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9 Minutes for Colonoscopy Withdrawal

Primary Purpose

Colon Polyps, Colorectal Adenomas

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
9-minute withdrawal
6-minute withdrawal
Sponsored by
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Polyps

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Changhai Hospital, Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

9-minute withdrawal group

6-minute withdrawal group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2018
Last Updated
December 27, 2019
Sponsor
Changhai Hospital
Collaborators
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
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1. Study Identification

Unique Protocol Identification Number
NCT03399045
Brief Title
9 Minutes for Colonoscopy Withdrawal
Official Title
Impact of 9-minute Withdrawal Time on Adenoma Detection Rate：a Multicenter, Prospective, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
January 20, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
Collaborators
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyps, Colorectal Adenomas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1027 (Actual)

8. Arms, Groups, and Interventions

Arm Title
9-minute withdrawal group
Arm Type
Experimental
Arm Description
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.
Arm Title
6-minute withdrawal group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
9-minute withdrawal
Intervention Description
Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw
Intervention Type
Procedure
Intervention Name(s)
6-minute withdrawal
Intervention Description
Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw
Primary Outcome Measure Information:
Title
adenoma detection rate(ADR)
Description
ADR was calculated adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.
Time Frame
30mins
Secondary Outcome Measure Information:
Title
adenomas per colonoscopy(APC)
Description
APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.
Time Frame
30mins

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Zhaoshen, M.D
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
ZIP/Postal Code
200433
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33220526
Citation
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.
Results Reference
derived

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9 Minutes for Colonoscopy Withdrawal

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