Condition category
Digestive System
Date applied
04/07/2017
Date assigned
12/07/2017
Last edited
10/07/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In the UK, around 1 in 16 men and 1 in 20 women will develop bowel cancer at some point in their lives. Most bowel cancers happen when a type of polyp (fleshy growth on the lining of the bowel) called an adenoma becomes cancerous. Doctors use a camera, known as a colonoscope, to see the inside of the large bowel to find and remove the polyps if necessary. Removing pre-cancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. A new device, called the Endocuff Vision, which is attached to the end of the colonoscope, has been shown to improve the rate of polyp detection at colonoscopy. It is a small plastic device which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel. Before the arrival of Endocuff a similar device called Cap has been in use to improve the detection and management of adenomas. The main drawback of the cap is the limited view of the bowel lining when it is attached to the tip of the colonoscope. The aim of this study is to find out if using the Endocuff Vision helps colonoscopists to find polyps which are hiding behind the folds. The study also assesses whether procedures performed using the Endocuff Vision are longer or more uncomfortable for the patient than colonoscopies performed with Cap.

Who can participate?
Adults over the age of 18 undergoing a colonoscopy

What does the study involve?
Each patient undergoes two colonoscopies with the Cap and Endocuff by the same endoscopist in a random order. After the first procedure, the cap or cuff is removed or fitted to the tip of colonoscope, and the second procedure begins immediately. Any polyps detected and removed are followed up. Patients remain in the study for 30 days to record any complications and side effects. There are no additional follow-up visits needed for this. The timing of outpatient appointments and results are not affected by the study and are as standard.

What are the possible benefits and risks of participating?
It is known that finding pre-cancerous polyps and removing them reduces the risk of bowel cancer. If this study shows that using the Endocuff Vision helps colonoscopists to find more polyps, the risk of bowel cancer in these patients is reduced when compared to the use of a cap. If these polyps are found to be pre-cancerous when they are looked at in the laboratory, the doctors’ team make sure participants receive the best treatment and follow up. On the other hand, the study may not benefit participants at this time, but the information from this study may help others who have polyps. Attaching the Endocuff Vision or cap to the end of the colonoscope slightly increases the width of the camera. This may make inserting the camera through the anus slightly more uncomfortable for a few seconds. There is a very small possibility that the Endocuff Vision or Cap becomes dislodged during the procedure. In this situation the colonoscopist removes the Endocuff or Cap using a net or graspers. The Endocuff Vision may cause very minor grazes to the bowel wall.

Where is the study run from?
London North West Hospitals NHS Trust - St Mark's Hospital (UK)

When is the study starting and how long is it expected to run for?
November 2015 to November 2017

Who is funding the study?
London North West Healthcare NHS Trust (UK)

Who is the main contact?
1. Dr Rajaratnam Rameshshanker
2. Dr Zacharias P. Tsiamoulos
ztsiamoulos@nhs.net

Trial website

Contact information

Type

Scientific

Primary contact

Dr Rajaratnam Rameshshanker

ORCID ID

http://orcid.org/0000-0002-4556-9052

Contact details

Wolfson Endoscopy Unit
St Mark's Hospital
Harrow
HA1 3UJ
United Kingdom

Type

Scientific

Additional contact

Dr Zacharias P. Tsiamoulos

ORCID ID

http://orcid.org/0000-0003-0235-7110

Contact details

Wolfson Endoscopy Unit
St Mark's Hospital
London
HA1 3UJ
United Kingdom
+44 (0)184 3725 3128
ztsiamoulos@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 6

Study information

Scientific title

Is EndocuffTM Vision assisted colonoscopy superior to Cap assisted colonoscopy to detect adenomas?

Acronym

DETECT

Study hypothesis

The hypothesis is that Endocuff improves polyp detection when compared to Cap, and that it would improve polyp detection rate by 10%.

Ethics approval

East of England - Cambridge East Research Ethics Committee, 04/01/2016, ref: 15/EE/0415

Study design

Prospective randomised back to back study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Colonic polyps detection

Intervention

This is a back to back study to compare the Cap and Endocuff to detect polyps during colonoscopy. Each patient will undergo two consecutive colonoscopies by the same endoscopist in a randomised order (computer generated randomisation sequence). After the procedure, the cap or cuff will be removed or fitted to the tip of colonoscope, and the second procedure will begin immediately. Intra-procedure data will be collected by the research team onto a case report form (CRF). Any polyps detected and removed will be followed up, and histological diagnosis recorded post procedure by the research team. All colonoscopies will be calibrated and serviced according to British Society Gastroenterology guidelines. Patients will remain in the study for 30 days to allow collection of standard post-colonoscopy complication data through review of medical notes after the 30 day period has elapsed. Serious Adverse Events (SAEs) will also be recorded for all patients from the time of colonoscopy to 30 days post-procedure. There will no additional follow-up visit needed as a result of this. The timing of out-patient appointments and results will not be affected by the study and will be as standard for each unit. Data will be collated and analysed by the research team by 31/08/2017.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Polyp miss rate, calculated at the end of the study period
2. Adenoma miss rate, calculated at the end of the study period

Secondary outcome measures

1. Caecal intubation time and withdrawal time, collected using case report form at baseline
2. Discomfort during the procedure, measured using standard scoring system used routinely in endoscopy units on a 5-point discomfort scale, collected at baseline
3. Removal rate of cap and Endocuff, collected using case report form at baseline

Overall trial start date

01/11/2015

Overall trial end date

30/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Adults over the age of 18 years undergoing a colonoscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

154

Participant exclusion criteria

1. Absolute contraindications to colonoscopy
2. Established or suspicion of large bowel obstruction or pseudo-obstruction
3. Known colon cancer or polyposis syndromes
4. Known colonic strictures
5. Known severe diverticular segment (that is likely to impede colonoscope passage)
6. Patients with active colitis (ulcerative colitis, Crohn’s colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy
9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants/antiplatelets who have not stopped this for the procedure.

Recruitment start date

15/04/2016

Recruitment end date

31/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

London North West Hospitals NHS Trust - St Mark's Hospital
Harrow
HA1 3UJ

Sponsor information

Organisation

London North West Healthcare NHS Trust

Sponsor details

Watford Road
Harrow
Harrow
HA1 3UJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

London North West Healthcare NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Rajaratnam Rameshshanker.

Intention to publish date

30/11/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes