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NCT Number: NCT02985944

Withdrawal Time and Use of Wide-angle Endoscope to Increase 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.

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Key information

Conditions

Colorectal Cancer Colon Polyp Colonic Diseases Colonic Polyps Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Intestinal Polyps Neoplasms Neoplasms by Site Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

ASST Rhodense

Garbagnate Milanese, Lombardy, 20020, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for colonoscopy, age 18-85

Exclusion criteria

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

Treatment and study plan

colonoscopy

Procedure

Colonoscopy performed in adult consecutive patients for different indications

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ASST Rhodense

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2016
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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