Does using Endocuff Vision device increase the ability to find bowel polyps in bowel cancer screening endoscopy?
| ISRCTN | ISRCTN30005319 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30005319 |
| Secondary identifying numbers | 33224 |
- Submission date
- 12/06/2017
- Registration date
- 16/06/2017
- Last edited
- 11/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Mr Martin Walls
Public
Public
South Tyneside District Hospital
Harton Lane
South Shields
Tyne and Wear
South Shields
NE34 0PL
United Kingdom
Study information
| Study design | Randomised; Interventional; Design type: Screening, Diagnosis, Prevention, Device |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | The B-ADENOMA Study: Bowel Scope - Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities |
| Study acronym | B-ADENOMA |
| Study objectives | The aim of this study is to evaluate the effectiveness of using Endocuff Vision in detecting colonic adenomas (polyps in the bowel which may progress to bowel cancer), making sure the procedure is the same or better than the current procedure in all other aspects. |
| Ethics approval(s) | West Midlands Research Ethics Committee - Solihull, 20/01/2017, ref: 16/WM/0514 |
| Health condition(s) or problem(s) studied | Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology; UKCRC code/ Disease: Cancer/ Malignant neoplasms of digestive organs, Oral and Gastrointestinal/ Other diseases of the digestive system |
| Intervention | Participants undergo a endoscopy as per usual practice. Participants are randomly allocated to one of the groups using randomisation software, stratifying for age group and gender. Treatment arm: Participants in this arm have the Endocuff Vision mounted on the endoscope for the one-off flexible sigmoidoscopy. Control arm: The one-off flexible sigmoidoscopy is completed as normal, without the Endocuff Vision on the scope. Participants are followed up for 14 days after the test test to ensure there are no adverse events. |
| Intervention type | Other |
| Primary outcome measure | Adenoma detection rate (ADR) is measured by histological examination of polyps, recorded 14 days after the procedure |
| Secondary outcome measures | 1. Mean adenomas detected per procedure are measured by histological examination of polyps, at 14 days after the procedure 2. Rate of cuff exchange (that is, how often the cuff has to be removed) at the time of the procedure 3. Complete withdrawal time in procedures where no polyps are detected, measured using withdrawal times at the time of the procedure 4. Overall procedure time is measured at time of procedure 5. ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation), recorded at the time of the procedure 6. Rate of discovered cancers is measured by histological examination of biopsies/polyps, recorded up to 14 days after the procedure 7. Examination extent is measured using anatomical assessment of and distance (in centimetres) of intubation at the time of the procedure 8. Patient satisfaction is measured using the modified Gloucester scale of assessment of patient comfort at day of procedure and 24 hours after 9. Differences in future colonoscopic workload produced by increased ADR is measured using the change in the number of patients referred for full colonoscopy at day of the procedure 10. Changes in ADR to assess any learning curve effect is measured using primary outcome data for the first and last 20% of cases per individual colonoscopist after recruitment has completed 11. ADR of each colonoscopist prior to trial recruitment compared with their individual ADR in patients where EndocuffTM Vision was not used is measured using data from the Bowel Cancer Screening programme collected pre-trial and after the trial has completed recruitment from primary outcome data |
| Overall study start date | 17/03/2016 |
| Completion date | 30/08/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 3222; UK Sample Size: 3222 |
| Total final enrolment | 3222 |
| Key inclusion criteria | 1. Age 55 to 61 years (both male and female) 2. Referral for screening flexible sigmoidoscopy 3. Ability to give informed consent |
| Key exclusion criteria | 1. Absolute contraindications to flexible sigmoidoscopy 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 sigmoidoscope passage) 6. Patients with active colitis (ulcerative colitis, Crohn’s colitis, diverticulitis, infective colitis) 7. Patients lacking capacity to give informed consent 8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure 9. Pregnancy |
| Date of first enrolment | 14/02/2017 |
| Date of final enrolment | 13/02/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
South Tyneside District Hospital (Lead Centre)
Harton Lane
Tyne and Wear
South Shields
NE34 0PL
United Kingdom
Tyne and Wear
South Shields
NE34 0PL
United Kingdom
St. Mark’s Hospital
Watford Road
Middlesex
HA1 3UJ
United Kingdom
Middlesex
HA1 3UJ
United Kingdom
Queen Alexandra Hospital
Southwick Hill Road
Cosham
PO6 3LY
United Kingdom
Cosham
PO6 3LY
United Kingdom
University Hospital North Tees
Hardwick Road
Hardwick
Stockton-on-Tees
TS19 8PE
United Kingdom
Hardwick
Stockton-on-Tees
TS19 8PE
United Kingdom
Bishop Auckland Hospital
Cockton Hill Road
Bishop Auckland
DL14 6AD
United Kingdom
Bishop Auckland
DL14 6AD
United Kingdom
North Tyneside General Hospital
Rake Lane
North Shields
NE29 8NH
United Kingdom
North Shields
NE29 8NH
United Kingdom
Queen Elizabeth Hospital
Queen Elizabeth Avenue
Gateshead
NE9 6SX
United Kingdom
Gateshead
NE9 6SX
United Kingdom
Northern General Hospital
Herries Road
Sheffield
S5 7AU
United Kingdom
Sheffield
S5 7AU
United Kingdom
Fairfield General Hospital
Rochdale Old Road
Bury
BL9 7TD
United Kingdom
Bury
BL9 7TD
United Kingdom
Gloucestershire Royal Hospital
Great Western Road
Gloucester
GL1 3NN
United Kingdom
Gloucester
GL1 3NN
United Kingdom
New Cross Hospital
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Heath Town
Wolverhampton
WV10 0QP
United Kingdom
Royal Bolton Hospital
Minerva Road
Farnworth
Bolton
BL4 0JR
United Kingdom
Farnworth
Bolton
BL4 0JR
United Kingdom
The Whittington Hospital
Magdala Avenue
London
N19 5NF
United Kingdom
London
N19 5NF
United Kingdom
Kettering General Hospital
Rothwell Road
Kettering
N19 5NF
United Kingdom
Kettering
N19 5NF
United Kingdom
John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
University College Hospital
235 Euston Road
Bloomsbury
London
NW1 2BU
United Kingdom
Bloomsbury
London
NW1 2BU
United Kingdom
Charing Cross Hospital
Fulham Palace Road
London
W6 8RF
United Kingdom
London
W6 8RF
United Kingdom
Royal Lancaster Infirmary
Ashton Road
Lancaster
LA1 4RP
United Kingdom
Lancaster
LA1 4RP
United Kingdom
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Dorset County Hospital
Williams Avenue
Dorchester
DT1 2JY
United Kingdom
Dorchester
DT1 2JY
United Kingdom
Watford General Hospital
Vicarage Road
Watford
WD18 0HB
United Kingdom
Watford
WD18 0HB
United Kingdom
Sponsor information
South Tyneside District Hospital
Hospital/treatment centre
Hospital/treatment centre
South Tyneside NHS Foundation Trust
Harton Lane
South Shields
NE34 0PL
England
United Kingdom
"ROR" |
https://ror.org/00q75av54 |
|---|
Funders
Funder type
Government
Arc Medical Design Limited
No information available
Norgine Limited
No information available
Results and Publications
| Intention to publish date | 31/12/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal by October 2019. International presentation at UEGW and BSG annual meetings. Presentation to BSG Endoscopy Research Committee and BCSP |
| IPD sharing plan | The datasets generated during and/or analysed during the current study is not expected to be made available due to no specific patient consent being given for this. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2020 | 26/11/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
11/01/2023: Updated Cancer Research UK lay summary link added to plain English summary field.
26/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
07/09/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/07/2018 to 13/02/2018.
2. The overall trial end date was changed from 01/10/2018 to 30/08/2018.
3. The intention to publish date was changed from 31/10/2019 to 31/12/2018.
13/06/2018: Cancer Research UK lay summary link added to plain English summary field.
14/05/2018: Internal review.
16/01/2018: Internal review.
06/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.
11/08/2017: Internal review.
