Investigation 10HDC00253 – No Post Treatment Care for Side Effects

http://www.hdc.org.nz/decisions/search-decisions/2010/10hdc00253/

Sadly, this patient died with many specific Postcholecystectomy Syndrome (PCS) complication symptoms in place. There is no record of diagnosis, or required post-care support needed to treat, or mitigate risks, ever being provided to the patient.

Based on the past HDC’s rulings that have been protecting New Zealand surgeons, it is strongly arguable that there is a continuance of a revenue-based modus operandi in place, and a requirement for surgery, that cannot be backed by any evidence-based medical studies. (See appendices for a link to a $10K-100K reward for providing information to the contrary and other HDC rulings.)

“Removal of the gallbladder is generally considered to have no lasting consequences, although some people experience more frequent and less formed stools or diarrhoea”

“When New Zealand surgeon, who has explained the (see above) general and specific complications of the procedure” 

The HDC incriminates itself for breaching the Code and is responsible as an accessory to subsequent patient deaths, allowing harm to occur when patients are left with no post-care support. Consequently, the HDC’s mandated protection given to New Zealand cholecystectomy surgeons continues and they are obtaining consent illegally through deception, concealment, misrepresentation of the risks, and hiding possible side effects affecting quality of life.

If a more honest investigation occurred, and the HDC protection was not in place, at the very least it could be determined that there is a breach of duty of care, by omission, and the patient’s death constitutes negligence.

Complaints of the patient detail many Postcholecystectomy Syndrome symptoms: [6]

  • Including tiredness, low energy levels, mild lower back pain, aching upper abdomen, shortness of breath, tightness in her lower chest, and a feeling of passing out.
  • Complaining of difficulty breathing, upper abdominal discomfort, weakness in the chest and lack of energy. She advised that Gaviscon gave her some relief for a short time.
  • Complained of extreme right upper quadrant discomfort and constant aching
  • Also diagnosed with gastritis[1] on two occasions
  • Swollen liver (non-alcoholic fatly Liver symptoms but not diagnosed)
  • And sadly diagnosed with liver and colon cancer

2. Take Home Points

  • According to this ruling, the doctors leave patients to develop post-surgery complications without advice or support to mitigate potential problems. As a result they suffer needlessly, providing no diagnosis or treatment provided when (PCS) problems eventuate. This, in fact, is breaching Human Rights and the Code of Health and Disability Services Consumers’ Rights, and should be referred to the Medical Council of New Zealand for review and should be referred to the Director of Proceedings to consider whether any further proceedings should be taken.
  • Based on past HDC rulings and the precedent set in this ruling, the HDC should be held accountable as an accessory to the fact for harm to patients resulting from side effects not treated. 

3. What Happened?

Over a one-year period, a 65 year old cholecystectomy patient, complains of symptoms to a doctor, specifically related to Postcholecystectomy Syndrome complications that affect up to 40% of patients, and as high as 43% for women. The Doctor diagnosed gastritis on two occasions and an iron deficiency anaemia. The patient then seeks a second opinion from another doctor. A swollen liver was identified and the patient was sent for tests, revealing a primary tumour in the caecum (Colon), and secondary cancer in liver. The patient died shortly after.

4. The HDC Investigation Outcome

Dr A treated Ms B’s symptoms of iron deficiency anaemia but did not undertake appropriate investigations to elucidate the cause of the anaemia.

Dr A breached Rights 4(1) [3] and 4(4) [4] of the Code for failing to appropriately investigate and manage Ms B’s iron deficiency anaemia. He also breached Rights 4(1) and 4(4) of the Code for failing to examine Ms B’s abdomen prior to diagnosing gastritis. And he breached Right 4(2) [5] by failing to meet professional standards in terms of his documentation.

The HDC Actions:

  1. Referred to Medical Council of New Zealand to consider whether a review of Dr A’s competence was warranted.
  2. Referred to the Director of Proceedings to consider whether any proceedings should be taken.

5. Breaches of Patient Rights Not Investigated (Unanswered Questions)

Was the doctor used as scapegoat for a much bigger breach of patient rights, affecting thousands of patients all over New Zealand, undergoing a cholecystectomy? And did this expose the HDC’s hypocritical intention to unlawfully block breaches of the Code of Rights ever being identified, in order to protect doctors?

There is refusal to acknowledge the side effect risks to patients during the informed consent process that can result in harm from a heterogeneous group of diseases that can develop following the gallbladder’s removal.

Hypothetically, if a more honest and transparent HDC investigation of patient rights took place, with an investigation into whether there was effective management of identified Postcholecystectomy syndrome complications; the HDC investigation outcome would look something like this :

The Doctor/Surgeon failed to undertake appropriate investigations to elucidate the cause of accepted post-Cholecystectomy complications and symptoms. Instead, simply providing ineffectual treatment that does not resolve the root problems for listed Postcholecystectomy Syndrome symptoms, not exclusive to:

  • Iron deficiency anaemia,
  • Gastritis and other various complaints,
  • Tiredness,
  • Low energy levels,
  • Mild lower back pain,
  • Aching upper abdomen,
  • Shortness of breath. (See appendices for Postcholecystectomy side effect risks)

The patient, under Right 4(1), has the right to have services provided in a manner that minimised the potential harm and optimised her quality of life (Right 4(4)). A failure to appropriately investigate and manage well-recognised Postcholecystectomy health complications breaches patient rights under the Code, in particular her right to have services provided with reasonable care and skill.

  • Cholecystectomy patients are entitled to receive services of an appropriate standard from the DHB’s surgeons and doctors. This includes not only receiving treatment for symptoms, but also having symptoms investigated appropriately to find, and confirm, an underlying cause diagnosis.
  • Patient safety is compromised through failing to get the basic assessments right. There is a failure to carry out an investigation into the underlying cause of symptoms needed to mitigate and treat side effect risks, also known as Postcholecystectomy Syndrome.
The doctor / surgeon failed to disclose the risk of harm from post-surgery side effects of cholecystectomy. In doing so, they breached the following rights:

Right (1) (a) of the Code provides that patients have the right to be treated with respect. Failure to disclose inadvertent harm from side effects involves tacit deception – respect for patient autonomy supports a truthful and sensitive discussion about what can go wrong once the gallbladder and its function is removed,  side-effects disabling a patient health and why

Right 5(2) of the Code every patient has the right to an environment that enables both patient and doctor to communicate openly, honestly, and effectively. Open and honest communication requires surgeons to disclose the truth about harm and injury to the body’s ability to function normally and side effects once the gallbladder function is removed on the part of the doctor;

Right 6(1) of the Code affirms every consumer’s right to the information that a reasonable consumer, in that consumer’s circumstances, would expect to receive. When side-effects occurs, the patient is entitled to open, truthful, and timely information about the post complications, its effect and its significance of quality of life

The HDC actions should include:

  1. Refer the case to the Medical Council of New Zealand to consider whether a review of Dr A’s competence was warranted.
  2. Refer the case to the Director of Proceedings to consider whether any proceedings should be taken.
  3. Undergo training on the management of Postcholecystectomy care support.

And potentially, if an honest HDC was established:

  1. The Medical Council of New Zealand would consider whether the HDC knowingly blocked patients from obtaining informed consent for their cholecystectomy?
  2. The case would be referred to the Director of Proceedings to consider whether any further proceedings should be taken against the HDC for likely harm as an accessory to the fact.

6. References:

  1. S Nogueira, L., Freedman, N. D., Engels, E. A., Warren, J. L., Castro, F., & Koshiol, J. (2014). Gallstones, Cholecystectomy, and Risk of Digestive System Cancers. American Journal of Epidemiology, 179(6), 731–739. http://doi.org/10.1093/aje/kwt322
  2. Zhang Y, Liu H, Li L, Ai M, Gong Z, He Y, et al. (2017) Cholecystectomy can increase the risk of colorectal cancer: A meta-analysis of 10 cohort studies. PLoS ONE 12(8): e0181852. https://doi.org/10.1371/journal.pone.0181852
  3. Wikipedia,  Postcholecystectomy syndrome.  https://en.wikipedia.org/wiki/Postcholecystectomy_syndrome
  4. S.S.JaunooS MohandasL.M.Almond. Postcholecystectomy syndrome (PCS) https://www.sciencedirect.com/science/article/pii/S1743919109001538
  5. Steen W Jensen, MD; Chief Editor: John Geibel, MD, DSc, MSc, AGAF Postcholecystectomy Syndrome https://emedicine.medscape.com/article/192761-overview#showall

7. Appendices:

Evidence of a cover up

More about: Postcholecystectomy Syndrome side effect complications:

The Postcholecystectomy Syndrome (PCS): is a heterogeneous group of diseases and symptoms presenting following gallbladder removal. Symptoms occur in about 5 to 40 percent of patients who undergo cholecystectomy, and can be transient, persistent or lifelong. The chronic condition is diagnosed in approximately 10% of postcholecystectomy cases.

