Bowel injury litigation after laparoscopy

Bowel injury litigation after laparoscopy

Vol. 1, No. 1, November 1993 TheJournal of the American Association of Gynecologic Laparoscopists Bowel Injury Litigation After Laparoscopy Richard...

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Vol. 1, No. 1, November 1993

TheJournal of the American Association of Gynecologic Laparoscopists

Bowel Injury Litigation After Laparoscopy

Richard M. Soderstrom, M.D., FACOG

Historical Perspective

time as bipolar instruments. The latter were designed to eliminate aberrant electrical pathways and stray sparking. Concern about the risks of monopolar energy was h e i g h t e n e d w h e n the C e n t e r s f o r D i s e a s e Control (CDC) reported monopolar electrosurgery as a direct cause of t h r e e deaths p r e s u m e d to be the result of delayed bowel perforation. 1 Of note however, is that because of a promise by the CDC not to disclose the names of the victims or the records, no subs e q u e n t histologic examinations of the injury sites were done to confirm or refute the cause of the perforations. In fact, in one of the three patients a perforation was never found; nevertheless, because monopolar energy was used, the injury was assumed to have an electrical cause. In retrospect, trauma was an equal possibility. In 1985, bowel perforations were inflicted on rabbits using a Veress needle, trocar, monopolar energy, or bipolar energy. 2 F o u r days after the injuries, the p e r f o r a t e d bowel was r e s e c t e d and analyzed. T h e gross appearance was inconclusive as to cause, but the microscopic findings were striking and diagnostic. Features of puncture injuries were limited, noncoagulative-type necrosis, m o r e severe in the muscle coat than the mucosa; rapid and abundant capillary ingrowth with rapid white cell infiltration; and rapid fibrin deposition at the injury site followed by fibroblastic proliferation. F e a t u r e s of electrical injuries were absence of capillary in-growth or fibroblastic muscle coat reconstruction; absence of white cell infiltration except in focal areas at the viable borders of

Since the first survey of the American Association of Gynecologic Laparoscopists ( A A G L ) , bowel injury has been recognized as one of the most serious complications of laparoscopy. Although it occurs infrequently, the result of an unrecognized bowel injury is usually serious, often leading to long-term complications. T h e case histories of such incidents are frequently open to medical scrutiny for the first time during legal review by expert witnesses. In forming an opinion on the standard of care, it is c o m m o n to rely on published treatises such as peer review articles, textbooks, and proceedings of medical organizations. Assumptions made in years past may prevail without scrutiny for decades if the fear of legal action prompts silence by those who have experienced a bad outcome. Such is the case with laparoscopic bowel perforation. Since the A A G L ' s first survey over 20 years ago, the cause of the injury generally has been attributed to trauma or electrical injury. Because monopolar electrical energy lends itself to the remote-control surgery requirements of operative laparoscopy, it was a logical choice of the early laparoscopists who, for the most p a r t , c o n f i n e d t h e i r l a p a r o s c o p i c e x p e r i e n c e s to female sterilization and lysis of adhesions. B e c a u s e s e v e r a l r e p o r t s in t h e e a r l y 1970s described abdominal skin burns and presumed bowel burns during m o n o p o l a r p r o c e d u r e s , nonelectrical methods of sterilization were introduced at the same

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injury; and an area of coagulation necrosis. S o o n a f t e r the p u b l i c a t i o n of t h e s e f e a t u r e s , lawyers from both sides of legal discovery sought out the authors for their review and opinions. T o date, 66 cases have been reviewed, each with adequate tissue samples to render a medical opinion based on histologic findings. In all cases of questionable etiology, a Mallory t r i c h r o m e stain was p e r f o r m e d to confirm coagulation necrosis secondary to electrical injury. In addition to microscopic findings, the case histories were scrutinized and the salient features recorded and filed for later review.

