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

NCT ID: NCT05368792

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-31
• Study Completion Date: 2022-12-01

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.

Detailed 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

Conditions

Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Complex Carbohydrate

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.

Group Type: EXPERIMENTAL

Complex Carbohydrate (PREcovery)

Intervention Type: 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)

Fasting

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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)

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enhanced Medical Nutrition

INDUSTRY

Sponsor Role: collaborator

St. Joseph's Health Centre Toronto

OTHER

Sponsor Role: lead

Responsible Party

Ian Bookman

Gastroenterologist; Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ian Bookman, MD

Role: CONTACT

Office@gibookman.com

14162262777

Other Identifiers

REB 21-198

Identifier Type: -

Identifier Source: org_study_id