Post-cholecystectomy Syndrome may include: 

  • Diarrhoeaas a troublesome problem range from 9 to 12% of which bile acid malabsorption (BAM) , 65% of these patients. [1]
  • Depression disorders occurring in 0.9%-3.0% of patients[2]
  • Bile (duodenogastric) reflux occurring in 20%-30% of patients[3,4,5].  Likely damage attributable to chronic bile exposure post-cholecystectomy includes:
    • cellular damage to esophagogastric junction
    • bile induced Gastroesophageal Mucosal Injury (Protective barrier that constrains the acidic reflux)
    • increase the incidence of gastric and esophageal cancer
  • Sphincter of Oddi dysfunction (SOD) isseen in 1% of patients after cholecystectomy, but in 14%-23% of patients with the post-cholecystectomy syndrome [6]
  • increased Body Mass Index (weight gain) with metabolic syndrome, gastritis, liposoluble vitamin deficiency.Cholecystectomy can have nutritional and metabolic consequences and in the long-term[7]

Postcholecystectomy Syndrome in more detail

Absence of the gallbladder leads to development of functional biliary hypertension and dilatation of common bile duct and the common hepatic duct. The dilatation of right and left hepatic ducts may be formed within 3-5 years after cholecystectomy. Functional hypertension in the common bile duct leads to development of functional hypertension in Wirsung’s pancreatic duct accompanied by chronic pancreatitis symptoms.

During this period in some patients this is accompanied by chronic pancreatitis progression, dysfunction of the sphincter of Oddi and duodeno-gastral reflux. Duodeno-gastral reflux causes the development of atrophic (bile-acid-depen­dent) antral gastritis . After cholecystectomy 40% to 60% of patients suffer from dyspeptic disorders, 5% to 40% from pains of different localizations. Up to 70% of patients show symptoms of chronic “bland” intrahepatic cholestasis, chronic cholestatic hepatitis and compensatory bile-acid-dependent apoptosis of hepatocytes. In some of cholecystectomized patients with high concentration of hydrophobic hepatotoxic co-cancerogenic deoxycholic bile acid in serum and/or feces high risk of the colon cancer is found.

“Postcholecystectomy Syndrome (PCS) describes the presence of abdominal symptoms after surgical removal of the gallbladder (cholecystectomy). Symptoms of Postcholecystectomy Syndrome may include: Upset stomach, nausea, and vomiting, gas, bloating, and diarrhoea. Persistent pain in the upper right abdomen.  Symptoms occur in about 5 to 40 per cent of patients who undergo cholecystectomy, and can be transient, persistent or lifelong. The chronic condition is diagnosed in approximately 10% of postcholecystectomy cases” [4]

“The incidence of postcholecystectomy syndrome has been reported to be as high as 40% in one study, and the onset of symptoms may range from 2 days to 25 years.  There may also be gender-specific risk factors for developing symptoms after cholecystectomy. In one study, the incidence of recurrent symptoms among female patients was 43%, compared to 28% of male patients.

“Cholecystectomy is associated with several physiological changes in the upper gastrointestinal tract which may account for the persistence of symptoms or the development of new symptoms after gallbladder removal. The cholecyst sphincter of Oddi reflex, cholecyst-antral reflex, and cholecyst-oesophagal reflexes are all disrupted and some local upper gastrointestinal hormonal changes also occur after cholecystectomy. Thus, there is an increased incidence of gastritis, alkaline duodene gastric reflux and gastro-oesophageal reflux after cholecystectomy, all of which may be the basis for postcholecystectomy symptoms.” [5]

http://lifewithnogallbladder.com/faq/postcholecystectomy-syndrome-pcs/

Gaviscon: – Can be used to treat heartburn and indigestion. The medicine forms a protective layer that floats on top of the contents of your stomach. This stops stomach acid (acid reflux) escaping up into your food pipe. Gaviscon also contains an antacid that neutralises excess stomach acid and reduces pain.

Colorectal cancer Postcholecystectomy:  A history of gallstones and cholecystectomy were associated with an elevated risk of subsequent digestive tract cancers, including noncardia gastric cancer and small intestine carcinoid, as well as auxiliary organ cancers, including hepatocellular carcinoma, cholangiocarcinoma, pancreatic cancer, and ampulla of Vater cancer.  Hence, gallstones and cholecystectomy are associated with the risk of cancers occurring throughout the digestive tract. Cancer; cholecystectomy; digestive system; gallstones; gastric cancer; liver; pancreas [2] [3]