she was observed for 72 hours and died. As m e n t i o n e d , all p a t i e n t s h a d a r e s e c t i o n of bowel for pathologic evaluation; 17 had concomitant colostomy. Sixteen patients had a wedge resection with an oversew of the defect; in the two patients with bowel burns, the repair subsequently b r o k e down, requiring reexploration and wide resection. Three deaths occurred, due to septic shock, disseminated intravascular coagulation, and respiratory distress syndrome. E a c h occurred after the patient had been observed for at least 72 hours prior to reexploration. Eighty percent of the patients were operated on on Thursday or Friday, a common pattern for scheduling laparoscopy. This may influence the response of the first health professional contacted when symptoms occur. Two of the six bowel burns were recognized at the initial operation and repaired. Of the other four, the delay from operation to symptoms was 5 to 15 days. Of the 60 traumatic perforations, the range of onset of s y m p t o m s was f r o m less t h a n 1 d a y to 9 days; 51 patients experienced increasing abdominal pain within 3 days. T w o - t h i r d s of the patients r e p o r t e d with t h e i r complaints to the local emergency room; two-thirds of this group were sent h o m e with instructions to call their p r i m a r y d o c t o r at a later date. If the on-call physician was contacted, three-fourths were told to contact the primary surgeon on Monday. All of these patients were operated on on Thursday or Friday. Of the 13 who reached their primary surgeon, only 1 was told to call back on Monday; each of these patients underwent surgery on Monday or Tuesday. When the patients were seen, each had their temperature recorded and blood drawn for a white blood cell count. Both values were within normal limits in 12; in less than 50% were both tests elevated. In every woman in whom both values were elevated, perforation had o c c u r r e d in the large intestine. All of the patients in whom both tests were normal had small bowel injuries. Fifty patients had either an abdominal radiograph or ultrasound evaluation. Only one-third of the radiographs confirmed free air. Of patients with intraabdominal abscesses, one-third of the abscesses were missed by ultrasound. O n e - t h i r d of the p a t i e n t s u n d e r w e n t surgical exploration within 24 hours of symptoms, one-third of these by repeat laparoscopy. Thirteen were explored

Case Studies T h e f o l l o w i n g o b s e r v a t i o n s m i g h t be c a l l e d "lessons learned from laparoscopic bowel perforation after legal discovery." It should be made clear that these cases have a p r o f o u n d selection bias, and the statistical weight of these findings should not be considered a true incidence risk. Still, common themes in these histories should alert surgeons who p e r f o r m laparoscopy or who might care for patients postoperatively. With our better understanding of the nuances of monopolar energy and its applied physics with cont e m p o r a r y generators, the stray sparking t h e o r y of bowel burn (fulguration) has now been refuted. Of the 66 cases, 6 were the result of direct electrical desiccation; the rest were secondary to trauma. Two of the burn cases were the result of defective equipment, three operator error, and one a calculated risk during lysis of extensive adhesions. In the 60 trauma cases, lacerations were from less than 5 to more than 10 mm, the majority being under 5 mm, suggesting either a needle puncture or a partial t r o c a r tip p u n c t u r e . T h r e e o c c u r r e d a f t e r o p e n laparoscopy, and in 12 cases disposable trocars with safety shields were used. Twenty-four percent of the patients had several punctures; all of these women had numerous intraabdominal adhesions. Fifty women had single punctures, and two-thirds of the patients had never had abdominal surgery. It is no s u r p r i s e t h a t o n e - t h i r d of the e v e n t s occurred after a laparoscopic sterilization since it is the most common indication for laparoscopy. Endometriosis was second and an advanced laparoscopic procedure was third. O f the 10 patients undergoing adhesiolysis, only 1 was considered at high risk by history of bowel injury. Despite that concern, when the patient developed increasing signs of peritonitis,

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ative procedures; one of five cases was in this category. Sterilization is the most c o m m o n indication for l a p a r o s c o p y , with e n d o m e t r i o s i s a close s e c o n d . Neither of these indications would place a patient at high risk for bowel perforation. Adhesiolysis was performed in 10 patients. One of four patients had a colostomy, each including this as a reason for making a claim. Two of the four cases of delayed bowel burn were oversewn with minimal resection; each repair broke down and required reexploration with segmental resection and colostomy. In 40 cases the primary surgeon-gynecologist, although available, did not attend the exploratory laparotomy. In each death, the signs and symptoms consistent with intraabdominal injury were apparent more than 48 hours b e f o r e the irreversible events t o o k place. Numerous consultants were involved in each patient's evaluation. It would appear that backup medical coverage, especially e m e r g e n c y r o o m p e r s o n n e l , h a v e to b e aware of a c o m m o n dictum after laparoscopy, patients should not have increasing abdominal pain; if they do, one must consider bowel injury early in the evaluation. The day of the week of surgery influenced the chance of patients seeking advice from an emergency room. U n r e c o g n i z e d bowel burns did have a d e l a y e d onset of symptoms compared with traumatic perforations, but nine trauma eases surfaced between 4 and 9 days after surgery. Only one-third of the patients who returned to the operating r o o m within the first 24 hours had a repeat l a p a r o s c o p y . In several of t h e m , the l a p a r o s e o p i c approach might have helped make the decision as to the size of incision; unsightly scar was a c o m m o n claim. By far the most common reason to file a lawsuit was the b e l i e f that a bowel b u r n was the cause of injury. If one removes the 2 eases of bipolar burns that were recognized at the time of surgery, only 4 (7%) of the remaining 56 claims had merit as to cause.

