Randomised controlled study of fundoplication or medical treatment for gastro-oesophageal reflux in children

ISRCTN ISRCTN82683558
DOI https://doi.org/10.1186/ISRCTN82683558
Secondary identifying numbers RHC22029
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
16/06/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Lloyd
Scientific

Royal Liverpool Children's Hospital NHS Trust
Professor of Paediatric Surgery
Institute of Child Health, Eaton Road
Eaton Road
Liverpool
L12 2AP
United Kingdom

Phone +44 (0)151 252 5250

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesTo measure the effectiveness of fundoplication compared to medical managements in a randomised study of children with severe gastro-oesophageal reflux and thus develop management strategies for the appropriate and cost-effective treatment of children with gastro-oesophageal reflux.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedDigestive system diseases: Other digestive system disease
InterventionFundoplication vs medical management
Intervention typeOther
Primary outcome measureBody weight Z scores.
Secondary outcome measures1. Continuing or recurrent gastro-oesophageal reflux
2. Complication rate after fundoplication, ECA on EGG
3. Validated quality of life score for patients and parents
Overall study start date01/10/2000
Completion date01/10/2003

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit16 Years
SexBoth
Target number of participants455
Key inclusion criteriaChildren aged less than 16 years with clinical evidence of gastro-oesophageal reflux. Phase One - 250 to 330. Phase Two - 115 to 125.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/10/2000
Date of final enrolment01/10/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Liverpool Children's Hospital NHS Trust
Liverpool
L12 2AP
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive North West (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan