Causes of laparoscopic injuries: a survey.
A surgeon inserted into her abdomen a needle through which carbon dioxide gas was passed to create an area in the cavity for him to work. He removed the needle and inserted a trocar--a hollow metal tube. Then, he inserted a sophisticated lighted tool, a laparoscope, into the trocar. The laparoscope permits a magnified view of the abdominal cavity to be projected on video monitors. Through small incisions, other trocars were then placed into her abdomen. The surgeon inserted surgical instruments into these in order to remove the gallbladder.
With his light, the surgeon viewed the interior of Dukes's abdomen, where he saw "a little blood," which he assumed was probably from the initial trocar insertion.
Dukes's blood pressure had dropped to 105/52. The anesthesiologist did not tell the surgeon this and did not ask if there was any bleeding. Dukes's pressure dropped further to 85/50, and her heart rate rose to 120 beats per minute.
At this point, the anesthesiologist assumed Mae Dukes was suffering a pulmonary embolism. He told the surgeon to step away from the table so the patient could be repositioned. During the next 10 minutes as the anesthesiologist searched for emboli, Dukes bled to death. Early in the procedure, during the insertion of the first trocar, the surgeon had severed her iliac artery.
An analysis of Dukes's and other cases involving similar surgical procedures and a review of the medical literature demonstrate the types of injuries that can occur during these procedures and the causes of the injuries.
Laparoscopes, endoscopes, and arthroscopes are names given to tools used by a variety of surgical subspecialties, including orthopedics, gastroenterology, cardiology, and gynecology. Generically, diagnostic and surgical interventions employing these tools, inserted through small incisions and holes, are referred to as minimally invasive surgery.
Laparoscopic surgery specifically refers to the performance of intra-abdominal surgery through small ports inserted through the abdominal wall while visualizing the surgery with a camera. The hand-operated tools can be fitted with lighting, viewing, reaming, drilling, cutting, burning, clipping, gripping, vacuuming, and other tool ends.
Until the mid-1980s, laparoscopy was predominantly used to perform diagnostic procedures or to perform sterilizations.(1) The first reported appellate case involving laparoscopy was a failed tubal ligation in 1974.(2) In that year, nine appellate laparoscopy cases involving failed tubal surgery were brought and lost by plaintiffs. Today, the tables have turned.
Erich Muhe performed the first laparoscopic cholecystectomy in 1986, in Germany.(3) In 1989, the first laparoscopic vaginal hysterectomy was performed. Today, only 11 years later, the public assumes that most laparoscopic technology and applications are safe. This may be a mistake.
When assessing the safety and efficacy of laparoscopic diagnostic and surgical procedures, the following factors should be considered:
* the "newness" of the procedure, as well as the potential use of alternative technologies such as ultrasound or medications, as competing diagnostic and treatment modalities;
* the paucity of large clinical studies regarding the safety and efficacy of many current laparoscopic applications; and
* the lack of a national reporting mechanism for laparoscopy-associated morbidity and mortality, and the tendency of published data to come from researchers rather than practitioners. For this reason, the published studies imply lower morbidity and mortality than probably occurs "in the field."
Laparoscopic v. open surgery
Some of the rationales offered in support of laparoscopy and other forms of minimally invasive surgeries (MIS) include shorter stays in the hospital and shorter convalescence periods, earlier diagnoses, shorter operation times, improved cosmetic results, less pain, fewer complications, and lower costs.
Whether these rationales apply and support choosing laparoscopy depends on the presentation of the patient and the procedure involved (for example, laparoscopic hernia repair, laparoscopic vaginal hysterectomy, laparoscopic appendectomy). Knowing the procedure-specific data in the peer-reviewed medical literature is important in assessing the adequacy of the patient's informed consent as to whether an MIS or open surgical option is selected.
It is generally true that a patient who undergoes laparoscopic diagnosis and surgery will have a shorter stay in the hospital and a more rapid return to work. However, new technologies, especially imaging technologies, can provide an earlier diagnosis than is possible with a laparoscopic examination. Thus, for certain diagnoses, choosing to use a laparoscope may be the error.
