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

This study has been completed.
Information provided by:
Institute of Child Health Identifier:
First received: November 30, 2005
Last updated: December 22, 2006
Last verified: December 2006

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

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal

Resource links provided by NLM:

Further study details as provided by Institute of Child Health:

Estimated Study Completion Date: December 2006

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

Inclusion Criteria: All patients with gastro - oesophagal reflux -

Exclusion Criteria:


  Contacts and Locations
Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00259961     History of Changes
Other Study ID Numbers: 05SG29
Study First Received: November 30, 2005
Last Updated: December 22, 2006
Health Authority: United Kingdom: Research Ethics Committee processed this record on April 17, 2014