Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy

Colon Adenoma Clinical Trial

Official title:

Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy: a Multicenter, Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651893
• Other study ID #: SFW2022-01
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 2024

Study information

• Verified date: April 2023
• Source: Changhai Hospital
• Contact: Zhaoshen Li, MD
• Phone: 86-021-31161365
• Email: li.zhaoshen[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1516
• Est. completion date: July 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma

Intervention

Behavioral:
• re-examination
During colonoscopy, the left colon was examined a second time in the forward view.
• extended withdraw time
During colonoscopy, the left colon was examined with double basic withdrawal time in the forward view.

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (20)

Lead Sponsor

Collaborator

Changhai Hospital

Anhui Provincial Hospital, Fudan University, Jiangsu Provincial People's Hospital, Jiangxi Provincial People's Hopital, Kunshan Hospital of Traditional Chinese Medicine, Ningjin County Hospital, No.85 Hospital, Changning, Shanghai, China, Qinghai People's Hospital, Qujing NO.1 Hospital, Shanxi Provincial People's Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, The First Affiliated Hospital of Yangtze University, The First People's Hospital of Changde City, The General Hospital of Eastern Theater Command, The Sixth Affiliated Hospital of Guangzhou Medical University, Wenzhou Central Hospital, Xiangya Hospital of Central South University, Xuzhou Central Hospital, Yueyang Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adenoma detection rate(ADR)	ADR is the number of patients with at least one adenoma, divided by the total number of patients.	60 minutes
Secondary	left colon adenomas per colonoscopy (LCAPC)	LCAPC was calculated as the number of adenomas detected during in left colon colonoscopy withdraw divided by the number of colonoscopies.	60 minutes