Newsletter Fall 2002
Laparoscopy Lawsuits

Laparoscopy accounts for an estimated 40% of urology, 50% of general surgery, and 70% of gynecology procedures. While minimally invasive surgeries, such as laparoscopy have become commonplace in current surgical practice, there has been a dramatic increase in complications and serious or fatal sequelae.

Laparoscopic surgery is made possible using endoscopes through which miniature instruments are passed to perform surgery. When a body space is expanded with gas and endoscopes are placed into the gas-filled space to look at the outer surface of the organs, the procedure is called laparoscopy.

The perception of laparoscopic surgery is that it is low-risk since the procedures are performed "closed" and have a limited inpatient hospitalization. However, professional liability insurance carriers have seen a growing number of claims associated with laparoscopic procedures and various types of laser procedures.

Urologic Laparoscopy
Within the last decade there has been a dramatic increase in urological procedures performed laparoscopically. One area where this has had a significant impact has been with organ donation.

The first live laparoscopic kidney donation was done in 1995. Medical literature supports that laparoscopy is expanding the potential donor pool. One institution reported a 100% increase in the number of live donations during the period in which laparoscopic donation became available compared with previous periods. Twenty percent of these donors indicated that they would not have donated a kidney if laparoscopic donation was not available. 1

Laparoscopic nephrectomies are also being done for more complex patients. Even patients with giant hydronephrosis, enlarged polycystic kidneys, and previous abdominal procedures are considered candidates for this procedure.1 Complications for laparoscopic nephrectomy are reported to be about 6% to 12%.

Currently many hospitals are considering laparoscopy for retroperitoneal lymph node dissections, for testicular cancers and renal cryoablation of small renal cancers.

Gynecologic Laparoscopy
Gynecologic surgery has been the forerunner of many of the laparoscopic procedures. Management of ectopic pregnancies, endometriosis and adhesion lysis dramatically improved with laparoscopy.

Treatment of ectopic pregnancy via laparoscopy has been shown to have outcomes equivalent to those of laparotomy at lower costs.2 Laparoscopic ovarian cystectomy has an advantage of decreased blood loss, shorter hospitalization (three versus six days), less post-surgical pain, and fewer post-surgical complications than laparotomy.

In comparing laparoscopically assisted vaginal hysterectomy to total abdominal hysterectomy, there is a reported twofold risk of vesicovaginal vaginal fistula and a thirty-fold risk of ureteral injury.3 High-risk patients include women with a history of multiple previous surgical procedures, and those with extensive adhesions, large fibroids, large adnexal masses, or endometriosis.

Complications related to gynecologic laparoscopic procedures generally involved injury to either major vessels or small bowel injuries. The primary cause was generally entry related issues, involving trocars of various types and needle injuries. This is due to the fact that the trajectory of insertion puts great vessels at risk. Mortality was related to delay in diagnosis of bowel penetration.4

One study addressing injury to the great vessels during laparoscopic surgery found that body habitus was an underlying factor in the injuries.5 There was considerable delay in recognition of the injury in almost half of the cases. Of the litigated cases, 62% resulted in settlement.

Autopsy
Laparoscopic autopsy provides more accurate data concerning the cause of death and has received a greater acceptance to the families of patients than the conventional form, resulting in a higher consent rate.6 Laparoscopic autopsy can also provide surgical residents with valuable training for laparoscopic skills.

Laparoscopic Cholecystectomy
At present more than 75% of cholecystectomies are performed laparoscopically7. Advantages to this approach include: a decreased rate of overall complications, a better cosmetic result, faster postoperative recovery, and a shorter hospital stay.

Serious complications such as major bleeding, wound infection, bile leak, and biliary injury, occur in about 2.5% of laparoscopic cholecystectomies (LC). Other complications include bowel and liver lacerations with bleeding, complications related to pneumoperitoneum, gallstone spillage into the abdominal cavity and subsequent abscess formation.8

In one study, the Physicians Insurers Association of America stated that LC injuries were not recognized prior to the conclusion of the surgery in 83% of claims. Injuries that were recognized were generally vascular in nature, whereas visceral injuries were more likely to be missed causing greater complications.9 These are in part due to the limited visibility with the minimally invasive approach. Of those who died as a result of injury the average age was 51 years.

