Comparing soft drink vs Carbex for double contrast upper GI studies
| ISRCTN | ISRCTN75939860 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75939860 |
| Secondary identifying numbers | 14/07/030 |
- Submission date
- 19/06/2014
- Registration date
- 08/07/2014
- Last edited
- 20/12/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English Summary
Background and study aims
A barium swallow and meal is a type of x-ray that allows doctors to examine the upper gastrointestinal tract (GI), which includes the throat, oesophagus (foodpipe), stomach and duodenum (first part of the small intestine). It is used in diagnosing problems and diseases in these organs. Usually, x-rays will only highlight bone and other parts of the body that block radiation, which makes them easy to see. Before the barium swallow and meal test can be done, the stomach has to be extended with gas to make the pictures as clear as possible. Patients are usually given a fizzy drink called Carbex. This study compares the Carbex with the use of the fizzy soft drinks Indian tonic water and ginger ale. We believe that using soft drinks rather than Carbex will not affect the quality of the test. If the study is successful, it will help us to introduce soft drinks routinely and help to reduce costs to the NHS.
Who can participate?
Patients 18 years and older that have been referred by doctors for a barium swallow and meal to investigate their upper GI tract.
What does the study involve?
Patients are randomly assigned to take either Carbex or a soft drink. If the soft drink does not give clear enough pictures, the patient is given Carbex to drink and the test continued. There are no health implications to this and the aftercare is the same as usual. Patients are then asked to complete a short questionnaire about their experience of the test.
What are the possible benefits and risks of participating?
Patients are likely to enjoy drinking the soft drink more than the Carbex, making the examination a more pleasant experience. Drinking either fizzy drink may cause bloating which can feel uncomfortable in the stomach. This is normal for this examination and is required to produce good pictures.
Where is the study run from?
Torbay Hospital (UK).
When is the study starting and how long is it expected to run for?
The study will run from July to December 2014.
Who is funding the study?
South Devon Healthcare NHS Foundation Trust (UK).
Who is the main contact?
Dr Alexander Crowther
acrowther1@nhs.net
Contact information
Scientific
Radiology Department
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
United Kingdom
| Phone | +44 (0) 1803 614567 |
|---|---|
| acrowther1@nhs.net |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Available on request to sdhct.research@nhs.net |
| Scientific title | Comparing soft drink vs Carbex for double contrast upper GI studies: a randomised controlled trial |
| Study hypothesis | Can a publicly purchased soft drink (i.e. Indian tonic water/ginger ale) achieve comparable distention of the upper gastrointestinal tract in comparison to Carbex during a double contrast barium study and provide a diagnostic study? On 31/07/2014 the anticipated start date was changed from 01/05/2014 to 18/07/2014. |
| Ethics approval(s) | NRES Committee South West - Cornwall & Plymouth, 16/07/2014, Ref: 14/SW/0126 |
| Condition | Oral and Gastrointestinal |
| Intervention | Participants are randomly allocated to one of two groups 1. Test group - drink soft drink (Indian tonic water or ginger ale) before taking barium 2. Control group - drink Carbex before taking barium All participants then undergo upper gastrointestinal (GI) tract radiography |
| Intervention type | Other |
| Primary outcome measure | 1. Is the experimental soft drink used for gaseous distension of the upper GI tract not inferior to the gold standard Carbex against delta at study clinic? 2. Does the experimental soft drink provide a diagnostic upper GI double contrast barium study when used in the place of Carbex at study clinic? |
| Secondary outcome measures | 1. If the soft drink effervescent agent is found to be noninferior then a superiority test will be performed to ascertain whether it is better than Carbex. 2. What are the potential cost savings of using the soft drink over Carbex within this institution and nationwide? Both assessed at the study clinic |
| Overall study start date | 18/07/2014 |
| Overall study end date | 01/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Participant inclusion criteria | 1. Any patient referred for an upper GI double contrast GI study and is able to give informed consent. 2. Include any patient over 18 not classified to belonging to a vulnerable group. No upper age limit |
| Participant exclusion criteria | 1. Aged below 18 years of age. 2. Unable to give consent 3. Member of vulnerable group |
| Recruitment start date | 18/07/2014 |
| Recruitment end date | 01/12/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
TQ2 7AA
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Manager of Research and Development
Research and Development Department
Horizon Centre
Torbay Hospital
Lawes Bridge
Torquay
TQ2 7AA
England
United Kingdom
| Phone | +44 (0) 1803 636635 |
|---|---|
| sdhct.research@nhs.net | |
| Website | http://www.sdhct.nhs.uk |
"ROR" |
https://ror.org/05374b979 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
20/12/2017: No publications found, verifying study status with principal investigator.