In a study published in 1996 of laparoscopic appendectomy versus open appendectomy in men, the findings suggest that the use of laparoscopy should be limited to men with atypical pain of uncertain diagnosis and men who are obese.(4) As this finding suggests, it is imperative that attorneys handling malpractice cases in this field search for articles specific to patient sex, size, and clinical presentation to see if laparoscopic surgery was appropriate for the plaintiff.
When the safety and efficacy of laparoscopic versus abdominal hysterectomy was studied, researchers found that women undergoing laparoscopic hysterectomies spent more time in surgery than those undergoing traditional hysterectomies (160 minutes as opposed to 102 minutes) but had significantly shorter hospital stays (2.4 days as opposed to 4.4 days).
This finding of increased surgery time predicts an increased anesthesia risk. The researchers admit that their results are preliminary (due to the sample size of 10 subjects) and suggest that when performed by experienced laparoscopists, laparoscopic-assisted vaginal hysterectomy is preferable to abdominal hysterectomy for selected patients.(5)
An analysis of malpractice insurance claims provides important data about laparoscopic safety, demographics, complications, and outcomes.
In the 1994 Physician Insurers Association of America Laparoscopic Procedure Study, the most current study available, 31 member companies reported 615 claims for 13 different procedures.(6)
Cholecystectomies--the surgical removal of the gallbladder--had the highest number of reported claims (331). General surgeons, as a specialty, were named in 304 of these claims.
A variety of injuries are associated with the laparoscopic cholecystectomy claims. The most common injury, a lacerated, transected, or punctured common bile duct, accounted for 197 claims. Similar injuries to the hepatic duct accounted for 45 claims, and perforations and lacerations to the bowel constituted 38 claims. Punctures and tears to arteries and veins (32), fistulas (8), equipment burns (7), and a smattering of other injuries round out the 331 total reported claims involving gallbladders.
The remaining 284 claims involved diagnostic laparoscopies, hernia repairs, appendectomies, and various gynecologic procedures. Diagnostic laparoscopic procedures--most commonly gynecologic in nature--comprised 50 percent of these claims. Tubal ligation was the next most prevalent procedure reported, making up another 25 percent. Women were claimants in more than 95 percent of the cases not involving gallbladders, and most of the claimants were under the age of 40.
Not surprisingly, the medical specialty most commonly involved in these claims was obstetrics/gynecology (more than 90 percent of the claims). General surgeons were involved in a smaller number of cases, most involving hernia repair and appendectomy procedures.
Across all of the procedures, the most common injury was perforation of the bowel. In gynecologic claims, ureter laceration was a common injury requiring surgical repair.
A complication in more than 80 percent of all claims was the need for an additional surgical procedure, most often an open procedure to repair the punctured, lacerated, or perforated organ or vessel. This complication is usually not a fruitful subject of litigation, because the surgical consent forms signed by the patient usually advise that this complication may occur and that the patient consents to an open procedure for correction. Where an injury occurs that should not have, or where an injury occurs and is not timely discovered and repaired, litigation is more likely to be successful.
As procedure-specific laparoscopic data develop, there will be increasingly valuable and reliable evidence of the comparative safety and efficacy of laparoscopic versus open surgeries.
Causes of injuries
An analysis of all types of injuries from all types of laparoscopic surgeries shows eight common causes of the injuries reported above:
* defects in hand-eye coordination;
* ignorance of anatomy;
* equipment and technique failures;
* improper patient selection;
* repositioning of patients during surgery; and
* failure to plan for complications.
With the introduction of any new technology, there are learning-curve errors.(7) Laparoscopy, as sophisticated as it is, is still in its infancy, and many physicians are just entering the MIS field.
Adequate training and experience involve a knowledge of basic anatomy and knowledge of the appropriate equipment and techniques. Practitioners should have had a preceptorship with an experienced surgeon; have been supervised by a teaching surgeon; have performed multiple procedures; and know the standards of care applicable to each procedure. Published standards of care identify the indications, contraindications, and applications of laparoscopic technology to specific diagnostic and treatment modalities.(8) At deposition, it is crucial to explore the defendant's training, experience with the procedure, and knowledge of the standard of care for the procedure.
The operator's hand-eye coordination and the role that habit plays in these procedures require the laparoscopic operator to set up equipment the same way for each procedure. Researchers have explored the concept of hand-eye coordination and paradoxical movement. For example, if the hand of the operator moves the laparoscopic forceps placed in the abdominal cavity in one direction, and the image shown on a video monitor is displayed normally, the image shows the working end of the forceps moving in the opposite direction. This also applies to up and down movements of the instruments.
