Clinical trial NCT05651893: Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy
Official title: Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy: a Multicenter, Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Adenoma
Keywords: Adenoma detection rate
colonoscopy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: No.85 Hospital, Changning, Shanghai, China
name: Shanxi Provincial People's Hospital
name: The General Hospital of Eastern Theater Command
name: The Sixth Affiliated Hospital of Guangzhou Medical University
name: Fudan University
name: Kunshan Hospital of Traditional Chinese Medicine
name: Ningjin County Hospital
name: Qinghai People's Hospital
name: The First Affiliated Hospital of Yangtze University
name: Qujing NO.1 Hospital
name: Jiangxi Provincial People's Hopital
name: Yueyang Central Hospital
name: The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
name: The First People's Hospital of Changde City
name: Xuzhou Central Hospital
name: Wenzhou Central Hospital
name: Anhui Provincial Hospital
name: Jiangsu Provincial People's Hospital
name: Xiangya Hospital of Central South University
First posted: 2022-12-15
Enrollment: 1516
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Left colon adenoma detection rate (LCADR)
timeFrame: 60 minutes
Secondary outcomes:
measure: adenoma detection rate(ADR)
timeFrame: 60 minutes
measure: left colon adenomas per colonoscopy (LCAPC)
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.