Drinking a solution prior to gastroscopy improves the view
| ISRCTN | ISRCTN13858956 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13858956 |
| Secondary identifying numbers | 10/H0504/82 |
- Submission date
- 24/01/2012
- Registration date
- 28/02/2012
- Last edited
- 11/08/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Diagnostic gastroscopy (camera examination of the gullet and stomach) provides a unique opportunity to answer specific diagnostic questions and identify lesions which develop into problems such as cancer at an early stage. There is, however, evidence to show that in the UK and the West there is a significant miss rate when assessing the identification of these early lesions. Stomach mucus and swallowed saliva can make it difficult to view the inner lining of the gullet and stomach during this procedure. Two commonly used medications (simethicone and N-acetylcysteine [NAC]) have been shown to be of potential benefit in clearing this obscuring mucus. We are trying to find out whether the use of a preparatory drink containing NAC and simethicone will improve visibility during gastroscopy.
Who can participate?
All patients aged 18 or over attending for gastroscopy are eligible to take part.
What does the study involve?
Patients undergo the standard preparation for gastroscopy at home (clear fluids only for 6 hours then nil by mouth for 2 hours). Patients are then randomly allocated into three groups.
1. Control no further intervention.
2. Water patients will drink sterile water 15-20 minutes before gastroscopy.
3. Solution patients will drink sterile water containing NAC and simethicone 15-20 minutes before gastroscopy.
The endoscopist and the nursing staff are unaware of the preparation used. During the gastroscopy the visibility is assessed by documenting the amount of water required to flush away mucus to enable a clear view of the lining of the stomach/gullet at specified areas. The time taken for the procedure and the areas requiring additional flushing are also documented. The procedure is performed as normal to answer the clinical questions posed.
What are the possible benefits and risks of participating?
There will be real immediate benefits from being involved in the test, other than the potential to have a more efficient procedure if the preparation improves visibility. There are no expected risks, the gastroscopy is performed as normal. Both medications have been used for decades and large trials have demonstrated no clinical side effects from their use in low oral doses.
Where is the study run from?
University Hospital Southampton.
When is study starting and how long is it expected to run for?
The study ran from April to August 2011.
Who is funding the study?
There were minimal costs associated with this study and it was self-funded by the investigators within the department.
Who is the main contact?
Dr James Neale
Contact information
Scientific
Department of Luminal Gastroenterology
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
Study information
| Study design | Randomised controlled endoscopist blinded single centre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pre-medication with N-acetylcysteine and simethicone improves mucosal visualisation during gastroscopy: a randomised, controlled, endoscopist-blinded study. |
| Study objectives | We hypothesise that drinking a solution containing n-acetylcysteine (NAC) and simethicone prior to gastroscopy improves endoscopic mucosal visualisation during the procedure. |
| Ethics approval(s) | NRES Committee Southampton B, 19 January 2011, ref: 10/H0504/82 |
| Health condition(s) or problem(s) studied | Gastrointestinal endoscopy |
| Intervention | Patients attend for gastroscopy having already undergone standard preparation at home (6 hours clear fluids only, 2 hours nil by mouth [NBM]). On entering the study they were randomised (number tables) into 3 groups: 1. Control - no further intervention 2. Water - 100ml sterile water 15-20 minutes prior to gastroscopy 3. Solutiuon - 100ml sterile water + 3ml NAC + 2.5ml simethicone 15-20 minutes prior to gastroscopy They will have a standard diagnostic gastroscopy performed by endoscopist blinded to this. During procedure all stubborn mucus that cannot be suctioned will be washed with water. The amount of water required, the area of the gastrointenstinal (GI) tract it is used and the time taken for the procedure will be recorded by nursing staff in the room. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | N-acetylcysteine, simethicone |
| Primary outcome measure | Amount of water required to clear stubborn mucus |
| Secondary outcome measures | 1. Area of GI tract 2. Time taken for procedure |
| Overall study start date | 01/04/2011 |
| Completion date | 01/08/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 75 |
| Key inclusion criteria | All adult patients attending for clinically required diagnostic gastroscopy |
| Key exclusion criteria | 1. Patients with previous allergic reactions to N-acetylcysteine or simethicone 2. Patients under the age of 18 years old 3. Patients who lack capacity to consent 4. Those patients not medically fit for endoscopy 5. Those patients where it is deemed unsafe to swallow liquids |
| Date of first enrolment | 01/04/2011 |
| Date of final enrolment | 01/08/2011 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
SO16 6YD
United Kingdom
Sponsor information
Hospital/treatment centre
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
England
United Kingdom
| Website | http://www.uhs.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/0485axj58 |
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? |
|---|---|---|---|---|---|
| Results article | results: | 01/07/2013 | Yes | No |
Editorial Notes
11/08/2016: Publication reference added
