Patient Informed Consent or Consent obtained by deception?

An example of patent informed consent process for undergoing gallbladder surgery for treatment of gallstones

Information provided necessary for
Obtaining Consent

Hand out

Direct Access Surgery – Gallbladder Surgery

Information for Patients

Your GP has diagnosed you with having biliary pain, which is likely being caused by gall stones.

Truth: The very first sentence is deceptive . First need need to under stand what the ” biliary system” AKA also called ” biliary tract” is and consist and related pain problems NOT associated with gallbladder pain or attacks “biliary colic” . i.e a stone formed in the liver or bile bile duct spontaneously passing, causing pain radiating towards the back

Biliary pain found in : The biliary tract, (biliary tree or biliary system) refers to the liver, gall bladder and bile ducts, and how they work together to make, store and secrete bile.

Truth: The definitive likely hood ‘biliary pain’ is gallstones needing gallbladder removed out is a lie

Truth : Likely hood of your friendly BOP GP correctly diagnosing root cause ” Biliary pain” , without required hospital best practice clinical tests provided is low to even sub 30%

Only 21% of doctors ( junior ) correctly diagnosed biliary colic. Despite the classical history of biliary colic, this was mis-diagnosed as dyspepsia in 40% of cases. GORD was correctly identified by 69% of doctors, but only 36% correctly diagnosed dyspeptic symptoms with 14% incorrectly attributing dyspeptic symptoms to biliary colic.

Dr Heather Lewis, Specialist Registrar in Gastroenterology, Dr Alistair McNair, Consultant Gastroenterologist, Queen Elizabeth Hospital

And:

Biliary colic can occur in the absence of gallstones (Acalculous Biliary Pain), particularly in young women of which only 15% undergo laparoscopic cholecystectomies. Common causes of such biliary pain include the following:

Microscopic stones—not detected by routine abdominal ultrasonography
Abnormal gallbladder emptying
An overly sensitive biliary tract
Sphincter of Oddi dysfunction
Hypersensitivity of the adjacent duodenum
Possibly gallstones that have spontaneously passed
Some patients eventually develop other functional GI disorders.

Ali A. Siddiqui, MD, Professor of Medicine, Division of Gastroenterology, Thomas Jefferson University. Acalculous Biliary Pain.

And

Diagnostics for from the viewpoint of a internist and surgeon: The evaluation of a patient with biliary symptoms requires a combination of history taking, physical examination, laboratory analysis, and imaging modalities. A high-quality magnetic resonance imaging (MRI) or computed tomography (CT) scan is usually sufficient to evaluate a patient with painless jaundice. Ultrasonography is helpful as an initial screening test to guide the diagnostic work-up.

Reimann FM1, Friess H. Diagnostics for diseases of the gallbladder and biliary tract from the viewpoint of the internist and surgeon. Demands made on radiological diagnostics 10.1007/s00117-005-1286-y

And

Medical dictionary : How are gallstones diagnosed?

• Ultrasonography
• Transabdominal ultrasonography
• Magnetic resonance cholangio-pancreatography (MRCP)
showing stones in the common bile duct: (a) Gallbladder with stones (b) Stone in bile duct (c) Pancreatic duct (d) Duodenum.
• Endoscopic ultrasonography (EUS)
• Cholescintigraphy (HIDA scan)
• Endoscopic retrograde cholangio-pancreatography (ERCP)
• Duodenal biliary drainage
• Oral cholecystogram (OCG)
• Intravenous cholangiogram (IVC)

What are the potential pitfalls of diagnosing gallstones?, a high prevalence of silent gallstones and the occasional gallstone that is difficult to diagnose.

https://www.medicinenet.com/gallstones/article.htm

This can be relieved with an operation. As you are otherwise healthy, it is possible for your GP to manage your pre-operative and post-operative care. This may expedite the process for you, and avoid multiple visits to the hospital to see the surgeon and anaesthetist.

Truth: ” can relieve ” is another statement, not sure but maybe are not great odds of receiving an accurate diagnosis for treatment from you GP

The big question: has your doctor been setup to wip gallbladders out without offering treatment options or definitive understanding of the root cause of pain and the best treatment while being in a healthy condition ?

It is important to know that you will still meet the surgeon and anaesthetist, however this may be only on the day of your surgery. If you are unhappy with this arrangement, or feel you would like to speak to either the surgeon or anaesthetist before the day of your surgery, please let your GP know. If this is the case, you will be referred through the conventional process. If you have had problems with surgery or anaesthetics before, or any of your family members have had problems with an anaesthetic before, please let your GP know as it may be better to see the surgeon and anaesthetist before the surgery. If after reading this pamphlet, you still have some questions, or would like to speak to the surgeon or anaesthetist, let your GP know so we can arrange an outpatient appointment for you.

WHAT IS THE GALLBLADDER?

The Gallbladder is a small pear-shaped organ that rests under your liver. Its main function is to collect and store bile, which is a fluid that helps digest fat. Gallstones can form in the gall bladder, and in a small percentage of these people, symptoms can develop. When you eat, bile flows freely from the gallbladder into your small bowel to help digest your food. However, if a gallstone plugs the outflow from the gallbladder, you may get pain. If the gallstones are left untreated, complications may develop. These include inflammation of the gallbladder, which is called cholecystitis. In some instances, these stones can travel into the bile duct, and cause a blockage of the bile duct that can result in pain, jaundice or pancreatitis (inflammation of the pancreas).

Generally the symptoms will resolve once the gallbladder has been removed. In some instances, the pain may persist, due to other conditions such as bile duct problems. If your symptoms persist following the operation, you will need to let your Doctor know, so this can be followed up.

Truth about ‘Followed up’. No treatment or diagnoses will likley be provided because prosy problems don’t exist., that’s according to this consent form. Patients complaints to HDC or BOP DHB will be rejected.

Once the gallbladder has been removed, bile will still flow freely into your small intestine, and you will be a be able to digest your food normally.

Truth is , once the gallbladder and its fuction is removed, there is no way food can every be processed normally gain

Direct Access Surgery – Gallbladder Surgery

WHAT CAUSES GALLSTONES?

The gallbladder concentrates bile, therefore if the bile, cholesterol or fluid becomes unbalanced within the gallbladder, the chemicals in bile can solidify and form a crystal. Gallstones then form. Most of them are made up of cholesterol. Doctors do not know exactly why some people get gallstones, while others do not, however pregnancy, obesity or rapid weight loss, female, older age and some ethnic groups of people are more likely to develop gallstones.

There is no treatment or diet that can prevent or treat gallstones, however, in most people gallstones do not cause symptoms and therefore the symptoms can come and go over many years. However, once you have been getting pain from gallstones it does tend to recur if left untreated. Gallstone pain typically occurs after a meal. It is a severe steady pain in the abdomen they can go to your back. There is often bloating or vomiting with the pain.

Medical Fraud Confirmed with this misinformation provided to patients here ?

Dissolution of Gallstones: ursodeoxycholic acid, Actigal®, is a medicine that can be given as a pill to dissolve gallstones. Therapy requires at least 6 to 12 months and is successful in dissolving stones in 40-80% of cases. When surgery is too risky, the symptoms are mild, the stones are small, and rich in cholesterol, dissolution of gallstones is a reasonable alternative.

American College of Gastroenterology http://patients.gi.org/topics/gallstones-in-women/

Oral Medications

Medications given by mouth to dissolve gallstones are appropriate for approximately 30 percent of people with gallstone-related disease. These medications, called chenodeoxycholic acid and ursodeoxycholic acid, are made of bile acids. The composition of gallstones affects the success rate with these medications. People with small cholesterol gallstones have the greatest chance of success with dissolution therapy. Those unlikely to benefit are people with large cholesterol stones, pigment stones composed of bilirubin and obese patients. Treatment can take several years and gallstones may recur.

Ursodeoxycholic Acid

Ursodeoxycholic acid (ursodiol, Actigall) dissolves up to 80 percent of very small gallstones within six months. Treatment with this medication is less successful when the stones are large. Even if treatment is successful, as many as 50 percent of patients experience recurrent gallstones. Ursodiol is not an appropriate treatment option for people with calcified cholesterol or pigment gallstones.

Possible side effects of ursodiol include diarrhea, constipation, upset stomach, indigestion, dizziness, vomiting, cough, runny nose, sore throat, back pain, joint or muscle pain, hair loss and frequent urination or painful urination.

Chenodeoxycholic Acid

Chenodeoxycholic acid (Chenodiol, Chenodal) is a bile acid that gradually dissolves cholesterol gallstones in certain patients, especially those with small stones composed primarily of cholesterol. Even when the medication is successful in dissolving gallstones, an estimated 50 percent of patients have a recurrence within 5 years.

Chenodiol should not be given to pregnant women or people with liver disease, gallbladder obstruction, gallstone complications or large, noncholesterol gallstones. Side effects may include diarrhea, liver inflammation, heartburn, decreased appetite, nausea, elevated blood cholesterol and a decreased white blood cell count.

Contact Dissolution Therapy

Contact dissolution of gallstones is experimental and is not widely accepted or available. The procedure involves injecting a chemical solvent directly into the gallbladder. The surgeon inserts a thin tube into the gallbladder and connects a pump that delivers small amounts of solvent directly into the organ over a period of hours or days. The procedure can reduce cholesterol stones rapidly, but the risk of complications is high due to the toxic nature of chemical solvents.

http://lifewithnogallbladder.com/?s=treatment+gallstones

WHAT IS A LAPAROSCOPIC CHOLECYSTECTOMY?

Laparoscopic cholecystectomy is the surgical removal of the gallbladder, using a tube shaped telescope (commonly known as keyhole surgery). Usually about four to five small incisions are made in the abdomen.

In a small number of cases, this procedure cannot be performed by keyhole surgery, and the surgeon will need to perform an “open” procedure instead. This involves making a larger incision, and may result in you staying in hospital for a longer period of time. Reasons for needing an “open” cholecystectomy include a history of previous abdominal

Direct Access Surgery – Gallbladder Surgery

surgery, severe inflammation, the surgeon being unable to visualise the organs, and risk of damage to surrounding internal organs, pregnancy, or bleeding disorders.

The surgeon will make the decision to perform an open procedure, either before or during your operation, based purely on the safest way to remove your gallbladder.

The gallbladder is not an essential organ, so you will still be able to digest food normally after this operation. However, some people do experience indigestion or bloating on occasions after having their gallbladder removed.

WHY A LAPAROSCOPIC CHOLECYSTECTOMY?

For most people laparoscopic procedure has benefits over an open procedure. These include less discomfort after surgery, a shorter time in hospital, a faster recovery, a better cosmetic experience and small scars instead of a large scar.

The surgery is performed through several small puncture wounds in the abdomen. Carbon dioxide is blown into the abdominal cavity to create a space, by lifting the abdominal wall off the liver and gallbladder. Then using a small video camera attached to the laparoscope, the surgeon is able to see inside your abdomen. The operating instruments are placed through small puncture wounds around the gallbladder, and under vision the tissues holding the gallbladder onto the liver are dissected free.

In some cases a dye test and x-ray is performed to ensure that there are no stones in the bile duct. If stones are in the bile duct, these may be removed at this time or at a later procedure. Clips are used to close off the artery that supplies the gallbladder and the cystic duct (the tube that drains the gallbladder). These clips remain in your body.

At the end of the procedure the carbon dioxide gas is allowed to escape from your body, and the incisions are closed.

Direct Access Surgery – Gallbladder Surgery

WHY DOES THE GALLBLADDER NEED TO BE REMOVED?

Gallstones in the gallbladder is a common problem, affecting about one in every 10 adults. If these gallstones are causing you pain and other symptoms, they are usually best treated by removing the gallbladder. If just the stones are removed, it is likely that they will just reform over time.

Root cause of Gallstones include:

Celiac – gluton Intolerance
Rapid weight loss
Contraception
Weight loss after pregnancy
Parasites causing brown Pigment stones

Resolve these issues, resolve stones

WHAT ARE THE RISKS?

Whilst this is a relatively safe procedure, as with any operation, it is not without risk.

