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Laparoscopic Cholecystectomy Cases: Maximizing Your Client's Recovery
By Bruce L. Braley of Waterloo, Iowa
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:
  1. Know the anatomy
  2. Know the indications for surgery
  3. Know the risks of surgery
  4. Know the instruments used during surgery
  5. Know the indications for intraoperative cholangiogram
  6. Know the proper surgical technique
  7. Know the complications
  8. Know the repair techniques
  9. Know the likely defenses
  10. 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.]
  1. Using two atraumatic graspers, gently elevate the liver by passing the graspers under the visible liver edge.
  2. If the gallbladder is not visible, carefully dissect adhesions to the underside of the liver and gallbladder using as little cautery as possible.
  3. 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.
  4. 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]
  5. 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.
  6. Begin dissection "directly adjacent to the gallbladder." Any adhesions should be sharply taken down to the base of the gallbladder.
  7. "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.
  8. 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.
  9. If a cholangiogram is going to be performed, the cystic duct must be dissected free for at least 1 cm to allow cholangiography.
  10. 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.
  11. 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.
  12. 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.
  13. The gallbladder is dissected away from its bed. The instruments used for this vary from hook cautery to cautery scissors or spatulas to laser.
  14. Before the gallbladder is removed, the gallbladder bed and ducts should be closely examined for evidence of bleeding.
  15. Irrigate with saline, using care to prevent dislodging the clips.
  16. After hemostasis is achieved, the gallbladder is freed from the liver.
  17. A grasper is used through one of the trocars to grasp the gallbladder near the cystic duct.
  18. 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.
  19. After removing the gallbladder, the surgical site should be inspected for bleeding.
  20. If necessary, a closed suction drain can be placed. [Open drains are not recommended, because they can increase the risk of infection.]
  21. 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.


Know The Likely Defenses

The most common (and irritating) defense to a botched gallbladder surgery case is, "The injury to the common duct is a known risk of the procedure, so it's not negligence to cause the injury." Here are some approaches to dealing with this defense:

Rules of the Road Analogy[8]
It can be a little confusing, being a juror in a case about medical mistakes.

It's confusing to try to figure out what the rules of surgery are when you are not a surgeon. And sometimes, good lawyers (looking at the defense) , who have done this lots of times, know that if they use words that people are not used to, like "known risk of the surgery", it makes it more confusing.

That's because those of us who don't deal with surgery every day have no idea about the rules of surgery....rules that surgeons take for granted. Rules that good surgeons know very well.

If this was a car accident case, we wouldn't be so easily confused, because we all know the rules of the road. We all live with them every day.

For instance, we all know that getting run over by an inattentive driver is a risk of walking from one corner of the street to the other at a cross walk.

We all know that getting hit broadside is a known risk of driving through a green light.

We all know that sometimes other drivers carelessly drift across the center line and hit other cars head on, and that we take a known risk of such an accident every time we drive.

We also know that we take a risk that WE might accidently run a red light, or miss a stop sign, and that too is a known risk of driving a car.

All of these things, and many more, are "known risks" of operating a motor vehicle.

Do the words "known risk" that mean that the we, or the other person who caused the wreck, shouldn't take personal repsonsibility for the harm they caused? What would you think if this were a car accident case, and a lawyer representing an inattentive driver stood up and tried to tell you that his client should be excused for drifting into the other lane because mistakes like that are just a "known risk"?

Yes, inattentive mistakes are a "known risk" of surgery too. Inattentive mistakes are a known risk of just about anything we do, but they are still mistakes.

But, just like the Rules of the Road, there are rules in surgery too. The first rule learned by every surgeon is that you have to know what you are cutting before you cut it. The first rule of surgery is to NEVER cut into a body part unless you know what it is. You don't guess about what you are cutting. You don't speculate about what you are cutting. You don't cut first and hope for the best later. If you don't know, you don't cut.

So let's not let the use of the words "known risk" confuse us, because they really don't mean anything. They don't help us decide what needs to be decided.


Break it Down[9]
  • cutting the CBD can and does occur because inexperienced surgeons negligently cut the CBD

  • cutting the CBD is a known risk because, in some circumstances, inexperienced doctors commit negligence.

  • patient never consented to the surgeon's failure to exercise reasonable care.

  • patient never consented to the surgeon's failure to recognize the anatomy, inability to use the equipment, and the inability to convert to an open surgery if he was confused.

  • learning curve leads to inexperienced and/or confused surgeons negligently cutting the CBD, which means that these injuries have been reported. merely because these injuries have been reported in the medical literature does not mean that they were not caused by physician negligence.


B.S. Analogy (I call 'em as I see 'em)
Death is a known risk of the procedure.

Bleeding is a known risk of the procedure.

Infection is a known risk of the procedure.

Cutting the common bile duct is a known risk of the procedure.

Because these things are known risks of the procedure, and because they have significant consequences for the patient, they impose a HIGH BURDEN on the surgeon to proceed carefully through the procedure, to identify the patient's anatomy with 100% certainty before clipping and cutting, and to use intraoperative cholangiogram if they have any doubt about what they're going to cut. Most good and conscientious surgeons will testify that if these steps are followed, the risk for any bad outcome is minimized to the point where injury can be and should be avoided.

This is why groups like SAGES publish CME materials devoted to reducing and eliminating the risk of bile duct injuries during lap chole procedures.

Emphasize that "known risk of the procedure" and informed consent are not equivalent to a "Get out of Jail Free" card. Informed consent is simply the minimal level of communication required before the physician has the RIGHT to cut into a patient's body. It doesn't give them carte blanche to screw up once they insert the first trocar.

Know Your Damages

Although this is the last category, it is often the most important criteria in evaluating a potential botched gallbladder surgery case. Even if the common bile duct is completely cut during surgery, the damages may not be significant if it is promptly recognized and immediately repaired by a qualified surgeon. Most of these cases are driven by the long-term consequences of the injury and whether additional medical care will be needed with additional complications that could ultimately result in a liver transplant. Given the astronomical cost of those procedures ($300,000 or more), the prospect of such a result, even if remote, can have a significant impact on a client's mental pain and suffering resulting from this injury.


Resources
  • Rice, Pamela, ed. Laparoscopic Cholecystectomy: A Compendium. 2000. Rice Medical-Legal Associates. Pam Rice is a paralegal member of ATLA's Professional Negligence Section and a valuable contributor to the Professional Negligence and Medical Malpractice listserves run by ATLA. This compendium includes contributions from med mal lawyers and paralegals across the country and includes a glossary of terms, tips about case evaluation, bile duct injuries, verdicts, standards of care, clinical pathways, anatomic considerations, operative techniques, diagnostic procedures, the "Learning Curve," cholangiography, complications, antibiotic prophylaxis, experts and depositions, resources, abstracts, etc. It is extremely valuable as a "one-stop-shopping" center for botched gallbladder surgery cases. I'm not sure if Pam still handles the requests for the compendium, which were quite voluminous, but she can be reached at RMLARN@aol.com. Tell her I said hello.

  • Scott-Conner,C.E.H, ed. The SAGES Manual: Fundamentals of Laparoscopy and GI Endoscopy. 1999 (The Society of American Gastrointestinal Endoscopic Surgeons[10] was the "pioneering society for minimally invasive surgery." This helpful book is available in a "softcover, pocket-sized format ideally suited to residents." It provides step-by-step outlines of the major laparoscopic and flexible endoscopic procedures, including the indications, patient preparation, set-up and operative techniques. Most importantly, "every chapter stresses the prevention, recognition and management of complications." The SAGES Manual is published by Springer-Verlag (www.springer-ny.com). It is an indispensable resource for handling botched gallbladder surgery cases.)

  • SAGES Guidelines, Statements and Standards. Also available from SAGES are the following helpful resources:
    1. Statement on Concentration in General Surgery Residency
    2. Position Statement on Advance Laparoscopic Training
    3. Integrating Laparoscopy into Surgical Residency
    4. Statement on First Assistants
    5. Global Statement on New Procedures
    6. Guidelines for the Clinical Application of Laparoscopic Biliary Tract Surgery
    7. Guidelines for Granting of Privileges for Laparoscopic and/or Thorascopic General Surgery
    8. Framework for Post-Residency Surgical Education and Training
    9. Granting of Privileges for Gastrointenstinal Endoscopy by Surgeons
    10. Summary Statement on Surgical Endoscopic Training and Practice
    11. Guidelines for Office Endoscopic Services
    12. Guidelines for General Surgery Resident Education in Gastrointestinal Endoscopy
    13. Guidelines for Training in Diagnostic and Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)

    SAGES Patient Information Brochures:
    1. Laparoscopic Gallbladder Removal (go to http://www.sages.org.pi_cholecystectomy.html)

    SAGES Laparoscopic Equipment Troubleshooting Guide:

    a laminated guide that attaches to a laparoscopic video cart

  • SAGES/EAS 2002 Postgraduate Course I: "When Bad Things Happen to Good Surgeons: Avoiding and Treating Complications of Laparoscopic Surgery." 8th World Congress of Endoscopic Surgery, March 14, 2002, New York Hilton, New York, NY. (This CME course outline was available online from Medscape, and included sessions on General Complications, Operation Specific Complications (including "13. Strategies to Prevent and Treat Bile Duct Injuries During Laparoscopic Cholecystectomy"), and Miscellaneous Considerations.)

  • Buckingham, B.K. When laparoscopic gallbladder surgery goes wrong. Trial (May 1999). Great article covering the basics of botched gallbladder surgery cases. One of my experts is quoted in this article. During his deposition, defense counsel asked him if he'd ever submitted an article for publication in Trial magazine. My expert looked confused and said he didn't think so. As defense counsel went deeper and deeper into this line of questioning, thinking he had some powerful impeachment evidence, I quietly pulled out my copy of the article and politely informed opposing counsel that, while it was true that he had been cited in an article in Trial magazine, he had not written it.

  • Anaise, David. Laparoscopic Surgery: A Primer for the Lawyer. Very helpful materials from Dr. Anaise's website, including a history of the surgery, complications, measures to reduce common bile duct injuries, etc. http://www.danaise.com

  • Anaise, David. Establishing Liability and Damages in Laparoscopic Cholecystectomy. Also available from Dr. Anaise's website, includes comparison of open v. laparoscopic cholecystectomy, standards of care, lateral retraction of the infundibulum, operative cholangiography, surgical repair, illustrations and photos, proctoring, videotaping, etc.

  • Fried, G.M. and Feldman, L.S., Laparoscopic Cholecystectomy. ACS Surgery, Principles & Practice. 2001. Formerly known as Scientific American Surgery, ACS Surgery is now published by WebMD© Scientific American� Medicine. ACS Surgery is sponsored by the American College of Surgeons and is "written by individuals who are recognized experts. The American College of Surgeons has designated that study of the text and updates of ACS Surgery can meet the criteria for 30 hours of Category 2 CME credit a year." ACS used to advertise that "More than 25% of Residency Training Programs in General Surgery Now Using Scientific American Surgery (including Harvard University School of Medicine and UCLA). Because of this strong endorsement from the American College of Surgeons, research published in this treatise can be helpful in establishing standards of care and liability. Figure 19 contains a helpful algorithm that outlines a screening approach when patients show signs suggesting a post-op intra-abdominal complication.

  • Flum, D.R., et al. Common Bile Duct Injury During Laparoscopic Cholecystectomy and the Use of Intraoperative Cholangiography: Adverse Outcome or Preventable Error? Arch Surg. 2001; 136:1287-1292. Vol. 136 No. 11, November 2001. (Conclusion: "The rate of CBD injury is significantly lower when IOC (intraoperative cholangiogram) is used. This effect is magnified during the early experience of surgeons. Systematic use of IOC may significantly reduce the rate of CBD injury.") (http://www.archsurg.com)

  • Netter, Frank. Medical illustration Plate Number 277A, "Variations in Cystic Duct (six examples) and Plate Number 277B, "Variations in Accessory [Aberrant] Hepatic Ducts."

  • Melton, G.B., et al. Major Bile Duct Injuries Associated with Laparoscopic Cholecystectomy: Effect of Repair on Quality of Life. Ann Surg 235(6):888-895, 2002. This article purports to assess the quality of life (QOL) of patients after surgical reconstruction of a major bile duct injury. Significantly, it analyzes these patients in the context of those who sought legal recourse for their injuries (31%) and those who did not. The authors conclude that "The presence of a lawsuit appears to be associated with a poorer QOL assessment."

  • Gallstones and Laparoscopic Cholecystectomy. 10 NIH Consensus Statement 1 (1992)

  • Zimmerman, Bradley S. Pretrial Issues in Laparoscopic Negligence Cases. ATLA Professional Negligence Section Newsletter. Vol. 10, Number 2, Winter 2002/2003: 4-7.

Bruce Braley is a member of Dutton, Braun, Staack & Hellman, P.L.C., which is located at P.O. Box 810, Waterloo, Iowa 50704. He may be reached by email at braleyb@wloolaw.com.

  1. I'm a firm believer in using "plain English" in medical negligence cases. Although these cases are routinely referred to as "lap chole" cases by doctors and lawyers, it's better to call them what they are, "botched gallbladder surgery" cases.

  2. Fried, G.M., Laparocopic Cholecystectomy. Scientific-American Surgery, Principles & Practice. Table 2, p. 2. 1994.

  3. The fundus is the wide closed end of the gallbladder situated at the inferior border of the liver.

  4. The infundibulum is the funnel-shaped structure at the open end of the gallbladder where the cystic duct enters the gallbladder.

  5. Calot's triangle is the triangle formed by the junction of the gallbladder, the cystic duct and the common hepatic duct (see figure above).

  6. Source: The SAGES Manual, Ch. 13.1. "Laparoscopic Cholecystectomy," pp. 132-36 (1999).

  7. An accessory bile duct is an extra bile duct.

  8. Attributed to Rick Friedman by Mike Abourezk.

  9. These thoughts were shared by Kenneth Chessick, MD, JD, Trial Attorney and General Surgeon from Schaumburg, Illinois.

  10. Society of American Gastrointestinal Endoscopic Surgeons, 2716 Ocean Park Blvd., Suite 3000, Santa Monica, CA 90405, Phone: 310-314-2404, web: www.sages.org.

© 2003, Bruce L. Braley. All rights reserved.
The above article may not be reproduced in whole or in part without the express written consent of the author.












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