Impact of Screen Size on Colorectal Adenoma Detection

Colorectal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04749303
• Other study ID #: 2020.327
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: August 31, 2021

Study information

• Verified date: February 2021
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 656
• Est. completion date: August 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colon Adenoma
• Colon Polyp
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean number of adenomas detected per colonoscopy	Mean number of adenomas detected per colonoscopy found in each arm	12 months
Secondary	Mean number of sessile serrated polyps	Mean number of sessile serrated polyps found in each arm	12 months
Secondary	Caecal intubation rate	percentage of caecal intubation rate in each arm	12 months
Secondary	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
Secondary	Procedure Time	Both intubation and withdrawal time will be recorded. Comparison of each arm.	12 months
Secondary	Severe adverse events	SAEs of both arms for comparisons	12 months