The following exposes UK surgeons to potential law suites for informed consent fraud. Ethical questions need to be answered.
The changing face of paediatric cholecystectomy
Q: Were these children patients ( parents ) provide with legally required informed consent. Advising the long term risk of health complications known as (Postcholecystectomy Syndrome) being as high as 48% for female patients. Or simply lied to . Simply advised ‘ live normal life’, ‘gallbladder is a non-essential organ’, ‘simply resume eating a normal healthy diet’, ‘no likely problems’.
Q: Were these children patients ( parents ) provided with necessary long term post care support to prevent possible long term Postcholecystectomy Syndrome complication risks
Q: Were these children patients (parents) advised of likely root cause their gallstones in order consider alternative treatments.
Root cause of gallstones including:
High levels of estrogen, insulin, or cholesterol can increase a person’s risk of developing them. Pregnancy or the use of birth control pills can slow down gallbladder activity and increase the risk of gallstones. So candiabetes, pancreatitis, and celiac disease. Other factors influencing gallstone formation are:
- infection
- obesity
- intestinal disorders
- a high-fat, low-fiber diet
- smoking
- rapid weight loss
Q: Were these children patients (parents) provide with alternative treatment options for gallstones alternative to surgery
Recommended Treatments include:
WATCHFUL WAITING: One-third of all patients with gallstones never experience a second attack. For this reason many doctors advise watchfulwaiting after the first episode. Reducing the amount of fat in the diet or following a sensible plan of gradual weight lossmay be the only treatments required for occasional mild attacks. A patient diagnosed with gallstones may be able tomanage more troublesome episodes by:
- applying heat to the affected area
- resting and taking occasional sips of water
- using non-prescription forms of acetaminophen (Tylenol or Anacin-3)
LITHOTRIPSY. Shock wave therapy (lithotripsy) uses high-frequency sound waves to break up the gallstones. Thepatient can then take bile salts to dissolve the fragments. Bile salt tablets are sometimes prescribed without lithotripsy todissolve stones composed of cholesterol by raising the level of bile acids in the gallbladder. This approach requires long-term treatment, since it may take months or years for this method to dissolve a sizeable stone.
CONTACT DISSOLUTION. Contact dissolution can destroy gallstones in a matter of hours. This minimally invasiveprocedure involves using a tube (catheter) inserted into the abdomen to inject medication directly into the gallbladder.
ALTERNATIVE THERAPIES, like non-surgical treatments, may provide temporary relief of gallstone symptoms. Alternative approaches to the symptoms of gallbladder disorders include homeopathy, Chinese traditional herbal medicine, and acupuncture. Dietary changes may also help relieve the symptoms of gallstones. Since gallstones seem to develop moreoften in people who are obese, eating a balanced diet, exercising, and losing weight may help keep gallstones fromforming.
For Collins Dictionary of Medicine: gallstones. (n.d.) Collins Dictionary of Medicine. (2004, 2005). Retrieved January 17 2018 from https://medical-dictionary.thefreedictionary.com/gallstones
Approach Considerations: medical treatments for gallstones, used alone or in combination, include the following
-
Oral bile salt therapy (ursodeoxycholic acid) (particularly for x-ray-negative cholesterol gallstones in patients with normal gallbladder function)
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Extracorporeal shockwave lithotripsy (particularly for noncalcified cholesterol gallstones in patients with normal gallbladder function)
Douglas M Heuman, MD, FACP, FACG, AGAF; Chief Editor: BS Anand, MD more…Gallstones (Cholelithiasis) Treatment & Management
https://emedicine.medscape.com/article/175667-treatment
Q: Were these children patients (parents) defrauded of there health, another case of unnecessary surgery.
In their own words – likely answer is YES for some of these children .
Results:
” Ninety-three children had a cholecystectomy in our centre, performed by two surgeons who subspecialised in this procedure. Seventy-one children (76%) were female and 60 (65%) procedures were laparoscopic. The mean age at surgery was 13 years (range: 1–16 years). All children who underwent surgery were symptomatic (exhibiting or involving medical symptoms) , except three children with hereditary spherocytosis and asymptomatic cholelithiasis, where cholecystectomy was performed at the time of splenectomy.
