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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:

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 charact
  Sponsor: ASST Rhodense
  

  Current Primary Outcome: 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
  
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome: 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
  
  
  

  Original Secondary Outcome: Same as current
  
  Information By: ASST Rhodense
  

  Dates:
  Date Received: November 27, 2016
  Date Started: June 2016
  Date Completion: December 2016
  Last Updated: December 7, 2016
  Last Verified: December 2016