Author: Admin

Laparoscopic Cholecystectomy Cases: Maximizing Your Client’s Recovery

Introduction

If you’re hoping for a comprehensive “how-to” book on handling botched gallbladder surgery cases from the initial consultation through the large deposit into your trust account, you’ll be greatly disappointed in what you’re about to read. Many others have undertaken that task, and I will share some of their work so you can check it out if you like. This presentation will focus on some of the practical challenges in handling botched gallbladder surgery[1] cases to help you prioritize your responsibilities and (hopefully) make the most out of your client’s case.

This paper begins with the overused “Top Ten Tips” for handling botched gallbladder surgery cases, followed by specific examples to illustrate how these tips play out in the real world. It concludes with a detailed list of resources that will significantly enhance your understanding of botched gallbladder surgery cases and will provide you with valuable information to assist your clients, with appropriate credit to the authors who truly deserve it.

Top Ten Tips:

  • Know the anatomy
  • Know the indications for surgery
  • Know the risks of surgery
  • Know the instruments used during surgery
  • Know the indications for intraoperative cholangiogram
  • Know the proper surgical technique
  • Know the complications
  • Know the repair techniques
  • Know the likely defenses
  • Know your damages

Know The Anatomy

The SAGES Manual and ACS Surgery (see below) have many helpful illustrations describing the critical anatomy in lap chole cases. Take the necessary time to familiarize yourself with the critical anatomy. In fact, ATLA member Mike Abourezk of Rapid City, South Dakota became frustrated with the lack of anatomical charts showing the process and sequence of lap chole surgery, so he taught himself to use a dry erase board during his opening to accurately draw the anatomy, clip and cut the cystic duct, remove the gallbladder, and perform the Roux-en-Y repair.

Know The Indications For Surgery

Some surgeons use nonspecific complaints of abdominal pain to justify the need for lap chole surgery. According to the American College of Surgeons, the Average Patient who undergoes lap chole surgery is middle-aged, muscular or obese, has recurrent biliary colic, a normal gallbladder wall, and previous pelvic surgery. “Difficult patients” include those who are elderly, morbidly obese, suffer from acute cholecystitis, have a thick or contracted gallbladder wall, and have had previous upper abdominal surgery with potential adhesions. The most important contraindication is “surgical inexperience.”[2] When you obtain your client’s medical records, be sure to determine their preoperative health and review the surgeon’s pre-op notes to nail down the indications for performing surgery.

Know The Risks Of Surgery

The known risks of lap chole surgery include excessive bleeding, infection, injury to surrounding organs, injury to the common bile duct, blood clots, injury to the lower digestive tract, and death. These risks are frequently covered in patient education materials given to the patient when surgery is discussed. Always review these materials in detail with the Defendant to establish the Defendant’s recollection of what was said/how the pamphlet was used, and what reasonable expectations the patient had going into the surgery. It is also important to understand the basis for these risks to deal with the potential defenses discussed below.

Know The Instruments Used During Surgery

The SAGES Manual, ACS Surgery, and many surgical texts describe the operating room layout and equipment needed to successfully perform a lap chole surgery. The equipment includes the following: an optical system, an electronic insufflator, trocars (cannulas), surgical instruments, and hemostatic devices.

The optical system includes a laparoscope, a high-intensity light source, a miniature video camera and camera box, and a high-resolution video monitor. The insufflator creates a working space within the abdomen by inserting carbon dioxide under positive pressure. The trocars are simply ports used to see the operative field inside the patient’s abdomen and to provide access for light and visual images and the surgical instruments. A minimal set of instruments for a lap chole surgery includes graspers, dissectors, clip applicators, scissors, a dissecting electrocautery hook, probes, reducers, endoloops, a Veress needle, needle holders, and a cholangiography catheter system. Hemostasis is typically achieved with electrocautery or the laser.

