Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
16/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Lloyd

ORCID ID

Contact details

Royal Liverpool Children's Hospital NHS Trust
Professor of Paediatric Surgery
Institute of Child Health
Eaton Road
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5250

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHC22029

Study information

Scientific title

Acronym

Study hypothesis

To 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Digestive system diseases: Other digestive system disease

Intervention

Fundoplication vs medical management

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Body weight Z scores.

Secondary outcome measures

1. 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 trial start date

01/10/2000

Overall trial end date

01/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged less than 16 years with clinical evidence of gastro-oesophageal reflux. Phase One - 250 to 330. Phase Two - 115 to 125.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

455

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2000

Recruitment end date

01/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive North West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes