Criteria:

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal


Related Conditions & MeSH terms


Intervention

Procedure:
open fundoplication

laparoscopic fundopliaction


Locations

Country Name City State
United Kingdom Great Ormond Street Hospital London

Sponsors (1)

Lead Sponsor Collaborator
Institute of Child Health

Country where clinical trial is conducted

United Kingdom,