Impact of Screen Size on Colorectal Adenoma Detection

NCT04749303 | Unknown DMC

• 1 other identifier: 2020.327
• Study Type: interventional
• Target: 656
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.

Conditions

Colon Polyp; Colon Adenoma; Colorectal Neoplasms

Keywords

Colonoscopy; Adenoma Detection Rate; Colorectal cancer screening; Screen size

Outcome Measures

Primary Outcomes (1)

• Adenoma Detection Rate (ADR)

  ADR is defined as the proportion of an endoscopist's screening colonoscopies in which one or more adenomas have been detected in patients

  12 months

Secondary Outcomes (6)

• Mean number of adenomas detected per colonoscopy

  12 months

• Mean number of sessile serrated polyps

  12 months

• Caecal intubation rate

  12 months

• Bowel cleansing level

  12 months

• Procedure Time

  12 months

Study Arms (2)

Large screen

ACTIVE COMPARATOR

This is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image.

Procedure: Large Screen

Standard screen

NO INTERVENTION

This is a high definition screen which gives a 37.5cm height and 32.5cm width (area: 1218.75cm2) endoscopic image.

Interventions

Large Screen PROCEDURE

Large screen size is 4x larger than standard screen, we hope that the colonoscopies carried out with large screens will confer to better lesion detection

Also known as: Standard Screen

Large screen

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or above
• Referred to the endoscopy unit for diagnostic or surveillance colonoscopy

You may not qualify if:

• Familial history of Familial adenomatous polyposis or Hereditary non-polyposis colorectal cancer
• Known history of inflammatory bowel disease
• Emergency endoscopy of any nature (such as for gastrointestinal bleeding, assessment of large bowel investigation and colonic decompression)
• Patients with colostomy
• Previously incomplete colonoscopy (not including insufficient preparation)
• Patients with known palliative colorectal malignant disease Patients with coagulopathies Inability to give informed consent

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Colonic Polyps; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Large screen vs standard screen

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 11, 2021
• Study Start: July 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)