While the incidence of bile duct injury (BDI) is reported as high with LC, it may be underestimated because of underreporting, and lack of long-term follow-up. 10 The Society of American Gastrointestinal Endoscopic Surgeons (SAGES) has established guidelines for the clinical application of laparoscopic biliary tract surgery. The guidelines describe the steps a surgeon must take in order to avoid this complication.11

The high rate of BDI associated with laparoscopic cholecystectomy has been attributed to the "learning curve". One study examining bile duct injuries with laparoscopic cholecystectomies found that 90% of bile duct injuries occurred in the first 30 cases performed.12

A study of 46 medical malpractice cases involving BDI during LC, found that most injuries were the result of technical errors. In 48% of the cases, injuries resulted from incorrect identification of normal anatomy. The majority of injuries resulted when the common bile duct was mistaken for the cystic duct due to inadequate dissection in the triangle of Calot.13 The other major cause of BDI was cautery injury in about 10% of the cases.

Injuries were not recognized during the initial surgery in 80% of these cases. Even when cholangiography was performed, misinterpretation of radiographic evidence of BDI occurred frequently. Of the 16 intraoperative cholangiograms performed, 11 were misinterpreted. It is also recommended that surgeons utilize sensitive, noninvasive studies such as ultrasonography or HIDA scans to identify potential injuries.

Fifty-four percent of the cases involved failure to cite a complication in the operative report or patient chart following laparoscopic cholecystectomy.13 Injuries not recognized during surgery generally presented with post-operative symptoms, such as complaints of shoulder or abdominal pain, nausea, vomiting, and elevation of liver function tests. Delay in diagnosis averaged about 10 days, despite the fact that almost all patients were seen within seven days of surgery. In 62% of cases increased damages were associated with diagnostic delays and complications.

The location and extent of the BDI is also related to long-term morbidity. Higher ductal injuries are associated with increased risk of post-reconstructive failure even after appropriate repair. 13 Even with early recognition and repair of a BDI, 20% had poor outcomes.

Repair of BDI is complicated because most surgeons performing laparoscopic cholecystectomies are inexperienced with the repair procedure. Patients generally require surgical repair at tertiary centers with special expertise. Surgeons with expertise in BDI repairs had superior results compared with primary surgeons (79% vs. 27% success).

Experts believe that long-term results of current biliary reconstruction secondary to BDI with LC will be worse than the results of biliary reconstruction in the open cholecystectomy era.14 Laparoscopic BDI may have a poorer outcome because of the high percentage of failed operations performed before referral to a tertiary center, the more complex nature of many of the injuries and significant inflammation and fibrosis secondary to the bile leakage.

Of the patients referred to a tertiary center for the treatment of BDI after LC, their quality of life was described as poor using both physical and mental scales.10 This may be explained by the prolonged, complicated, and unexpected nature of these injuries. Over 30% of these patients that described a poor quality of life associated with BDI following LC sought legal recourse for their injuries. 15

Malpractice cases involving BDI associated with LC are generally reported to be resolved in favor of plaintiffs in almost 90% of cases through either settlements or verdicts. Settlement payments averaged $221,000, while trial awards averaged $214,000.13 However, another review study cites that the mean payment in settlement for BDI was $469,711. Of the cases that went on to trial, 83% were defended successfully.16

The question as to the hospital's responsibility to ensure the competency of surgeons is also raised. SAGES has published guidelines for privileging qualified surgeons in the performance of general surgical procedures utilizing laparoscopy, which state the surgeon must have the judgment, training and the capability of immediately proceeding to a traditional open abdominal procedure when circumstances so indicate. Hospitals could improve their capacity to supervise surgeons by requiring videotaping and using the tapes as a means to proctor, supervise and credential surgeons. 17

Myths of Laparoscopic Surgery
While laparoscopic surgery is becoming increasingly popular and performed with increasing frequency, the surge of these procedures has been partly motivated by forces outside the medical profession.3 Despite the apparent successes of laparoscopic surgery, there are several myths that need to be addressed.

1. Laparoscopic surgery is cost-effective and provides cost savings
Often due to the cost of the equipment, longer operating times and delayed recovery of patients, the cost savings may be minimal, if not more, than conventional approaches. A study of numerous gynecologic procedures found that laparoscopic surgery was actually more expensive and that the failed laparoscopic approach was the most expensive.11

2. New technology is better than old
The attitude behind the presentation of the new technology was that it was better because it was new, without studies to support the benefits and clinical relevance. With the explosion of technology, came sales representatives in the operating room or classroom pushing their products. New instruments such as the harmonic scalpel, the argon beam coagulator, the yttrium-aluminum-garnet laser, and disposable endoscopic stapling instruments are very expensive and require additional operating room support staff and maintenance whereas electrosurgery and reusable instruments can be safely used to help bring down costs.