Specific risks of Laparoscopic cholecystectomy:

-If, after starting the operation, your surgeon believes that it is not safe to continue doing the operation laparoscopically (by keyhole surgery), the surgeon will make a larger cut in your abdomen to remove the gallbladder. This is called an open operation. An open operation may be necessary if there is infection of the gallbladder, gangrene of the gallbladder, abnormal anatomy, scar tissue within the abdomen or any other problem that stops the surgeon getting a clear view of the gallbladder. Conversion to an open operation is not a complication of the surgery but rather is done to protect the patient and in the interests of your safety. Normally, conversion to an open procedure occurs in 1 in 20 patients, but may be as high as 1 in 5 patients if there is inflammation.

-Unintended injury to the nearby structures can occur. The most important structure in the area of the gallbladder is the common bile duct. Damage to the bile duct happens in 1 in 400 cases. This would likely require a further operation to repair the bile duct, and runs the risk of having strictures in the bile duct or ongoing problems in the future that may need further operations or treatment.

-Other complications that can occur are bleeding from the liver, infections in the wound, damage to other internal organs such as the small bowel, or a bile leak following the surgery. A bile leak happens in one in 100 cases, and usually if there is inflammation at the neck of the gallbladder. If there is concern about bile leak at the time of surgery, your surgeon will place a small drain in your abdomen to drain the bile. This will be removed once the bile stops leaking, or in some instances you may require a further procedure, called an ERCP, to repair the leak.

General risks of surgery:

There are some risks which can occur with any operation. These include bleeding, which may require a blood transfusion or another operation, infections in the wound, damage to other internal organs such as the small bowel and an allergy to the drugs used, heart attack (very unusual if you are fit), blood clots in your legs, and pneumonia. Complications such as these occur in 1 in 1000 to 1 in 10,000 cases.

Direct Access Surgery – Gallbladder Surgery

General risks from an anaesthetic:

You will have your operation under general anaesthetic, meaning, you will be asleep. The anaesthetist will give you a mixture of drugs to keep you unconscious and pain-free during your operation. Modern anaesthetics are very safe, and the risk of dying from your anaesthetic is less than the risk of you dying in a car accident on the way to the hospital. However, risks do still exist.

It is not uncommon to get side-effects from your anaesthetic, these include nausea or vomiting, headache, pain at injection sites, sore throat and blurred vision. Less commonly you may have muscle pain, weakness or a mild allergic reaction to the medications with itching or a rash.

Other common side-effects include awareness under anaesthetic, damage to teeth, damage to the voice box which may cause temporary loss of voice, damage to nerves and pressure areas, and an epileptic seizure.

Rear risks which may cause death include an allergy to the medication, very high temperature (malignant hyperpyrexia), a stroke or heart attack, pneumonia, paralysis, blood clot to the lungs or a brain injury.

These risks can be increased if you are elderly, have a bad cold, flu or asthma, are a smoker, overweight, have diabetes, have heart disease, have kidney disease, have high blood pressure or other serious medical conditions.

AFTER YOUR SURGERY

Following your operation, you will wake up in the recovery room. Once stable you will be transferred to the post operative Day Ward. Your blood pressure, pulse, and wounds will be monitored closely, and you will be able to start drinking shortly after your operation. You will be able to get out of bed a few hours after your surgery, and able to eat as soon as you feel you can.

Shortly after your operation, it is not uncommon to feel nausea or to have pain in your shoulders. These symptoms generally settle down within a few hours of the operation.

When you go home you may have abdominal bloating and gas pains, these will also settle down once your digestive system returns to normal. Be aware that some pain medication may affect your bowels and cause constipation.

Likely hood of this is ZERO

The gallbladder has a very important function and can be described as a protector of the liver and colon. It serves as a storage site for bile. Bile is designed to emulsify (digest) fats. When we eat meals with moderate amounts of fat the gallbladder releases its stores of bile to aid the liver in digesting the fat. The loose stools and urgency are very common side effects of gallbladder removal and/or dysfunction.

Because fats are essential for human health, they cannot simply be avoided. Good luck trying! Fats are required in the diet to help us absorb fat soluble vitamins such as Vitamin A,D,E and K. Fats are also important for the brain and our cell membranes. Fats also provide the building block for steroid hormones in the body such as estrogen, testosterone etc

Most patients recover after the surgery within a week or so. You can help yourself recover by not lifting anything heavy and not doing vigourous exercise for 3 weeks after your surgery.

