Endoscopy Botox

Patient Consent:
I acknowledge that the doctor has explained:

• my medical condition and the proposed procedure, including additional treatment if the doctor finds something unexpected. | understand the risks, including the risks that are specific to me.
• The anesthetic/sedation required for this procedure. I understand the risks, including the risks that are specific to me.
• other relevant procedure/treatment options and their associated risks.
• my prognosis and the risks of not having the procedure.
• that no guarantee has been made that the procedure will improve my condition even though it has been carried out with due professional care.
• the procedure may include a blood transfusion.
• if immediate life-threatening events happen during the procedure, they will be treated based on my discussions with the doctor, transferring to a hospital setting for further care.
• You understand that if any complications do arise, you will contact the or the any emergency services out of our hours service immediately and accept their advice regarding care If you need to be moved to a hospital for care, costs are not included in the packages of Enfield Royal Clinic.
• Your packages do not include any other hospital treatment, service or accommodation which will be charged for separately by related hospital.

I have been given the following Patient Information Sheet/s:
1. Upper Gastrointestinal Endoscop
2. Gastric Botox for Weight Loss
3. Sedation Anesthesia

I request to have the procedure
Patient Name:  

Signature:  

I have explained to the patient all the above points under the Patient Consent and I am of the opinion that the patient/substitute decision- maker has understood the information.

Doctor Name:  

Sign & Stamp: 

What is the upper gastrointestinal endoscopy (Gastroscopy)?
• An upper gastrointestinal (Gl) endoscopy is where the doctor uses an instrument called an endoscope to look at the inside lining of your esophagus (food pipe), stomach and duodenum (first part of the small intestine). This is done to look at reasons as to why you may have swallowing problems, nausea, vomiting, reflux, bleeding, indigestion, abdominal pain or chest pain.
• An endoscope is a long, thin, flexible tube with a small camera and light attached which allows the doctor to see the pictures of the inside of your gut on a video screen. The scope bends, so that the doctor can move it around the curves of your gut. The scope also blows air into your stomach; this expands the folds of tissue in your stomach so that the doctor sees the stomach lining better. As a result, you might feel some pressure, bloating or cramping during the procedure.
• This instrument can also be used to remove or burn growths or to take tissue biopsies.
• You will then lie on your left side, and the doctor will pass the endoscope into your mouth and down your esophagus (food pipe), stomach and duodenum (first part of the small intestine). Your doctor will examine the lining again as the endoscope is taken out.
• The endoscope does not cause problems with your breathing.
• You should plan on 2 to 3 hours for waiting, preparation and recovery. The procedure itself usually takes anywhere from 10 to 15 minutes.
• If the doctor sees anything unusual or want to test for bacteria in the stomach, they may need to take a biopsy (small pieces of tissue) for testing at Pathology.
• This procedure may or may not require a sedation anesthetic.

Will There be any discomfort? Is any Aesthetic needed?
The procedure can be uncomfortable and to make the procedure more comfortable a sedative injection or a light anesthetic can be given.
If you prefer, it can be done without sedation. Before the procedure begins the doctor:
• will put a drip into a vein in your hand or forearm. This is where the sedation or anesthetic is injected and
• may spray your throat with a numbing agent that will help prevent gagging.

What is sedation?
Sedation is the use of drugs that give you a ‘sleepy-like’ feeling. It makes you feel very relaxed during a procedure that may be otherwise unpleasant or painful.
You may remember some or little about what has occurred during the procedure.
Anesthesia is generally very safe but every anesthetic has a risk of side effects and complications. Whilst these are usually temporary, some of them may cause long-term problems.
The risk to you will depend on:--
personal factors, such as whether you smoke or are overweight.
whether you have any other illness such as asthma, diabetes, heart disease, kidney disease, high blood pressure or other serious medical conditions

What are the risks of this specific procedure +/- sedation?
There are risks and complications with this procedure. They include but are not limited to the following. Common risks and complications include:
• Nausea and vomiting.
• Faintness or dizziness, especially when you start to move around.
• Headache.
• Pain, redness or bruising at the sedation injection site (usually in the hand or arm).
• Muscle aches and pains.
• Allergy to medications given at time of the procedure.

Uncommon risks and complications include: • About 1 person in every 1,000 will experience bleeding from the esophagus (food pipe), stomach and duodenum where a lesion or polyp was removed. This is usually minor and can usually be stopped through the endoscope. Rarely, surgery is needed to stop bleeding.
• Heart and lung problems such as heart attack or vomit in the lungs causing pneumonia. Emergency treatment may be necessary.
• Damage to your teeth or jaw due to the presence of instruments in your mouth. An existing medical condition that you may have gotten worse.

Rare risks and complications include:
• Missed polyps or growths.
• About 1 person in every 5,000 will accidentally get a hole (perforation) in the esophagus, stomach or duodenum. This can cause a leak of stomach contents into the abdomen. If a hole is made, you will be admitted to hospital for further treatment which may include surgery
• Your procedure may not be able to be finished due to problems inside your body or because of technical problems.
• Bacteremia (infection in the blood). This will need antibiotics.
• Dead arm’ type feeling in any nerve, due to positioning with the procedure — usually temporary.
• Anaphylaxis (severe allergy) to medication given at the time of procedure.
• Death as a result of complications to this procedure is rare

Your responsibilities before having this procedure
You are less at risk of problems if you do the following:
• Bring all your prescribed drugs, those drugs you buy over the counter, herbal remedies and supplements and show your doctor what you are taking. Tell your doctor about any allergies or side affects you may have.
• Do not drink any alcohol and stop recreational drugs 24 hours before the procedure. If you have a drug habit, please tell your doctor.
• If you take Warfarin, Persantin, Clopidogrel (Plavix or is cover), Asasantin or any other drug that is used to thin your blood ask the doctor ordering the test if you should stop taking it before the procedure as it may affect your blood clotting. Do not stop taking them without asking your doctor.

Tell your doctor if you have;--
-had heart valve replacement surgery.
-received previous advice about taking antibiotics before a dental treatment or a surgical procedure. If so, you may also need antibiotics before the colonoscopy.

Preparation for the procedure
Your stomach must be empty for the procedure to be safe and thorough, so you will not be able to eat or drink anything for at least six hours before the procedure.

What if the doctor finds something wrong?
Your doctor may take a biopsy (a very small piece of the stomach lining) to be examined at Pathology. • Biopsies are used to identify many conditions even if cancer is not thought to be the problem.

What are polyps and why are they removed?
Polyps are fleshy growths in the bowel lining, and they can be as small as a tiny dot or up to several centimeters in size. They are not usually cancer but can potentially grow into cancer over time. Taking polyps out is an important way of preventing bowel cancer. The doctor usually removes a polyp along the endoscope by using a wire loop. An electric current is sometimes also used. This is not painful.

What if | don’t have the procedure?
Your symptoms may become worse, and the doctor will not be able to give you the correct treatment without knowing the cause of your problems.

Are there any other tests | can have instead?
No. Your doctor could discuss with you other ways of managing your condition.

What can | expect after this procedure?
You will remain in the recovery area for about 2 hours until the effect of the sedation wears off. Your doctor will tell you when you can eat and drink. Most times this is straight after the procedure.

Your throat may feel sore and you might have some cramping pain or bloating because of the air entering the stomach during the procedure.

You will be told what was found during the examination or you may need to come back to discuss the results, and to find out the results of any biopsies that may have been taken.

What are the safety issues?
Sedation will affect your judgment for about 24 hours. For your own safety and in some cases legally: • Do NOT drive any type of car, bike or other vehicle. You must be taken home by a responsible adult person.
Sedation with your procedure
Informed consent: patient information
This information sheet answers frequently asked questions about having sedation. It has been developed to be used in discussion with your doctor or healthcare professional.

What is sedation?
Sedation involves small amounts of the medicines used for anesthesia which make you feel relaxed and sleepy but not unconscious for your procedure/treatment/surgery. You may remember some or little about what has happened. You may still be somewhat aware of your surroundings, what is happening and be able to respond to instructions.
Most sedation is given by using a needle to put a cannula (thin plastic tube) into a vein in the back of your hand or arm. If needles worry you, please tell your anesthetists/he healthcare professional who might be able to do things to help you.

What does my anesthetist do?
Your anesthetist is a doctor with specialist training who will:
• assess your health
• discuss sedation and the risks of sedation
• agree to a plan with you for your sedation and pain control
• be responsible for giving your sedation and caring for you during your procedure and straight after your procedure.

What are the risks of sedation? Modern sedation is generally very safe but there is still a risk of side effects and complications. Whilst side effects are usually temporary, some of them may cause long-term problems, Side effects and complications are also increased if you:
• are elderly
• smoke
• are overweight,
• if you have an illness, including the following:
- hypertension
- heart disease
- kidney disease
- a bad cold or flu, asthma or other chest disease
- diabetes
- high blood pressure
- other serious or chronic medical conditions

Common side effects and complications include:
• nausea and vomiting
• headache

What are the risks of sedation? (continued)
• Pain and/or bruising at the injection site sore or dry throat and lips
• dizziness or feeling faint, especially when you start to move around
• falling blood pressure
• mild allergic reaction such as itching or a rash
• damage to teeth, dental prosthetics and lips
• where there is a deep level of sedation (which may be required for your procedure):
- loss of consciousness-
- responsiveness only to painful touch
- difficulty breathing
- heart function can be affected
- the anesthetist is trained to manage the
- above situations.

Uncommon side effects and complications include:
• weakness
• allergic reactions and/or asthma
• an existing medical condition getting worse,

Rare risks and complications include;
• vomiting which can force stomach contents into the lungs and cause pneumonia
• severe allergic reaction or shock
• damage to nerves and pressure areas
• stroke or heart attack
• blood clotting the lungs
• epileptic seizure
• brain damage
• death.

There may also be risks specific to your individual condition and circumstances, Please discuss these with your doctor/healthcare professional and ensure they are written on the consent form before you sign it.

What are the risks of not having sedation?
There may be consequences if you choose not to have the sedation. Please discuss these with your doctor/healthcare professional.

What are my responsibilities before having sedation?
You are at less risk of problems from an anesthetic if you do the following:
In preparation for your procedure:
• Increase your fitness before your procedure to improve your blood circulation and lung health. Ask your doctor about exercising safely.
• If you are overweight, losing some weight will reduce many of the risks of having an anesthetic. Ask your GP about losing weight safely.
• Stop smoking as early as possible before your surgery to give your lungs and heart a chance to improve. Smoking cuts down the oxygen in your blood and increases breathing problems during and after an operation.
• Drink less alcohol, as alcohol may alter the effect of the anesthetic medicines.
• Do not drink any alcohol 24 hours before surgery.
• Stop taking recreational drugs before your surgery as these may affect the anesthetic.
• If you take anticoagulant or antiplatelet (blood thinning) medicines, such as warfarin, aspirin, clopidogrel (Plavix, Iscover,Coplavix), prasugrel (Effient), dipyridamole (Persantin or Asasantin), ticagrelor (Brilinta) ticlopidine (Tilodene), apixaban (Eliguis), dabigatran (Pradaxa), rivaroxaban (Xarelto) or omplementary/ herbal/alternative medicines, such as fish oil or turmeric: if you are asked to stop taking blood thinning medicine before your procedure, ask your doctor when you can restart the blood thinning medicine.

On the day of your procedure:
• Nothing to eat or drink (‘nil by mouth’): you will be told when to have your last meal and drink. Do NOT eat (including lollies), drink, or chew gum after this time otherwise your operation may be delayed or cancelled.

