NCT03399045

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,027

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 16, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2019

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

1.4 years

First QC Date

January 8, 2018

Last Update Submit

December 27, 2019

Conditions

Colon PolypsColorectal Adenomas

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • adenomas per colonoscopy(APC)

    30mins

Study Arms (2)

9-minute withdrawal group

EXPERIMENTAL

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

6-minute withdrawal group

ACTIVE COMPARATOR

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

Interventions

9-minute withdrawalPROCEDURE

Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw

9-minute withdrawal group
6-minute withdrawalPROCEDURE

Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw

6-minute withdrawal group

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (1)

  • 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.

    PMID: 33220526DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Li Zhaoshen, M.D

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 16, 2018

Study Start

January 20, 2018

Primary Completion

July 1, 2019

Study Completion

July 6, 2019

Last Updated

January 2, 2020

Record last verified: 2019-12

Locations

CN(1)