Impact of Screen Size on Colorectal Adenoma Detection

Impact of Screen Size on Colorectal Adenoma Detection Rate: a Single Centre Randomised Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Neoplasms; Colon Adenoma; Colon Polyp
• Intervention / Treatment: Procedure: Large Screen

Detailed Description

Colorectal cancer is the 3rd most common cancer in the world. Recently in Hong Kong it has surpassed lung cancer to be the most common cancer. Hence it is essential not only to have up-to-date surgical and oncological treatment but also a need an effective preventative strategy.

In the past few decades, removal of pre-malignant colonic lesions such as adenomas have been shown to prevent development of colorectal cancers. Colonoscopy is currently the only technique which can perform both detection and treatment during the same procedure. However, concerns have been raised about the effectiveness of colonoscopy in the prevention of CRC after several studies reported unexpected high incidence rates of interval carcinomas (IC), especially in the proximal colon. Most ICs are suspected to arise from missed colon lesions during colonoscopy. Factors concerning missed colonic lesions are multifactorial such as adequate bowel preparation, skill level of endoscopists, the number of endoscopy staff in the room as "eyes" to help with polyp detection and withdrawal time.

Following a pilot study in our endoscopy unit, we believe the size of the screen projecting the endoscopic image may have a positive influence on adenoma detection. Therefore, we feel that a well-designed and adequately powered randomised controlled trial may help to confirm this.

• Study Type: Interventional
• Enrollment (Anticipated): 656
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Prince of Wales Hospital
    • Contact: Tony WC Mak, MD, FRCS; Phone Number: 26321495; Email: tonymak@surgery.cuhk.edu.hk
    • Contact: Kaori Futaba, FRCS; Phone Number: 35051495; Email: kfutaba@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Large screen; This is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image.	Procedure: Large Screen; 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; Other Names: Standard Screen
No Intervention: Standard screen; This is a high definition screen which gives a 37.5cm height and 32.5cm width (area: 1218.75cm2) endoscopic image.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of adenomas detected per colonoscopy	Mean number of adenomas detected per colonoscopy found in each arm	12 months
Mean number of sessile serrated polyps	Mean number of sessile serrated polyps found in each arm	12 months
Caecal intubation rate	percentage of caecal intubation rate in each arm	12 months
Bowel cleansing level	According to the Boston bowel preparation scale (0=worst bowel preparation to 9= best bowel preparation). Comparison of each arm.	12 months
Procedure Time	Both intubation and withdrawal time will be recorded. Comparison of each arm.	12 months
Severe adverse events	SAEs of both arms for comparisons	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 6, 2021
• First Posted (Actual): February 11, 2021

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Colonoscopy; Colorectal cancer screening; Adenoma Detection Rate; Screen size
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: 2020.327

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No