9 Minutes for Tandem Colonoscopy Withdrawal

NCT04797065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 733

Last updated 2022-02-01

No results posted yet for this study

Summary

A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.

Conditions

  • Colon Polyp
  • Colorectal Adenoma

Interventions

PROCEDURE

6-minute then 9-minute withdrawal

Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 2 minutes then in 3 minutes during each colonic segment. In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes.

PROCEDURE

9-minute then 6-minute withdrawal

Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 3 minutes then in 2 minutes during each colonic segment. In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes.

Sponsors & Collaborators

  • No.85 Hospital, Changning, Shanghai, China

    collaborator OTHER
  • Yantaishan Hospital of Yantai City, Yantai, China

    collaborator UNKNOWN
  • Seventh Medical Center of PLA Army General Hospital

    collaborator OTHER
  • The First Affiliated Hospital of Dalian Medical University

    collaborator OTHER
  • The First Affiliated Hospital of the Medical College, Shihezi University

    collaborator UNKNOWN
  • Shanghai 8th People's Hospital

    collaborator OTHER
  • Shanxi Provincial People's Hospital

    collaborator OTHER_GOV
  • Qinghai People's Hospital

    collaborator OTHER
  • Leqing People's Hospital

    collaborator UNKNOWN
  • Affiliated Hospital of North Sichuan Medical College

    collaborator OTHER
  • Zhejiang University

    collaborator OTHER
  • Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    collaborator OTHER_GOV
  • The General Hospital of Eastern Theater Command

    collaborator OTHER
  • Heilongjiang provincial hospital

    collaborator UNKNOWN
  • The Second Hospital of Hebei Medical University

    collaborator OTHER
  • Changhai Hospital

    lead OTHER

Principal Investigators

  • Zhaoshen Li, M.D · Changhai Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2021-11-05
Completion
2021-12-05

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04797065 on ClinicalTrials.gov