Condition category
Cancer
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
05/12/2014
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 A Cole

ORCID ID

Contact details

Southern Derbyshire Acute Hospitals NHS Trust
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131 ext 5046
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077132412

Study information

Scientific title

Walk in nasal endoscopy (WINES) study: a pilot evaluation of the safety and feasibility, and cost savings of introducing a radically new approach to upper gastrointestinal (GI) endoscopy

Acronym

Study hypothesis

Evaluation of safety and feasibility of a walk in two week cancer waiting list upper GI endoscopy using nasal endoscope and only one assistant. A single consultant ATC doing the procedures.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Cancer: Gastrointestinal

Intervention

Nasal endoscopy is currently performed in the endoscopy unit at Derby City General Hospital but in a procedure analogous to conventional endoscopy using two nurse assistants. The study will be a pilot randomised controlled study comparing conventional with nasal (ultraslim endoscopy) to assess primarily the safety and feasibility of performing nasal endoscopy with just one assistant and the patient in a seated position.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Primary endpoints will be the proportion of cases in which this procedure could be performed and the number of early to late (within 1 week) complications. Assessment of safety will be by pro forma records of complications during endoscopy and prior to discharge and by using a patient questionnaire administered 1 week later.
The endoscopist will assess the feasibility of the nasal procedure. Completeness of endoscopy and visualisation of the duodenum, antrum, body and fundus of the stomach and oesophagus will be recorded.

Secondary outcome measures

Secondary endpoints will be a questionnaire of the patients acceptability of the procedure and a preliminary assessment of the savings in staff costs of this procedure.

Overall trial start date

21/10/2003

Overall trial end date

01/12/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients attending for endoscopy through two-week cancer waiting list.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

21/10/2003

Recruitment end date

01/12/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hospitals NHS Trust
Derby
DE22 3NE
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute Hospitals NHS Trust (UK)

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