This is to make sure your stomach is empty so that if you vomit, there will be nothing to go into your lungs.
• If you are a smoker or drink alcohol: do not smoke or drink alcohol.
• If you are taking medicines: most medicines should be continued before an operation, but there are some important exceptions:

What are my responsibilities before having sedation? (continued)
- your doctor will provide specific instructions about your medicines. Take to the hospital all your - prescribed medicines, those medicines you buy over the counter, herbal remedies and supplements to show your anesthetist what you are taking. - If you feel unwell: telephone the ward/hospital for advice.

Tell your doctor and the anesthetist if you have:
- health problems (e.g., diabetes, high blood pressure, infectious diseases, serious illnesses), including if regular treatment or a stay in hospital is needed
- an alcohol or drug addiction
- had previous problems and/or known family problems with anesthesia
- false teeth, caps, loose teeth or other dental problems
- any implants you have
- been taking prescribed and/or over the counter medicines, herbal remedies and supplements; this may include and are not limited to blood thinning medicines, the contraceptive pill, antidepressants and/or diabetic medicines (e.g., insulin)
- allergies/intolerances of any type and side effects. Ask your surgeon and/or anesthetist if you should stop taking it before surgery as it may affect your blood clotting.
- do NOT stop blood thinning medicines without asking your doctor

What happens after the procedure has finished?
After the procedure, nursing staff will watch you closely until you are fully awake. This is usually in an area known as recovery. You will then be given something to eat and drink. You can rest until you have recovered enough to go home.

Following sedation Sedation medicines may affect your judgment for about 24 hours or sometimes longer. For your own safety during this time:
• Ask your doctor/health professional whether you can:
- drive any type of car, bike or other vehicle
- operate machinery including cooking implements
• do NOT make important decisions (such as withdrawal of money from the ATM machine or sign legal documents
• do NOT drink alcohol, take other mind-altering substances, or smoke as these substances may react with the sedation medicines
• have an adult with you on the first night after your procedure

Gastric Injection of Clostridium Botulinum Toxin-A (Gastric Botox) is a relatively new and promising technique for weight loss. It is a non-surgical procedure that helps people to lose some weight who suffer being overweight or obese.

This information booklet has been written to explain the procedure. This will help you to make an informed decision before consenting to the procedure. Please read the booklet and consent form carefully.

Botulinum toxin-A (Botox® and similar agents) is a neurotoxin produced by the bacterium Clostridium A. Botulinum toxin relaxes the muscles on areas it is injected. One possible angle for treating obesity could be slowing down the gastric emptying time. By prolonging the gastric emptying time, the person would ideally experience increased sensation of satiety, and in the long run reduce food intake. In that way it helps you limit the calorie intake and loss some weight. Gastric Botox shows its effect within 2-3 days. And since its effect lasts 4 to 6 months, results may not be permanent. Some people may experience not losing weight as desired or weight re-gain after losing some weight, if they do not follow weight loss team's recommendations and follow-ups.

Gastric Botox Injection Procedure:
Botox will be delivered and injected to your stomach wall by an upper endoscopy (gastroscopy) assistance.
Once the upper endoscope is down into the stomach, the endoscopist surgeon will start to inject the Botox with a special endoscopic fine needle into the specific areas of the stomach wall.

The Botox will be injected in measured proportions according to your needs, not randomly. The stomach Botox is an outpatient procedure, and it doesn't require you to stay in the hospital at night. It takes from 20 to 30 minutes, then you can go back home directly, and you can continue your daily routine the following day.

Even Gastric Botox is considered a safe procedure it may cause some complications and side-effects. As with any medical procedure, the risk must be compared to the benefit of having the procedure.

