NCT00259961

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

December 25, 2006

Status Verified

December 1, 2006

First QC Date

November 30, 2005

Last Update Submit

December 22, 2006

Conditions

Gastro -Oesophagal Reflux

Interventions

open fundoplicationPROCEDURE
laparoscopic fundopliactionPROCEDURE

Eligibility Criteria

Age3 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Great Ormond Street Hospital

London, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 24532685DERIVED

Study Officials

  • Pierro Agostino, Prof

    Great Ormond Street Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 1, 2005

Study Completion

December 1, 2006

Last Updated

December 25, 2006

Record last verified: 2006-12

Locations

GB(1)