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

NCT02985944 | Completed DMC

• 1 other identifier: W-time
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

ColoRectal Cancer; Colon Polyp

Keywords

colorectal cancer; Colon polyp; Colonoscopy; Adenoma detection rate

Outcome Measures

Primary Outcomes (1)

• Adenoma detection rate

  The rate of patient with at least one adenoma detected at colonoscopy

  Up to 10 days from the end of endoscopy

Secondary Outcomes (1)

• Factors affecting the withdrawal time

  Up to 10 days from the end of endoscopy

Study Arms (4)

Standard scope-short time

Standard colonoscopy with unmonitored withdrawal time

Procedure: Colonoscopy

FUSE scope-short time

Wide-angle colonoscopy with unmonitored withdrawal time

Procedure: Colonoscopy

Standard scope-long time

Standard colonoscopy with monitored withdrawal time

Procedure: Colonoscopy

FUSE scope-long time

Wide-angle colonoscopy with monitored withdrawal time

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

Colonoscopy performed in adult consecutive patients for different indications

FUSE scope-long time; FUSE scope-short time; Standard scope-long time; Standard scope-short time

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult outpatients undergoing colonoscopy for different indications

You may qualify if:

• Indication for colonoscopy, age 18-85

You may not qualify if:

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

Sponsors & Collaborators

• ASST Rhodense: lead

Study Sites (1)

ASST Rhodense

Garbagnate Milanese, Lombardy, 20020, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Polyps

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• gianpiero manes, MD

  ASST Rhodense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of th Gastroenterology Unit

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 7, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)