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

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ClinicalTrials.gov Identifier: NCT02985944
Recruitment Status : Unknown
Verified December 2016 by gianpiero manes, ASST Rhodense.
Recruitment status was:  Recruiting
First Posted : December 7, 2016
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
gianpiero manes, ASST Rhodense

Brief Summary:
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.

Condition or disease Intervention/treatment
ColoRectal Cancer Colon Polyp Procedure: Colonoscopy

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
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of a Longer Withdrawal Time or of the Use of a Wide-angle Endoscope on the Adenoma Detection Rate of Screening Colonoscopy
Study Start Date : June 2016
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult outpatients undergoing colonoscopy for different indications
Criteria

Inclusion Criteria:

  • Indication for colonoscopy, age 18-85

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02985944


Contacts
Contact: gianpiero manes, MD 3477790886 gimanes@tin.it

Locations
Italy
ASST Rhodense Recruiting
Garbagnate Milanese, Lombardia, Italy, 20020
Contact: gianpiero manes, MD    3477790886    gimanes@tin.it   
Sponsors and Collaborators
ASST Rhodense
Investigators
Principal Investigator: gianpiero manes, MD ASST Rhodense

Responsible Party: gianpiero manes, Head of th Gastroenterology Unit, ASST Rhodense
ClinicalTrials.gov Identifier: NCT02985944     History of Changes
Other Study ID Numbers: W-time
First Posted: December 7, 2016    Key Record Dates
Last Update Posted: December 8, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by gianpiero manes, ASST Rhodense:
colorectal cancer
Colon polyp
Colonoscopy
Adenoma detection rate

Additional relevant MeSH terms:
Colorectal Neoplasms
Adenoma
Colonic Polyps
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical