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

NCT ID: NCT00259961

Last Updated: 2006-12-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Completion Date

2006-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastro -Oesophagal Reflux

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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open fundoplication

Intervention Type PROCEDURE

laparoscopic fundopliaction

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

3 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Child Health

OTHER

Sponsor Role lead

Principal Investigators

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Pierro Agostino, Prof

Role: PRINCIPAL_INVESTIGATOR

Great Ormond Street Hospital

Locations

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Great Ormond Street Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24532685 (View on PubMed)

Other Identifiers

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05SG29

Identifier Type: -

Identifier Source: org_study_id