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
The evolving trends of epidemiology and management of paediatric cholecystitis over the past 12 years were analysed. The aim was to forecast future practice and develop strategies to deal with the increasing incidence of primary cholelithiasis presenting to paediatric surgeons
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.
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:
- intestinal disorders
- a high-fat, low-fiber diet
- 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)
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
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 .
” 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  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.
Patient Informed Consent requires the following Post Cholecystectomy risks disclosure by NHS Doctors
Not disclosed to Patients, specialist medical opinion and studies list the following expected risks, side effects, diseases, syndromes and conditions after the removal of the gallbladder and its function (Cholecystectomy). The majority of these problems are not accepted or present by NHS doctors and blocked from disclosure to patients during the informed consent process, or advised during post-operative follow-ups.
They are but not exclusive to:
|Biliary track||Biliary injury
Clip migration / Inaccurate clip placement
Nonspecific dilatation or hypertension
Dilation without obstruction
Hypertension or nonspecific dilation
Malignancy and cholangiocarcinoma
|Colon||Adhesions; incisional hernia; irritable bowel diseaseConstipationDiarrhoea
|Duodenum||AdhesionsDuodenal diverticulaIrritable bowel disease
Peptic ulcer disease
|Gallbladder and cystic Duct remnant||InflammationLeakMirizzi’s syndrome
Neuroma (Amputation ), suture granuloma
Residual or reformed gallbladder
|Liver||Chronic idiopathic jaundiceCirrhosisCyst
Fatty liver; hepatitis; cirrhosis; idiopathic jaundice
|Nerve||Intercostal lesionsIntercostal neuralgiaNeuroma
Psychic tension or anxiety
Spinal nerve lesions
|Pancreas||Benign tumorsFunctional pancreatic sphincter disorderPancreatic cysts
|Periampullary||PapillomaSphincter of Oddi dysfunction (Functional biliary sphincter disorder); spasm; hypertrophyspasm; hypertrophySphincter of Oddi stricture
|Small bowel||AdhesionsAdhesions; incisional hernia; irritable bowel diseaseIncisional hernia
Irritable bowel disease
|Stomach||Bile gastritisPeptic ulcer disease|
|Vascular||Coronary anginaInjury to hepatic artery, portal vein (pseudoaneurysm, portal vein thrombosis)Intestinal angina
|Miscellaneous||Dropped GallstonesParasitic infestation (Ascariasis)Thermal injury
Trocar site hernia
|Other||AnxietyBacteria overgrowth in the stomachBarrett’s oesophagusBezoars
Bile Acid Malabsorption
Decrease in bile secretion
Dumping of bile Syndrome
Foreign bodies, including gallstones and surgical clips
Irritable Bowel Syndrome
Pain – right upper abdomen
Pain – shoulders and abdomen
Evidence based medical studies confirming statistically significant increased risk of cancer following cholecystectomy, required by law but never disclosed by doctors during the informed consent process listed as:
Ampulla of Vater cancer
Colorectal cancer (Colon / Bowl)
Hepatocellular carcinoma cancer
Smallintestine carcinoid cancer
“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 percent of patients who undergo cholecystectomy, and can be transient, persistent or lifelong”
“Biliary Diseases Laparoscopic Cholecystectomy. Postcholecystectomy Syndrome Dr. Jacob L. Turumin (Iakov L. Tyuryumin), MD, PhD, DMSci”
“The absence of the gallbladder leads to functional biliary hypertension and increased hepatic and common bile duct . 3-5 years after cholecystectomy increases right and left hepatic ducts equity.
Functional hypertension in the common bile duct contributes to the appearance of functional and hypertension in Wirsung’s pancreatic duct with the development of the phenomena of chronic pancreatitis . At the same time period in some patients this is accompanied by the progression of chronic pancreatitis, sphincter of Oddi dysfunction and duodenogastric (Biliary / bile ) reflux.
Duodenogastric reflux of mixture of bile with pancreatic juice promotes atrophic gastritis in the antral part of stomach.
From 40% to 60% of patients after cholecystectomy dyspeptic suffering from various disorders, from 20% to 40% of pains of different localization .
Up to 70% of patients after cholecystectomy have chronic effects of “bland” cholestasis, chronic cholestatic hepatitis and chronic compensatory bile acid-dependent apoptosis of hepatocytes.
Patients undergoing cholecystectomy had an increased prevalence of metabolic risk factors for cardiovascular disease, including type 2 diabetes mellitus, high blood pressure, and high cholesterol levels.
