NCT04397120

Brief Summary

The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13,495

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
Last Updated

May 21, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 16, 2020

Last Update Submit

May 19, 2020

Conditions

Adenoma Detection RateColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    the proportion of colonoscopies in which at least one adenoma was detected

    After histopathologically examined, reviewed, and confirmed, an average of 7 days.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Endoscopy Department of a university Hospital

You may qualify if:

  • Patients were retrospectively included in this study if they had undergone a completed colonoscopy.

You may not qualify if:

  • prior colonoscopy within 3 years;
  • medical history of inflammatory bowel disease (IBD), CRC, or abdominal surgery;
  • fair or poor quality of bowel preparation (fair quality: some semisolid stool that could be suctioned or washed away but \>90% of mucosal surface seen; poor quality: semisolid stool that could not be suctioned or washed away with \<90% of mucosal surface seen);
  • failure in cecal intubation;
  • withdrawal time without removing\<6 min.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

Location

Study Officials

  • Bin Lu, M.D.

    First Affiliated Hospital of Zhejiang Chinese Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 21, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

April 30, 2020

Last Updated

May 21, 2020

Record last verified: 2020-05

Locations

CN(1)