- Email: [email protected]
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after intravaginal prostaglandin E2 during preinduction cervical ripening. Am J Obstet Gynecol 1991;165:1006 –9. Smith CV, Rayburn WF, Miller AM. Intravaginal prostaglandin E2 for cervical ripening and initiation of labor. Comparison of a multidose gel and single, controlled-release pessary. J Reprod Med 1994;39:381– 6. Chyu JK, Strassner HT. Prostaglandin E2 for cervical ripening: A randomized comparison of Cervidil versus Prepidil. Am J Obstet Gynecol 1997;177:606 –11. Wing DA, Ortiz-Omphroy G, Paul RH. A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction. Am J Obstet Gynecol 1997;177:612– 8. Sanchez-Ramos L, Peterson DE, Delke I, Gaudier FL, Kaunitz AM. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: A randomized trial. Obstet Gynecol 1998;91:401–5. Ottinger WS, Menard MK, Brost BC. A randomized clinical trial of prostaglandin E2 intracervical gel and a slow release vaginal pessary for preinduction cervical ripening. Am J Obstet Gynecol 1998;179:349 –53. Stewart JD, Rayburn WF, Farmer FC, Liles EM, Schipul AH Jr, Stanley JR. Effectiveness of prostaglandin E2 intracervical gel (Prepidil), with immediate oxytocin, versus vaginal insert (Cervidil) for induction of labor. Am J Obstet Gynecol 1998;179:1175– 80. Hennessey MH, Rayburn WF, Stewart JD, Liles EC. Preeclampsia and induction of labor: A randomized comparison of prostaglandin E2 as an intracervical gel, with oxytocin immediately, or as a sustained-release vaginal insert. Am J Obstet Gynecol 1998;179:1204–9. Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: An annotated bibliography of scales and checklists. Control Clin Trials 1995;16:62–73. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies. J Natl Cancer Inst 1959;22:719 – 48. Breslow NE, Day NE. Statistical methods in cancer research. Vol 1, no. 32. The analysis of case control studies. Lyon, France: IARC Scientific Publications, 1980. L’Abbe KA, Detsky AS, O’Rourke K. Meta-analysis in clinical research. Ann Intern Med 1987;107:224 –33. Follmann D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol 1992;45:769 –73.
Lower urinary tract injury during gynecologic surgery and its detection by intraoperative cystoscopy D. T. Gilmour, MD, FRCSC, P. L. Dwyer, MBBS, FRACOG, and M. P. Carey, MD, FRACOG Objective: To review the frequency of lower urinary tract injuries after major gynecologic surgery and the role of From the Royal Women’s Hospital and the Mercy Hospital for Women, Melbourne, Australia.
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28. Egger M, Davey Smith G, Schneider M, Minder C. Bias in metaanalysis detected by a simple, graphical test. BMJ 1997;315:629 –34. 29. Blair FC, Tassone SA, Pearman CR, St Cyr MB, Rayburn WF. Inducing labor with a sustained-release PGE2 vaginal insert. Experience at a community hospital. J Reprod Med 1998;43:408 –12. 30. Taylor AV, Boland J, Bernal AL, MacKenzie IZ. Prostaglandin metabolite levels during cervical ripening with a controlled-release hydrogel polymer prostaglandin E2 pessary. Prostaglandins 1991;41:585–94. 31. Taylor AV, Boland J, MacKenzie IZ. The concurrent in vitro and in vivo release of PGE2 from a controlled-release hydrogel polymer pessary for cervical ripening. Prostaglandins 1990;40:89 –98. 32. Lyndrup J, Nickelsen C, Guldbaek E, Weber T. Induction of labor by prostaglandin E2: Intracervical gel or vaginal pessaries? Eur J Obstet Gynecol Reprod Biol 1991;42:101–9. 33. Orhue AA. Induction of labour at term in primigravidae with low Bishop’s score: A comparison of three methods. Eur J Obstet Gynecol Reprod Biol 1995;58:119 –25. 34. Stampe Sorensen S, Palmgren Colov N, Andreasson B, Bock JE, Berget A, Schmidt T. Induction of labor by vaginal prostaglandin E2. A randomized study comparing pessaries with vaginal tablets. Acta Obstet Gynecol Scand 1992;71:201– 6. 35. Keirse MJ. Prostaglandins in preinduction cervical ripening. Metaanalysis of worldwide clinical experience. J Reprod Med 1993;38: 89 –100. 36. Owen J, Winkler CL, Harris BA Jr, Hauth JC, Smith MC. A randomized, double-blind trial of prostaglandin E2 gel for cervical ripening and meta-analysis. Am J Obstet Gynecol 1991;165:991– 6.
