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ORIGINAL RESEARCH |
From the Department of Obstetrics and Gynaecology, Dalhousie University, Halifax, Nova Scotia, Canada
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: The prevalence of urinary tract injury and the relative risks of litigation from an injury were determined from the national hospital discharge abstract and the national physician malpractice databases. Multiple logistic regression was performed on a subset of litigation cases.
RESULTS: The prevalence of urinary tract injury at benign gynecologic surgery was low (0.33%). If a patient sustained a urinary tract injury, there was a high relative risk of litigation (relative risk 91, 95% confidence interval [CI] 55–158). Patients had a higher chance of major disability after urinary tract injury from hysterectomy for abnormal uterine bleeding (odds ratio [OR] 6.16, 95% CI 1.13–39.01, P = .04), but a lower chance of this being a permanent disability (OR 0.23, 95% CI 0.05–0.96, P = .05). Permanent disability was more likely after an obstructed ureter compared with other types of urinary tract injuries (OR 4.54, 95% CI 1.55–14.88, P = .008). Only 18% of the injuries were recognized intraoperatively. An acute bladder injury was more likely to be recognized intraoperatively than other types of injury (OR 14.98, 95% CI 3.89–57.74, P < .001). No obstructed ureters or urinary tract fistulae were recognized intraoperatively.
CONCLUSION: Urinary tract injuries are an uncommon but significant complication from benign gynecologic surgery. Such injuries are associated a high relative risk of litigation.
LEVEL OF EVIDENCE: II-3
There are 3 levels for prevention of urinary tract injuries at gynecologic surgery.3 Primary prevention consists of avoiding lower urinary tract injury by careful surgical technique, including identifying the ureters and bladder during major gynecologic surgery.4 Secondary prevention is the intra-operative recognition and repair of the injury. Tertiary prevention, or minimizing the morbidity and sequelae once urinary tract injuries become symptomatic in the postoperative period, usually involves further diagnostic and surgical interventions to confirm and manage the injury. When compared with tertiary prevention, primary and secondary prevention are often easier, more successful, less morbid, and probably result in less litigation.5 Although better patient care and improved clinical outcomes should be the main goal of any preventive measures, medico-legal outcomes should also be considered.
The Canadian Medical Protective Association is the major medical mutual defense organization, representing more than 95% (61,281) of Canadian physicians. Since 1976, as part of continuing quality assurance, research, and educational programs, the Canadian Medical Protective Association has maintained a database of all cases for which legal actions were opened and closed. The Risk Management Services Division at the Canadian Medical Protective Association has maintained this database since January 1, 1987. Medical analysts abstract and code medical and legal data from the case files according to a coding manual developed and maintained by Risk Management Services. This manual is based on a combination of International Classification of Diseases, 9th Revision, Canadian Classification of Diagnostic, Therapeutic, and Surgical Procedures, Physician Insurers Association of America Expansion Codes, and internal codes that were developed to code data not captured by these other systems.6 Systematic audits of abstracting, coding, and data entry are performed regularly.
Since 1996, The Canadian Institute of Health Information, a nonprofit national organization, has developed and maintained the Discharge Abstract Database. This database provides clinical, demographic, and administrative information on patients discharged from Canadian Hospitals (except for the provinces of Quebec and rural Manitoba). The Canadian Medical Protective Association has access to 2 years of this database (April 1, 1998, to March 31, 2000).
Because of the almost universal nature of the Canadian health service and physician malpractice protection systems and the databases maintained by The Canadian Institute of Health Information and Canadian Medical Protective Association, we were able to study various outcomes of urinary tract injuries at gynecologic surgery in Canada. Our first goal was to estimate the prevalence of urinary tract injury and the relative risk of litigation from an injury for major benign gynecologic surgery in Canada during 1998 to 2000. To establish whether there were independent risk factors that predicted medical and legal outcomes, we analyzed all cases of gynecologic litigation, including a subset of litigation cases from urinary tract injury over the 6 years from 1996 through 2001.
