Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1178 participants
INTERVENTIONAL
2017-10-01
2020-04-01
Brief Summary
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Detailed Description
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The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer.
This study is a randomized controlled trial with 900 patients.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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endocuff
all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff
endocuff
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
no cuff
all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff
no endocuff
colonoscopy is performed without endocuff.
Interventions
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endocuff
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
no endocuff
colonoscopy is performed without endocuff.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
50 Years
75 Years
ALL
Yes
Sponsors
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Herning Hospital
OTHER
Responsible Party
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Claudia Jaensch
principan investigator
Locations
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Kirurgisk Afdeling
Herning, Central Jutland, Denmark
Countries
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References
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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.
Other Identifiers
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1-16-02-828-17
Identifier Type: -
Identifier Source: org_study_id