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9 Minutes for Tandem Colonoscopy Withdrawal

Primary Purpose

Colon Polyp, Colorectal Adenoma

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
6-minute then 9-minute withdrawal
9-minute then 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 Polyp focused on measuring withdrawal time, adenoma miss rate, tandem colonoscopy, adenoma detection rate

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Changhai Hospital, Second Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

6-minute then 9-minute withdrawal

9-minute then 6-minute withdrawal

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
adenoma detection rate(ADR)
ADR is the number of patients with at least one adenoma, divided by the total number of patients.
adenomas per colonoscopy(APC)
APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.
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

Full Information

First Posted
March 10, 2021
Last Updated
January 29, 2022
Sponsor
Changhai Hospital
Collaborators
No.85 Hospital, Changning, Shanghai, China, Yantaishan Hospital of Yantai City, Yantai, China, Seventh Medical Center of PLA Army General Hospital, The First Affiliated Hospital of Dalian Medical University, The First Affiliated Hospital of the Medical College, Shihezi University, Shanghai 8th People's Hospital, Shanxi Provincial People's Hospital, Qinghai People's Hospital, Leqing People's Hospital, Affiliated Hospital of North Sichuan Medical College, Zhejiang University, Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine, The General Hospital of Eastern Theater Command, Heilongjiang provincial hospital, The Second Hospital of Hebei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04797065
Brief Title
9 Minutes for Tandem Colonoscopy Withdrawal
Official Title
Impact of 9-minute Withdrawal Time on Adenoma Miss Rate: A Multicenter, Prospective, Randomized Controlled Trial of Tandem Colonoscopy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)

3. Sponsor/Collaborators

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

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp, Colorectal Adenoma
Keywords
withdrawal time, adenoma miss rate, tandem colonoscopy, adenoma detection rate

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
733 (Actual)

8. Arms, Groups, and Interventions

Arm Title
6-minute then 9-minute withdrawal
Arm Type
Experimental
Arm Description
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.
Arm Title
9-minute then 6-minute withdrawal
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
6-minute then 9-minute withdrawal
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
9-minute then 6-minute withdrawal
Intervention Description
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.
Primary Outcome Measure Information:
Title
adenoma miss rate(AMR)
Description
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.
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
advanced adenoma miss rate(AAMR)
Description
AAMR is the number of advanced adenomas detected in the second-pass examination/total number of advanced adenomas detected in the two pass.
Time Frame
60 minutes
Title
adenoma detection rate(ADR)
Description
ADR is the number of patients with at least one adenoma, divided by the total number of patients.
Time Frame
60 minutes
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
60 minutes
Title
patient-level AMR(pAMR)
Description
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
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoshen Li, 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

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
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PubMed Identifier
30738046
Citation
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.
Results Reference
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9 Minutes for Tandem Colonoscopy Withdrawal

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