Impact of Screen Size on Colorectal Adenoma Detection
Primary Purpose
Colon Polyp, Colon Adenoma, Colorectal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Large Screen
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon Polyp focused on measuring Colonoscopy, Adenoma Detection Rate, Colorectal cancer screening, Screen size
Eligibility Criteria
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
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Large screen
Standard screen
Arm Description
This is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image.
This is a high definition screen which gives a 37.5cm height and 32.5cm width (area: 1218.75cm2) endoscopic image.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Mean number of adenomas detected per colonoscopy
Mean number of adenomas detected per colonoscopy found in each arm
Mean number of sessile serrated polyps
Mean number of sessile serrated polyps found in each arm
Caecal intubation rate
percentage of caecal intubation rate in each arm
Bowel cleansing level
According to the Boston bowel preparation scale (0=worst bowel preparation to 9= best bowel preparation). Comparison of each arm.
Procedure Time
Both intubation and withdrawal time will be recorded. Comparison of each arm.
Severe adverse events
SAEs of both arms for comparisons
Full Information
NCT ID
NCT04749303
First Posted
February 2, 2021
Last Updated
February 6, 2021
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04749303
Brief Title
Impact of Screen Size on Colorectal Adenoma Detection
Official Title
Impact of Screen Size on Colorectal Adenoma Detection Rate: a Single Centre Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp, Colon Adenoma, Colorectal Neoplasms
Keywords
Colonoscopy, Adenoma Detection Rate, Colorectal cancer screening, Screen size
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Large screen vs standard screen
Masking
None (Open Label)
Allocation
Randomized
Enrollment
656 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Large screen
Arm Type
Active Comparator
Arm Description
This is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image.
Arm Title
Standard screen
Arm Type
No Intervention
Arm Description
This is a high definition screen which gives a 37.5cm height and 32.5cm width (area: 1218.75cm2) endoscopic image.
Intervention Type
Procedure
Intervention Name(s)
Large Screen
Other Intervention Name(s)
Standard Screen
Intervention Description
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
Primary Outcome Measure Information:
Title
Adenoma Detection Rate (ADR)
Description
ADR is defined as the proportion of an endoscopist's screening colonoscopies in which one or more adenomas have been detected in patients
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean number of adenomas detected per colonoscopy
Description
Mean number of adenomas detected per colonoscopy found in each arm
Time Frame
12 months
Title
Mean number of sessile serrated polyps
Description
Mean number of sessile serrated polyps found in each arm
Time Frame
12 months
Title
Caecal intubation rate
Description
percentage of caecal intubation rate in each arm
Time Frame
12 months
Title
Bowel cleansing level
Description
According to the Boston bowel preparation scale (0=worst bowel preparation to 9= best bowel preparation). Comparison of each arm.
Time Frame
12 months
Title
Procedure Time
Description
Both intubation and withdrawal time will be recorded. Comparison of each arm.
Time Frame
12 months
Title
Severe adverse events
Description
SAEs of both arms for comparisons
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Prince of Wales Hospital
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tony WC Mak, MD, FRCS
Phone
26321495
Email
tonymak@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Kaori Futaba, FRCS
Phone
35051495
Email
kfutaba@surgery.cuhk.edu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
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Impact of Screen Size on Colorectal Adenoma Detection
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