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

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

re-examination

extended withdraw time

About this trial

This is an interventional diagnostic trial for Colon Adenoma focused on measuring Adenoma detection rate, colonoscopy

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Changhai Hospital, Second Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Second forward view examination group

Extended withdrawal time group

Arm Description

After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected.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.

After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. The colonoscope was withdrawn to the anus directly with withdrawal time extended to the double routine withdrawal time of the left colon.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

adenoma detection rate(ADR)

ADR is the number of patients with at least one adenoma, divided by the total number of patients.

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.

Full Information

NCT ID

NCT05651893

First Posted

December 7, 2022

Last Updated

April 5, 2023

Sponsor

Changhai Hospital

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05651893

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Changhai Hospital

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Adenoma

Keywords

Adenoma detection rate, colonoscopy

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

1516 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Second forward view examination group

Arm Type

Experimental

Arm Description

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.

Arm Title

Extended withdrawal time group

Arm Type

Experimental

Arm Description

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.

Intervention Type

Behavioral

Intervention Name(s)

re-examination

Intervention Description

During colonoscopy, the left colon was examined a second time in the forward view.

Intervention Type

Behavioral

Intervention Name(s)

extended withdraw time

Intervention Description

During colonoscopy, the left colon was examined with double basic withdrawal time in the forward view.

Primary Outcome Measure Information:

Title

Left colon adenoma detection rate (LCADR)

Description

LCADR is the number of patients with at least one adenoma in the left colon, divided by the total number of patients.

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

adenoma detection rate(ADR)

Description

ADR is the number of patients with at least one adenoma, divided by the total number of patients.

Time Frame

60 minutes

Title

left colon adenomas per colonoscopy (LCAPC)

Description

LCAPC was calculated as the number of adenomas detected during in left colon colonoscopy withdraw divided by the number of colonoscopies.

Time Frame

60 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

No

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhaoshen Li, MD

Phone

86-021-31161365

Email

li.zhaoshen@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Yu Bai, MD

Phone

86-021-31161335

Email

baiyu1998@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhaoshen Li, MD

Organizational Affiliation

Changhai Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Changhai Hospital, Second Military Medical University

City

Shanghai

ZIP/Postal Code

200433

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yu Bai, MD

Phone

86-021-81873241

Email

baiyu1998@hotmail.com

First Name & Middle Initial & Last Name & Degree

zhaoshen Li, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

33220526

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.

Results Reference

background

PubMed Identifier

30738046

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.

Results Reference

background

Colon Adenoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial