Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy
1 other identifier
interventional
1,516
1 country
1
Brief Summary
The incidence of colorectal cancer in China is increasing year by year. Studies have shown that colorectal cancer is more common in the left colon，especially in the China. Our previous study also showed a higher rate of missed adenoma in the left colon than the right colon during colonoscopy. Additionally, prolonging withdrawal time could only improve the ADR of right colon, but had limited effect on the ADR of left colon in our previous research. Our aim is to evaluate the effect of a second forward view examination of the left colon on the detection of adenoma detection during colonoscopy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2023
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2022
CompletedFirst Posted
Study publicly available on registry
December 15, 2022
CompletedStudy Start
First participant enrolled
January 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2024
CompletedApril 6, 2023
April 1, 2023
1 year
December 7, 2022
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Left colon adenoma detection rate (LCADR)
LCADR is the number of patients with at least one adenoma in the left colon, divided by the total number of patients.
60 minutes
Secondary Outcomes (2)
adenoma detection rate(ADR)
60 minutes
left colon adenomas per colonoscopy (LCAPC)
60 minutes
Study Arms (2)
Second forward view examination group
EXPERIMENTALAfter successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. Then the left colon, including the splenic curvature to the anus, is examined twice in the forward view.
Extended withdrawal time group
EXPERIMENTALAfter successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. The colonoscope was withdrawn to the anus directly with withdrawal time extended to the double routine withdrawal time of the left colon.
Interventions
During colonoscopy, the left colon was examined a second time in the forward view.
During colonoscopy, the left colon was examined with double basic withdrawal time in the forward view.
Eligibility Criteria
You may qualify if:
- Patients whose age are between 40-75, or aged 76-85 depending on his condition
- Patients who have indications for screening
- Patients who have signed inform consent form.
You may not qualify if:
- Patients who have undergone colonic resection
- 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 before colonoscopy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Changhai Hospitallead
- No.85 Hospital, Changning, Shanghai, Chinacollaborator
- Shanxi Provincial People's Hospitalcollaborator
- The General Hospital of Eastern Theater Commandcollaborator
- The Sixth Affiliated Hospital of Guangzhou Medical Universitycollaborator
- Fudan Universitycollaborator
- Kunshan Hospital of Traditional Chinese Medicinecollaborator
- Ningjin County Hospitalcollaborator
- Qinghai People's Hospitalcollaborator
- The First Affiliated Hospital of Yangtze Universitycollaborator
- Qujing NO.1 Hospitalcollaborator
- Jiangxi Provincial People's Hopitalcollaborator
- Yueyang Central Hospitalcollaborator
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicinecollaborator
- The First People's Hospital of Changde Citycollaborator
- Xuzhou Central Hospitalcollaborator
- Wenzhou Central Hospitalcollaborator
- Anhui Provincial Hospitalcollaborator
- Jiangsu Provincial People's Hospitalcollaborator
- Xiangya Hospital of Central South Universitycollaborator
Study Sites (1)
Changhai Hospital, Second Military Medical University
Shanghai, 200433, China
Related Publications (2)
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: 33220526BACKGROUNDZhao 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.
PMID: 30738046BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li, MD
Changhai Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Study Record Dates
First Submitted
December 7, 2022
First Posted
December 15, 2022
Study Start
January 1, 2023
Primary Completion
January 1, 2024
Study Completion
July 1, 2024
Last Updated
April 6, 2023
Record last verified: 2023-04