|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
11 February 2019 |
|
Main ID: |
ISRCTN18516614 |
|
Date of registration:
|
02/08/2015 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A prospective randomised trial on the palatability and efficacy of Coca-Cola Zero® versus water for polyethylene glycol bowel preparation before colonoscopy
|
|
Scientific title:
|
A prospective randomised trial on the palatability and efficacy of Coca-Cola Zero® versus water for polyethylene glycol bowel preparation before colonoscopy |
|
Date of first enrolment:
|
04/12/2013 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN18516614 |
|
Study type:
|
Interventional |
|
Study design:
|
Interventional randomised controlled trial with two study branches (Diagnostic)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Singapore
| | | | | | | |
|
Contacts
|
|
Name:
|
Isaac
Seow-En |
|
Address:
|
22 Saraca Road
807368
Singapore
Singapore |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Francis
Seow-Choen |
|
Address:
|
22 Saraca Road
807368
Singapore
Singapore |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
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
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Palatability, safety, and efficacy of Coca-Cola Zero as a solvent for polyethylene bowel preparation for colonoscopy
Digestive System
|
|
Intervention(s)
|
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.
|
|
Primary Outcome(s)
|
|
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(s)
|
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
|
|
Secondary ID(s)
|
|
FCHIRB/05/1213
|
|
Source(s) of Monetary Support
|
|
Investigator initiated and funded (Singapore)
|
|
Ethics review
|
Status:
Approval date:
Contact:
Fortis Colorectal Hospital Institutional Review Board approval, 02/12/2013, ref: FCHIRB/05/1213
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
31/05/2014 |
|
URL:
|
|
|
|