Condition category
Digestive System
Date applied
20/07/2015
Date assigned
02/08/2015
Last edited
03/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A colonoscopy is an examination of your entire large bowel using a device called a colonoscope. The colon must be clean and empty for best results. To clean the bowels, the patient is required to drink a few litres of bowel preparation solution in a short span of time. Routinely used bowel preparations such as polyethylene glycol (PEG) are safe and well tolerated, but have an unpleasant salty taste and commonly result in nausea (feeling sick). This results in some patients being unable to complete the recommended dose, leading to postponement of the colonoscopy or inadequate assessment of the colon. An unpalatable experience may also lead to patients avoiding a repeat or follow-up procedure. We aim to evaluate the use of a common soft drink beverage as a solvent for bowel preparation and give clinicians and patients a viable alternative to alleviate the problem of drinking large volumes of conventional bowel cleansing solution.

Who can participate?
Adults over 21 years old who are healthy or with mild or well controlled chronic illnesses and are scheduled for an elective colonoscopy at our institution.

What does the study involve?
Participants were randomly allocated to dissolve PEG in either drinking water or undiluted Coke Zero. Participants were encouraged to drink the preparation as quickly as could be comfortably tolerated, although a guide of at least a litre per hour was recommended. They were also advised to follow a low fibre, low residue diet on the day before the procedure and to fast from 12 midnight aside from clear fluid and the bowel preparation. All colonoscopies were performed under sedation by a single experienced endoscopist. Cleanliness of the colon was assessed by the endoscopist and two experienced endoscopy nurses. Prior to discharge each patient completed a questionnaire detailing the time taken to complete the bowel preparation, overall palatability, reactions to the preparation, willingness to drink the solution again or recommend it to others, and the worst part of the colonoscopy experience.

What are the possible benefits and risks of participating?
Benefits include knowledge gained from the study, which may allow the use of Coca Cola Zero as an alternative solvent for patients undergoing colonoscopy. Indirect benefits include results and knowledge that can be used as a basis for future studies. Risks include a potential breach of confidentiality. Also, there is a potential health hazard of drinking 2L of Coca Cola in a relatively short span of time.

Where is the study run from?
Fortis Colorectal Hospital/Fortis Surgical Hospital (Singapore).

When is the study starting and how long is it expected to run for?
From December 2013 to December 2014.

Who is funding the study?
Investigator initiated and funded.

Who is the main contact?
Dr Isaac Seow-En
Prof Francis Seow-Choen

Trial website

Contact information

Type

Public

Primary contact

Dr Isaac Seow-En

ORCID ID

Contact details

22 Saraca Road
Singapore
807368
Singapore

Type

Scientific

Additional contact

Prof Francis Seow-Choen

ORCID ID

Contact details

22 Saraca Road
Singapore
807368
Singapore

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

FCHIRB/05/1213

Study information

Scientific title

A prospective randomised trial on the palatability and efficacy of Coca-Cola Zero® versus water for polyethylene glycol bowel preparation before colonoscopy

Acronym

Study hypothesis

To assess if Coca-Cola (Coke) Zero is a safe and effective solvent for polyethylene glycol (PEG) and is better tolerated by patients instead of water.

Ethics approval

Fortis Colorectal Hospital Institutional Review Board approval, 02/12/2013, ref: FCHIRB/05/1213

Study design

Interventional randomised controlled trial with two study branches

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Palatability, safety, and efficacy of Coca-Cola Zero as a solvent for polyethylene bowel preparation for colonoscopy

Intervention

All patients received two sachets of Fortrans (Beaufour Ipsen Pharma, Paris, France), each containing 64 g macrogol 4000, 5.7 g sodium sulphate, 1.68 g sodium bicarbonate, 1.46 g sodium chloride, 0.75 g potassium chloride and 0.1 g saccharin sodium. Patients were instructed to dissolve each sachet of PEG in 1 L of drinking water or undiluted Coke Zero depending on the study group assigned and to complete 2 L of preparation no longer than 6 hours prior to colonoscopy.

Participants were encouraged to complete the preparation as quickly as could be comfortably tolerated, although a guide of at least a litre per hour was recommended. They were also advised to take low fibre, low residue diet the day before the procedure and to fast from 12 midnight aside from clear fluid and the bowel preparation.

All colonoscopies were performed under sedation by a single experienced endoscopist. Cleanliness of the colon was assessed by the endoscopist and two experienced endoscopy nurses who were not involved in the trial. All three were blind to the type of solvent used for the preparation. Each colon was judged to have no staining, minor staining or residual stool independently post-procedure by the three assessors and the majority consensus was later assigned by the study nurse.

Prior to discharge each patient completed a questionnaire detailing the time taken to complete the bowel preparation, overall palatability, reactions to the preparation, willingness to drink the solution again or recommend it to others, and the worst part of the colonoscopy experience. Palatability of bowel preparation was judged based on a scale of 1 to 4, with a score of 1 correlating with the best taste and 4 the worst.

Intervention type

Other

Phase

Drug names

Primary outcome measures

The palatability of the PEG+Coke solution compared to the PEG+water solution. Palatability was judged based on a four-point questionnaire which was issued to the patient prior to discharge.

Secondary outcome measures

1. Cleanliness of the bowel preparation was judged by the endoscopist as well as two endoscopy nurses during the colonoscopy
2. Adverse reactions, willingness to repeat the same solution again or recommend it to a friend were measured based on the same patient questionnaire prior to discharge after the endoscopy

Overall trial start date

02/12/2013

Overall trial end date

31/05/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adults over 21 years old
2. Healthy or with mild or well controlled chronic illnesses. Control of systemic disease was determined on the basis of no increase in medication or development of new symptoms or complications within the past year
3. Scheduled for an elective colonoscopy at our institution

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

1. Pregnant patients
2. Patients with suspected intestinal obstruction
3. Patients at risk of aspiration
4. Patients with serious systemic or poorly controlled chronic illnesses

Recruitment start date

04/12/2013

Recruitment end date

30/04/2014

Locations

Countries of recruitment

Singapore

Trial participating centre

Fortis Colorectal Hospital/Fortis Surgical Hospital
289891
Singapore

Sponsor information

Organisation

Seow-Choen Colorectal Centre Pte Ltd (Singapore)

Sponsor details

290 Orchard Road
#06-06 Paragon Shopping Centre
Singapore
238859
Singapore

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Singapore)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planning to publish results of trial soon.

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes