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:
Information provided by:
Institute of Child Health
ClinicalTrials.gov Identifier:
NCT00259961
First received: November 30, 2005
Last updated: December 22, 2006
Last verified: December 2006

November 30, 2005
December 22, 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
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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:

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Both
3 Years to 20 Years
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP