by Arnold Seid, MD
After almost two decades of experience with laparoscopic cholecystectomy (LC), the literature continues to report a disappointingly high incidence of bile duct injury (BDI). Despite extensive residency training in the operation and many articles addressing this problem, we surgeons continue to see a BDI rate of about one case for every 200 LCs performed. Each year in the United States, we perform 750,000 LCs that result in more than 3,000 BDIs.
For the unfortunate patients, these injuries cause an enormous amount of pain and disability, occasional lifelong problems and even mortality. For the surgeons, the injuries can lead to the dreaded letter from a plaintiff’s attorney, followed by years of anguish with litigation and potential economic ruin. Needless to say, we should all be expending as much effort as possible to avoid inflicting such an injury on our patients. Toward that end, I have distilled my experience to suggest five simple rules to minimize patient suffering and surgical liability.
Let me start by stating my bona fides to comment on this subject. Since 1990, I have personally performed 1,500 LCs and assisted at 1,000 more. In the early years of the procedure (1991-1995), I organized weekend courses to train surgeons in performing LC, and I have lectured worldwide on the subject.
Most importantly, it is my 15 years of acting as an expert witness in LC malpractice cases that gives me a unique perspective and prompted me to write this article. I have reviewed many cases of LC surgery where litigation was contemplated. Also, I have had my deposition taken and have testified as an expert witness in court. I have discussed such cases extensively with attorneys for both plaintiffs and defendants and have received feedback on jury reaction to my testimony.
All of this experience has led me to formulate five simple rules that, if followed, should dramatically lower the incidence of BDI. And if, despite adherence to these rules, a BDI occurs, then at the very least the surgeon will have a good chance to obtain a defense verdict if litigation results.
Rule 1: Never perform a laparoscopic cholecystectomy without a skilled surgeon as your assistant.
BDI occurs as a result of misidentification of anatomy. The incidence of this error will be reduced significantly if two surgeons are diligently working to avoid it. A BDI is the result of surgeon error, and two surgeons are less likely to confuse what they are seeing than one.
Most operations can be conducted safely without the assistance of a fellow surgeon. I do open appendectomies, bowel obstruction procedures, hernia repairs, colon resections and even laparoscopic appendectomies without an assistant. However, LC is a different breed of cat. I have never done an LC without my associate, and he never does one without me. Four eyeballs on a monitor are better than two. In the 2,500 LCs that we have done together, five BDIs were averted because the assistant saw something that the primary surgeon missed. Anastomotic leaks and wound infections will occur even when meticulous attention is paid to surgical technique. Not so with BDI.
I can hear howls of indignation from surgeons across the country, particularly in smaller communities, who don’t accept Rule 1. They don’t have the luxury of arranging for another busy surgeon to assist them. Furthermore, they have done hundreds of LCs without an assistant and without any problems. True enough. However, 60% of the legal cases that I have reviewed were performed by only one surgeon. These cases are too complicated and the consequences of a BDI are so catastrophic that it is well worth the inconvenience to the surgeon to give the patient the best chance of avoiding the lifelong problems that can be associated with BDI.
Furthermore, LC is almost invariably an elective procedure, and if two surgeons decide to work together, they can rearrange their schedules if they are sufficiently motivated to do so. If the patient is jaundiced or febrile and your assistant is unavailable and you feel that the patient can’t be “cooled down” before the assistant is available, then this is precisely the case that should not be attempted alone. Rather than attempt an LC on an inflamed and edematous gallbladder without help, the surgeon should proceed immediately to open cholecystectomy.
Rule 2: Slow down.
What is the rush? Speed kills. Take your time.
I recently reviewed a malpractice case that was performed on what was described as an intensely inflamed gallbladder with a scrub tech as the assistant, and the operation was completed in 31 minutes. Small wonder that this resulted in a type II BDI. I never do an LC in less than an hour. Regardless of the level of the surgeon’s skill, if he or she tries to perform an LC on a patient with acute cholecystitis in 31 minutes without another surgeon as the assistant, I would predict at least a 10% BDI rate.
Avoid shortcuts. Do not use a Veress needle and blind trocar placement. Spend a few more minutes and use a Hasson cannula and you will avoid bowel and vascular injuries. The incidence of bowel and vascular injuries is twice as high when a blind approach is used rather than an open, careful Hasson technique. Blindly inserting a large-bore needle and then a large trocar into the peritoneal cavity is contrary to the careful technique that we adhere to in all other procedures. The blind approach is unesthetic, negligent and frankly a bit barbaric. Needless to say, there is no prize for the fastest LC in town.
Here is a technique that has served me very well over the years in preventing the dreaded complication of BDI. After the peritoneal cavity has been entered carefully and the cystic duct dissected out, the real operation begins. Before you place your first clip on what you have identified as the cystic duct, pause, take a deep breath and look at the clock. Now, spend 10 more minutes meticulously dissecting out and clearing this structure of all the surrounding connective tissue. Follow the structure toward the gallbladder and demonstrate that it broadens out as it becomes the ampulla of the gallbladder. Follow the structure away from the gallbladder and assure yourself that it is entering the common bile duct. If the structure turns caudad and heads for the duodenum, there may be a major problem. Assure yourself that no tubular structures are entering what you have identified as the cystic duct. If you see a tubular structure that you identify as an accessory duct or a second cystic duct or a second cystic artery, then you and your patient are in deep trouble. Check the clock again. Have 10 minutes gone by? If they have and you are still not 125% convinced that you understand the anatomy, proceed to rule 3.
Rule 3: Knowledge is power.
Opening can be salvation. Do not be afraid to open. It will provide you with more information. And information is what you and your patient need.
It is now time to make decisions that will keep your patient healthy and keep you out of court. You must perform cholangiography and/or convert to an open procedure. If your cholangiogramclearly demonstrates the right and left hepatic ducts, the common hepatic duct, the common bile duct and the cystic duct, then you can safely clip the cystic duct and finish the operation. If there is any doubt, then convert to an open procedure. You will not lose face and your patient will not be upset.
A difficult LC will not be an easy open procedure, but you will now have the advantage of a three-dimensional view of the operating field rather than the two-dimensional perspective on the monitor, and tactile information in addition to the visual information. If you note intense inflammation and/or aberrant anatomy and you still feel unable to safely complete the operation, then put in a cholecystostomy tube and close so that you and your patient will live to fight another day.
After all these maneuvers, you may still end up with a BDI, but down the road you will also probably end up with a defense verdict. You have done everything that you could to avoid the complication, and you have not operated in a negligent fashion.
Leave your ego at the scrub sink. Many surgeons will struggle through bleeding and scar and edematous tissues and unclear anatomy, all to complete an operation laparoscopically. This is hubris; it is dangerous; and it amounts to negligence.
Furthermore, if you are “unhappy” or “uncomfortable” with how the operation proceeded, then you have a BDI until it has been proved otherwise. Put in a drain and keep the patient overnight and order a complete blood cell count (CBC), liver function tests, and amylase and lipase measurements in the morning. If there is any bile drainage or any laboratory abnormalities, then proceed to Rule 5.
Rule 4: Do not repair a bile duct injury.
At the Pottery Barn, they say, “You break it, you buy it.” Not so here. If you break the common duct, it is not your job to fix it. You do not know how. Call in the cavalry.
Unless you are a liver transplant surgeon or have done 25 hepaticojejunostomies, do not try to repair a ductal injury. A general surgeon like you or me has only a 20% chance of an uncomplicated repair! A skilled liver surgeon has a 90% chance. Do the math. Put in a drain and call the nearest and best center with a liver surgeon and skilled interventional radiologists and get your patient there as soon as possible.
Rule 5: Do not ignore postoperative complaints.
Ignoring postoperative complaints is malpractice. A cry for help should be answered. Ignoring a complication does not make it go away.
An uncomplicated LC should be virtually symptom-free in 24 to 48 hours. Therefore, any complaint or any call to the office postoperatively must be completely evaluated. Any delay in the diagnosis and treatment of a complication is considered negligent and opens the surgeon to liability for all subsequent problems that develop. The longer it takes for you to recognize and initiate treatment, the harder it is to repair the injury that you caused.
I have reviewed malpractice cases in which postoperative complaints were ignored and the consequences were disastrous, for both the patient and the surgeon to whom negligence, causation and damages were subsequently attributed in court. In one case, persistent complaints were ignored for 12 days! The patient was finally evaluated and found to have a distended abdomen, fever, elevated bilirubin, elevated white blood cell count and anemia. This is the type of case in which the surgeon’s best defense is to roll over and beg for mercy.
Recently, I did an LC on a 30-year-old, somewhat histrionic, patient. Two days postoperatively, she called to report abdominal pain and shortness of breath. I met her in the emergency room and within three hours had obtained a CBC, liver function tests, amylase and lipase measurements, an HIDA (hepatobiliary iminodiacetic acid) study, right upper quadrant ultrasonography and abdominal computed tomography (CT). The results of all these tests were normal, but she continued to complain of shortness of breath. We proceeded to CT angiography to rule out pulmonary embolism. Fortunately, this result was also normal. She turned out to be fine. But it was not fine with me simply to watch her and possibly miss the opportunity to make an early diagnosis. Her workup may seem to some a bit excessive, but to do anything less would have been below the standard of care. A missed complication is not a matter to trifle with.
These five rules are not foolproof by any means, but if they are followed, the incidence of BDI will drop significantly and a surgeon’s ability to defend himself or herself in court will be dramatically strengthened.
Finally, let me address the common defense of BDI as a “recognized complication.” Some experts have opined that BDI is the result of “visual perception illusion” and the “heuristic nature [unconscious assumptions] of human visual perception.” Basically, a surgeon injures a common bile duct. He then defends himself by arguing that he did not believe that the structure he transected was the common bile duct. And thus, he is not liable. This type of postmodern logic does not convince me and tends not to convince juries.
That rationale sounds like the driver who fails to stop at an intersection and hits and badly injures a pedestrian in the crosswalk. Afterward, he claims that the heuristic nature of his visual perception caused him to misinterpret the octagonal red sign at the side of the road, and thus there was no reason for him to stop. That argument doesn’t hold water in traffic cases, nor should it in LC surgery. Fortunately, I have never transected a common bile duct during an LC. If I did, though, I would not feel that I was blameless and seek to defend myself by saying that it was not my negligence that caused the problem. Rather, the darned visual perception error was the real culprit. When I was trained as a surgeon, we were taught that when a problem occurs, don’t blame the nurses, the lighting, the sutures, the instruments, your assistant or anything else. And certainly don’t blame a visual perception error. Avoid complications, but if you have one, take responsibility.
When patients ask a surgeon to remove their gallbladder and sign a consent form, they acknowledge that complications such as BDI can occur, but they do not agree that the surgeon is absolved of responsibility if the operation is performed in a negligent fashion.
My fellow surgeons, I draw the conclusion that if we fail to perform cholangiography or convert to an open procedure and cause a BDI, then we have not availed ourselves of all the information, and, as such, we have operated in a negligent fashion.