Does drinking a small amount of anti-foam before endoscopy improve the views obtained?

ISRCTN	ISRCTN30607490
DOI	https://doi.org/10.1186/ISRCTN30607490
Protocol serial number	N0436118041
Sponsor	Department of Health
Funder	Leeds Teaching Hospitals NHS Trust (UK) NHS R&D Support Funding

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr B J Rembacken
Scientific

Gastroenterology
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom

Phone	+44 (0)113 243 2799

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Surgery: Anaesthesia
Intervention	Anti-foam before endoscopy vs standard practice.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	200
Key inclusion criteria	All patients able to give informed consent and referred for upper digestive endoscopy at lower gastrointestinal (LGI).
Key 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.
Date of first enrolment	30/06/2002
Date of final enrolment	30/12/2005

Gastroenterology

Leeds
LS1 3EX
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan