Does drinking a small amount of anti-foam before endoscopy improve the views obtained?
| ISRCTN | ISRCTN30607490 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30607490 |
| Secondary identifying numbers | N0436118041 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 10/09/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Contact information
Dr B J Rembacken
Scientific
Scientific
Gastroenterology
Clarendon Wing
Leeds General Infirmary
Leeds
LS1 3EX
United Kingdom
| Phone | +44 (0)113 243 2799 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 30/06/2002 |
| Completion date | 30/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Gastroenterology
Leeds
LS1 3EX
United Kingdom
LS1 3EX
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Leeds Teaching Hospitals NHS Trust (UK) NHS R&D Support Funding
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
