9 Minutes for Colonoscopy Withdrawal

Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial

A withdrawal time of at least 6 minutes has been considered to be necessary to guarantee the adenoma detection rate and the critical quality criterion of colonoscopy. However, several large observational investigations demonstrated that 9 minutes will be in favor of higher adenoma detection rate and lower risk of interval colorectal cancer, when compared with 6-minute withdrawal. Meanwhile, a few studies also indicated that no significant benefit were observed in longer withdrawal time. Up to now, no randomized controlled trials have been conducted to give a definitive conclusion. Therefore, we performed a multicenter, prospective, randomized Controlled trial to compare adenoma detection rate of 6-minute and 9-minute withdrawal in colonoscopy.

Study Overview

• Status: Completed
• Conditions: Colon Polyps; Colorectal Adenomas
• Intervention / Treatment: Procedure: 9-minute withdrawal; Procedure: 6-minute withdrawal

• Study Type: Interventional
• Enrollment (Actual): 1027
• 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 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients whose age is between 40-85.
• Patients who have indications for screening, surveillance and diagnostic colonoscopy.
• Patients who have signed inform consent form

Exclusion Criteria:

• Patients who have undergone colonic resection
• Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
• Patients with severe chronic cardiopulmonary and renal disease.
• Patients who are unwilling or unable to consent.
• Patients who are not suitable for colonoscopy
• Patients who received urgent or therapeutic colonoscopy
• Patients with pregnancy, inflammatory bowel disease, polyposis of colon, colorectal cancer, or intestinal obstruction
• Patients who are taking aspirin, clopidogrel or other anticoagulants
• Patients with Aronchick score > 3

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 9-minute withdrawal group; Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy will not be included in the 9 minutes.	Procedure: 9-minute withdrawal; Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw
ACTIVE_COMPARATOR: 6-minute withdrawal group; Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw. A stop watch will be utilized to remind endoscopists the withdrawal time. The time to perform polyp biopsy willwill not be included in the 9 minutes.	Procedure: 6-minute withdrawal; Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenoma detection rate(ADR)	ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.	30mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenomas per colonoscopy(APC)	APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.	30mins

Collaborators and Investigators

• Sponsor: Changhai Hospital
• Collaborators: Shaanxi Provincial People's Hospital; Qinghai People's Hospital; The First Affiliated Hospital of Dalian Medical University; First Affiliated Hospital of Harbin Medical University; Changzhi People's Hospital; No.85 Hospital, Changning, Shanghai, China; Seventh Medical Center of PLA Army General Hospital; Yantaishan Hospital of Yantai City; The Second Clinical Medical College of Jinan University; Shanghai 8th People's Hospital; Ningbo Medical Center Li Huili Eastern Hospital; The Third People's Hospital of Datong; The First Affiliated Hospital of the Medical College, Shihezi University
• Investigators: Principal Investigator: Li Zhaoshen, M.D, Changhai Hospital

Publications and helpful links

General Publications

• 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): January 20, 2018
• Primary Completion (ACTUAL): July 1, 2019
• Study Completion (ACTUAL): July 6, 2019

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (ACTUAL): January 16, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 2, 2020
• Last Update Submitted That Met QC Criteria: December 27, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: withdrawal time-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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