Address reprint requests to:
Luis Sanchez-Ramos, MD Department of Obstetrics and Gynecology University of Florida Health Science Center 653-1 West 8th Street Jacksonville, FL 32209 E-mail: [email protected] Received November 2, 1998. Received in revised form February 18, 1999. Accepted March 4, 1999. Copyright © 1999 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
routine intraoperative cystoscopy during major gynecologic surgery in the detection of lower urinary tract injuries. Data Sources: We combined a MEDLINE search for reports from 1966 to October 1998, using the terms “urinary tract injury,” “ureter/ureteric/ureteral obstruction/fistula/injury,” “bladder fistula/injury,” and “vesico-vaginal fistula,” with a second search for all reports of gynecologic surgical procedures. Additional references were obtained from relevant articles and review articles. Methods of Study Selection: Included were all English language articles on the frequency of unintentional urinary tract injuries identified during or after benign gynecologic surgery. There were 22 reports on the frequency of lower urinary tract injuries after gynecologic surgery and eight on the use of routine cystoscopy during gynecologic surgery to diagnose unsuspected injuries.
0029-7844/99/$20.00 PII S0029-7844(99)00456-1
883
Tabulation, Integration, and Results: In the reports of studies not involving routine cystoscopy, the frequency of ureteral injury varied from 0 to 14.6 injuries per 1000 operations, with an overall frequency of 1.6 per 1000. The frequency of bladder injury varied from 0.2 to 19.5 per 1000, with an overall frequency of 2.6 per 1000. Only 11.5% of ureteral injuries and 51.6% of bladder injuries were identified and managed intraoperatively. In the reports of studies involving routine cystoscopy, the frequency of ureteral injury varied from 0 to 26.8 per 1000, with an overall frequency of 6.2 per 1000. The frequency of bladder injury varied from 0 to 29.2 per 1000, with an overall frequency of 10.4 per 1000. Up to 90% of unsuspected ureteral injuries and 85% of unsuspected bladder injuries were identified with the use of cystoscopy and were managed successfully intraoperatively. In 69% of the unsuspected ureteral and bladder injuries, the intraoperative management consisted of removing and replacing sutures or repairing unintentional cystotomies. Conclusion: Use of routine intraoperative cystoscopy during major gynecologic and urogynecologic surgery might prevent sequelae from lower urinary tract injuries. (Obstet Gynecol 1999;94:883–9. © 1999 by The American College of Obstetricians and Gynecologists.)
There is potential for lower urinary tract injuries during gynecologic surgery because of the anatomic proximity of the reproductive and lower urinary tracts. Almost every major gynecologic operation has been reported to lead to a lower urinary tract injury.1 Unrecognized lower urinary tract injuries after gynecologic surgery can be asymptomatic or can present with immediate postoperative pain, fever, peritonitis, ileus, or other morbidity and lead to further surgery. Long-term sequelae of bladder and ureteral injuries include urine leakage from fistulas and loss of renal function. More recently, medicolegal sequelae are becoming more of a concern because surgeons are being found negligent increasingly for lower urinary tract injuries, even when surgery is documented as anything but straightforward.2 The best approach is to avoid lower urinary tract injury, by meticulous and careful surgical technique— identifying, dissecting, and reflecting contiguous lower urinary tract structures during gynecologic surgery.3 If injury occurs despite those efforts, the next best approach is intraoperative recognition and repair. Routine intraoperative cystoscopy after all major gynecologic operations may facilitate the recognition of a real or potential injury, allowing intraoperative repair. Repair at the primary surgery often is easier, more successful, less morbid for the patient, and advantageous for the surgeon from a legal point of view.4 The objectives of this study were to review the frequency of lower urinary tract injuries after major gynecologic surgery and the role of routine intraoperative cystoscopy after major gynecologic surgery in the 884 Gilmour et al
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diagnosis of unsuspected lower urinary tract injuries and, as a consequence, in the prevention or limitation of their sequelae.
Sources We did a MEDLINE search covering 1966 to October 1998 using a combination of thesaurus and single-term search strategies. The initial search was for all reports with any of the following key words: “urinary tract injury,” “ureter/ureteric/ureteral obstruction/fistula/injury,” “bladder fistula/injury,” or “vesico-vaginal fistula.” That search was combined with a second search for all reports involving gynecologic surgical procedures. Our review was limited to articles published in English.
