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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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