NCT03622281

Brief Summary

Quality measures in colonoscopy are important guides for improving the quality of patient care. But quality improvement intervention is not taking place, primarily because of the inconvenience and expense. To address the difficulties above, we used artificial intelligence for quality control of colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
676

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

July 16, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 20, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

July 16, 2018

Last Update Submit

February 10, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adenoma detection rate

    Adenoma detection rate was defined as the number of exams with findings of adenoma divided by the total number of exams.

    8 months

Study Arms (2)

Colonoscopists who received quality intervention

EXPERIMENTAL
Other: quality improvement intervention using artificial intelligence

Colonoscopists who did not received quality intervention

NO INTERVENTION

Interventions

Colonoscopists received performance measure monitoring and feedback

Colonoscopists who received quality intervention

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged between 18 and 80;
  • agree to give written informed consent.

You may not qualify if:

  • patients with the contraindications to colonoscopy examination;
  • patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
  • patients with prior failed colonoscopy and high suspicion of polyposis syndromes, IBD and typical advanced CRC;
  • patients refused to participate in the trial;
  • the colonoscopyprocedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
  • the colonoscopy procedure have to be terminated due to complications of anaesthesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

Related Publications (1)

  • Su JR, Li Z, Shao XJ, Ji CR, Ji R, Zhou RC, Li GC, Liu GQ, He YS, Zuo XL, Li YQ. Impact of a real-time automatic quality control system on colorectal polyp and adenoma detection: a prospective randomized controlled study (with videos). Gastrointest Endosc. 2020 Feb;91(2):415-424.e4. doi: 10.1016/j.gie.2019.08.026. Epub 2019 Aug 24.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of QiLu Hospital

Study Record Dates

First Submitted

July 16, 2018

First Posted

August 9, 2018

Study Start

October 20, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations