| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN35624133 |
| Date ISRCTN assigned | 30/09/2004 |
| Local reference number(s) | N0077132412 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer: Gastrointestinal |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients attending for endoscopy through two-week cancer waiting list. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 21/10/2003 |
| Anticipated end date | 01/12/2004 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. 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. 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. |
| Primary outcome measure(s) | 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 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. |
| Sources of funding | Southern Derbyshire Acute Hospitals NHS Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Dr A Cole |
| Contact details | Southern Derbyshire Acute Hospitals NHS Trust
Derby City General Hospital
Uttoxeter Road
Derby
United Kingdom
DE22 3NE |
| Contact telephone | +44 (0)1332 340131 Ext 5046 |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN35624133 |
| Date last extracted from ISRCTN register | 17/04/2008 |
