Impact of Screen Size on Colorectal Adenoma Detection

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

Detailed Description
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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.

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

Conditions
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Colon Polyp, Colon Adenoma, Colorectal Neoplasms

Intervention / Treatment
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* Procedure: Large Screen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Large screen vs standard screen
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Large screen<br>This is a high definition screen which gives a 76cm height and 67cm width (area: 5092cm2) endoscopic image. | Procedure: Large Screen<br>* 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<br>* Other names: Standard Screen;|
| No Intervention: Standard screen<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Adenoma Detection Rate, Colorectal cancer screening, Screen size