9 Minutes for Tandem Colonoscopy Withdrawal

Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Adenoma; Colon Polyp
• Intervention / Treatment: Procedure: 6-minute then 9-minute withdrawal; Procedure: 9-minute then 6-minute withdrawal

• Study Type: Interventional
• Enrollment (Actual): 733
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200433
    • Changhai Hospital, Second Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients whose age is between 40-75.
• Patients who have indications for screening
• Patients who have signed inform consent form.

Exclusion Criteria:

• Patients who have undergone colonic resection or polypectomy
• Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
• Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days
• Patients with inflammatory bowel diseases
• Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
• Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
• Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
• Patients with failed cecal intubation
• Patients with poor BPQ that necessitated a second bowel preparation
• Patients with therapeutic colonoscopy for existing lesions
• Patients refusing to participate or to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 6-minute then 9-minute withdrawal; Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 6 minutes then in 9 minutes during the segmental withdrawal. At 6-minute withdrawal, the left colon, transverse colon and right colon will take 2 minutes each. Then at 9-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 3 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.	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.
Active Comparator: 9-minute then 6-minute withdrawal; Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 9 minutes then in 6 minutes during the segmental withdrawal. At 9-minute withdrawal, the left colon, transverse colon and right colon will take 3 minutes each. Then at 6-minute withdrawal, the observation of the left colon, transverse colon and the right colon will be maintained for 2 minutes each. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenoma miss rate(AMR)	Adenomas detected in the second-pass examination were defined as missed adenomas; the AMR was defined as follows: number of adenomas detected in the second-pass examination/total number of adenomas detected in the two pass.	60 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenoma detection rate(ADR)	ADR is the number of patients with at least one adenoma, divided by the total number of patients.	60 minutes
advanced adenoma miss rate(AAMR)	AAMR is the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.	60 minutes
adenomas per colonoscopy(APC)	APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.	60 minutes
patient-level AMR(pAMR)	the number of participants with adenomas detected only during the second-pass colonoscopy divided by the total number of participants with adenomas detected during the tandem colonoscopy	60 minutes

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: The Second Hospital of Hebei Medical University; Zhejiang University; Qinghai People's Hospital; The First Affiliated Hospital of Dalian Medical University; Affiliated Hospital of North Sichuan Medical College; The General Hospital of Eastern Theater Command; Shanxi Provincial People's Hospital; No.85 Hospital, Changning, Shanghai, China; Seventh Medical Center of PLA Army General Hospital; Heilongjiang provincial hospital; Shanghai 8th People's Hospital; The First Affiliated Hospital of the Medical College, Shihezi University; Yantaishan Hospital of Yantai City, Yantai, China; Leqing People's Hospital; Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Publications and helpful links

General Publications

• Zhao S, Wang S, Pan P, Xia T, Chang X, Yang X, Guo L, Meng Q, Yang F, Qian W, Xu Z, Wang Y, Wang Z, Gu L, Wang R, Jia F, Yao J, Li Z, Bai Y. Magnitude, Risk Factors, and Factors Associated With Adenoma Miss Rate of Tandem Colonoscopy: A Systematic Review and Meta-analysis. Gastroenterology. 2019 May;156(6):1661-1674.e11. doi: 10.1053/j.gastro.2019.01.260. Epub 2019 Feb 6.
• Zhao S, Yang X, Wang S, Meng Q, Wang R, Bo L, Chang X, Pan P, Xia T, Yang F, Yao J, Zheng J, Sheng J, Zhao X, Tang S, Wang Y, Wang Y, Gong A, Chen W, Shen J, Zhu X, Wang S, Yan C, Yang Y, Zhu Y, Ma RJ, Wang R, Ma Y, Li Z, Bai Y. Impact of 9-Minute Withdrawal Time on the Adenoma Detection Rate: A Multicenter Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Feb;20(2):e168-e181. doi: 10.1016/j.cgh.2020.11.019. Epub 2020 Nov 19.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): November 5, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 10, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 29, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: adenoma detection rate; adenoma miss rate; withdrawal time; tandem colonoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: withdrawal time-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No