Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/08/2011
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

Mr Roger Ackroyd

ORCID ID

Contact details

STH NHS Trust
General Surgery
K Floor
Royal Hallamshire Hospital
Sheffield
S10 2JF
United Kingdom
+44 (0)114 226 1398
roger.ackroyd@sth.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0059103687

Study information

Scientific title

Acronym

Study hypothesis

To prospectively compare laparoscopic anterior versus posterior partial fundoplication in patients with gastro-oesophageal reflux disease.

Ethics approval

Ethics approval received from the South Sheffield Research Ethics Committee

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Gastro-oesophageal reflux disease (GORD)

Intervention

Comparison of laparoscopic anterior versus posterior partial fundoplication.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Dysphagia
2. Reflux control

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/10/2001

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

100 patients with gastro-oesophageal reflux disease.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Previous anti-reflux surgery
2. Other concomitant disease being operated at the same time, e.g., gallstones
3. Aged less than 18 or greater than 75 years

Recruitment start date

01/10/2001

Recruitment end date

30/09/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

STH NHS Trust
Sheffield
S10 2JF
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Sheffield Teaching Hospitals (Central Campus) (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

1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20795962

Publication citations

  1. Results

    Khan M, Smythe A, Globe J, Stoddard CJ, Ackroyd R, Randomized controlled trial of laparoscopic anterior versus posterior fundoplication for gastro-oesophageal reflux disease., ANZ J Surg, 80, 7-8, 500-505, doi: 10.1111/j.1445-2197.2009.05197.x.

Additional files

Editorial Notes