Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3−Year Follow-up Study of Randomized Controlled Trial.

This study has been completed.

First Received: November 30, 2005 Last Updated: December 22, 2006 History of Changes

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

No publications provided

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

ClinicalTrials.gov processed this record on May 07, 2009