Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Protocol V 2.0
Study information
Scientific title
St Mark's Conventional Endoscopy versus transNasal oesophagogastroduodenoscopy Trial
Acronym
SCENT
Study hypothesis
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
Harrow Research Ethics Committee (North London REC 3) on the 11/06/2008: Reference number 08/H0719/24.
Study design
Randomised controlled study (parallel design)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/09/2008
Overall trial end date
30/11/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Adult patients referred for diagnostic OGD to St Marks Hospital Endoscopy Unit
2. Patients who are able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/09/2008
Recruitment end date
30/11/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Wolfson Unit for Endoscopy
London
HA1 3UJ
United Kingdom
Funders
Funder type
Research organisation
Funder name
Self funded by the investigators
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Research support received from Endoscopy UK and Fujinon (Europe) in the form of loan endoscopes
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Endoscopy Research Fellowship Grant and Keymed-Olympus (UK) in the form of loan endoscopes
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