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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00259961
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : December 25, 2006
Information provided by:
Institute of Child Health

Brief 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.

Condition or disease Intervention/treatment
Gastro -Oesophagal Reflux Procedure: open fundoplication Procedure: laparoscopic fundopliaction

Study Type : Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Study Completion Date : December 2006

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Ages Eligible for Study:   3 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: All patients with gastro - oesophagal reflux -

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00259961

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