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MATERIALS AND METHODS |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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We estimated the prevalence of urinary tract injury, litigation rates, and the relative risk of litigation from hysterectomy and adnexal surgery combined, from hysterectomy alone, and from adnexal surgery alone. The injury prevalence, litigation rates, and relative risks of litigation from hysterectomy alone and from adnexal surgery alone may be limited by the fact that The Canadian Institute of Health Information data probably overestimates the injuries from hysterectomy and underestimates the injuries from adnexal surgery. The reason for this is that urinary tract injury cases from The Canadian Institute of Health Information with combined hysterectomy and adnexal surgery were coded as hysterectomy, because it was not possible to determine which part of the surgical procedure (the hysterectomy or the adnexal surgery) resulted in the injury. For most urinary tract injury cases from the Canadian Medical Protective Association Database it was possible to determine which part of the surgical procedure (the hysterectomy or the adnexal surgery) resulted in the injury and thus each was classified accordingly.
For the 6-year period 1996–2001, we examined all closed legal-civil case files involving gynecologic litigation from the Canadian Medical Protective Association Database. Closed legal-civil files included all cases that were settled, dismissed, or resulted in judgment for the surgeon or plaintiff. The years 1996 to 2001 were chosen to reflect recent trends and patterns. Multiple logistic regression analysis was performed. Step-wise backwards selection was used with a significance level of 0.15 for removing variables; however, we have reported variables significant at the 0.05 level.7
There were 604 closed gynecologic legal-civil files between 1996 and 2001. Cases involving urinary continence surgeries were excluded. Of the 604 files, 99 cases involved a urinary tract injury at benign gynecologic surgery and 505 cases involved gynecologic litigation not related to urinary tract injury. The first model was a comparison of these 2 groups. The independent variables were "primary gynecologic diagnosis," "type of surgical procedure," "level of disability," and "length of disability." The second, third, fourth, and fifth models were performed upon 97 of the 99 legal-civil files of urinary tract injuries that resulted in either a major or a minor disability, removing one case that resulted in no disability and a second case that resulted in death from pulmonary embolism. The second model explored "time of recognition" (ie, intraoperative or postoperative) of the injury with "primary gynecologic diagnosis," "type of surgical procedure," and "type of urinary tract injury" as the independent variables. The third and fourth models explored "level of disability" (ie, major or minor) and "length of disability" (ie, permanent or temporary), respectively, with "primary gynecologic diagnosis," "type of surgical procedure," "type of urinary tract injury," and "time of recognition" of the injury as the independent variables. Only the categories containing significant independent variables (P < .05) were reported. The fifth model explored whether time of recognition was predictive of legal outcome, legal costs, or duration of litigation.
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RESULTS |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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For our first model, comparing 99 cases of urinary tract injury with 505 cases of no urinary tract injuries, there were only 3 significant risk factors. A primary gynecologic diagnosis of "other uterine pathology" (adenomyosis, uterine prolapse, cervical dysplasia, or unwanted pregnancy) was protective. The odds ratio of a urinary tract injury in this group was 0.48 (95% confidence interval [CI] 0.24–0.91, P = .03) compared with adnexal disease, uterine fibroids, abnormal uterine bleeding, or other pelvic diseases. If the type of surgical procedure performed was hysterectomy compared with adnexal surgery or other pelvic surgery, the odds ratio of urinary tract injury was 7.45 (95% CI 4.64–12.22, P < .001). No disability (or the assignment of no disability by a medical analyst) was more likely if a patient was not in the urinary tract injury group, with an odds ratio of 0.14 (95% CI 0.01–0.66, P = .05).
For our second model, exploring "time of recognition" of the injury, 17 (18%) of the injuries were recognized intraoperatively and 80 (82%) were recognized postoperatively. The final multivariate model gave an odds ratio of 14.98 (95% CI 3.89–57.74, P < .001) for recognition of perforation or laceration of the bladder intraoperatively compared with an obstructed ureter, a perforated or lacerated ureter, or a urinary tract fistula. None of the obstructed ureters (n = 35) or the urinary tract fistulae (n = 10) was recognized intraoperatively. All of the urinary tract fistulae occurred after hysterectomy and none occurred after adnexal or other pelvic surgery.
