Tuesday, October 18, 2005

Changing the Culture....
A companion piece to the JACS article mentioned yesterday by the Aggravated Doc Surg is this one by the same author:Biliary Injury in Laparoscopic Surgery: Part 2. Changing the Culture of Cholecystectomy. The article goes into the different steps to take to ensure patient and physician safety, such as things to cover during informed consent. But the best part of the article is this:
In many industries there are stopping rules. These rules are applied in the face of dangerous conditions and are intended to stop a process before it continues into a zone of great risk. Good examples exist in aviation. If a flight is diverted to a secondary airport, it may be that the "ceiling" was too low at the primary airport. The process in making this decision is instructive. When the altimeter is at a specific value, the pilot must be able to see the runway clearly. If the runway cannot be seen the landing must be aborted. There is no leeway in this decision, no descending another 20 or 30 feet to take a peek. It is a hard and fast stopping rule for certain types of aircraft. The negative effects of diversion to a secondary airport are considered to be minor compared with the risk of a dangerous landing and its possible disastrous consequences. Note that the principle here is not merely avoidance of a crash. It is avoidance of entry into a danger zone in which the probability of a crash begins to rise to an unacceptable level. In a nuclear reactor, the core temperature is closely monitored and there are inviolate stopping rules that shut down the reactor when certain parameters are exceeded. Again, the principle is to halt before a zone of great danger is entered.

The application of a stopping rule to cholecystectomy for cholelithiasis is not as simple as that for a mechanical device such as an airplane or a nuclear power plant. The human body is much more complex than these mechanical systems; there are no "pop ups" on the video monitor during a laparoscopic cholecystectomy that signal the need to convert to open cholecystectomy. But what is important is the adoption of the mindset of the stopping rule in which safety is the chief consideration that governs decisions when danger is apparent. This is especially appropriate in a benign disease such as cholelithiasis, particularly because there are alternatives to pushing ahead with a difficult dissection.

When operative difficulty is encountered during laparoscopic cholecystectomy, the surgeon should pause to determine whether the operation should be continued laparoscopically. Local operative factors and operative experience of the surgeon are key considerations. Failure of progression of the dissection, anatomic disorientation, difficulty in visualization of the field, and inability of the laparoscopic equipment to carry out usual tasks such as grasping of the gallbladder or separation of tissues, are events that might be used as triggers of the stopping rule mentality in which subsequent actions are governed chiefly by considerations of safety. In most cases these events are indicators for conversion (or consultation). The negative effects of conversion are minor compared with the negative effect of a biliary injury, so like the airplane landing, it is best to back off when the zone of serious danger is entered rather than to determine if the procedure can be completed under dangerous conditions.....
(emphasis mine)
Dr. Strasberg then carries this line of thinking to its' next level. What of the difficult open cholecystectomy?
The stopping rule mentality should not end after an incision has been made and applies equally to the difficult open cholecystectomy, in which the risk of completing an open cholecystectomy must be balanced against the risk of injury. Cholecystostomy is a good alternative in very difficult patients, and it is almost always possible. Partial cholecystectomy is another reasonable alternative in some cases of difficult open cholecystectomy. The worst injuries we have seen have come after conversion in patients with severe inflammation and have involved major vascular injuries and injuries to the bile ducts. Although the airplane analogies are useful, they can be taken only so far. Because of variation in operative experience, what constitutes the zone of serious danger may differ somewhat among surgeons.

In my opinion, the points made in the previous paragraphs cannot be emphasized too strongly and should be ingrained in all trainees, even though today these are in the "ought to be" category that will require a change in culture to achieve. There is an outlet when laparoscopic cholecystectomy is very difficult and potentially hazardous: conversion. There is an outlet when open cholecystectomy is very difficult and potentially hazardous: cholecystostomy. It is not appropriate to proceed laparoscopically when conditions are patently hazardous. For instance, it is inappropriate to attempt to stop bleeding laparoscopically when one cannot see well and there is a possibility that application of clips might also clip and injure bile ducts. In addition, the presence of clips on such a structure after operation, when it has been described that they have been used to arrest hemorrhage (and when other local operative conditions fall into the expected range for this procedure), is likely to convince most experts that the action was practice below the standard of care. The mind set of surgical trainees should be directed to methods that result in completing a large number of cholecystectomies safely, even if that means that fewer cholecystectomies are completed laparoscopically and that more converted laparoscopic procedures are completed by cholecystostomy.

(emphasis mine)
So if you are not a physician, not to mention a surgeon, what's the big deal? Part of it is the need to approach this procedure, as well as all others, with the idea of "safety first". When explaining the procedure and the possibility of conversion to patients I tell them that the goal is to remove the gallbladder in the safest way possible, and that the convenience of a laparoscopic procedure comes in a distant second.
Another concern is the volume of litigation related to this condition. From the first article:
There are no precise current statistics, but based on information received from risk management sources, it seems that biliary injury is by far the most common cause for litigation in gastrointestinal surgery. Claims arising from laparoscopic surgery represent 20% of all general surgery claims, and 50% of laparoscopic claims are for bile duct injury. In terms of indemnity (dollars paid out by insurers), the situation is even more serious because 33% of general surgery indemnity arises from laparoscopic procedures, and half of that is for biliary injury. So, about 15% of all general surgery indemnity is from biliary injuries. The percentage of biliary injuries litigated is very high. There are no current reliable statistics on the incidence of biliary injury. The latest high quality studies relate to operations performed in the last decade. Biliary injury has probably declined,2 but it seems still to be greater than during the period of open cholecystectomy.

And who knows? That could be your common bile duct with a titanium clip across it.
One of the concerns with surgical residents these days is that they often don't get enough exposure to open cholecystectomy. See here and here for more.
Weblog Commenting and Trackback by HaloScan.com

This page is powered by Blogger. Isn't yours?