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

NCT ID: NCT02985944

Last Updated: 2021-01-20

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

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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ColoRectal Cancer Colon Polyp

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Standard scope-short time

Standard colonoscopy with unmonitored withdrawal time

Colonoscopy

Intervention Type PROCEDURE

Colonoscopy performed in adult consecutive patients for different indications

FUSE scope-short time

Wide-angle colonoscopy with unmonitored withdrawal time

Colonoscopy

Intervention Type PROCEDURE

Colonoscopy performed in adult consecutive patients for different indications

Standard scope-long time

Standard colonoscopy with monitored withdrawal time

Colonoscopy

Intervention Type PROCEDURE

Colonoscopy performed in adult consecutive patients for different indications

FUSE scope-long time

Wide-angle colonoscopy with monitored withdrawal time

Colonoscopy

Intervention Type PROCEDURE

Colonoscopy performed in adult consecutive patients for different indications

Interventions

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Colonoscopy

Colonoscopy performed in adult consecutive patients for different indications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Indication for colonoscopy, age 18-85

Exclusion Criteria

* Previous abdominal colon resection, colon obstruction, inadequate preparation and incomplete examination
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ASST Rhodense

OTHER

Sponsor Role lead

Responsible Party

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gianpiero manes

Head of th Gastroenterology Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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gianpiero manes, MD

Role: PRINCIPAL_INVESTIGATOR

ASST Rhodense

Locations

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ASST Rhodense

Garbagnate Milanese, Lombardy, Italy

Site Status

Countries

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Italy

Other Identifiers

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W-time

Identifier Type: -

Identifier Source: org_study_id

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