Study Selection We retrieved 272 abstracts. The reference sections of all relevant articles and review articles were scrutinized for articles not found with our search. A total of 135 articles were reviewed in detail. Considered were all reports on the frequency of unintentional urinary tract injuries identified during or after benign gynecologic surgery. Because lower urinary tract injuries after gynecologic surgery are relatively rare, only reports of studies with more than 500 patients were included. We excluded letters to the editor, case reports, small case series, and reports in which injuries secondary to radical pelvic surgery or obstetric complications could not be separated from injuries secondary to benign gynecologic surgery. Because reports of studies involving routine intraoperative cystoscopy during gynecologic surgery were scarce and these studies involved fewer women, all of those reports were included in our review, even if fewer than 500 subjects were studied. We identified 30 reports that fit our criteria, 22 on the frequency of lower urinary tract injuries after gynecologic surgery and eight on the use of routine cystoscopy during gynecologic surgery to diagnose unsuspected injuries.
Results Frequencies of ureteral and bladder injuries are summarized from studies involving and those not involving routine intraoperative cystoscopy. Overall frequency was determined by dividing the number of ureteral or bladder injuries by the number of operations. To facilitate comparisons, we have converted all frequencies of ureteral and bladder injuries to frequencies per 1000 operations. Types of operations are listed as accurately as could be determined from each study. With the exception of Dicker et al,5 the studies were retrospective. Newell6 included injuries recognized postoperatively and those recognized at autopsy. Obstetrics & Gynecology
Table 1. Frequency of Ureteral Injuries After Major Gynecologic Surgery
Study 7
Rosen et al Saidi et al8 Harkki-Siren et al9 Liu and Reich10 Stanhope et al11 Daly and Higgins12 Falk and Bunkin13 Harkki-Siren et al9 Goodno et al14 Kunz15 Dicker et al5 Amirikia and Evans16 Thompson and Benigno17 Falk and Bunkin13 Holloway18 Newell6 Harkki-Siren et al9 Falk and Bunkin13 Newell6 Stanhope et al11 Harkki-Siren et al9 Goodno et al14 Kudo et al19 Dicker et al5 Amirikia and Evans16 Thompson and Benigno17 Falk and Bunkin13 Copenhauer20 Edwards and Beebe21 Total
Year
Operation
1996 1996 1998 1994 1991 1988 1954 1998 1995 1984 1982 1979 1971 1954 1950 1939 1998 1954 1939 1991 1998 1995 1990 1982 1979 1971 1954 1962 1949
Open Burch colposuspension Major laparoscopic surgery* Laparoscopic hysterectomy Laparoscopic hysterectomy Major abdominal surgery† Major abdominal surgery† Adnexal surgery Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Subtotal abdominal hysterectomy Subtotal abdominal hysterectomy Subtotal abdominal hysterectomy Major vaginal surgery‡ Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy
No. of operations
No. of ureteral injuries
929 953 2741 518 2833 1093 567 43,149 2469 737 1283 4228 2287 1114 808 944 10,854 1577 2072 2546 5636 1054 9230 568 2111 1533 1664 1000 570 107,068
4 4 37 1 2 16 1 17 8 3 3 5 9 1 6 8 3 1 5 16 1 5 3 0 2 1 2 2 2 168
No. of ureteral injuries/1000 operations 4.3 4.2 13.5 1.9 0.7 14.6 1.8 0.4 3.2 4.1 2.3 1.2 3.9 0.9 7.4 8.5 0.3 0.6 2.4 6.3 0.2 4.7 0.3 0 0.9 0.7 1.2 2.0 3.5
No. of injuries recognized intraoperatively
No. of injuries recognized postoperatively
0 0 2 0 0 8 0 0 NE 1 0 NE NE 0 1 0 1 1 1 0 0 NE NE 0 NE NE 0 0 0 15
4 4 35 1 2 8 1 17 NE 2 3 NE NE 1 5 5 2 0 2 16 1 NE NE 0 NE NE 2 2 2 115
NE ⫽ not able to elicit information about whether ureteric injury was diagnosed intraoperatively or postoperatively from the details provided in the report. * Including laparoscopic hysterectomy (with/without adnexectomy), ovarian cystectomy, and ablation of severe (grade 4) endometriosis.6 † Including total abdominal hysterectomy and/or other abdominal gynecologic operations for the treatment of pelvic conditions.9,10 ‡ Including vaginal hysterectomy and/or other vaginal operations for the correction of vaginal prolapse.9
