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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
November 30, 2005
December 1, 2005
December 25, 2006
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Complete list of historical versions of study NCT00259961 on ClinicalTrials.gov Archive Site
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Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3−Year Follow-up Study of Randomized Controlled Trial.
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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.
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Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
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Gastro -Oesophagal Reflux
  • Procedure: open fundoplication
  • Procedure: laparoscopic fundopliaction
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Pacilli M, Eaton S, McHoney M, Kiely EM, Drake DP, Curry JI, Lindley KJ, Pierro A. Four year follow-up of a randomised controlled trial comparing open and laparoscopic Nissen fundoplication in children. Arch Dis Child. 2014 Jun;99(6):516-21. doi: 10.1136/archdischild-2013-304279. Epub 2014 Feb 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2006
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Inclusion Criteria: All patients with gastro - oesophagal reflux -

Exclusion Criteria:

Sexes Eligible for Study: All
3 Years to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00259961
05SG29
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Institute of Child Health
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Principal Investigator: Pierro Agostino, Prof Great Ormond Street Hospital
Institute of Child Health
December 2006