None listed
Conditions
Brief summary
* The purpose of this study is to find out which form of unsedated gastroscopy is the most comfortable and preferred by patients. * Gastroscopies are very safe standard procedures that are performed in most hospitals all over the world since many years. In our Gastroenterology Department we perform thousands of gastroscopies every year and we believe that this study may help us to directly to improve our patient care. What is a Gastroscopy, what means unsedated and what different forms are there? A gastroscopy is a very safe endoscopic procedure to assess the food pipe, stomach and the beginning of the small bowel. The complete procedure only takes three to nine minutes. The instrument used is called a gastroscope, which is essentially a long tube with a camera at the tip that can be passed through the mouth or the nose into your oesophagus and from there into the stomach and also a very short distance into the small bowel. A gastroscopy is required to investigate swallowing difficulties, heartburn, early satiety, chest and abdominal pain or bleeding from the oesophagus or stomach. There are two different types of gastroscopes available differing essentially only in diameter: * Conventional gastroscopes that have a diameter just below 10 mm (half the diameter of a 10 cent coin) and these are the current standard here in New Zealand. 1) Can only be passed through the mouth! * Slim gastroscopes that have only a diameter of 5mm and these can be passed therefore also easily through the nose. Ear-nose-throat specialists commonly use such instruments here in New Zealand. 1) Can be passed through the mouth. 2) Can be passed through the nose (generally not requiring sedation). Therefore three different forms of gastroscopy procedures are possible due to two different diameter scopes available. The conventional larger diameter scope can only be passed through the mouth and this is the current standard here in New Zealand for in and out patient procedures. The slim endoscopes with a diameter half the size can be passed through the mouth, but also through the nose and the latter can be performed with topical anesthetic in general. This approach is called transnasal gastroscopy and the procedure has been used in for many years in countries such as Japan and France. A further advantage of the transnasal gastroscopy is that it enables people to talk throughout the procedure. Performing a gastroscopy unsedated/ without sedation means that prior to the gastroscopy only a topical anesthetic is sprayed into your mouth or nostrils. The topical anesthetic will cause reduced sensation for a short time in your nose and throat, which will decrease the chances of gagging and discomfort during the gastroscopy. As the gastroscopy is performed through the mouth, a mouth guard is used to protect your teeth. Unfortunately, you cannot talk throughout the procedure due to the mouth guard and the gastroscope being in place. In our current clinical practice, sedation is additionally used in approximately half of the gastroscopies performed with conventional gastroscopes. Sedation means that the doctor administers medication over a needle into a small superficial vein (blood vessel) in your arm that makes you sleepy, reduces anxiety and discomfort. This is usually due to patient or doctor preference or due to patients not tolerating this procedure with a conventional gastroscope without sedation due to gagging, coughing or anxiety. In the Waitemata District Health Board region currently all outpatient gastroscopies are organized as a procedure that may be performed with sedation and only conventional size gastroscopes are used. Therefore all patients have to take a day off work and organize a family member or friend to pick them up, as you are not allowed to drive, use the public transport system or take a taxi following the administration of sedation. In general, the big advantage of unsedated gastroscopy is that patients are allowed to drive and do not require an accompanying person. Furthermore, the time spent in the Endoscopy unit is a lot shorter as patients can leave directly after the procedure. Patients are also able to return to work the same day and this is not possible when a gastroscopy is performed under sedation. Furthermore, complications such as blood pressure and breathing compromise, although rare, are usually associated with sedation. Therefore, we believe offering unsedated gastroscopies and in turn alleviating the need for a support person and taking a day off work would be greatly appreciated in our community. It is our goal that this service should offer the most comfortable form of gastroscopy to the patient. There is however conflicting evidence as to which form of unsedated gastroscopy is the most comfortable. As a result, we have designed this study to clarify what form of unsedated gastroscopy is the most comfortable and preferred by patients.
Interventions
Unsedated oesophagogastroduodenoscopy (EGD) Arm 1: Transnasal EGD followed by small-caliber per-oral EGD followed by conventional EGD Arm 2: Small-caliber per oral EGD followed by transnasal EGD followed by conventional EGD Arm 3: Conventional EGD followed by transnasal EGD followed by per-oral EGD Three EGDs are performed during two sessions. The two small caliber EGDs (transnasal and per-oral approach) are performed during one session and the conventional EGD is performed during one session. Conventional EGD uses a 9-10mm diameter scope that is passed through the mouth, oropharynx, bypassing the larynx into the oesophagus, stomach and proximal small bowel. The assessment of oesophagus, stomach and duodenum requires between 3-9mins. Transnasal EGD uses a ~5mm diameter endoscope that is passed into the upper gastrointestinal tract via the nostrils, nasopharynx and thereafter the passage is similar to the conventional EGD (see above). The procedure time is in average longer (approx. one minute longer) due to the insertion through the nostril which also affects the handling throughout the procedure. Small caliber per-oral EGD (SC-PO) uses the same endoscope that is used for the transnasal approach, however the insertion pathway is similar to the conventional approach. The procedure time is also similar to the conventional EGD with about 3-9minutes. The session during which both small caliber approaches (TN and PO) are performed requires a 45 minute slot. Between the procedures and after the second procedure an approx. ten minute pause is planned to allow filling in of the participant questionnaire. The session during which the conventional EGD will be performed requires a 30 minute slot. We aim to perform the two sessions within two days to two weeks. We use two different anesthetics which are applied through a nozzle into the pharynx and then swallowed or into each nostril: For the conventional EGD and SC-PO EGD: Oral pump spray (Xylocaine Pump Spray 10%/ trademark) lidocaine 10%. 5 squirts twice into the pharynx. For the transnasal EGD: Combination nasal spray (Co-Pheynylcaine Forte/ trademark) 5% lignocaine hydrochloride and 0.5% phenylephrine hydrochloride. 5 squirts per nostril.
Sponsors
Study design
Eligibility
Inclusion criteria
Age >15 We include healthy volunteers and patients that are referred to our service for the purpose of an outpatient EGD and patients that are under the Gastroenterology Department follow up requiring an EGD. No specific condition or symptom is targeted in the patient population other then the requirement for an outpatient EGD.
Exclusion criteria
Age < 16, acute illness that does not allow safe performance of EGD as per study protocol, pregnancy, acute nasal trauma, active epistaxis, active upper gastrointestinal bleeding, allergy to topical anaesthetic