Impact of SE of the Proximal Colon on the AMR

NCT05712304 | Unknown

• 1 other identifier: LL202211
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

Brief Summary

.Studies have demonstrated that the second examination of the proximal colon can significantly increase the proximal ADR.This study aimed to determine the impact of second examination of the proximal colon on AMR compared to conventional examination.Consecutive patients aged 40-75years undergoing colonoscopy for screening.Tandem withdrawal was used in the proximal colon.Patients were randomly assigned to either the second examination(SE) or the conventional examination(CE) group.The primary outcome measure was proximal AMR,defined as the number of proximal adenomas detected in the second pass（CE group）or the third pass（SE group）divided by the total number of proximal adenomas detected during the tandem colonoscopy.

Conditions

Adenoma Miss Rate

Outcome Measures

Primary Outcomes (1)

• proximal AMR

  the number of proximal adenomas detected in the second pass（CE group）or the third pass（SE group）divided by the total number of proximal adenomas detected during the tandem colonoscopy.

  2 years

Secondary Outcomes (5)

• proximal polyp miss rate

  2 years

• Per-patient proximal AMR or per-patient proximal PMR

  2 years

• The adenoma detection rate (ADR) or polyp detection rate (PDR)

  2 years

• Adenoma per colonoscopy (APC) or polyp per colonoscopy (PPC)

  2 years

• proximal advanced AMR(AAMR)

  2 years

Study Arms (2)

conventional examination

NO INTERVENTION

For patients in the CE group, the colonoscope was withdrawn directly from the splenic flexure to the rectum, and polyps that were found were removed

second examination

EXPERIMENTAL

For patients in the SE group, the colonoscope was reinserted into the cecum, additional polyps were removed from the proximal colon during the third withdrawall(third pass), and the remainder of the colon from splenic flexure to rectum was examined in a standard manner

Diagnostic Test: second examination of the proximal colon

Interventions

second examination of the proximal colon DIAGNOSTIC_TEST

For patients in the SE group, the colonoscope was reinserted into the cecum, additional polyps were removed from the proximal colon during the third withdrawall(third pass), and the remainder of the colon from splenic flexure to rectum was examined in a standard manner

second examination

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients aged 40-75years undergoing colonoscopy for screening

You may not qualify if:

• failed cecal intubation, prior colorectal resection, inadequate bowel preparation quality (Boston Bowel Preparation Scale (BBPS)scores \< 2 in any segment of the colon), inflammatory bowel disease or intestinal tuberculosis, familial polyposis syndrome, coagulation dysfunction, or polyp retrieval failure.

Sponsors & Collaborators

• Third People's Hospital of Jingdezhen City: lead

Study Sites (2)

Second People's Hospital of Jingdezhen City

Jingdezhen, Jiangxi, 333000, China

RECRUITING

Third People's Hospital of Jingdezhen City

Jingdezhen, Jiangxi, 333000, China

RECRUITING

Study Officials

• li yang

  Third People's Hospital of Jingdezhen,

  STUDY DIRECTOR

Central Study Contacts

xiaojia zhu

CONTACT

15879497590; zhuxiaojia2021@163.com

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

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: February 15, 2023
• Primary Completion: December 15, 2024
• Study Completion: December 30, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)