Know The Indications For Intraoperative Cholangiogram

If the patient is morbidly obese, has a significant prior history of disease or surgery in their abdomen, or if the surgical field is difficult to see due to the patient’s anatomy or internal bleeding, the surgeon can always attempt an intraoperative cholangiogram (IOC) to verify the precise location of the common bile duct before clipping and cutting the cystic duct. Many surgeons, particularly those practicing in a university setting, suggest that IOC be used in every lap chole case. Unfortunately, the national consensus conference called by the National Institutes of Health in 1992 concluded that routine IOC was not a necessary requirement for lap chole procedures, and it is not considered to be part of the standard of care for routine lap chole surgeries. Instead, it is often used as a condition of continued privileging for those surgeons who cause repeated injuries to the common bile duct during gallbladder surgery.

Know The Proper Surgical Technique

[Note: see SAGES Manual, pp. 130-32,”Trocar Position and Choice of Laparoscope” for a discussion of recommended trocar positions and recommendation for a 30-degree laparoscope vs. 0-degree laparoscope.]
Using two atraumatic graspers, gently elevate the liver by passing the graspers under the visible liver edge.
If the gallbladder is not visible, carefully dissect adhesions to the underside of the liver and gallbladder using as little cautery as possible.
If the gallbladder is inflamed and tense, it must be decompressed before attempting to grasp it. This is done using a Veress needle to stab and suction the gallbladder.
When the fundus[3] of the gallbladder is exposed, the first assistant grasps the fundus with an atraumatic locking grasper and pushes the gallbladder over the liver toward the right shoulder to open the subhepatic space and expose the infundibulum.[4]
The surgeon or assistant places a second atraumatic grasper on the base of the gallbladder. KEY: “The direction of traction is critical to prevent errors in identification of the ductal structures in this area.” The infundibular grasper must be retracted laterally while the fundus is retracted toward the right axilla to expose Calot’s triangle.[5] If the infundibulum is retracted anteriorly or upward it creates a “tenting” effect that tends to collapse Calot’s triangle and increase the risk of ductal injury.
Begin dissection “directly adjacent to the gallbladder.” Any adhesions should be sharply taken down to the base of the gallbladder.
“Identify the cystic duct where it enters the gallbladder.” [This is the point where surgical error frequently begins.] The infundibular grasper should be moved backward and forward and side-to-side so the junction of the cystic duct and the gallbladder can be identified with certainty.
Additional incisions can be created in the peritoneum to elevate the gallbladder and create a space behind it to make it easier to identify the ductal structures.
If a cholangiogram is going to be performed, the cystic duct must be dissected free for at least 1 cm to allow cholangiography.
Two clips are placed side-by-side as close to the gallbladder as possible and two similar clips are placed on the cystic duct, using care not to place them too close to the junction of the cystic duct and the common duct.
The infundibular grasper is repositioned to grasp the gallbladder next to the cystic duct. The gallbladder is retracted anteriorly and laterally to expose the cystic artery for dissection.
The cystic artery is divided with clips, leaving a minimum of two clips on the stump of the artery. This division allows the gallbladder to be pulled farther away using the infundibular grasper.
The gallbladder is dissected away from its bed. The instruments used for this vary from hook cautery to cautery scissors or spatulas to laser.
Before the gallbladder is removed, the gallbladder bed and ducts should be closely examined for evidence of bleeding.
Irrigate with saline, using care to prevent dislodging the clips.
After hemostasis is achieved, the gallbladder is freed from the liver.
A grasper is used through one of the trocars to grasp the gallbladder near the cystic duct.
The gallbladder is removed. If the gallbladder contains bile or stones, they should first be aspirated from the gallbladder before it is withdrawn through the trocar.
After removing the gallbladder, the surgical site should be inspected for bleeding.
If necessary, a closed suction drain can be placed. [Open drains are not recommended, because they can increase the risk of infection.]
Remove the trocars and close the wounds in normal fashion.[6]

Know The Complications

The major complications of a botched gallbladder surgery include bleeding, gallbladder problems, post-op bile leakage, and bile duct injury. Although inconsequential oozing of blood is not uncommon, hemostasis is critical before the patient is closed. Any unusual bleeding in the triangle of Calot is cause for concern. Surgeons should not apply clips blindly or they will risk injury to the right hepatic duct, right hepatic artery, or common bile duct. Another difficult source of bleeding is from the gallbladder fossa. Any bleeding between the posterior wall of the inflamed gallbladder and the liver bed should be controlled immediately.

Gallbladder problems include an inflamed gallbladder (difficult to grasp), a perforated gallbladder (leading to contamination of the peritoneal cavity and potential infection), gallbladders containing large stones (difficult to remove through abdominal cavity) and undiagnosed carcinoma. The potential for contamination of the peritoneal cavity is one factor that needs to be considered in the pre-op assessment of whether prophylactic antibiotics should be given before gallbladder surgery.

Post-op bile leakage can result from injury to the cystic duct or right hepatic duct, cystic duct stump leakage, or injury to an accessory[7] bile duct. Any suspected collection of bile post-op should be investigated with radionucleide scan and ERCP, which is used for both diagnosis and treatment.

Most injuries to the hepatic ducts, the hepatic common duct, or the common duct occur during dissection at the triangle of Calot. Improper cephalad traction can cause the cystic duct to lie in a straight line with the common duct, which is then mistaken for the cystic duct. If the injury is detected during the procedure, the surgeon should immediately convert to an open procedure to allow for better access for repair.

Know The Repair Techniques

Depending on where and when the injury to the common duct is detected, it may be as simple to repair as reconstructing the duct over a T-tube, or as complex as performing a reconstruction of with a hepaticojejunostomy/Roux-en-Y procedure. Injuries to the lateral wall of the common duct may be treated with external drainage and biliary stenting.

Electronic Discovery

We paralegals are in the story business. Through our work on legal cases, we are introduced to the skeleton of an account and must try to reconstruct the truth using the discovery process.

Most of our working hours are spent filling in the blanks. What we find when we do our jobs, and how we find it, can change a case’s direction, focus and even outcome.

Electronic discovery has revolutionized the way paralegals work and has given us unparalleled access to information. So our new challenges are time management and resource management: We must locate the most relevant information without becoming bogged down in the sheer supply of material. When we have accomplished this, the information fills in the gaps and can bolster our clients’ cases.

Not very long ago, discovery was limited to the hard copy files our clients kept (or did not keep). Ten associates and paralegals locked in a conference room would review 50 boxes of paper for days on end, creating “hot” document binders and sorting documents by relevance and issue. Numerous days and billable hours were required to weed through the information and then organize the material for use in a variety of trial scenarios.

Before the electronic database defined a new age of discovery, we occasionally found hidden gems of evidence or new ideas to support the client’s strongest position. But the infrequent cry of “Eureka!” is downright routine today. Because we have more data and it’s better organized, it’s so much easier to find new ideas and approaches. If a new approach to a case comes up during a document review, we can more frequently “discover” supporting information electronically.

This ability to more effectively manage the case information through the use of databases is just one example of how technology improves the litigation process.

At my firm we have established a practice group that focuses on providing discovery counsel, document review and production and litigation support services. At every stage, this group uses technology to improve its processes: by using databases to provide litigation support, by leveraging technology to assist in substantive document reviews for responsiveness and by conducting narrowly focused “snapshot” reviews even before the litigation is filed.

A perfect example of how technology enables litigation professionals to provide services that may not have been possible in the past, all-paper world is the snapshot review. It is a limited review done in order to quickly locate key information for the client Ñ e.g., for internal investigations or for pre-litigation risk assessment. This type of review can save firms and clients time and expense by allowing us to quickly get to the heart of the matter. And it can often help to produce an amicable settlement.

Consider this scenario: A client calls his law firm for help with a case. Adamant about his position, he waves around what he considers to be a “smoking gun” document and says he wants to file a complaint as soon as possible. The law firm persuades the client to conduct a snapshot review for additional fact-finding before filing. The firm harvests e-mail and other electronic documents from a few key players at the client’s organization. Using special software, the firm culls out redundant materials, applies date ranges and runs keyword searches – greatly reducing the volume of material for review. The attorneys then review the remaining documents, using the software’s visual mapping and search capabilities to quickly home in on the most relevant documents. They locate not only the smoking gun document that the client first brought to their attention, but also a number of e-mails and documents that clearly show the client’s case is not as strong as originally believed.

The snapshot review process has changed the complexion of early negotiations. The client now has a more accurate view of the situation and may decide not to pursue the case after all. But had the snapshot review shown his position to be well supported, the client could have proceeded to file the complaint and aggressively approach the next phase of litigation, confident that the more extensive document review required by the discovery phase would not likely introduce unexpected plot twists.

Technology also plays an important role in the discovery phase, where an even larger collection of information must be reduced to the subset of responsive documents that will be given to the opposing side and loaded into litigation support databases. And once again the litigation support team will need to zero in on the most important pieces of information.

Paralegals who effectively use electronic discovery and take advantage of technological innovations can bring clarity to a case. And with that clearer picture, the client has more data points to consider trial strategy and settlement negotiations.

Primer On Laparoscopic Gallbladder Surgery and Injury To the Biliary Tract

The biliary ducts carry bile from the liver to the small intestine. Bile aids in the digestion of fatty foods. The biliary tract begins as the left lobe duct and the right lobe duct which descend from the liver. These two liver ducts form at their bifurcation the common hepatic duct. As the hepatic duct descends toward the small intestine, the cystic duct which leads from the gallbladder joins the hepatic duct to form the common bile duct. The common bile duct descends into the small intestine. The ampulla of vater is the sphincter of tissue that controls the flow of bile from the common bile duct into the small intestine.

Cholecystectomy is the removal of the gallbladder due typically to gallstones or sludge formation. Most often a cholecystectomy is an elective or planned procedure though emergency cases occur. The gallbladder is removed surgically by clipping and transecting the cystic duct and the cystic artery so as to allow the gallbladder to be removed. The gallbladder is not a vital organ and if gallstones or sludge formation have occurred, it can be readily removed without a change in lifestyle or liver or biliary tract function.

An open procedure used to be the surgical method whereby the patient’s abdomen was opened and the biliary tract was examined in a traditional manner by the surgeon. In the late 1980s, laparoscopic surgery became the popular method of removal of the gallbladder. Laparoscopic surgery was touted as causing less pain to the patient and a shorter recuperative period.

Surgeons who were in active practice in the late 1980s oftentimes went through training which included proctoring at their hospitals by qualified and experienced laparoscopic surgeons. Medical students began laparoscopic training in medical school and were not required to undergo training after medical school.

Preceding removal of the gallbladder during laparoscopic surgery, trocars are introduced into the patient’s abdomen. The trocars allow for lighting, video camera illustration, surgical instruments and carbon dioxide insufflation. The abdomen is insufflated with carbon dioxide initially and video camera and surgical instruments are used to scan the abdomen for any abnormalities. The liver is lifted and the gallbladder is exposed. The gallbladder is grasped and a process of meticulous dissection begins to remove tissue and/or adhesions from the gallbladder and cystic duct so that accurate identification of the anatomy occurs. The better practice is to pull the base of the gallbladder to the patient’s right so that the cystic duct is perpendicular to the common bile duct. When the base of the gallbladder is not pulled to the patient’s right side then oftentimes the cystic duct aligns parallel to the common bile duct and this can lead to misidentification. A short cystic duct can contribute to misidentification of the anatomy. However, a short cystic duct is not an excuse since meticulous dissection will reveal the junction between the gallbladder and the cystic duct.

Because there are variations in the biliary anatomy, most surgeons agree that the safest practice is to perform a cholangiogram before a transection of any duct. A cholangiogram is a test where dye is introduced into the biliary system and outlines the system so that the anatomy is more readily identified. A cholangiogram is a safeguard for the patient since it helps to confirm that the surgeon has properly identified the anatomy and also the lack of any ductal injury. It also confirms that a gallstone is not obstructing the biliary tract below thereby eliminating a possible problem requiring re-invasive treatment at a later time.

Surgical journals reveal that many iatrogenic (“physician-caused”) injuries during laparoscopic cholecystectomies are oftentimes due to lack of experience. The Southern Surgeon’s Club reported that the new laparoscopic technique resulted in a learning period. The learning curve reflected a higher incidence of bile duct injury. The Southern Surgeon’s Club’s study found that within the first 13 cases of any participant’s experience, the bile duct injury rate was 2.2%, compared with 0% after the 13th case. During the initial 12 – 13 procedures the surgeon is on his “learning curve”. Another cause for injuries is the surgeon’s overconfidence resulting in failure to meticulously dissect and conclusively identify the biliary anatomy prior to transection.

The Society of American Gastrointestinal Endoscopic Surgeons (hereinafter “SAGES”) sets forth well-established principles for the prevention of injury during laparoscopic biliary tract surgery:

the cystic duct should be identified at its junction with the gallbladder;
traction on the gallbladder infundibulum should be lateral rather than cephalad (towards the “head”);
meticulous dissection of the cystic duct and cystic artery is essential;
gallbladder holes should be closed to prevent loss of stones;
the surgeon should not hesitate to convert to an open operation for technical difficulties, anatomic uncertainties or anatomic anomalies, especially in cases of acute cholecystitis (infection of the gallbladder);
liberal use of operative cholangiography is desirable to discover surgically important anomalies, clarify difficult anatomy and to detect unsuspected common bile duct stones;
all energy sources can cause occult injury.
Correct dissection exposes the cystic artery and the entire gallbladder infundibulum but not the common bile duct. The steps of dissection that will avoid confusing the common bile duct for the cystic duct are:
retraction of the infundibulum laterally;
initiation of dissection on the gallbladder (dissection should begin on the gallbladder and proceed along the cystic duct towards the common bile duct rather than vice-versa);
opening up all folds in the gallbladder;
stopping medial dissection when a sufficient portion of the cystic duct has been cleaned for cholangiography and clipping; and
application of the first clip to the base of the pedunculated gallbladder where it begins to taper to its stalk.

Because the cystic duct and cystic artery are the structures to be divided, it is these structures only that must be conclusively identified in every laparoscopic cholecystectomy. Accordingly, the cystic duct and artery should not be clipped or cut until conclusively identified. To achieve conclusive identification, Calot’s Triangle must be dissected free of fat, fibrous and areolar tissue and the lower end of the gallbladder dissected off of the liver bed. (The latter is an essential measure that precludes the possibility of injury to an aberrant duct.) At the completed dissection, there should only two structures seen to be entering the gallbladder, and the bottom liver bed should be visible. Note that it is not necessary to see the common duct. It is at this point that the surgeon has achieved the critical view of safety and the cystic structures may be occluded because they have been conclusively identified. Failure to achieve the critical view of safety because of difficulty of dissection as a result of inflammation or any other cause is an absolute indication for cholangiography or conversion to open cholecystectomy to define ductal anatomy.

If an injury is recognized early, it can be repaired by the surgeon and the patient stands a much greater chance of no resulting complications. Therefore, the standard of practice requires the surgeon to search for potential injuries prior to completing the surgery. The omission of cholangiography increases the odds of an injury failing to be recognized.

Injuries to the biliary tract can have a devastating impact on a patient’s life. Injuries that are discovered post-operatively should be referred to a specialized center with expertise in hepatobiliary surgery because the first attempt at repair is critical. The biliary ductal anatomy often has modest blood circulation when healthy. After an injury, a stricture or narrowing of the duct or lumen may occur due to inadequate blood supply and/or scar tissue. Further, studies show the probability of increased risk of stricturing after the initial stricture as well as increased mortality.

