Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
10/09/2012
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 B J Rembacken

ORCID ID

Contact details

Gastroenterology
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
+44 (0)113 243 2799

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0436118041

Study information

Scientific title

Acronym

Study hypothesis

We will undertake a prospective, double-dummy controlled study to determine:
1. Are the endoscopic views improved significantly with the use of anti-foam pre-medication?
2. Can the endoscopic examination be carried out quicker with the use antifoam pre-medication?
3. Are we able to detect more significant abnormalities with the use of antifoam pre-medication?

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

Treatment

Patient information sheet

Condition

Surgery: Anaesthesia

Intervention

Anti-foam before endoscopy vs standard practice.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

Improved endoscopic views of gastric mucosa. Patient opinion on the pre-medication drink, duration of the endoscopy as measured from intubation to extubation, the endoscopists views of the areas of the upper digestive tract will be assessed, rating of the amount of mucosa seen without having to resort to washing the area, independent rating of the proportion of mucosa obscured by bubbles or mucus, endoscopic findings.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

30/06/2002

Overall trial end date

30/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients able to give informed consent and referred for upper digestive endoscopy at lower gastrointestinal (LGI).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

200

Participant exclusion criteria

Ventilated patients, patients with dysphagia or unable to swallow a mouthful of liquid for any reason, patients already included in a separate endoscopy study will not be recruited.

Recruitment start date

30/06/2002

Recruitment end date

30/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Gastroenterology
Leeds
LS1 3EX
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Leeds Teaching Hospitals NHS Trust (UK) NHS R&D Support Funding

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