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

NCT05368792 | Unknown

• 1 other identifier: REB 21-198
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Colonoscopy

Keywords

Fasting; Pre-Operative Carbohydrate; Discomfort; Hydration; Bowel preparation; Bowel visibility

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Hydration

  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

• Compliance

  30 minutes before the colonoscopy

• Bowel Visibility

  During the colonoscopy (Time point 0)

• Post-procedure Patient Reported Discomfort

  up to 6 hours after the colonoscopy visit

Study Arms (2)

Complex Carbohydrate

EXPERIMENTAL

Participants in the intervention group will be instructed to follow standard bowel preparation guidance AND consume two servings of the complex CHO (12.5% maltodextrin) drink (PREcovery®, Enhanced Medical Nutrition, Toronto, Canada) the evening prior to the procedure, and one serving 2-3 hours prior to the colonoscopy. Participants should not consume anything within 2 hours prior to the procedure's start time. One serving consists of one package (50 g maltodextrin) stirred into 400 mL of cold water. Standard bowel preparation guidance is as follows a split-dose 2L PEG ± bisacodyl (iso-osmolar) solution (Bi-PegLyte®, Pendopharm, Montreal, Canada) taken according to the physician's order. All participants will be instructed to follow a clear fluid diet starting the day before the procedure. Participants will also be verbally instructed to consume 2L of clear liquids the day before their colonoscopy in addition to the PREcovery.

Dietary Supplement: Complex Carbohydrate (PREcovery)

Fasting

NO INTERVENTION

The Fasting arm will follow the current standard of care for colonoscopy preparations in Ontario, Canada. This includes fasting from midnight before the procedure and following a PEG bowel preparation All participants will follow a standard bowel preparation guidance, a split-dose 2L PEG ± bisacodyl (iso-osmolar) solution (Bi-PegLyte®, Pendopharm, Montreal, Canada) taken according to the physician's order. All participants will be instructed to follow a clear fluid diet starting the day before the procedure. Participants will also be verbally instructed to consume 2L of clear liquids the day before their colonoscopy. Participants in the fasting arm will be instructed to not have any oral intake after 00:00 of the day of their colonoscopy.

Interventions

Complex Carbohydrate (PREcovery) DIETARY_SUPPLEMENT

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)

Complex Carbohydrate

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• referred for a routine colonoscopy for cancer screening
• Physician indicates a bowel preparation of split dose 2L PEG ± bisacodyl (iso-osmolar) solution

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Health Centre Toronto: lead
• Enhanced Medical Nutrition: collaborator

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Central Study Contacts

Ian Bookman, MD

CONTACT

14162262777; Office@gibookman.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The principal investigator, clinic staff and outcome assessors of colon visibility and hydration will be blinded to the treatment allocation of participants
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterologist; Assistant Professor

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: May 10, 2022
• Study Start: May 31, 2022
• Primary Completion: September 30, 2022
• Study Completion: December 1, 2022
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share