Examining Techniques on Adenoma Miss Rate in Proximal Colon (SINOCOLO2017)

November 22, 2017 updated by: En-Da Yu, Changhai Hospital

Efficacy of Segmental Re-examination and Retroflexion of Proximal Colon for Adenoma Miss Rate During Colonoscopy

The primary aim of this study is

- to explore the usefulness of re-examination and retroflexion on adenoma miss rate (AMR) in the proximal colon.

Other aims include to explore the data below when re-examination or retroflexion is used.

  • Adenoma detection rate, ADR
  • Polyp miss rate, PMR
  • Polyp detection rate, PDR
  • Withdrawal time, WT

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

AMR = number of adenomas missing during the first examination/ total number of adenomas in both examinations = number of adenomas detected only in the second examination/(number of adenomas detected during the first examination + number of adenomas detected only in the second examination)

Study Type

Interventional

Enrollment (Anticipated)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Zhongshan Hospital Affiliated to Fudan University
      • Tianjin, China, 300121
        • Tianjin Renmin Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital of Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients between 45 and 80 years who undergo colonoscopy examination for screening, and who receive primary screening and get positive result

Exclusion Criteria:

  • Pregnant female patients
  • Patients received colonoscopy in the past 5 years
  • Patients who have history of colorectal cancer, colorectal polyposis, inflammatory bowel disease or heredity colorectal neoplasm syndrome such as familiar adenomatous polyposis, Lynch Syndrome and so on
  • Patients who had previous abdominal surgery
  • Patients who are known to have colonic stricture or obstructing tumor from the results of radiography (X ray, CT scan or barium enema)
  • Patients who are presenting acute surgical conditions such as severe colitis, megacolon and active gastrointestinal bleeding
  • Patients who have inadequate bowel preparation
  • Patients who reject to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Re-examination Group
Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined in the same fashion. After that, the rest of the colon is examined in routine method.
Procedure: Re-examination
Re-examination in colonoscopy means examining the cecum and ascending colon twice in the routine fashion.
EXPERIMENTAL: Retroflexion Group
Routine intubation is performed. After cecal intubation, the cecum and ascending colon is examined with colonoscope tip in forward direction for the first time. Re-intubation is performed after the first examination of the cecum and ascending colon, and then this region of the large bowel is re-examined with the colonoscope tip in reverse direction (retroflexion fashion). After that, the rest of the colon is examined in routine method.
Procedure: Retroflexion
Retroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma miss rate in the proximal colon (AMR)
Time Frame: At the end of the procedure, up to 1 hour
AMR refers to the rate of adenoma missing, calculated as the proportion of adenomas which are missing in the first examination. AMR in the proximal colon is calculated with only the proximal colon concerned.
At the end of the procedure, up to 1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma Detection Rate in the proximal colon (ADR)
Time Frame: At the end of the procedure, up to 1 hour
ADR refers to the rate of adenoma detection, calculated as the proportion of subjects with at least one adenoma. ADR in the proximal colon is calculated with only the proximal colon concerned.
At the end of the procedure, up to 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2018

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

November 22, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (ACTUAL)

November 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 28, 2017

Last Update Submitted That Met QC Criteria

November 22, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SINOCOLO2017
  • 2017YFC1308802 (OTHER_GRANT: National Key R&D Program of China)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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