Direct Access Surgery – Gallbladder Surgery

WHEN CAN I GO HOME?

There are a number of factors that need to be considered before you can go home. Firstly, you will need to have a responsible adult stay with you for the 1st night and day after your operation. You may be discharged once you are able to eat and drink without vomiting, mobilise to the toilet, and have passed urine. You will be given a prescription for tablets for pain relief and for prevention of nausea. These are the same medications that you would receive if you were to stay in hospital overnight.

RECOVERY

You will be able to move around from a few days after the operation, however if you do anything strenuous, you may get pain. This is your body telling you to slow down. You may need help in the first day or two after the operation, and you may feel tired and or need a sleep in the first few afternoons after your operation. This will settle down and by 2-3 weeks you should feel fine.

FOLLOW UP

Please see your doctor if you have increasing pain, nausea and vomiting or severe abdominal distention (swelling) after the operation.

You should see your doctor 1 – 2 weeks after the surgery for a checkup, and to get the results of your gallbladder histology. If your doctor has any concerns about your progress, he/she will be in touch with your surgeon and if necessary, arrange for us to review you in the hospital surgical clinic.

After reading the above – Paitents are asked to confirm and provide informed consent

Direct Access Surgery Patient Consent

It is important for you to have read and understood all the information given to you regarding this procedure. The information will help you make an informed decision, and allow you to proceed with your eyes open.

The proposed pathway will allow you to have your operation with fewer visits to the hospital. However, you understand that you will not see the surgeon or the anaesthetist until the day of your surgery. You are aware that if you would like to speak to your surgeon or anaesthetist before surgery you can either let your GP know or tick the box on this form and we will organise an outpatient appointment for you.

Once you have read this booklet, take the time to think about it and direct any questions you may have to your GP. When you are ready, please sign this page to confirm you understand and accept the process of direct access surgery.

I, _____________________________________________________________________________ confirm that I have read and understood all of the information given to me in this booklet, including the risk of surgery and my responsibilities. I have been given sufficient opportunities to ask the questions and have my questions answered to my satisfaction.

? I have had my questions answered to my satisfaction.

? I have not had my questions answered to my satisfaction and would like an outpatient appointment.

Signed: ____________________________________________ Date:__________________

Eyes wide open = Complete non disclosure of likely long term Postcholecystectomy Syndrome (PCS) complications such as :

Not exclusive to: Achalasia, Adhesions, Adrenal cancer, Aerophagia, Anxiety, Arthritis, Bacteria overgrowth in the stomach, Barrett’s oesophagus, Benign tumours, Bezoars, Bile Gastritis, Bile Reflux, Bloating, Celiac Disease, Cholangitis, Choledocholithiasis, Chronic idiopathic jaundice, Cirrhosis, Colon Cancer, Constipation, Coronary angina, Cramps, Cyst, Decrease in bile secretion, Depression, Diabetes, Diaphragmatic hernia, Diarrhoea, Dilation without obstruction, Dubin-Johnson syndrome, Dumping of bile, Duodenal diverticulitis, Dyskinesia, Oesophageal cancer, Fatty infiltration of liver, Fistula, Gas, Gastric cancer, Gastroparesis, GERD Reflux, Gilbert disease, Heartburn, Hepatitis, Hepatolithiasis, Hiatal hernia, Hydrohepatosis, Hypertension or nonspecific dilation, Incisional hernia, Intercostal neuralgia, Intestinal angina, Irritable bowel disease, Irritable Bowel Syndrome, Malignancy and cholangiocarcinoma, Malnutrition, Nausea, Neuroma, Neurosis, Obstruction, Pain – right upper abdomen, Pain – shoulders and abdomen, Pancreatic cancer, Pancreatic cysts, Pancreatic stone, Pancreatitis, Papilloma, Peptic ulcer disease, Psychic tension, Residual or reformed gallbladder, Sclerosing cholangitis, Sphincter of Oddi Dysfunction, Spasms or hypertrophy, Spinal nerve lesions, Strictures, Stump cholelithiasis, Sympathetic imbalance, Thyrotoxicosis, Trauma, vomiting, Weight gain, Weight loss

Patient group which have a higher incidence of PCS, these include: