Professional Documents
Culture Documents
surgeon and what the patient will experience from the the consent procedure may appear as “smoke,” ie, poor
start of preparation for the operation until full recovery. practice suggesting other poor practice to a lawyer inves-
3. The risks of the procedure by type, incidence severity, and tigating a case. If members of a jury believe that the
consequences. standard of care was breached in obtaining consent, they
4. The alternatives to the proposed treatment. are probably more likely to conclude that it was also
The procedure should be explained in plain terms and breached elsewhere. Good documentation is important
from a patient’s perspective. Details such as the degree of because without it, the patient’s claim of not being in-
postoperative pain and how pain will be managed, when formed usually will take precedence over the surgeon’s
oral intake will be stopped and resumed, and when nor- claim that proper information was given, even when the
mal activity and work will be possible are important to same consent is always provided by the surgeon, ie, that
patients. Risk of complications should be described in it is custom and habit to do so.
realistic terms with approximate but accurate data. Rea- Documentation that the risk of complications and spe-
sons for conversion to open cholecystectomy should be cifically biliary injury have been discussed with the patient
discussed and the role of conversion as a safety measure may be recorded in the letter of consultation in the opera-
emphasized. When there is an increased chance of con- tive note or elsewhere. Although this is acceptable, it is my
version, as in patients with acute cholecystitis,1 the in- opinion, given the frequency of litigation arising from lapa-
creased possibility of conversion should be made clear. roscopic cholecystectomy, that a new approach should be
In providing information for consent, the surgeon is the adopted: the use of a checklist. Checklists are common
patient’s teacher and like a good teacher, should confirm safety measures in many industries including aviation. An
example is shown in Figure 1. It is suggested that a checklist
that the patient understands what has been said and
be used as a guide in the consent discussion for patients
knows what to expect. Whenever possible, explanations
being prepared for cholecystectomy and that the checklist
should be given in front of close family members, typi-
then be shown or given to the patient, with an opportunity
cally a spouse, and should be followed by the surgeon
to discuss items on the list. Such an approach will not be
initiating an opportunity to ask questions (“Did you
forgotten by the patient and the list provides proof that the
understand everything and are there any questions that
consent was obtained in an exemplary manner. The check-
you would like to ask?”). Brochures designed to explain
list shown in the table goes into moderate detail. A checklist
the procedure and its risks are very helpful and their use could be as simple as the four key points in consent listed
is encouraged. But they do not replace the need for the previously and bolded in Figure 1, or as detailed as the
surgeon to discuss the procedure with the patient. information provided in some patient information sites.2,3
Patients, some of whom are medically naïve, are often In addition, the American College of Surgeons has recently
provided with many facts by several different individuals sponsored a publication about avoidance of litigation that
(family doctor, surgeon, nurses, and others) at the time contains other useful information about the importance of
they present with symptomatic cholelithiasis. Not sur- interpersonal relationships.4
prisingly, many do not remember they were told preop-
eratively that occasionally, perhaps because of local con- The operation
ditions, such as inflammation and anatomic variation, Identification of the cystic structures
biliary injury unavoidably occurs during cholecystec- The main cause of biliary injury, as noted in the companion
tomy. Unquestionably, litigation may be initiated not article, is misidentification of the common bile duct, the
because there was actual negligence during performance common hepatic duct, or an aberrant duct (usually on the
of a procedure in which biliary injury occurred, but be- right) as the cystic duct. So the goal of dissection in chole-
cause the patient and family were not informed in such a cystectomy is the conclusive identification of the cystic
way that they retained the information that allowed structures. The surgeon has an obligation to use a method
them to know what to expect. whose purpose is to obtain conclusive identification of the
Documentation of the explanations leading to con- cystic duct (and artery), although as indicated in the com-
sent is mandatory. Negligence in obtaining consent is panion article,5 the method may not always succeed. I
usually not the key issue in litigation, but it may be a know of four such methods in current use: cholangiogra-
complicating issue. Failure of clear documentation of phy, the critical view technique, the infundibular tech-
606 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 J Am Coll Surg
Figure 3. (A) ERCP showing aberrant right hepatic duct which has been preserved during a earlier laparoscopic cholecystectomy. The clips
beside the duct show that the cystic duct entered the aberrant duct. The aberrant duct is the duct from segment 5. (B) Reconstruction of the
image to show what a cholangiogram would look like if the aberrant duct had been cannulated. Very few surgeons would recognize that one
segmental duct was missing on the right side and an injury to the aberrant duct would probably follow. (C) Reconstruction of the image to show
what a cholangiogram would look like if the aberrant duct was actually the right main bile duct. Note the much more obvious cholangiographic
abnormality of total absence of right hepatic ducts. Arrow points to left hepatic duct.
of great risk. Good examples exist in aviation. If a flight during a laparoscopic cholecystectomy that signal the
is diverted to a secondary airport, it may be that the need to convert to open cholecystectomy. But what is
“ceiling” was too low at the primary airport. The process important is the adoption of the mindset of the stopping
in making this decision is instructive. When the altime- rule in which safety is the chief consideration that gov-
ter is at a specific value, the pilot must be able to see the erns decisions when danger is apparent. This is especially
runway clearly. If the runway cannot be seen the landing appropriate in a benign disease such as cholelithiasis,
must be aborted. There is no leeway in this decision, no particularly because there are alternatives to pushing
descending another 20 or 30 feet to take a peek. It is a ahead with a difficult dissection.
hard and fast stopping rule for certain types of aircraft. When operative difficulty is encountered during lapa-
The negative effects of diversion to a secondary airport roscopic cholecystectomy, the surgeon should pause to
are considered to be minor compared with the risk of a determine whether the operation should be continued
dangerous landing and its possible disastrous conse- laparoscopically. Local operative factors and operative
quences. Note that the principle here is not merely experience of the surgeon are key considerations. Failure
avoidance of a crash. It is avoidance of entry into a dan- of progression of the dissection, anatomic disorienta-
ger zone in which the probability of a crash begins to rise tion, difficulty in visualization of the field, and inability
to an unacceptable level. In a nuclear reactor, the core of the laparoscopic equipment to carry out usual tasks
temperature is closely monitored and there are inviolate such as grasping of the gallbladder or separation of tis-
stopping rules that shut down the reactor when certain sues, are events that might be used as triggers of the
parameters are exceeded. Again, the principle is to halt stopping rule mentality in which subsequent actions are
before a zone of great danger is entered. governed chiefly by considerations of safety. In most
The application of a stopping rule to cholecystectomy cases these events are indicators for conversion (or con-
for cholelithiasis is not as simple as that for a mechanical sultation). The negative effects of conversion are minor
device such as an airplane or a nuclear power plant. The compared with the negative effect of a biliary injury, so
human body is much more complex than these mechan- like the airplane landing, it is best to back off when the
ical systems; there are no “pop ups” on the video monitor zone of serious danger is entered rather than to deter-
Vol. 201, No. 4, October 2005 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 609
mine if the procedure can be completed under danger- nical injuries is beyond the scope or purpose of this
ous conditions. The stopping rule mentality should not article, and these subjects are very well covered in stan-
end after an incision has been made and applies equally dard texts of laparoscopic surgery.
to the difficult open cholecystectomy, in which the risk
of completing an open cholecystectomy must be bal- Intraoperative consultation
anced against the risk of injury. Cholecystostomy is a The value of intraoperative consultation with a surgical
good alternative in very difficult patients, and it is al- colleague cannot be overestimated, but that consultation
most always possible. Partial cholecystectomy is another should occur early in the period of difficulty. I have never
reasonable alternative in some cases of difficult open read an operative note, either as a surgeon who has re-
cholecystectomy.14 The worst injuries we have seen have paired biliary injuries or as an expert witness, in which a
come after conversion in patients with severe inflamma- surgical colleague was called into the operating room to
tion and have involved major vascular injuries and inju- assist in the surgery and in the decision-making before
ries to the bile ducts. Although the airplane analogies are the occurrence of an injury. It seems that the chance of
useful, they can be taken only so far. Because of variation injury is much lower when this is done, or perhaps if an
in operative experience, what constitutes the zone of injury occurs in the presence of two trained surgeons,
serious danger may differ somewhat among surgeons. the chance of litigation is reduced. A surgical colleague
In my opinion, the points made in the previous para- in the operating room may be the best stopping process.
graphs cannot be emphasized too strongly and should be
ingrained in all trainees, even though today these are in Conduct when an intraoperative injury is detected
the “ought to be” category that will require a change in If an injury is diagnosed intraoperatively, it should be
culture to achieve. There is an outlet when laparoscopic repaired at the time if the skills required for repair are
cholecystectomy is very difficult and potentially hazard- within the expertise of the surgeon or an available col-
ous: conversion. There is an outlet when open cholecys- league. Cystic duct leaks, leaks from the gallbladder bed,
tectomy is very difficult and potentially hazardous: cho- and partial lacerations to the bile duct are within the skill
lecystostomy. It is not appropriate to proceed set of most surgeons. Complete transections of major
laparoscopically when conditions are patently hazard- bile ducts or aberrant ducts usually require hepaticoje-
ous. For instance, it is inappropriate to attempt to stop junostomy. Several publications now attest to the value
bleeding laparoscopically when one cannot see well and of referral of these complex injuries to a dedicated hepa-
there is a possibility that application of clips might also tobiliary service.15-17 Most tertiary care facilities that
clip and injure bile ducts. In addition, the presence of house hepatobiliary services have doctor access lines or
clips on such a structure after operation, when it has “hotlines” that are readily reached through the main tele-
been described that they have been used to arrest hem-
phone number of the hospital. Using this form of access,
orrhage (and when other local operative conditions fall
expertise can be obtained within minutes from within
into the expected range for this procedure), is likely to
the operating room (often operating room to operating
convince most experts that the action was practice below
room).
the standard of care. The mind set of surgical trainees
should be directed to methods that result in completing Laparotomy should not be performed for diagnosis or
a large number of cholecystectomies safely, even if that drainage only. Injury can be extended by dissection,
means that fewer cholecystectomies are completed lapa- which is performed solely for diagnosis, drains can be
roscopically and that more converted laparoscopic pro- inserted laparoscopically, and the laparotomy may make
cedures are completed by cholecystostomy. subsequent repair more difficult. Above all, surgeons
Misidentification is not the only cause of biliary in- should have a plan of what to do in case of suspected or
jury. Technical causes such as cautery burns to ducts, actual biliary injury, rather than try to formulate one at
slippage of clips that have been applied to ducts, entry a time of increased stress. Poor outcomes after a repair in
into a bile duct in the gallbladder bed, and tenting of the the primary institution is “smoke.” Even if the injury
common bile duct while applying clips, can result in was not negligent and the repair was performed within
biliary injury. Injury might also complicate bile duct the standard of care, the probability of an extensive
exploration. A complete discussion of avoidance of tech- search of the evidence is high.
610 Strasberg Biliary Injury in Laparoscopic Surgery, Part 2 J Am Coll Surg
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