9 Minutes for Colonoscopy Withdrawal

Sponsor

Changhai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03399045

Collaborator

No.85 Hospital, Changning, Shanghai, China (Other), The Second Clinical Medical College of Jinan University (Other), Qinghai People's Hospital (Other), Shaanxi Provincial People's Hospital (Other), Shanghai 8th People's Hospital (Other), Yantaishan Hospital of Yantai City (Other), First Affiliated Hospital of Harbin Medical University (Other), Changzhi People's Hospital (Other), Ningbo Medical Center Li Huili Eastern Hospital (Other), The Third People's Hospital of Datong (Other), The First Affiliated Hospital of the Medical College, Shihezi University (Other), The First Affiliated Hospital of Dalian Medical University (Other), Seventh Medical Center of PLA Army General Hospital (Other)

1,027

Enrollment

Location

Arms

17.5

Actual Duration (Months)

58.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colon Polyps Colorectal Adenomas	Procedure: 9-minute withdrawal Procedure: 6-minute withdrawal	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1027 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 20, 2018

Actual Primary Completion Date :

Jul 1, 2019

Actual Study Completion Date :

Jul 6, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

adenoma detection rate(ADR) [30mins]
ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.

Secondary Outcome Measures

adenomas per colonoscopy(APC) [30mins]
APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital, Second Military Medical University	Shanghai		China	200433

Sponsors and Collaborators

Changhai Hospital
No.85 Hospital, Changning, Shanghai, China
The Second Clinical Medical College of Jinan University
Qinghai People's Hospital
Shaanxi Provincial People's Hospital
Shanghai 8th People's Hospital
Yantaishan Hospital of Yantai City
First Affiliated Hospital of Harbin Medical University
Changzhi 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
The First Affiliated Hospital of Dalian Medical University
Seventh Medical Center of PLA Army General Hospital

Investigators

Principal Investigator: Li Zhaoshen, M.D, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital

ClinicalTrials.gov Identifier:

NCT03399045

Other Study ID Numbers:

withdrawal time-1

First Posted:

Jan 16, 2018

Last Update Posted:

Jan 2, 2020

Last Verified:

Dec 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Adenoma

Study Results

No Results Posted as of Jan 2, 2020