NCT04963010

Brief Summary

To evaluate the impact of second forward view examination of the proximal colon on adenoma detection rate Inclusion criteria:Patients ≥18 years of age undergoing screening, follow-up monitoring, and diagnostic colonoscopy Exclusion criteria:①Cecal intubation failed. ②Have a history of colorectal surgery. ③Insufficient bowel preparation, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores \< 2 in any segment of the colon). ④Inflammatory bowel disease or intestinal tuberculosis. ⑤Familial polyp syndrome. ⑥polyp retrieval failure. ⑦Patients with coagulation dysfunction. Patients ≥ 18 years of age who came to our hospital's Digestive Endoscopy Center for screening, follow-up monitoring and diagnosis of colonoscopy. After successfully insert the cecum, colonoscope withdrawal to the splenic flexure, all polyps found during the withdrawal process were resection,then they were randomized to standard withdrawal colonoscopy or second forward view according to the random number table (1:1) to perform.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
910

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

June 14, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 15, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 15, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2022

Completed
Last Updated

June 13, 2022

Status Verified

June 1, 2022

Enrollment Period

12 months

First QC Date

June 15, 2021

Last Update Submit

June 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • proximal colon adenoma detection rate

    proportion of patients with proximal colon adenoma found in all colonoscopy patients

    up to 2 years

Secondary Outcomes (7)

  • whole colon adenoma detection rate

    up to 2 years

  • Cecal insertion time

    up to 2 years

  • proximal colon withdrawal time

    up to 2 years

  • total withdrawal time

    up to 2 years

  • BBPS

    up to 2 years

  • +2 more secondary outcomes

Study Arms (2)

standard withdrawal colonoscopy

NO INTERVENTION

Observation of conventional colonoscopy

second forward view

EXPERIMENTAL

second forward view examination of the proximal colon

Diagnostic Test: second forward view

Interventions

second forward viewDIAGNOSTIC_TEST

second forward view examination of the proximal colon

second forward view

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Third People's Hospital of Jingdezhen City

Jingdezhen, Jiangxi, 333000, China

RECRUITING

Study Officials

  • Li Yang

    Third People's Hospital of Jingdezhen City

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

June 15, 2021

First Posted

July 15, 2021

Study Start

June 14, 2021

Primary Completion

June 8, 2022

Study Completion

June 8, 2022

Last Updated

June 13, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

Sharing data after the research over

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Half a year after the research over and lasts for 2 years
Access Criteria
Gastroenterologist
More information

Locations