Top ten lie presented to patients in order to obtain consent: “A gallbladder containing gallstones by medical definition is diseased”, “the only safe treatment is to remove the gallbladder”

“Doctors should ensure that patients are involved within the limits of their capacities, in understanding the nature of their problems, the range of possible solutions, as well as the likely benefits, risks, and costs, and shall assist them in making informed choices”

“If it can be shown that a doctor has failed to provide adequate information and thereby failed to ensure that the patient comprehends, so far as is possible, the factors required to make decisions about medical procedures, such failure could be considered medical misconduct and could be the subject of disciplinary proceedings.”

Every patient have the right to the information that a reasonable consumer in his circumstances would expect to receive, including an explanation of :

  1. Alternative treatment options available, and
  2. An assessment of the expected risks, and
  3. Side effects (affecting quality of life),

Benefits and costs of each option: Failing to disclose risks during the informed consent process breached the Code of Health and Disability Services Consumers’ Rights (Right 6(1) (b) of the Code

Note: A District Health Boards advised the following, ‘It is very common that patients wait longer than 6 months if further diagnostic action, treatment or assessment by other specialties is required.’ 

As such, NZ Surgeons who doing nothing and offering no alternative non-surgical treatment options during this period could be considered as guaranteeing a further client for surgery and is a failure to provide a duty of care to the patient. This is a breach of Right 4(4), ‘Every consumer has the right to have services provided in a manner that minimises the potential harm to, and optimises the quality of life of the consumer.’ Alternative treatment options could have included diet changes and bile salt dissolution.

More about non-surgical treatment options:

Cholesterol gallstone disease is a common clinical condition influenced by genetic factors, increasing age, female gender, and metabolic factors. Although laparoscopic cholecystectomy is currently considered the gold standard in treating patients with symptomatic gallstones, new perspectives regarding medical therapy of cholelithiasis are currently under discussion, also taking into account the pathogenesis of gallstones, the natural history of the disease and the analysis of the overall costs of therapy. A careful selection of patients may lead to successful non-surgical therapy in symptomatic subjects with a functioning gallbladder harboring small radiolucent stones. The classical oral litholysis by ursodeoxycholic acid has been recently paralleled by new experimental observations, suggesting that cholesterol-lowering agents which inhibit cholesterol synthesis (statins) or intestinal cholesterol absorption (ezetimibe), or drugs acting on specific nuclear receptors involved in cholesterol and bile acid homeostasis, might be proposed as additional approaches for treating cholesterol gallstones. In this review we discuss old, recent and future perspectives on medical treatment of cholesterol cholelithiasis.

Therapy of gallstone disease: What it was, what it is, what it will be. Portincasa P1, Ciaula AD, Bonfrate L, Wang DQ.

Submission 1 : Consent froms

Queensland Government health Services: Cholecystectomy -Laparoscopic informed consent document  

“Alternative treatments: Oral Dissolution Therapy. Oral dissolution therapy is the taking of chemicals by mouth to dissolve the gallstones. It is most effective for patients, who are not overweight, in a younger age group, have small or single gallstones and a gall bladder that is working well.

Cholecystectomy Laparoscopic consent form:

Submission 2: Ursodeoxycholic acid

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

More about Ursodeoxycholic acid:

250 to 300, 500 to 600, or 900 to 1000 mg/d, was given orally for 6 to 38 months to 53 patients with cholesterol gallstones and functioning gallbladders. Forty-two patients (79%) had greater than 50% reduction in gallstone volume, number, or both, without apparent dose dependence and 27 (50%) of these patients had complete gallstone dissolution. Results of laboratory studies including liver function tests were not affected adversely and biliary lithocholic acid concentration did not increase during therapy. Most biliary symptoms seemed to disappear within 3 months and no patient developed diarrhea.

Thus, ursodeoxycholic acid appears to be a safe and effective alternative to surgery in selected patients with gallstones.

Tint GS, Salen G, Colalillo A, Graber D, Verga D, Speck J, Shefer S. Ursodeoxycholic acid: a safe and effective agent for dissolving cholesterol gallstones.

Submission 3: Percutaneous cholecystostomy:

(PC), a technique that consists of percutaneous catheter placement in the gallbladder lumen under imaging guidance, has become an alternative to surgical cholecystostomy in recent years. Indications of PC include calculous or acalculous cholecystitis, cholangitis, biliary obstruction and opacification of biliary ducts. It also provides a potential route for stone dissolution therapy and stone extraction. Response rates to PC in the literature are between the range of 56-100% as the variation of different patient population. (First performed by an American surgeon, Dr. John Stough Bobbs, in 1867)

Akhan O1, Akinci D, Ozmen MN. Percutaneous cholecystostomy.

Submission 4: Contact dissolution of cholesterol gallstones with organic solvents

The availability of safe, effective cholesterol solvents and solvent transfer devices means that cholesterol gallbladder stones can be eliminated rapidly and safely by CDOS, without the risk of general anesthesia or surgical dissection of the gallbladder bed. Patients with single gallstones are better candidates for CDOS than are patients with multiple gallstones because recurrence after dissolution is less common. Contact dissolution may well be judged the treatment of choice by the medical-surgical gallstone management team in some patients.

Hofmann AF1, Schteingart CD, vanSonnenberg E, Esch O, Zakko SF. Contact dissolution of cholesterol gallstones with organic solvents.

Submission 5: Extracorporeal shock-wave lithotripsy:

Extracorporeal shock-wave lithotripsy (ESWL) is an infrequently used method for treating gallstones, particularly those lodged in bile ducts. ESWL generators produce shock waves outside of the body that are then focused on the gallstone. The shock waves shatter the gallstone, and the resulting pieces of the gallstone either drain into the intestine on their own or are extracted endoscopically. Shock waves also can be used to break up gallstones via special catheters passed through an endoscope at the time of ERCP.

Jay W. Marks, MD. Gallstones.

Submission 5: Bile acid dissolution therapy:

Medical therapy with oral bile acids is appropriate for patients who present with small cholesterol stones and for patients with larger cholesterol gallstones who cannot or will not have surgery. Oral bile acids may also be valuable in the treatment of gallstone recurrence before it has become symptomatic or to prevent recurrence after prior success Am J Surg. 1989 Sep; 158(3): 198-204.

Hofmann AF. Medical dissolution of gallstones by oral bile acid therapy.  The American Journal of Surgery.

Submission 6: Watchful waiting help treat gallstones: 

Though a gallstone episode can be extremely painful or frightening, almost a third to half of all people who experience an attack never have a recurrence. In some cases, the stone dissolves or becomes dislodged. Because the problem may solve itself without intervention, many doctors take a wait-and-see approach following the initial episode.

Further Suggested reading: