Withdrawal Time and Use of Wide-angle Endoscope to Increase the Adenoma Detection Rate of Screening Colonoscopy

January 17, 2021 updated by: gianpiero manes, ASST Rhodense

Effect of a Longer Withdrawal Time or of the Use of a Wide-angle Endoscope on the Adenoma Detection Rate of Screening Colonoscopy

Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy withdrawal time >6min has been suggested to increase the ADR since it allows for thorough evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle view. In the present study the authors evaluate the impact of WT on ADR for High Definition Standard Endoscopes with just a single imager to the FUSE endoscope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Introduction Colonoscopy outcome is strictly related to the adenoma detection rate. An endoscopy withdrawal time >6min has been suggested to increase the adenoma detection rate since it allows for accurate evaluation of the several hidden areas of the colon. The FUSE endoscope has been demonstrated also to reduce the rate of missed lesions due to its wide angle view.

Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a FUSE endoscope or of interventions directed at optimizing withdrawal time.

to assess the impact of different factors in influencing the withdrawal time

Methods A prospective non-randomized observational single-center study involving consecutive outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous abdominal colon resection, obstruction, inadequate preparation and incomplete examination were exclusion criteria.

In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy withdrawal times will be measured without the endoscopists' knowledge of being monitored.

During a subsequent 3-month period the same endoscopists will perform further 500 colonoscopies with standard and FUSE scopes using dedicated inspection techniques and a minimum 6-minute withdrawal time. In this second phase withdrawal times will be again measured, but endoscopists will be aware of being monitored.

The following parameters will be recorded:

  • Demographic and general characteristics
  • Indications to colonoscopy
  • Colonoscopy findings
  • Quality of preparation: Boston scale
  • Time to reach the coecum
  • Withdrawal time The adenoma detection rate and the mean adenomas per patients will be calculated.

Study Type

Observational

Enrollment (Actual)

1000

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

  • Italy
    • Lombardia
      • Garbagnate Milanese, Lombardia, Italy, 20020
        • ASST Rhodense

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

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adult outpatients undergoing colonoscopy for different indications

Description

Inclusion Criteria:

  • Indication for colonoscopy, age 18-85

Exclusion Criteria:

  • Previous abdominal colon resection, colon obstruction, inadequate preparation and incomplete examination

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard scope-short time
Standard colonoscopy with unmonitored withdrawal time
Procedure: Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
FUSE scope-short time
Wide-angle colonoscopy with unmonitored withdrawal time
Procedure: Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
Standard scope-long time
Standard colonoscopy with monitored withdrawal time
Procedure: Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications
FUSE scope-long time
Wide-angle colonoscopy with monitored withdrawal time
Procedure: Colonoscopy
Colonoscopy performed in adult consecutive patients for different indications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: Up to 10 days from the end of endoscopy
The rate of patient with at least one adenoma detected at colonoscopy
Up to 10 days from the end of endoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Factors affecting the withdrawal time
Time Frame: Up to 10 days from the end of endoscopy
Analysis of the factors (quality of preparation, indications for colonoscopy) likely to influence the withdrawal time
Up to 10 days from the end of endoscopy

Collaborators and Investigators

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

Sponsor

ASST Rhodense

Investigators

  • Principal Investigator: gianpiero manes, MD, ASST Rhodense

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

June 1, 2016

Primary Completion (ACTUAL)

December 1, 2018

Study Completion (ACTUAL)

December 1, 2018

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

December 4, 2016

First Posted (ESTIMATE)

December 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

January 20, 2021

Last Update Submitted That Met QC Criteria

January 17, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • W-time

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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