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9 Minutes for Colonoscopy Withdrawal

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03399045
Recruitment Status : Completed
First Posted : January 16, 2018
Last Update Posted : January 2, 2020
Sponsor:
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
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : January 20, 2018
Actual Primary Completion Date : July 1, 2019
Actual Study Completion Date : July 6, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arms and Interventions
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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
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Primary Outcome Measures :
  1. adenoma detection rate(ADR) [ Time Frame: 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 :
  1. adenomas per colonoscopy(APC) [ Time Frame: 30mins ]
    APC was calculated as the number of adenomas detected during colonoscopy withdraw divided by the number of colonoscopies.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03399045


Locations
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China
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
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Principal Investigator: Li Zhaoshen, M.D Changhai Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03399045    
Other Study ID Numbers: withdrawal time-1
First Posted: January 16, 2018    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms