Condition category
Digestive System
Date applied
12/03/2011
Date assigned
29/03/2011
Last edited
08/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chris Fraser

ORCID ID

Contact details

Wolfson Unit for Endoscopy
St Mark's Hospital and Academic Institute
Watford Road
Harrow
London
HA1 3UJ
United Kingdom

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 Mark’s 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

Sponsor information

Organisation

North West London Hospitals NHS Trust (UK)

Sponsor details

R&D Department
Northwick Park Hospital
Watford Road
Harrow
London
HA1 3UJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes