Investigation 03HDC18935 – Used for Training Experience?

https://www.hdc.org.nz/decisions/search-decisions/2004/03hdc18935/

There is no evidence reviewed in this investigation to confirm that the assistant surgeon was not in fact, the main surgeon conducting the surgery, resulting in conversion to open cholecystectomy. And if so, was assistant in question inexperienced at the time of the surgery. The HDC did not investigate this imperative question, yet the requirement for all risk disclosure is strongly expressed in the investigation.

1. Take Home Points

• Patients have a right to give informed consent for trainee participation in surgery.
• Arguably, fraud is exposed for every laparoscopic cholecystectomy carried out by a registrar surgeon in training, or an inexperienced surgeon with less than 75 procedures, in cases where the patient has not been advised of the likely increased of surgery complication risks.
• The likelihood of being advised during the informed consent process in New Zealand is slim to none.

Right to make an informed consent (Not by fraudulent deception)  Right 6(2) Right to be informed as to who would be performing the surgery. This is information that a reasonable consumer, in these particular circumstances, would expect to be given. Right 7(1) Right to make an informed choice and give informed consent, Every consumer has the right to make an informed choice and give informed consent. Services may be provided to a consumer only if that consumer makes an informed choice and gives informed consent. Without this information, patients are denied that opportunity to legally give informed consent. Reference HDC Investigation # 09hdc01565

2. What Happened?

The patient underwent an open cholecystectomy at Tauranga Hospital, performed by a ‘surgeon’s assistant registrar’. The patient developed a persistent post-operative wound infection. After suffering complications for over a year, the patient underwent an operation to resolve the issue, without any mention of the wound complications inflicted in the first instance ever being life-threating. 

3. The HDC Investigation Outcome

The Commissioner found the operation was performed in accordance with professional standards. However the surgeon did not adequately manage the post-operative wound infection, and breached Right 4(1) of the Code of Patients’ Rights.

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

Question 1: Was Informed consent for laparoscopic cholecystectomy obtained illegally by deception and concealment?

Doctors have a statutory obligation to abide by the Code of Health and Disability Services Consumers’ Rights (the Code). Under the Code every patient has the right to make an informed choice on who is operating on them (unless stated on the consent document) and to give informed consent.

(See links to consent documentation)

Question 2: Was there a failure to provide the information necessary for the patient to make an informed decision about the surgery’s procedure risks?

In the absence of any record, documenting evidence presented to the investigation, it would appear consent was not obtained. Instead, this was a medical procedure carried out in a manner for training purposes, without valid informed consent. As such, this is a criminal offence under the Crimes Act 1961.

Note: We are very happy to receive information to the contrary that informed confirmed consent was given.  

The surgeon, for whom this complaint was made, had a legal obligation to inform the patient. The surgeon who operated on the patient was a registrar in training, and not simply assisting, but actually carrying out the keyhole laparoscopic surgery. This compounded the risk of a bile duct injury. By failing to inform the patient, there is a breach of Right 6(1) of the Code. The right to be fully informed and ‘notification of any proposed participation in teaching (surgeon in training) or research, including whether the research requires and has received ethical approval’.

In both the 1990 and 1995 statements, the Medical Council has said:

• “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.”
• Common law says that any invasive medical procedure performed without consent constitutes a trespass. Failure by a doctor to disclose the risks associated with a proposed treatment and possible alternative treatments options may expose the doctor to negligence if something goes wrong.

Canterbury v Spence13, a decision of the US Court of Appeals, District of Columbia. The following key points can be extracted from the judgement:

1. To determine what should be done with his or her body (And by whom), a patient is entitled to make an informed choice, which entails knowing the options and risks (increased if laparoscopic cholecystectomy carried out by surgeon in training) attendant upon the proposed treatment.
2. The scope of the doctor’s duty to communicate with the patient is measured by the patient’s need for information that is material in enabling the patient to make a decision about consenting to proposed treatment.
3. A risk is material when a reasonable person, in what the physician knows or should know to be the patient’s position, would be likely to attach significance to the risk in deciding whether or not to forego the proposed therapy.

Medical notes:

The ‘learning curve’ and bile duct injury:

“The laparoscopic “learning curve” of the surgeon is a key-factor contributing to the high rates of bile duct injury. However, in comparison with air plane pilots, this surgical concept of learning curve is by some aspects ethically unacceptable.” [1]

“The southern Surgeons Club series reported bile duct injury rate in the first 13 patients operated on was 2.2%, compared to 0.1% subsequent patients. Later, the same group reported 90% of BDI in a series of 8,8829 LC occurred before 30 cases of experience” [2]

“In the Connecticut state audit reported by Orlando et al, 53% of the reported BDI occurred during the surgeon’s first ten cases, 33% between case 11-50 and only two cases (13%) after 50.” [3]

For laparoscopic cholecystectomy, the learning curve ranges from 10 to 75 procedures [4]

More about Bile Duct Injury: 

 “The incidence of Bile Duct Injury (BDI) during laparoscopic cholecystectomy has decreased but remains as high as 1.4%” “Despite the excellent functional outcome after repair, the occurrence of a BDI has a great impact on the patient’s physical and mental quality of life, even at long-term follow-up”  [5]

In this case, there was a failure to advise the patient of side effects likely to affect their quality of life:

• There is no evidence that the risks of the side effects likely to affect the quality of life of the patient were discussed in regards to the surgery.
• This is confirmed by informed consent documentation obtained from the BOP DHB over the last 9 years. At no time, are the true side effect risks ever disclosed to their patients, a requirement needed in order to obtain legal consent.

 (See link: False and illegal informed consent documentation – BOP DHB)

Right 6(1) (b) 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).

5. References

1. A – Gigot, J.-Fr. Bile Duct Injury during Laparoscopic Cholecystectomy: Risk Factors, Mechanisms, Type, Severity and Immediate Detection. https://doi.org/10.1080/00015458.2003.11679400
2. B – Nuzzo G, Giuliante F, Giovannini I, Ardito F, D’Acapito F, Vellone M, Murazio M, Capelli G. Bile Duct Injury During Laparoscopic CholecystectomyResults of an Italian National Survey on 56 591 Cholecystectomies. Arch Surg. 2005;140(10):986–992. doi:10.1001/archsurg.140.10.986 https://jamanetwork.com/journals/jamasurgery/fullarticle/509003
3. C – G.E.I.ShallalyA.Cuschieri(Prof). Nature, aetiology and outcome of bile duct injuries after laparoscopic cholecystectomy https://doi.org/10.1016/S1365-182X(17)30693-7
4. Firilas AM, Jackson RJ, Smith SD. Minimally invasive surgery: the pediatric surgery experience. J Am Coll Surg 1998;186:542–4. DOI: https://doi.org/10.1016/S1072-7515(98)00087-8
5. Boerma, D., Rauws, E. A. J., Keulemans, Y. C. A., Bergman, J. J. G. H. M., Obertop, H., Huibregtse, K., & Gouma, D. J. (2001). Impaired Quality of Life 5 Years After Bile Duct Injury During Laparoscopic Cholecystectomy: A Prospective Analysis. Annals of Surgery, 234(6), 750–757. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1422134/