In another equipment setup, where the instrument and the viewing telescope are directly opposite to the operator's line of sight to the video monitor, a left-to right movement by the operator's hand is seen as a left-to right movement on the video monitor.(9) A consistent equipment setup in the operating room, repetitive habits, and experience offer the best prevention against the types of problems that can result from this reversal of the images.
The potential complications from this paradoxical-movement quandary are obvious. This illustrates the importance of discovering whether the surgeon can repeat by rote his or her equipment setup. Surgeons who use different equipment setups for the same procedure on different patients are at special risk of committing this type of error.
Surprisingly, ignorance of human anatomy is a major contributing cause of complications in MIS. There are many important blood vessels (not counting ducts, organs, and nerves) for the ignorant, unwary, or unlucky operator to hit. Understanding the layers of overlapping anatomy is important because the instruments move through anatomical planes. Asking the defendant to detail what structures lie on top of what structures will frequently show an ignorance of anatomy.
The angle of placement of a trocar, whether a trocar tip is conical or pyramidal, and the force of insertion are all technical variables, which, when coupled with anatomical ignorance, offer a potential for great injury.
In many laparoscopic procedures, more than one trocar is inserted. Inserting the first trocar carries the most danger because it is inserted somewhat blindly. For this reason, complications associated with the first trocar insertion are sometimes legally defensible, although the failure to recognize and treat the injuries is not. Injuries caused by second or third trocar insertions are largely indefensible. Visualization through the first trocar should allow for safe insertions of subsequent trocars because the anatomic structures at the insertion sites can be seen in advance.
Equipment and technique failures
Equipment failures may be the result of product defect, but most often the fault lies with improper assembly, maintenance, and use of equipment. Insulated surfaces, for example, should be inspected before each surgery to minimize inadvertent burns. Electrical malfunction is frequently due to poor cable connection or operator error. At deposition, each item of equipment, hookup, and placement must be established. Where relevant, exemplar pieces of equipment should be purchased for use in depositions and as demonstrative evidence.
Technique failure is usually related to the inability to attain an initial inflated abdomen.(10) Injecting the inflating gas above, instead of below, the serous membrane lining the abdominopelvic walls is a common complication, often due to inexperience, improper equipment, or poor patient selection. Testing intraperitoneal placement with fluid in a syringe "is mandatory prior to gas insufflation."(11)
Insufflation is the process of injecting gas via machine (an insufflator) into the intra-abdominal space to create a tent to allow for the safe placement of later trocars, visualization of the operative field, and manipulation of instruments during the procedure. The amount and type of gas used for insufflation should be monitored and recorded. Room air, carbon dioxide, and nitrous oxide are common insufflation gases. Each option has its own risks and benefits.
Deciding whether to use unipolar or bipolar electrogenerators also involves crucial choices. Unipolar electrogenerators develop currents that travel through the entire body before returning to the ground electrodes. This increases the risk of arcing through unintended anatomical structures if that route to the ground electrodes is more direct.
In contrast, a bipolar system develops current only between the jaws of the forceps. This offers greater safety and decreased risk of damage to tissue due to lower voltage.
The operator must also recognize that repairing burns or lacerations is more difficult where they are caused by unipolar current, because unipolar damage is harder to see but usually more extensive than bipolar damage. For this reason, suture repairs of unipolar-caused injuries require taking larger margins to ensure only undamaged tissue is sutured. A suture of dead tissue will fail because dead tissues cannot mend when connected.
Infection is reportedly a rare complication of laparoscopy, even with complicated and lengthy cases.(12) Establishing liability is almost impossible. Because surgery of all types, open or MIS, carries a risk of infection, most surgical infection cases do not make good plaintiff cases.
Patient selection is another crucial variable. Performing minimally invasive surgeries on patients for whom the procedure is not appropriate is common and an invitation to danger. Patients with a previous laparotomy are at increased risk of surgical complication.(13)
Further, because the performance of laparoscopy has profound effects on movement of blood and respiration, emergency, older, or acutely medically impaired patients may not be able to tolerate the procedure well.(14)
Septic peritonitis, multiple previous surgical procedures, diaphragmatic hernia, chronic pulmonary disease, intolerance to proper positioning, and obesity also constitute relative contraindications to laparoscopic surgery complications.(15)
Thin, athletic women who have never been pregnant are at even higher risk of complications than the obese patients because the fibrous tissue deep within their skin is not pliable enough "to facilitate safe trocar insertion."(16)
Absolute contraindications to laparoscopy currently include the presence of shock caused by low blood volume (hypovolemic shock); intestinal obstruction with extensive bowel distention; the presence of a large pelvic or abdominal mass; or severe cardiac decompensation.(17)
The repositioning of the patient after insufflation but before all trocars are placed, or repositioning by the anesthesiologist or surgeon during the surgical procedure, may shift organs and anatomical structures by moving previously safe organs into the way of harm. "Moving the patient ... or even tucking the arm can change the anatomy so much that the planned puncture becomes dangerous."(18)
Complications are predictable. The surgical team must
* be prepared to perform an open procedure for correction;
* have available redundant equipment in the event of equipment failure;
* have proper informed consent forms signed in anticipation of the need for an open procedure;
* be prepared to stop the surgery and exhaustively search for perforations, burns, or other injuries because changes in intra-abdominal anatomy, through repositioning, may obscure an injury; and
* have adequate personnel, blood products, and equipment available to address specific complications.(19)
Attorneys representing patients or physicians in laparoscopic malpractice cases must thoroughly understand the planes of anatomy, the equipment, and its configuration and placement. They must also understand the repetitive protocols used by a defendant surgeon for insufflation and trocar placements.
If the surgeon cannot repeat at deposition, by rote, each step of insufflation technique, angle of trocar introduction, and so on, it is likely that the surgeon does not follow strict and repetitive protocols, a practice necessary to avoid complications in the patient.
Attorneys must recognize that many laparoscopic procedures are filmed in whole or part. If these films exist, they should be requested at the earliest possible date and carefully reviewed.
During discovery, it is imperative to probe the education, training, and experience of the surgeon and each member of the surgical team. Each piece of equipment used, how each was positioned, and the settings of each must be discovered. The names and duties of each team member, and the number of trocars used and their sizes must also be explored.
Counsel should ask the physician to draw the surgical table, the angle of table position, the position of the patient, and the placement of equipment. If the patient was repositioned, who did it? How many times was it done? When was it done? Were there corresponding changes in vital signs? Was any blood noticeable after the initial trocar insertion? What was the source of the blood? What did the surgeon do to explore its source?
It is important to understand the anesthesia record. Respirations, blood pressure, and other vital signs noted in the anesthesia chart frequently provide the earliest warning of a problem. The communication between the anesthesiologist and the surgeon must be probed in detail.
As the case of Mae Dukes shows, the surgeon who does not thoroughly explore the origin of a problem and an anesthesiologist who fails to recognize that a dramatic drop in blood pressure and increase in respirations may be due to a bleed can cause death.
Laparoscopy is a relatively new technology, more widely disseminated than the safety and efficacy data might justify. The "popularization" and promotion of laparoscopy to the public may be responsible for the dissemination and use of this technology at a faster rate than the professions can properly train operators. Economic and market share concerns may also motivate some physicians to operate solo before they are ready.
As the "science" of laparoscopy develops and as the various surgical colleges and professional organizations develop standards of practice, including standardized criteria for the education and training of surgeons,(20) it is hoped that laparoscopy will become safer with more frequent and broader applications.
As surgeon training, supervision, standards of practice, and incident analysis more fully define appropriate laparoscopic uses and the limitations of the procedure, we can expect a continued flowering of laparoscopy, a most useful technology, in the hands of experienced surgeons. Hopefully, trial lawyers representing physicians and patients can make a positive contribution to this process.
J. Douglas Peters, a shareholder with Charfoos & Christensen, Detroit, and a principal with Peters & Christensen, Philadelphia, is also an adjunct associate professor, Department of Community Medicine, Wayne State University School of Medicine. Michelle Aiello, a former nurse, is an attorney associate with Charfoos & Christensen.
(1). See Frank Willem Jansen et al., Complications of Laparoscopy: A Prospective Multicentre Observational Study, 104 BRIT. OBSTETRICS & GYNAECOLOGY 595 (1997).
(2). See, e.g., Raitt v. Johns Hopkins Hosp., 322 A.2d 548 (Md. Ct. Spec. App.), rev'd, 336 A.2d 90 (Md. 1975).
(3). Erich Muhe, The First Cholecystectomy Through the Laparoscope, LANGENBECK, ARCHIVES CHIROPRACTY 369 (1986).
(4). Didier Mutter et al., Laparoscopy Not Recommended for Routine Appendectomy in Men: Results of a Prospective Randomized Study, 120 SURGERY 71 (1996). Moberg and Montgomery studied many of the same parameters regarding laparoscopic application to appendicitis. This study also found no significant difference in the length of hospital stays or the complication rate between the two groups. It did find that the post-operative need for pain medication was lower but that the operation time was significantly longer in the laparoscopic group. These authors concluded that the greatest benefits of laparoscopic over open surgery is that it caused less trauma (evidenced by less use of post-operative analgesia) and provided better diagnostic accuracy and a better cosmetic result than the conventional operation. Ann-Cathrin Moberg & Agneta Montgomery, Appendicitis: Laparoscopic Versus Conventional Operation, 7 SURGICAL LAPAROSCOPY & ENDOSCOPY 459 (1997).
(5). Farr Nezhat et al., Laparoscopic Versus Abdominal Hysterectomy, 37 REPRODUCTIVE MED. 247 (1992).
(6). PHYSICIAN INSURERS ASS'N OF AMERICA, LAPAROSCOPIC PROCEDURE STUDY 7 (1994).
(7). See Paivi Harkki-Siren et al., Major Complications of Laparoscopy: A Follow-Up Finnish Study, 94 OBSTETRICS & GYNECOLOGY 94, 98 (1999);see also Jansen et al., supra note 1, at 599.
(8). For examples of clinical guidelines, see Society of American Gastrointestinal Endoscopic Surgeons Committee on Standards of Practice, Revised Guidelines for the Clinical Application of Laparoscopic Biliary Tract Surgery (1999); Society of American Gastrointestinal Endoscopic Surgeons Committee on Standards of Practice, Revised Guidelines for Diagnostic Laparoscopy (1998); Charles Chapron et al., ESHRE Guidelines for Training, Accreditation, and Monitoring in Gynaecological Endoscopy, 12 HUMAN REPRODUCTION 867 (1997); Guidelines for Diagnostic Laparoscopy, 13 SURGICAL ENDOSCOPY 202 (1999). For an example of training and education criteria, see Society of American Gastrointestinal Endoscopic Surgeons Committee on Credentialing, Revised Guidelines for the Granting of Privileges for Laparoscopic and/or Thoracoscopic General Surgery (1997). Copies of documents from the Society of American Gastrointestinal Endoscopic Surgeons can be obtained on the Internet at http://www.sages.org.
(9). Michael Patkin & Luis Isabel, Ergonomics and Laparoscopic General Surgery, in LAPAROSCOPIC ABDOMINAL SURGERY ch. 8, at 83-88 (John N. Graber et al. eds., 1993).
(10). Edward Beadle, Complications of Laparoscopy, in LAPAROSCOPIC ABDOMINAL SURGERY, supra note 9, at ch. 7.
(11). Mark Pentecost & Earnest Curtis, Laparoscopy, in GYNECOLOGIC SURGERY: ERRORS, SAFEGUARDS, SALVAGE 135 (John H. Ridley ed., 2d ed. 1981).
(12). Beadle, supra note 10, at 78.
(13). Jansen et al., supra note 1, at 599.
(14). Beadle, supra note 10, at 75.
(15). Id. at 77.
(16). Barbara S. Levy, 3 OB-GYN MALPRACTICE PREVENTION, Feb. 1996, at 11.
(17). Beadle, supra note 10, at 76.
(18). Levy, supra note 16.
(19). Beadle, supra note 10, at 81.
(20). See sources cited at note 8. It should be noted that physicians do not always follow clinical guidelines for various reasons. See Michael D. Cabana et al., Why Don't Physicians Follow Clinical Practice Guidelines? A Framework for Improvement, 282 JAMA 1458 (1999).
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|Date:||May 1, 2000|
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