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

ISRCTN	ISRCTN35624133
DOI	https://doi.org/10.1186/ISRCTN35624133
Protocol serial number	N0077132412
Sponsor	Department of Health
Funder	Southern Derbyshire Acute Hospitals NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 05/12/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

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 A Cole
Scientific

Southern Derbyshire Acute Hospitals NHS Trust
Derby City General Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Phone	+44 (0)1332 340131 ext 5046
Email	abc@email.com

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/12/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key inclusion criteria	Patients attending for endoscopy through two-week cancer waiting list.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	21/10/2003
Date of final enrolment	01/12/2004

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Southern Derbyshire Acute Hospitals NHS Trust

Derby
DE22 3NE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan