Detection of Adenomas in Screening Colonoscopy
1 other identifier
interventional
1,178
1 country
1
Brief Summary
The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedFirst Posted
Study publicly available on registry
December 3, 2020
CompletedDecember 3, 2020
November 1, 2020
1.2 years
March 1, 2018
November 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
adenoma
number of adenomas found during colonoscopy
2 weeks
Secondary Outcomes (5)
cecal intubation rate
up to 2 hours
cecal intubation time
up to 2 hours
withdrawal time
up to 60 minutes
adenoma size
up to 4 weeks
adenoma site
up to 4 weeks
Study Arms (2)
endocuff
EXPERIMENTALall patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff
no cuff
ACTIVE COMPARATORall patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff
Interventions
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
Eligibility Criteria
You may qualify if:
- all Citizens participating in the national bowel screening program
You may not qualify if:
- persons who are disabled and who do not understand the Danish language
- persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection
- persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan.
- persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herning Hospitallead
Study Sites (1)
Kirurgisk Afdeling
Herning, Central Jutland, 7400, Denmark
Related Publications (1)
Jaensch C, Jepsen MH, Christiansen DH, Madsen AH, Madsen MR. Adenoma and serrated lesion detection with distal attachment in screening colonoscopy: a randomized controlled trial. Surg Endosc. 2022 Sep;36(9):1-9. doi: 10.1007/s00464-022-09049-5. Epub 2022 Feb 9.
PMID: 35141776DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- participant, care provider, investigator and outcomes assessor know whether or not a endocuff has been used for the colonoscopy
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principan investigator
Study Record Dates
First Submitted
March 1, 2018
First Posted
December 3, 2020
Study Start
October 1, 2017
Primary Completion
December 1, 2018
Study Completion
April 1, 2020
Last Updated
December 3, 2020
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share