after 72 hours of s y m p t o m onset; t h r e e eventually died. Seven cases were reviewed after the rabbit study; each had been settled before that study was published. All w e r e s e t t l e d in f a v o r of t h e plaintiffs on the assumption that a bowel burn had occurred. When the slides were reviewed, all injuries proved to be due to trauma, m o r e likely than not from needle or trocar injury during insertion. After 1985, of the 59 remaining cases, one-third were d r o p p e d or dismissed in s u m m a r y j u d g m e n t . Five cases reached court, each ending in a verdict for the d e f e n s e . O f the r e m a i n i n g cases, " f a v o r a b l e " settlements were reached equally between defendant and plaintiff. In m o s t cases, s e v e r a l claims w e r e declared by the plaintiff. In 58 cases the leading claim was electrical bowel injury leading to p e r f o r a t i o n ; postoperative neglect was cited in 24.

Lessons Learned The lessons learned from this series of complications are many, some expected and others revealing. It should be emphasized that this is not a cohort or a case-control study but a series of case reports of bowel injuries during and after laparoscopic p r o c e d u r e s . Claims were filed against the involved health professionals where some form of negligent behavior was suspected. Recognizing the bias of such a series, can m e d i c a l lessons b e g l e a n e d , as well as w a r n i n g s regarding risk management? T h e assumption that a frequent cause of bowel perforation is due to monopolar injury was not substantiated in this series. Open laparoscopy and disposable trocar sheaths with protective safety shields did not eliminate traumatic bowel perforation; thus their use should not lull the surgeon into a sense of false security when assessing a patient with increasing postoperative pain. Although previous abdominal surgery may be a flag of caution w h e n p e r f o r m i n g l a p a r o s c o p y , the u n o p e r a t e d abdomen carries some risk as well. The small bowel, especially the ileum, is most frequently involved, and the injury may not cause clear-cut or rapid s y m p t o m s and a b n o r m a l l a b o r a t o r y values. Abdominal imaging techniques are of help only if they are abnormal. When large bowel perforations occur, the symptoms and initial evaluation are usually more obvious. It is too early to tell the impact of advanced oper-

Summary We must realize that bowel injury is a risk of all laparoscopic procedures. Highlights of this medicolegal exercise and review are as follows. Patients should only improve after a laparoscopic operation, even the advanced operative p r o c e d u r e s

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performed today; in such patients there is little place for an admission for observation. Physicians who agree to cover for a patient's postoperative care would do well to remember this, and respect the potential for this serious, albeit unusual, complication of so-called bandaid surgery. It would seem wise to remove all areas of bowel perforation, with wide resection of those areas where electrical injury is in question. Special histologic stains to identify heat injury (i.e., Mallory trichrome) should be applied. Using polarized light, a picrous red stain is considered by some to be more specific for confirming an electrical injury. Although the decision to perform a colostomy is one of judgment, all options should be considered. A good risk-management tool is the presence of the gynecologic surgeon at the time of bowel repair. Equipment and surgical techniques that are said to avoid bowel injury have not proved their claim. A delayed perforation does not mean a bowel burn has occurred; an early perforation, within 72

hours, is most surely a traumatic injury, and may be beyond the control of the most skilled laparoscopist. Abnormal laboratory and imaging tests are helpful in confirming the diagnosis; normal test results should not be reassuring. More and more, patients are taking part in managing their own health; they and the rest of the health care team should be made aware that increasing abdominal pain after laparoscopic procedures demand an expedient evaluation even if it requires a repeat laparoscopy with negative findings. References

1. Anonymous: Deaths following female sterilization with unipolar electrocoagulating devices. MMWR 30:149, 1981 2. Levy BS, Soderstrom RM, Dail DH: Bowel injuries during laparoscopy: Gross anatomy and histology. J Reprod Med 30:168 179, 1985

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