Our third model, "level of disability" (ie, major or minor), and fourth model, "length of disability" (ie, permanent or temporary), are presented in Tables 2 and 3, respectively. There were significant independent risk factors for "level of disability" from a urinary tract injury (Table 2). For "primary gynecologic diagnoses," in comparison with a patient with an injury who presented with an adnexal disease (reference group), the probability of experiencing major disability was increased 6-fold when a patient with an injury had presented with abnormal uterine bleeding (P = .04) and increased 5-fold when a patient with an injury had presented with other pelvic diseases (P = .03). For "type of surgery," in comparison with a patient who had adnexal or other pelvic surgery performed (reference group), the risk of major disability from an injury was decreased 5-fold when a patient had a hysterectomy (P = .01).
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Our fifth model explored whether "time of recognition" was predictive of legal outcome, legal costs, or duration of litigation. Eighty-two percent (14/17) of the injuries recognized intraoperatively had a favorable legal outcome (dismissal or judgment for the surgeon). Sixty percent (48/80) of the injuries not recognized intraoperatively had a favorable legal outcome. The final multiple logistic regression model did not show any significant relationship among intraoperative recognition and favorable legal outcome, lower legal costs, or shorter duration of litigation.
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DISCUSSION |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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For all cases that proceeded to litigation during the 6-year period 1996 to 2001, urinary tract injuries were more likely to be present after hysterectomy than after adnexal or other pelvic surgery. The higher risk of injury with hysterectomy may be because removing the uterus puts the lower urinary tract at risk of injury at more locations than does adnexal or other pelvic surgery. Alternatively, adnexal surgery or other pelvic surgery may have inherently higher risks of injury, but surgeons, being more aware of these risks, may modify their behavior and techniques to avoid injury: for example, routinely dissecting out the ureter at the pelvic brim before removing adnexa. Within the group of gynecologic cases that proceed to litigation, urinary tract injuries at hysterectomy emerge as an important group to potentially decrease medical and legal sequelae.
Various categories of injury were more or less likely to be diagnosed intraoperatively. Bladder injuries were diagnosed 15 times more often intraoperatively than other urinary tract injuries, such as an obstructed ureter, a perforated or lacerated ureter, or urinary tract fistulae. The most likely reason for this is that an indwelling catheter is usually placed to drain the bladder during gynecologic surgery. Seeing the catheter balloon in the operative site increases the chance of recognizing an injury, allowing for intraoperative management. None of the obstructed ureters were recognized intraoperatively. The most likely reason for this is that for the standard technique of hysterectomy for benign disease, surgeons do not routinely dissect out and identify the distal ureter. This is not recommended because of the increased risks of intraoperative bleeding and of devascularization of the ureter, potentially leading to late complications from ischemia and necrosis of the ureter(s).
Medical analysts assigned "level of disability" and "length of disability" to each case file after review of the expert testimony and legal file. The risk of a patient with an injury being assigned a major disability was significantly greater for patients who presented with the "primary gynecologic diagnosis" of abnormal uterine bleeding or other pelvic diseases, but "type of surgery" as hysterectomy (compared with adnexal or other pelvic surgery) was protective. The risk of a patient with an injury being assigned a permanent disability was significantly less for patients who presented with the primary diagnoses of fibroids and abnormal uterine bleeding. The risk of a patient with an injury being assigned a permanent disability was significantly greater for an obstructed ureter than for other categories of urinary tract injuries. Bias might explain most of these findings. Possibly there is a "sympathy factor" by which certain diagnoses, types of surgeries, or types of injuries result in variable intensities at legal proceedings for pursuing supportive or unsupportive expert witness testimony. Consequently, these file characteristics may influence whether the medical analysts assign major or permanent disabilities. However, the "sympathy factor" or intensity of legal proceedings is likely related to the degree of suffering or perceived suffering by the patient. Thus, urinary tract injuries that lead to litigation are a likely cause of significant physical and psychologic morbidity and sequelae for the individuals who experience them.
