Prospective Trial Of Osmolar Protocol Solution on Colonoscopy Outcomes and Patient Experience

Colonoscopy Clinical Trial

— POOPSCOPE  

Official title:

Prospective Trial Of Osmolar Protocol Solution on Colonoscopy Outcomes and Patient Experience

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05368792
• Other study ID #: REB 21-198
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 31, 2022
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2022
• Source: St. Joseph's Health Centre Toronto
• Contact: Ian Bookman, MD
• Phone: 14162262777
• Email: Office[@]gibookman.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fasting is the current standard of care for colonoscopies. Recent changes to anesthesia guidelines have allowed for clear fluids to be provided up to 2 hours before procedures, including colonoscopies.

This study will compare fasting to a 12.5% carbohydrate solution 2 hours before colonoscopy on patient-reported measures of discomfort, hydration, and colon visibility.

The investigators hypothesize that the carbohydrate solution will improve patient-reported measures of discomfort, hydration, and colon visibility.

Description:

Fasting and bowel preparation before colonoscopy procedures has been the clinical protocol for decades. Evidence suggests that patients undergoing this traditional standard of care before procedures may be associated with common undesirable outcomes, including anxiety, thirst, and poor patient experience. The impacts of fasting and poor satisfaction can create a cascade of challenges regarding communication between clinicians and patients.

The new standard of care utilizes an innovative clear fluid protocol, allowing patients to consume clear fluids up to 2-3 hours prior to their procedure. The consumption of a complex carbohydrate (CHO) drink may reduce dehydration, improve patient-reported outcomes, enhance patient communication and clinician workflow, ultimately resulting in improved patient experience and cancer screening/detection. Although clinical validation and implementation of a complex CHO drink have already been completed in surgical patients within clear fluid protocols, this needs to be expanded to patients undergoing colonoscopy procedures.

A prospective, single-blinded, single-centre, randomized control design will be used to compare fasting from midnight the day of the colonoscopy [the current standard of care] to a clear fluid protocol [a complex CHO drink consumed the night before and 2 hours before the colonoscopy]. The physician performing the colonoscopy will be blinded to the group allocation. The primary outcome of the present study is pre and post-procedure patient-reported measures of discomfort in adults undergoing routine colonoscopy for cancer screening. Secondary outcome measures are compliance, hydration, and bowel visibility.

Hypotheses

1. Patient-reported measures of discomfort pre and post colonoscopy will be lower in patients in the clear fluid group than the standard of care group.

2. Hydration status will be greater in the clear fluids group than the fasting group.

3. Colon visibility score (BBPS) will be higher in the clear fluids group

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 1, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 74 Years

Eligibility

Inclusion Criteria:

• referred for a routine colonoscopy for cancer screening

• Physician indicates a bowel preparation of split dose 2L PEG ± bisacodyl (iso-osmolar) solution

Exclusion Criteria:

• patients with colonic resection, inflammatory bowel disease; any condition that would preclude colonoscopy of the whole colon;

• patients with lower gastrointestinal bleeding, patients with ileus, gastric retention, intestinal perforation, gastrointestinal obstruction;

• patients with significant heart disease, impaired renal function, decompensated liver disease

• patients who have diabetes

• patients on opioid medications.

• Patients with a corn allergy, or allergy to any ingredient in the complex CHO drink

Related Conditions & MeSH terms

• Colonoscopy

Intervention

Dietary Supplement:
• Complex Carbohydrate (PREcovery)
Each serving of the complex carbohydrate drink is a clear, colorless, 12.5% maltodextrin drink with a citrus taste, prepared by mixing 54 g of powder (50g carbohydrate) with 400mL of cold water. Participants will consume 2 servings of the complex carbohydrate drink the evening before colonoscopy (100g carbohydrate, 800mL fluid), and 1 serving 2 hours before their colonoscopy (50g carbohydrate, 400mL fluid)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Health Centre Toronto	Enhanced Medical Nutrition

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pre-procedure Patient Reported Discomfort	Domains of discomfort will be evaluated by digital VAS: anxiety, depression, hunger, inability to concentrate, malaise, nausea, pain, thirst, tiredness, unfitness, and weakness. Visual analogue scales (VAS) will be used to measure each domain. the VAS will be measured from 1-10 representing "not at all _____" and "Very ____" respectively.	30 minutes before the colonoscopy
Secondary	Hydration	Plasma osmolality will be used to measure hydration status.	Blood samples will be collected from participants immediately after the colonoscopy has ended (time point 30 minutes) and they are cleared to leave the clinic
Secondary	Compliance	Patients in the Treatment group will report the number of 50g maltodextrin packets they consumed before the procedure. Those having consumed all 3 packets provided will be reported as having 100% compliance. If the consumed none of the packets they will get a score of 0% compliance. 1 packet will result in a compliance score of 33%. 2 packets will result in a compliance score of 66%.	30 minutes before the colonoscopy
Secondary	Bowel Visibility	The Boston Bowel Preparation Scale (BBPS) will be used to evaluate visibility during the colonoscopy. The scale uses a 0-3 rating where 0 is the worst visibility rating ("inadequate") and 3 is the best visibility rating ("excellent"). Each of the 3 sections of the colon (left, transverse, and right) are rated using this scale and a cumulative score is determined from the sum of these three ratings.	During the colonoscopy (Time point 0)
Secondary	Post-procedure Patient Reported Discomfort	Domains of discomfort will be evaluated by digital VAS: anxiety, depression, hunger, inability to concentrate, malaise, nausea, pain, thirst, tiredness, unfitness, and weakness. Visual analogue scales (VAS) will be used to measure each domain. the VAS will be measured from 1-10 representing "not at all _____" and "Very ____" respectively.	up to 6 hours after the colonoscopy visit