Part of patients after cholecystectomy with increased concentration of hydrophobic hepatotoxic co-carcinogenic deoxicholic bile acid in serum and/or feces with increased risk of colon cancer”
Postcholecystectomy syndrome (PCS), S. Mohandas, L.M. Almond, Department of General Surgery, Worcestershire Royal Hospital, Worcester, UK
“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.”
The postcholecystectomy syndrome: A review, Khalid R Murshid, Department of Surgery, King Khalid University Hospital, Riyadh, Saudi Arabia
Instance of Post Cholecystectomy Syndrome sustainably increased when patients followed for 5-9 years vs. only two years’ follow-up
Cholecystectomy and Clinical Presentations of Gastroparesis, the NIDDK Gastroparesis Clinical Research Consortium (GpCRC)*
Patients with cholecystectomy had more comorbidities, particularly chronic fatigue syndrome, fibromyalgia, depression, and anxiety. Postcholecystectomy gastroparesis patients had increased health care utilization and had a worse quality of life.
Jacob L. Turumin, Victor A. Shanturov, Helena E. Turumina Irkutsk Institute of Surgery, Irkutsk Regional Hospital, Irkutsk 664079, Russia
The basic role of the gallbladder in a human is a protective. The gallbladder decreases the formation of the secondary hydrophobic toxic bile acids (deoxycholic and lithocholic acids) by accumulating the primary bile acids (cholic and chenodeoxycholate acids) in the gallbladder, thus reducing their concentration in gallbladder-independent enterohepatic circulation and protecting the liver, the mucosa of the stomach, the gallbladder, and the colon from their effect
- Wikipedia, Postcholecystectomy syndrome. https://en.wikipedia.org/wiki/Postcholecystectomy_syndrome
- Steen W Jensen, MD; Chief Editor: John Geibel, MD, DSc, MSc, AGAF Postcholecystectomy Syndrome [medscape.com]
- S.S.JaunooS MohandasL.M.Almond. Postcholecystectomy syndrome (PCS) [ScienceDirect]
- Sureka B, Mukund A. Review of imaging in post-laparoscopy cholecystectomy complications. Indian J Radiol Imaging 2017;27:470-81 [Indian Journal of Radiology and Imaging]
- Murshid KR. The postcholecystectomy syndrome: A review. Saudi J Gastroenterol [serial online] 1996 [cited 2018 Jan 15];2:124-37. Available from: http://www.saudijgastro.com/text.asp?1996/2/3/124/34017
- Girometti, R., Brondani, G., Cereser, L., Como, G., Del Pin, M., Bazzocchi, M., & Zuiani, C. (2010). Post-cholecystectomy syndrome: spectrum of biliary findings at magnetic resonance cholangiopancreatography. [The British Journal of Radiology, 83(988), 351–361]
- Jacob L. Turumin, Victor A. Shanturov, Helena E. Turumina. Irkutsk Institute of Surgery, Irkutsk Regional Hospital, Irkutsk 664079. The role of the gallbladder in human [ScienceDirect]
- Dr. Jacob L. Turumin, MD, PhD, DMSci Biliary Diseases Laparoscopic Cholecystectomy. Postcholecystectomy Syndrome. http://www.drturumin.com/en/index.html#sthash.Y35Uey8C.dpuf
- Martin, Walton. “RECENT CONTROVERSIAL QUESTIONS IN GALL-BLADDER SURGERY.” Annals of Surgery 79.3 (1924): 424–443. Print. [PMC]
- Donato F. Altomare*, Maria T. Rotelli, Nicola Palasciano. Diet After Cholecystectomy . Current Medicinal Chemistry Volume 24 , 201 http://www.eurekaselect.com/node/152535/article
- The NIDDK Gastroparesis Clinical Research Consortium (GpCRC). “Cholecystectomy and Clinical Presentations of Gastroparesis.” Digestive diseases and sciences 58.4 (2013): 1062–1073. [PMC]
- Yong Zhang , Hao Liu , Li Li , Min Ai , Zheng Gong, Yong He, Yunlong Dong, Shuanglan Xu, Jun Wang , Bo Jin, Jianping Liu, Zhaowei Teng Cholecystectomy can increase the risk of colorectal cancer: A meta-analysis of 10 cohort studies Published: August 3, 2017 https://doi.org/10.1371/journal.pone.0181852
- Mearin, F., De Ribot, X., Balboa, A. Duodenogastric bile reflux and gastrointestinal motility in pathogenesis of functional dyspepsia. Role of cholecystectomy. Digest Dis Sci (1995) 40: 1703. https://doi.org/10.1007/BF02212691
- Simona Manea, Georgeta & Carol, Stanciu. (2008). DUODENOGASTROESOPHAGEAL REFLUX AFTER CHOLECYSTECTOMY. Jurnalul de Chirurgie. 4 [Researchgate]