If commencing litigation is correlated with pain and suffering, our study confirms that the tertiary prevention approach to minimizing the morbidity and sequelae from urinary tract injuries after they occur is not ideal. Many centers in North America recommend secondary preventive measures such as liberal use of intraoperative cystoscopy at the time of gynecologic and urogynecologic surgery to allow earlier diagnosis and management of injury, limiting the postoperative sequelae.8,9,10,11 From our analysis, some of the more severe outcomes, such as obstructed ureters, may have been identified and corrected with intraoperative cystoscopy. Selective use of intraoperative cystoscopy in cases with concerns about lower urinary tract integrity may have decreased the frequency and severity of these injuries. However, whether routine or universal use of intraoperative cystoscopy will be cost-effective in preventing sequelae from urinary tract injuries remains to be determined.
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Footnotes |
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Presented in part at the Annual Clinical Meeting of the Society of Obstetricians and Gynecologists of Canada, Charlottetown, Prince Edward Island, Canada, June 25–30, 2003.
Parts of this material are based on data and information provided by the Canadian Institute for Health Information. However, the analyses, conclusions, opinions, and statements expressed herein are those of the authors and not necessarily those of the Canadian Institute for Health Information.
Reprints are not available. Address correspondence to: Dr. D. T. Gilmour, IWK Health Centre, 5850/5980 University Avenue, PO Box 3070, Halifax, Nova Scotia B3J 3G9, Canada; e-mail: Catherine.Hamblin{at}iwk.nshealth.ca.
Received April 21, 2004. Received in revised form August 11, 2004. Accepted August 19, 2004.
doi:10.1097/01.AOG.0000144127.78481.8c
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REFERENCES |
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2. Baskett TF, Clough H. Perioperative morbidity of hysterectomy for benign gynecological disease. J Obstet Gynaecol 2001;21:504–6.
3. Thompson JD. Operative injuries to the ureter: prevention, recognition, and management. In: Rock JA, Thompson JD, editors. TeLinde's operative gynecology. 8th ed. Philadelphia (PA): Lippincott-Raven; 1997. p. 1135–74.
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6. The Canadian Medical Protective Association (CMPA). Coding manual for the CMPA database. Ottawa (Canada): CMPA Risk Management Services; 2001.
7. Hosmer DW, Lemeshow S. Model-building strategies. In: Applied logistic regression. 2nd ed. New York (NY): John Wiley & Sons; 2000. p. 86.
8. Ferro A, Byck D, Gallup D. Intraoperative and postoperative morbidity associated with cystoscopy performed in patients undergoing gynecologic surgery. Am J Obstet Gynecol 2003;189:354–7.[Medline]
9. Kwon CH, Goldberg RP, Koduri S, Sand PK. The use of intraoperative cystoscopy in major vaginal and urogynecologic surgeries. Am J Obstet Gynecol 2002;187:1466–72.[Medline]
10. Jabs CF, Drutz HP. The role of intraoperative cystoscopy in prolapse and incontinence surgery. Am J Obstet Gynecol 2001;185:1368–73.[Medline]
11. Stevenson KR, Cholhan HJ, Hartmann DM, Buchsbaum GM, Guzick DS. Lower urinary tract injury during the Burch procedure: is there a role for routine cystoscopy? Am J Obstet Gynecol 1999;181:35–8.[Medline]
This article has been cited by other articles:
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  D. T. Gilmour, S. Das, and G. Flowerdew Rates of urinary tract injury from gynecologic surgery and the role of intraoperative cystoscopy. Obstet. Gynecol., June 1, 2006; 107(6): 1366 - 1372. [Abstract] [Full Text] [PDF]
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