- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00259961
Clinical Outcome of Laparoscopic Versus Open Nissen Fundoplication in Children: 3-Year Follow-up Study of Randomized Controlled Trial.
December 22, 2006 updated by: Institute of Child Health
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom
- Great Ormond Street Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria: All patients with gastro - oesophagal reflux -
Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Pierro Agostino, Prof, Great Ormond Street Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
December 1, 2006
Study Registration Dates
First Submitted
November 30, 2005
First Submitted That Met QC Criteria
November 30, 2005
First Posted (Estimate)
December 1, 2005
Study Record Updates
Last Update Posted (Estimate)
December 25, 2006
Last Update Submitted That Met QC Criteria
December 22, 2006
Last Verified
December 1, 2006
More Information
Terms related to this study
Other Study ID Numbers
- 05SG29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastro -Oesophagal Reflux
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Klinikum Garmisch-PatenkirchenNot yet recruitingReflux, Gastroesophageal | Gastro-esophageal RefluxGermany
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Asian Institute of Gastroenterology, IndiaCompletedGastro Esophageal Reflux DiseaseIndia
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Medtronic - MITGCompletedGastro Esophageal Reflux DiseaseIsrael
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Vrije Universiteit BrusselCompletedGastro-esophageal RefluxBelgium
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Mayo ClinicWithdrawnGastro-esophageal Reflux Disease (GERD)United States
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NorgineCompletedAcid Reflux | Gastro Oesophageal Reflux DiseaseUnited Kingdom
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Grubnik VolodymyrCompletedGastro Oesophageal Reflux Disease
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Imperial College LondonCompletedGastro-oesophageal Reflux DiseaseUnited Kingdom
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Medtronic - MITGWithdrawnGastro Esophageal Reflux DiseaseIsrael
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MAAB (Shanghai) Medical Device LimitedRD Biomed LtdCompletedGastro-esophageal Reflux DiseaseChina
Clinical Trials on open fundoplication
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Turku University HospitalCompleted
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Institute of Child HealthCompletedGastro-Oesophageal RefluxUnited Kingdom
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Foregut Research FoundationRecruitingHiatal Hernia Large | Gastro Esophageal Reflux | Hiatal Hernia | Hiatal Hernia, Paraesophageal | Reflux, Gastroesophageal | Reflux AcidUnited States
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L. Michael BruntUniversity of Oregon; Northwestern University; Duke University; University of WashingtonCompletedEsophageal AchalasiaUnited States
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University of Turin, ItalyCompleted
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University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI)CompletedGastroesophageal Reflux | Idiopathic Pulmonary FibrosisUnited States
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University of UtahCompletedNervous System Diseases | Gastroesophageal Reflux | Enteral Nutrition | FundoplicationUnited States
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Chinese University of Hong KongUnknownGastroesophageal Reflux DiseaseHong Kong
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Grubnik VolodymyrCompletedGastro Oesophageal Reflux Disease
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Federal University of São PauloHospital State PublicCompletedGastroesophageal RefluxBrazil