Clinical trial NCT04749303: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Polyp
Colon Adenoma
Colorectal Neoplasms
Keywords: Colonoscopy
Adenoma Detection Rate
Colorectal cancer screening
Screen size
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-02-11
Enrollment: 656
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Large screen vs standard screen
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Adenoma Detection Rate (ADR)
timeFrame: 12 months
Secondary outcomes:
measure: Mean number of adenomas detected per colonoscopy
timeFrame: 12 months
measure: Mean number of sessile serrated polyps
timeFrame: 12 months
measure: Caecal intubation rate
timeFrame: 12 months
measure: Bowel cleansing level
timeFrame: 12 months
measure: Procedure Time
timeFrame: 12 months
measure: Severe adverse events
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: