St Mark's Conventional Endoscopy versus transNasal endoscopy Trial
| ISRCTN | ISRCTN77474635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN77474635 |
| Secondary identifying numbers | Protocol V 2.0 |
- Submission date
- 12/03/2011
- Registration date
- 29/03/2011
- Last edited
- 08/04/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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 Chris Fraser
Scientific
Scientific
Wolfson Unit for Endoscopy
St Mark's Hospital and Academic Institute
Watford Road
Harrow
London
HA1 3UJ
United Kingdom
Study information
| Study design | Randomised controlled study (parallel design) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | St Mark's Conventional Endoscopy versus transNasal oesophagogastroduodenoscopy Trial |
| Study acronym | SCENT |
| Study objectives | In a UK setting, transnasal OGD (tOGD) is non-inferior to conventional (oral) OGD (cOGD) in terms of patient safety, diagnostic capability and feasibility. We also hypothesise that tOGD is superior to cOGD in terms of patient satisfaction |
| Ethics approval(s) | Harrow Research Ethics Committee (North London REC 3) on the 11/06/2008: Reference number 08/H0719/24. |
| Health condition(s) or problem(s) studied | Upper Gastrointestinal Endoscopy (OGD) |
| Intervention | 1. Transnasal OGD versus conventional (oral) OGD - a comparison of two routinely performed endoscopy procedures 2. Patients receved either a conventional OGD or a transnasal OGD only once and did not require any additional drugs or follow-up in relation to the study |
| Intervention type | Other |
| Primary outcome measure | Patient tolerance, feasibility and safety of tOGD procedures (done using 4.9mm and 5.9mm ultrathin (UT) endoscopes) as compared to cOGD procedures (done using standard 9.0mm or UT 4.9mm and 5.9mm endoscopes) |
| Secondary outcome measures | 1. Patient tolerance, feasibility and safety of tOGD procedures (done using 4.9mm UT endoscopes)as compared to tOGD procedeures (done using 5.9mm ultrathin (UT) endoscopes). 2. Patient tolerance, feasibility and safety of tOGD procedures done using 4.9mm and 5.9mm ultrathin (UT) endoscopes) and cOGD procedeures (done under sedation using standard 9.0mm or UT 4.9mm and 5.9mm endoscopes) 3. Patient tolerance, feasibility and safety of tOGD procedures done using 4.9mm and 5.9mm ultrathin (UT) endoscopes) and cOGD procedeures (done without use of sedation using standard 9.0mm or UT 4.9mm and 5.9mm endoscopes) |
| Overall study start date | 01/09/2008 |
| Completion date | 30/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Adult patients referred for diagnostic OGD to St Marks Hospital Endoscopy Unit 2. Patients who are able to give informed consent |
| Key exclusion criteria | 1. Patients who are unwilling to have a tOGD 2. Patients with a history of nasal trauma or nasal surgery 3. Patients with a history of recurrent epistaxis 4. Patients with a history of haemorrhagic tendency or who are on anticoagulation 5. Patients with a history of severe co-morbidity (especially respiratory disease) as judged by the investigators 6. Patients already participating in another trial 7. Patients lacking capacity to give informed consent |
| Date of first enrolment | 01/09/2008 |
| Date of final enrolment | 30/11/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Wolfson Unit for Endoscopy
London
HA1 3UJ
United Kingdom
HA1 3UJ
United Kingdom
Sponsor information
North West London Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Department
Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
England
United Kingdom
"ROR" |
https://ror.org/04cntmc13 |
|---|
Funders
Funder type
Research organisation
Self funded by the investigators
No information available
Research support received from Endoscopy UK and Fujinon (Europe) in the form of loan endoscopes
No information available
Endoscopy Research Fellowship Grant and Keymed-Olympus (UK) in the form of loan endoscopes
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 |
