Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Colon Mucous
  • Colonoscopy
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Double (Investigator, Outcomes Assessor)Primary Purpose: Screening

Participation Requirements

Age
Between 20 years and 75 years
Gender
Both males and females

Description

This will be a multi-site, blinded investigators, prospective randomized controlled trial (RCT). Randomization (CO2, WE with water, WE with 50% saline, WE with 25% saline) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) w...

This will be a multi-site, blinded investigators, prospective randomized controlled trial (RCT). Randomization (CO2, WE with water, WE with 50% saline, WE with 25% saline) will be based on computer generated random numbers placed inside opaque sealed envelopes. The envelope (in pre-arranged order) will be opened to reveal the code when the colonoscopist is ready to insert the endoscope to begin the examination. This will be a comparison of two different insertion methods with four arms (CO2 insufflation, WE with water, WE with 50% saline, WE with 25% saline) to see which solution used in WE is better in reducing mucus production. Patients who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigators and indication of colonoscopy (screening, surveillance, or positive fecal immunochemical test). Mode of sedation will include unsedated (Taipei Medical University Hospital), conscious sedation (Evergreen General Hospital), or full sedation with propofol (Taipei Medical University Hospital). Randomization (prepared by statistics consultant) will be carried out by the method of random permuted block design (based on computer generated random numbers) with variable block of 3 and 6. Control method: One arm of the study will include sedated/unsedated colonoscopy with water infusion during insertion as the control method. Residual air in the colon will be removed and sterile water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual fecal debris, predominantly during insertion. Another arm of the study will include sedated/unsedated colonoscopy with CO2 insufflation during insertion as an additional control method. Study method: Two arms of the study will include sedated/unsedated colonoscopy with saline infusion of different strength, i.e., 50% saline and 25% saline, during insertion. Residual air in the colon will be removed and normal saline will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual fecal debris, predominantly during insertion.

Tracking Information

NCT #
NCT04769739
Collaborators
Not Provided
Investigators
Principal Investigator: Chiliang Cheng, MD Evergreen General Hospital, Taoyuan, Taiwan