3. Steep learning curves are acceptable
Many people accept the theory of complications related to the learning curve of new procedures but minimize the dramatic increased risk associated with the newer procedures. In part due to the eagerness of surgeons performing the procedures and equipment companies selling the products, risks may be minimized or compared as nominal to open procedures. Complications may be grossly underestimated because there is no national registry or mechanism for reporting laparoscopic complications.

4. Market shares are dependent on new techniques
Surgeons may have been tempted to perform laparoscopic procedures they might not have done otherwise, in part believing that if they could not perform them, the patient would go elsewhere. However, in the long run, a professional practice may be harmed more if complications arise from procedures, especially if litigation becomes an issue.

5. Oncology surgery is safely performed laparoscopically
Laparoscopic exploration of malignancies is a controversial topic. The fear of laparoscopic tumor spillage, port site or peritoneal seeding, and, ultimately, local tumor recurrences has been substantiated by experience with laparoscopic resection of colorectal, gallbladder, and ovarian malignancies.14 Animal model clearly showed that intra-abdominal tumor spread occurs when the abdomen is pressurized and tumor cells are essentially "blown" around the abdomen. One study found a dramatic progression of ovarian cancer in over 70% of women undergoing initial laparoscopy, followed by laparotomy delayed by over 8 days.

6. All surgeons are qualified to perform laparoscopy
Laparoscopic techniques may not be mastered by all surgeons because of the loss of the three-dimensional perspective. While training sessions in laparoscopic procedures abound and are described as easy to learn, some procedures are difficult for even the most experienced laparoscopic surgeons. While laparoscopic surgery is generally safe, it is critical that surgeons assess their individual skills, because for a surgeon to think that they can and must do these procedures may lead to unacceptable complications.

Conclusion
Important strategies to reduce patient injury and to prevent potential malpractice claims associated with laparoscopy need to be addressed. Documentation must include a discussion of the specific indications, potential complications and the possibility of converting to an open procedure.

Understanding the mechanism of injury with laparoscopic injuries is critical. Often correct diagnosis of operative complications may be missed and have significant long-term damage. The Legal Nurse Consultants at Century Consulting, LLC are experienced and qualified to identify these key issues.

1) Hedican,S; Laparoscopy in Urology Surgical Clinics of North America; 2000 80 (5)

2) http://www.uptodate.com/subscribers/index.asp

3) Hopkins, M.; The myths of laparoscopic surgery; American Journal of Obstetrics and Gynecology; 2000 Jul;183(1):1-5

4) Corson, S.L.; Survey of laparoscopic entry injuries provoking litigation. Journal of the American Association of Gynecologic Laparoscopists ; 2001 Aug;8(3):341-7

5) Vilos,G.A.; Litigation of laparoscopic major vessel injuries in Canada; Journal of the American Association of Gynecologic Laparoscopists ; 2000 Nov;7(4):503-9

6) Cacchione, R.N.; Laparoscopic autopsies; Surgical Endoscopy; 2001 Jun;15(6):619-22

7) Laparoscopic Cholecystectomy; Annals of Surgery; 2001Dec;234(6):750-7

8) http://www.utdol.com/application/topic.asp?file=biliaryat/6036

9) http://www.pronational.com/news/advisor/Surgery3Q1998.htm

10) Boerma, D.; Rauws, E.;Impaired Quality of Life 5 Years After Bile Duct Injury During Laparoscopic Cholecystectomy; Annals of Surgery; 2001Dec;234(6):750-7

11) http://www.danaise.com/Lap-Chole.html#open

12) http://www.danaise.com/Lap-Chole.html#open

13) http://www.rmf.harvard.edu/publications/forum/v18n4/article4/index.html

14) http://www.danaise.com/Lap-Chole.html#open

15) Melton, G. Lillemoe, K.; Major Bile Duct Injuries Associated With Laparoscopic Cholecystectomy; Annals of Surgery; 2002 Jun;235(6):888-95

16) Kern, K.A.; Malpractice litigation involving laparoscopic cholecystectomy. Cost, cause, and consequences; Archives Surgery; 1997 Apr; 132(4): 392-397.