Neoplasms

Digestive System Diseases

All Conditions

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Colorectal Neoplasms

Congenital Abnormalities

Adenoma

Colonic Polyps

Polyps

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Intestinal Polyps

Pathological Conditions, Anatomical

Herbal and Botanical

All Drugs and Chemicals

Orange

Participants in this arm undergo Endocuff Vision-assisted colonoscopy

Participants in this arm undergo standard colonoscopy

Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).

Endocuff Vision

Wee Sing Ngu, MBChB, MRCS

Gayle Clifford, BSc

John Silcock, MBBS, FRCP

Matthew Rutter, MBBS, FRCP

Brian Saunders, MBBS, FRCP

Arvind Ramadas, MBBS, FRCP

Arvind Ramadas, MBBS,FRCP

Thomas Lee, MBBS, FRCP

Colin Rees, MBBS, FRCP

John Painter, MBBS, FRCP

The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.

A difference in mean adenomas detected per procedure between both groups

The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups

Duration of complete withdrawal time in procedures where no polyps are detected between both groups

Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).

Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups

Number of of proximal sessile serrated polyps in both groups

Distribution of polyps in the colon in both groups by location

Adenoma detection rate of BCSP and non-BCSP colonoscopists

Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.

Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.

South Tyneside and Sunderland NHS Foundation Trust

Pain

Central Nervous System Depressants

Entonox

Anesthetics

Patients randomized to this arm will be asked to inhale Entonox throughout the insertion phase of colonoscopy

Patients randomised to this arm will be asked to use Entonox if and when they have pain

Entonox will be used according to the allocated method

Stuart A Riley, MB ChB

This study will randomise patients undergoing screening colonoscopy to receive Entonox either continuously or as required.

Both these methods are used in the published studies of Entonox and in clinical practice.

Null hypothesis There will be no difference in pain levels between these two methods of Entonox administration

Optimizing the Use of Entonox® During Screening Colonoscopy

Optimizing the Use of Entonox® During Screening Colonoscopy: an Open Randomised Controlled Trial

Patients will be asked about their overall recollection of pain on a 10 point numerical ratings scale prior to discharge

Patients will be asked about their experience of pain during colonoscopy. In addition patients will be asked about their overall recollection of pain immediately after colonoscopy and 1-3 days following colonoscopy.

Patients additional use of sedation and analgesia will be compared in each treatment arm

Patients will be asked about their overall level of satisfaction immediately prior to discharge and 1-3 days later

Patients will be asked about their willingness to have a repeat colonoscopy prior to discharge and 1-3 days following colonoscopy

Patients will be asked about the presence of side effects during colonoscopy. This will be quantified according to whether it limited the use Of Entonox.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities	NCT02552017	Colorectal Neop... Colonic Polyps Adenoma	Endocuff Vision	18 Years -	South Tyneside and Sunderland NHS Foundation Trust
Optimizing the Use of Entonox® During Screening Colonoscopy	NCT01865721	Bowel Cancer Sc... Analgesia Entonox Colonoscopy	Entonox	60 Years - 75 Years	Sheffield Teaching Hospitals NHS Foundation Trust
Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities	NCT02552017	Colorectal Neop... Colonic Polyps Adenoma	Endocuff Vision	18 Years -	South Tyneside and Sunderland NHS Foundation Trust

Spots Global Cancer Trial Database for bowel cancer screening