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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259961
First Posted: December 1, 2005
Last Update Posted: December 25, 2006
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.
Information provided by:
Institute of Child Health
  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

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

Further study details as provided by Institute of Child Health:

Estimated Study Completion Date: December 2006
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria: All patients with gastro - oesophagal reflux -

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00259961     History of Changes
Other Study ID Numbers: 05SG29
First Submitted: November 30, 2005
First Posted: December 1, 2005
Last Update Posted: December 25, 2006
Last Verified: December 2006