Sixty-one children (66%) had primary cholelithiasis with no underlying comorbidity. The rest had predisposing risk factors for gallstones such as haemolytic anaemia (hereditary spherocytosis, sickle-cell disease), cystic fibrosis, hyperlipidaemia and prolonged parenteral nutrition.”
| 184 | total Cholecystectomy’s carried out on children by NHS under 16 in 2009 | |
| 93 | 50.54% carried out by two surgeons at this one center. Reasons were: | |
| 3 | gallstones not presenting problems (asymptomatic cholelithiasis), with hereditary risk of spherocytosis | |
| 29 | predisposing risks only ( because cholelithiasis not listed as being diagnosed – NO gallstones / gallbladder problems presented) | |
| 61 | primary cholelithiasis (Gallstones present, but not disclosed as causing problems ? ) | |
3x Children with gallstones not presenting problems (asymptomatic cholelithiasis), with hereditary risk of spherocytosis
Recommended medical treatment for Hereditary Spherocytosis does not include ripping out gallbladders cause in problems. But instead
- NHS guidliens: “In children undergoing splenectomy, the gall bladder should be removed concomitantly if there are symptomatic gallstones. If stones are an incidental finding without symptoms, the value of cholecystectomy remains controversial.
Paula H.B. Bolton-Maggs, Jacob C. Langer, Achille Iolascon, Paul Tittensor, May-Jean King. Guidelines for the Diagnosis and Management of Hereditary Spherocytosis. The British Committee for Standards in Haematology [UK NHS Gloshospitals publication]
Cholelithiasis (gallstones) in Children: Treatment recommendations
Choledocholithiasis – This refers to blockage of the common bile duct where a gallstone has left the gallbladder or has formed in the common bile duct (primary cholelithiasis)
- “Conclusions: Although evaluation of the underlying causes of gallstone formation and appropriate diagnostic/therapeutic implications is still a challenging issue in the management of childhood cholelithiasis, in asymptomatic cases or those with gallstones of certain sizes, it is only recommended to monitor the disease or rule out the underlying causes
Karami H, Kianifar H R, Karami S. Cholelithiasis in Children: A Diagnostic and Therapeutic Approach, J Pediatr Rev. 2017 ;5(1):e9114. doi: 10.17795/jpr-9114.
- “Approach Considerations: Indications for laparoscopic cholecystectomy in cholelithiasis include symptoms of biliary colic or chronic abdominal pain or the presence of cholecystitis. Removal of the gallbladder in asymptomatic children with cholelithiasis is not standard practice, with the exception of those with sickle cell anemia.
Pediatric Gallstones (Cholelithiasis) Treatment & Management . https://emedicine.medscape.com/article/927522-treatment
- CONCLUSIONS: the etiologies of cholelithiasis are hemolytic (20% -30%), other known etiology (40%-50%) such as total parenteral nutrition, ileal disease, congenital biliary diseases, and idiopathic (30-40 %). Spontaneous resolution of gallstones is frequent in infants and hence a period of observation is recommended even for choledocholithiasis. Children with gallstones can present with typical biliary symptoms (50%), nonspecific symptoms (25%), be asymptomatic (20%) or complicated (5% -10%). Cholecystectomy is useful in children with typical biliary symptoms but is not recommended in those with non-specific symptoms. Prophylactic cholecystectomy is recommended in children with hemolytic disorders.
Poddar U. Gallstone disease in children [PUBMED]
Q: Where these patients, legal and human rights breached
ETHICAL – Violations
The concept of consent arises from the ethical principle of patient autonomy and basic human rights. Patient’s has all the freedom to decide what should or should not happen to his/her body and to gather information before undergoing a test/procedure/surgery. No one else has the right to coerce the patient to act in a particular way.
LEGAL – Violations
No one has the right to even touch, let alone treat another person. Any such act, done without permission (as a result of making informed consent), is classified as “battery” – physical assault and is punishable.
The issue: Non disclosure for the following risks post removal of gallbladder and function. False information putting patient safety at risk
The legal position regarding the provision of information needed to make an infromed consent derives from the 1985 case of Sidaway v Board of Governors Bethlem Royal Hospital (Sidaway v Board of Governors Bethlem Royal and the Maudsley Hospital [1985] 2 WLR 480), where the House of Lords held that the legal standard to be used in deciding whether adequate information had been given to a patient would be the same as that in judging whether a doctor had been negligent in their care.
HUMAN RIGHTS – Violations
The International Human Rights law including the Universal Declaration of Human Rights (1948) proclaims the right for all human beings to live in conditions that enable them to enjoy good health and health care. The problems associated with this procedures (carried out mainly to woman/femails ) often have brutal consequences for a woman’s physical and mental health
The Convention on the Elimination of All Forms of Discrimination against Women (1979), the Convention against Torture, and other Cruel, Inhuman or Degrading Treatment or Punishment, prohibits the infliction of physical or mental pain or suffering on women
Article 5: No one shall be subjected to cruel, inhuman or degrading treatment
Article 25: Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family, including food, clothing, housing and medical care and necessary social services, and the right to security in the event of unemployment, sickness, disability, or other lack of livelihood in circumstances beyond his control.