The major health risks and complications are including but not limited to: • Perforation on the wall of the upper gastrointestinal system as esophagus (gullet), stomach, duodenum: this may require additional endoscopic applications and even surgical procedures to repair them in one of our partner hospitals. This is the most serious complication which may cause a death.
• Bleeding from the injection site in the stomach: this usually settles down on its own
• Disturbance in your heart rate and breathing
• A reaction to any of the medications used
• A sore throat and abdominal tenderness. As the gastroscope passes down the digestive tract, it brushes against the lining and may cause a small amount of bruising
• Adverse reactions to Clostridium Botulinum Toxin-A (Botox) include skin rashes, chest pain heartburn, fever or joint pain. Other reactions include abdominal pain, diarrhea, and dry mouth, difficulty swallowing, vomiting or feeling sick.
• Allergic reactions to Botox include swelling of the face and throat, difficulty breathing or feeling faint.
• Aspiration pneumonia (inflammation of the lungs caused by inhaling or choking on vomit).

The major side effects are including but not limited to:
Serious side effects from this procedure are rare, but for the rest of the day you may have a sore throat. You may also feel a little bloated if some of the air we use is left behind. Both these things will pass, with no need for medication. You can also have mild stomach cramping and nausea in a first few days after the procedure but these are mostly settled by their self. If you experience any of the following problems after the procedure, please contact your doctor immediately:
• Severe abdominal cramping or pain
• A firm and swollen abdomen
• Chest pain
• High temperature or feeling feverish
• Severe nausea and vomiting
• Skin rash
• Difficulty breathing

If you are unable to contact or speak to your doctor and you are experiencing any of these symptoms, we would advise you to attend your nearest hospital's Emergency Department.

I understand this is an elective procedure and | hereby voluntarily consent to treatment with Gastric Injection of Clostridium Botulinum Toxin-A (Botox) for Weight Loss by Upper Gastrointestinal Endoscopy (Gastroscopy) Assistance. The procedure has been fully explained to me. I have read the above and understand it. My questions have been answered satisfactorily. I accept all risks and complications mentioned above, but not limited with them, regarding the procedure and | understand that no guarantees are implied as to the outcome of the procedure.

The Gastric Injection of Clostridium Botulinum Toxin-A (Botox) for Weight Loss by Upper Gastrointestinal Endoscopy (Gastroscopy) Assistance procedure (here in after referred to as gastric botox or the procedure) offers a simple, safe and effective method for combating obesity. Their role in helping patients to lose weight and maintain that weight loss is proven. However, it is vitally important to understand that the gastric Botox is one of the medical treatment options of overweight and obesity. Consequently, we would ask that you read and understand the following:
by a special endoscopic fine needle passing inside of the endoscope.

That there are potential immediate risks and complications as sociated with gastric botox procedure, and that these are to be discussed with the Endoscopic Surgeon..

However, notwithstanding any subsequent discussions with the Endoscopic Surgeon, you accept and understand that these complications include but are not limited to the following:
• Injury to the gullet or stomach due to endoscope itself
• Bleeding due to trauma
• Injury to the gullet or stomach on botox injection sites (including perforation)
You understand that:
Medications, other treatment and/or surgery may be necessary during the course of the procedure should any complications arise, and you specifically consent to these also.

Even once the gastric botox is successfully performed, other complications may arise and that these are to be discussed with the Endoscopic Surgeon and Specialist Anesthetist. However, notwithstanding any subsequent discussions with the Endoscopic Surgeon and Specialist (leste you accept and understand that these complications include but are not limited to the following:
• Procedure intolerance
• Dehydration due to prolonged stomach cramping and sickness may require IV fluids at our clinic during day time at a hospital
• Metabolic problems +/- renal failure/thiamine deficiency
• Reflux esophagitis
• Gastric erosions +/- bleeding
• Gastric ulcers +/- perforation
• Acute gastric dilatation
• Allergic reactions or side effects due to Botox or Blue dye (Methilen Blue IV form)
• Infections
• Alterations in bowel habit

You understand that if any complications do arise, you will directly contact Enfield Royal Clinic or the any emergency services out of our hours of service immediately and accept their advice regarding care. If you need to be moved to a hospital for care, costs are not included in the Enfield Royal Clinic Weight Management package.

Your package does not include any other hospital treatment or accommodation which will be charged for separately by related hospital.

Regarding Weight Loss
The gastric Botox is an accepted method of treatment for mild to moderate obesity in adults. This procedure is being undertaken to help you control your weight.

In recorded discussions with the Enfield Royal Clinic, you have confirmed that you have a history of obesity and a poor relationship with food, and that you have tried alternative forms of treatment over years and all have been unsuccessful, and all the other treatment modalities have been discussed with you, including general dietary control, very low-calorie diets, anti-obesity medications and anti- obesity surgery. After all these discussions relating to alternative treatment modalities, we have agreed that the very best course of treatment for you is the gastric Botox.

You understand that:
The gastric Botox is a promising method with a limited time of effect (4-6 months) to help with behavior modification and that you must participate in a dedicated follow-up for behavioral modification and support to increase its chance of success.

Consequently, that you will do all that you can to help yourself in this process, including attending all review appointments in person, by telephone or internet call.

You have been advised that further follow-ups and other consultations of behavioral modification and further care may be required and that you will attend all appointments for this, and follow all advice given to you.

No specific assurance has been given to you about the amount of weight that you may lose.
Regarding Unforeseeable Circumstances An Abnormality Found at Endoscopy - You understand that:
If during your endoscopy an abnormality is found, it may not be possible to perform gastric Botox, temporarily or permanently.
If, following endoscopy, it is not possible to perform gastric Botox at all, including at any time in the future: • You will receive a refund of any monies remaining after all incurred costs have been deducted. Costs will include, but not limited to: Doctors consultations, body composition analyzing, blood tests and cost of the upper gastrointestinal endoscopy (Gastroscopy).

If, following endoscopy, you are found to have a treatable benign condition that merely means your gastric Botox application must be postponed, the decision as to whether to be treated and then proceed is entirely yours:

• If you decide to proceed, you understand that costs have already been incurred and there will be additional upper gastrointestinal endoscopy (Gastroscopy) and other procedures as biopsy, if any, cost to pay.

Failure To Follow Eating/Fasting Instructions - You understand that: Failure to follow pre-insertion eating and fasting instructions may result in your procedure being abandoned.

If food is found in your stomach and it is not possible to perform gastric Botox:
• Should you decide to proceed at a later date, you understand that costs have already been incurred and there will be additional upper gastrointestinal endoscopy (Gastroscopy) cost to pay.
• If you decide not to reschedule you will receive a refund of any monies remaining after all incurred costs have been deducted. Costs will include, but not limited to: Doctors’ consultations, body composition analyzing, blood tests and cost of the upper gastrointestinal endoscopy (Gastroscopy).

Failure to Lose Weight
With any medical procedure or biological process there is a range of success recorded. Some patients just naturally do better than others, some may even cheat and continue to eat or drink very high calorie liquidized food. The Enfield Royal Clinic Weight Management Unit Programs are specifically set up to maximize each patient's own potential for success. We are therefore unable to offer any refund whatsoever in the event that patients are disappointed with the results of their gastric Botox application

I have read and understood the contents of GASTROSCOPY, SEDATION ANESTHESIA and Gastric Injection of Clostridium Botulinum Toxin-A (Botox) for Weight Loss including the risks and possible complications before, during and after these procedures. The procedures and their associated risks and possible complications have been clearly explained to me. I had the opportunity prior to the procedures to direct all my questions to the attending doctor and was given satisfactory answers.

I am not breastfeeding:

I am not pregnant and do not think | may be pregnant during my 6-month programmed:

I, hereby give my consent to doctors of to perform a Gastroscopy (with or without biopsy/polypectomy) and Intragastric Balloon Placement on me