When a stricture occurs follows an injury, one effect is “back flow” pressure in the liver since the bile no longer flows to the intestine. If this pressure is not relieved, liver damage can result. One of the effects of prolonged stricture formation is dilation of the intra-hepatic ducts. (The extra-hepatic ducts are the ducts that flow out of the liver towards the intestine. The intra-hepatic ducts are the ducts within the liver.)

Repair of an injury to the common bile duct by the surgeon involves bringing up a loop of the small intestine and suturing it directly to the remaining duct. A Roux-en-Y hepaticojejunostomy is a surgical procedure often used to attempt to repair bile duct lesions or injuries high (towards the liver) on the bile duct. A hepaticojejunostomy involves removing a 8-10 inch loop of bowel from the small intestine, suturing one end closed, suturing a top portion of the loop to the remaining bile duct, and re-suturing the lower end into the intestine. Strictures also occur at the site of the anastomosis or the location where the remaining duct is sutured to the loop of intestine.

Cholangitis is infection or inflammation of the bile ducts. Since the ampulla of vater no longer is present in the injured patient, the sphincter of tissue that normally control the flow of bile from the common bile duct to the small intestine is no longer present. Therefore, the bacteria and other matter present in the small intestine can flow up the previously “sterile” biliary duct to cause infection possibly extending into the liver. Antibiotics are used to treat the cholangitis which is then usually resolved but may re-appear intermittently. Severe cases of cholangitis can be life-threatening particularly after several episodes due to the effect on the ducts and possibly the liver.

After a repair surgery, stricturing and re-stricturing occurs unfortunately. Many studies reflect that only 10-28% patients undergoing hepaticojejunostomy in these circumstances experience a stricture of the ductal anatomy. However, these studies arguably include “selection bias” of the physicians in choosing their patients reporting their results and the studies do not involve long periods of patient history review. Further, re-stricturing is more likely after an initial stricture. The author’s contact with experts reveals that strictures may occur as late as 20 years after the initial repair surgery. A minimum of 5-7 years is required in follow-up of the patient before a patient’s chances of stricture following a repair surgery diminish significantly.

Another option (other than surgical re-attachment higher on the duct) available to resolve the obstruction caused by stricture is a balloon dilation. During a balloon dilation, a catheter is inserted into the biliary duct above the stricture and a balloon is introduced. The balloon is threaded down to the stricture where it is threaded into or across the stricture prior to the ballooning which expands the duct allowing the flow of bile. The risks of the significant bleeding, infection and other complications of the balloon dilation procedure is approximately 11%. Further, repeated balloon dilations efforts and other necessary gastrointestinal studies increase the risk of scar tissue within the ductal anatomy at the anastomosis and at other locations where friction occurs.

In one patient’s case presently in litigation, the repair surgeon wrote in the Operative Notes that there was a 90% chance that the patient would completely recover from the repair surgery. Four months later, the patient experienced a stricture of the anastomosis or repair site, cholangitis, a balloon dilatation sequence involving two dilatations and repeated episodes of an apparent continuing peptic ulcer. Another result of the hepaticojejunostomy repair is that stomach acids no longer neutralize the bile as before. Rather, the bile acids directly flow into the intestinal loop and this can cause an ulcer as the acids inflame the intestinal tissue.

Another client’s experience began in 1990 when her bile duct was divided during a laparoscopic cholecystectomy. A cholangiogram was not performed and the injury was not diagnosed nor repaired until approximately 14 days later. This patient’s management has included two major surgeries (re-attachments) and numerous balloon dilatations of recurrent stricture. Therefore, the author suggests that an attorney practicing in this field of medical malpractice should not resolve his or her client’s case without an understanding of the significant and chronic risks facing the injured patient.