9 Minutes for Tandem Colonoscopy Withdrawal
NCT04797065 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 733
Last updated 2022-02-01
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 Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes.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 Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes.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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