Back to results

Detection of Adenomas in Screening Colonoscopy

Primary Purpose

Adenoma Colon

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

endocuff

no endocuff

About this trial

This is an interventional diagnostic trial for Adenoma Colon focused on measuring adenoma detection rate, screening colonoscopy

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

all Citizens participating in the national bowel screening program

Exclusion Criteria:

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

Sites / Locations

Kirurgisk Afdeling

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

endocuff

no cuff

Arm Description

all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff

all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff

Outcomes

Primary Outcome Measures

adenoma

number of adenomas found during colonoscopy

Secondary Outcome Measures

cecal intubation rate

is the cecum reached during the colonoscopy

cecal intubation time

number of minutes from start procedure to cecum reached

withdrawal time

number of minutes from cecum reached to end of the procedure, only if no polyps are found

adenoma size

size of adenomas detected

adenoma site

where in the bowel the adenoma was detected

Full Information

NCT ID

NCT04651062

First Posted

March 1, 2018

Last Updated

November 25, 2020

Sponsor

Herning Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04651062

Brief Title

Detection of Adenomas in Screening Colonoscopy

Official Title

Detection of Adenomas in Screening Colonoscopy - Endocuff Study

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 1, 2017 (Actual)

Primary Completion Date

December 1, 2018 (Actual)

Study Completion Date

April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herning Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adenoma Colon

Keywords

adenoma detection rate, screening colonoscopy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

this is a randomized controlled trial

Masking

None (Open Label)

Masking Description

participant, care provider, investigator and outcomes assessor know whether or not a endocuff has been used for the colonoscopy

Allocation

Randomized

Enrollment

1178 (Actual)

8. Arms, Groups, and Interventions

Arm Title

endocuff

Arm Type

Experimental

Arm Description

all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff

Arm Title

no cuff

Arm Type

Active Comparator

Arm Description

all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff

Intervention Type

Device

Intervention Name(s)

endocuff

Intervention Description

Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.

Intervention Type

Procedure

Intervention Name(s)

no endocuff

Intervention Description

colonoscopy is performed without endocuff.

Primary Outcome Measure Information:

Title

adenoma

Description

number of adenomas found during colonoscopy

Time Frame

2 weeks

Secondary Outcome Measure Information:

Title

cecal intubation rate

Description

is the cecum reached during the colonoscopy

Time Frame

up to 2 hours

Title

cecal intubation time

Description

number of minutes from start procedure to cecum reached

Time Frame

up to 2 hours

Title

withdrawal time

Description

number of minutes from cecum reached to end of the procedure, only if no polyps are found

Time Frame

up to 60 minutes

Title

adenoma size

Description

size of adenomas detected

Time Frame

up to 4 weeks

Title

adenoma site

Description

where in the bowel the adenoma was detected

Time Frame

up to 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: all Citizens participating in the national bowel screening program Exclusion Criteria: 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

Facility Information:

Facility Name

Kirurgisk Afdeling

City

Herning

State/Province

Midtjylland

ZIP/Postal Code

7400

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35141776

Citation

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.

Results Reference

derived

Learn more about this trial

Detection of Adenomas in Screening Colonoscopy

We'll reach out to this number within 24 hrs