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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Colon Adenoma
• Intervention / Treatment: Behavioral: re-examination; Behavioral: extended withdraw time

• Study Type: Interventional
• Enrollment (Anticipated): 1516
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhaoshen Li, MD; Phone Number: 86-021-31161365; Email: li.zhaoshen@hotmail.com
• Study Contact Backup: Name: Yu Bai, MD; Phone Number: 86-021-31161335; Email: baiyu1998@hotmail.com

Study Locations

• China
  • Shanghai, China, 200433
    • Recruiting
    • Changhai Hospital, Second Military Medical University
    • Contact: Yu Bai, MD; Phone Number: 86-021-81873241; Email: baiyu1998@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Second forward view examination group; After 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.	Behavioral: re-examination; During colonoscopy, the left colon was examined a second time in the forward view.
Experimental: Extended withdrawal time group; After 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.	Behavioral: extended withdraw time; During colonoscopy, the left colon was examined with double basic withdrawal time in the forward view.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenoma detection rate(ADR)	ADR is the number of patients with at least one adenoma, divided by the total number of patients.	60 minutes
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 7, 2022
• First Posted (Actual): December 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: colonoscopy; Adenoma detection rate
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: SFW2022-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No