Condition category
Surgery
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
16/03/2016
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 Donald Manifold

ORCID ID

Contact details

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696955
donald.manifold@bsuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0051127200

Study information

Scientific title

Intra-operative balloon dilatation of the pylorus in oesophagogastrectomy

Acronym

Study hypothesis

To determine if routine intra-operative balloon dilatation of the pylorus eliminates delayed gastric emptying and may therefore be a feasible alternative to pyloroplasty/pyloromyotomy.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oesophagogastrectomy

Intervention

Randomised Controlled Trial to determine if routine intra-operative balloon dilatation of the pylorus eliminates delayed gastric emptying and may therefore be a feasible alternative to pyloroplasty/pyloromyotomy.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

1. Contrast swallow score
2. Symptom score
3. Weight gain
4. Duodenogastric reflux
5. Oesophageal acid reflux

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2003

Overall trial end date

31/03/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing oesophagogastrectomy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not match inclusion criteria

Recruitment start date

01/04/2003

Recruitment end date

31/03/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Brighton and Sussex University Hospitals NHS Trust (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

16/03/2016: No publications found, verifying study status with principal investigator.