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

NCT ID: NCT05651893

Last Updated: 2023-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1516 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected.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

Group Type EXPERIMENTAL

re-examination

Intervention Type BEHAVIORAL

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

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After successful intubation of the cecum, the colonoscope is withdrawn to the splenic curvature with the colonic mucosa carefully inspected. The colonoscope was withdrawn to the anus directly with withdrawal time extended to the double routine withdrawal time of the left colon.

Group Type EXPERIMENTAL

extended withdraw time

Intervention Type BEHAVIORAL

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

Interventions

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re-examination

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

Intervention Type BEHAVIORAL

extended withdraw time

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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No.85 Hospital, Changning, Shanghai, China

OTHER

Sponsor Role collaborator

Shanxi Provincial People's Hospital

OTHER_GOV

Sponsor Role collaborator

The General Hospital of Eastern Theater Command

OTHER

Sponsor Role collaborator

The Sixth Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Fudan University

OTHER

Sponsor Role collaborator

Kunshan Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role collaborator

Ningjin County Hospital

UNKNOWN

Sponsor Role collaborator

Qinghai People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Yangtze University

OTHER

Sponsor Role collaborator

Qujing NO.1 Hospital

UNKNOWN

Sponsor Role collaborator

Jiangxi Provincial People's Hopital

OTHER

Sponsor Role collaborator

Yueyang Central Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

The First People's Hospital of Changde City

OTHER

Sponsor Role collaborator

Xuzhou Central Hospital

OTHER

Sponsor Role collaborator

Wenzhou Central Hospital

OTHER

Sponsor Role collaborator

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Jiangsu Provincial People's Hospital

OTHER

Sponsor Role collaborator

Xiangya Hospital of Central South University

OTHER

Sponsor Role collaborator

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, MD

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital, Second Military Medical University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoshen Li, MD

Role: CONTACT

86-021-31161365

Yu Bai, MD

Role: CONTACT

86-021-31161335

Facility Contacts

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Yu Bai, MD

Role: primary

86-021-81873241

References

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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.

Reference Type BACKGROUND
PMID: 33220526 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30738046 (View on PubMed)

Other Identifiers

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SFW2022-01

Identifier Type: -

Identifier Source: org_study_id

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