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Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3−Year Follow-up Study of Randomized Controlled Trial.
This study has been completed.
Sponsored by: Institute of Child Health
Information provided by: Institute of Child Health
ClinicalTrials.gov Identifier: NCT00259961
  Purpose

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.


Condition Intervention
Gastro -Oesophagal Reflux
Procedure: open fundoplication
Procedure: laparoscopic fundopliaction

U.S. FDA Resources
Study Type: Observational
Study Design: Longitudinal, Defined Population, Prospective Study

Further study details as provided by Institute of Child Health:

Estimated Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   3 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: All patients with gastro - oesophagal reflux -

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259961

Locations
United Kingdom
Great Ormond Street Hospital
London, United Kingdom
Sponsors and Collaborators
Institute of Child Health
Investigators
Principal Investigator: Pierro Agostino, Prof Great Ormond Street Hospital
  More Information

Study ID Numbers: 05SG29
Study First Received: November 30, 2005
Last Updated: December 22, 2006
ClinicalTrials.gov Identifier: NCT00259961  
Health Authority: United Kingdom: Research Ethics Committee

ClinicalTrials.gov processed this record on January 14, 2009