Seventeen reports contained frequencies of ureteral injuries after various major gynecologic surgeries (Table 1). The frequency of ureteral injury in those studies varied from 0 to 14.6 injuries per 1000 operations, with an overall frequency of 1.6 per 1000. In 13 of the 17 reports, we ascertained times of identification and management of ureteral injuries. Of 130 injuries in those 13 studies, only 15 ureteral injuries (11.5%) were identified and managed during the primary operation, and 115 (88.5%) were diagnosed and managed postoperatively. Fourteen reports contained frequencies of bladder injuries after various major gynecologic surgeries (Table 2). The frequency of bladder injuries varied from 0.2 to 19.5 per 1000, with an overall frequency of 2.6 per 1000. In 11 reports, we ascertained times of identification and management of bladder injuries. Of 157 injuries in those 11 studies, 81 bladder injuries (51.6%) were recorded as identified and successfully managed intraoperatively and 76 (48.4%) were recorded as identified and manVOL. 94, NO. 5, PART 2, NOVEMBER 1999
aged postoperatively. Most postoperatively recognized bladder injuries presented as vesicovaginal fistulas (74 of 76, 97%). Eight reports contained frequencies of unsuspected ureteral and/or bladder injuries diagnosed with the use of intraoperative cystoscopy during major gynecologic and urogynecologic surgeries (Tables 3 and 4). All of those studies were retrospective. Cystoscopy was performed transurethrally or transvesically with or without the use of intravenous indigo carmine to help confirm ureteral patency. In the studies involving routine cystoscopy, the frequency of ureteral injuries varied from 0 to 26.8 per 1000, with an overall frequency of 6.2 per 1000. The frequency of bladder injuries varied from 0 to 29.2 per 1000, with an overall frequency of 10.4 per 1000. In the studies involving intraoperative cystoscopy, there were 20 unsuspected ureteral injuries (Table 3). Eighteen (90%) of the 20 unsuspected ureteral injuries Gilmour et al
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Table 2. Frequency of Bladder Injuries After Major Gynecologic Surgery
Study 8
Saidi et al Harkki-Siren et al9 Ou et al22 Liu and Reich10 Harkki-Siren et al9 Kunz15 Dicker et al5 Amirikia and Evans16 Falk23 Graber et al24 Howkins25 Holloway18 Harkki-Siren et al9 Harkki-Siren et al9 Kudo et al19 Dicker et al5 Amirikia and Evans16 Copenhauer20 Allen and Peterson26 Total
Year
Operation
1996 1998 1994 1994 1998 1984 1982 1979 1967 1964 1963 1950 1998 1998 1990 1982 1979 1962 1954
Major laparoscopic surgery* Laparoscopic hysterectomy Laparoscopic hysterectomy Laparoscopic hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Subtotal abdominal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy
No. of operations
No. of bladder injuries
953 2741 839 518 43,149 737 1283 4228 1000 819 1000 808 10,854 5636 9230 568 2111 1000 2280 89,754
11 24 8 6 54 1 4 18 5 16 2 8 3 1 44 9 4 11 2 231
No. of bladder injuries/1000 operations 11.5 8.8 9.5 11.6 1.3 1.4 3.1 4.3 5.0 19.5 2.0 9.9 0.3 0.2 4.8 15.8 1.9 11.0 0.9
No. of injuries recognized intraoperatively
No. of injuries recognized postoperatively
8 14 NE 5 9 1 4 NE 2 11 1 6 2 0 NE 8 NE 10 0 81
3 10 NE 1 45 0 0 NE 3 5 1 2 1 1 NE 1 NE 1 2 76
Abbreviation as in Table 1. * Including laparoscopic hysterectomy (with/without adnexectomy), ovarian cystectomy, and ablation of severe (grade 4) endometriosis.6
were diagnosed and managed successfully during the primary surgery. In ten (56%) of the 18 cases, obstructing sutures were removed and absence of obstruction was confirmed with repeat cystoscopy. In three (17%) of the 18 cases, women required cystotomies, ureteral stents, or ureteral reimplantation during primary surgery. No details were provided on intraoperative man-
agement of ureteral obstructions in five cases (28%) or on final functional outcome in any of the cases. Two (10%) of the 20 unsuspected ureteral injuries were not diagnosed and managed intraoperatively (Table 3). In one case, after a vaginal hysterectomy, culdoplasty, and anterior and posterior repair, the surgeon identified a ureteral injury with the use of intraopera-
Table 3. Frequency of Ureteral Injuries Diagnosed With the Use of Routine Cystoscopy During Major Gynecologic Surgery
Study
Year
Operation
Wiskind and Thompson27 Dwyer et al28 Pace et al29 Dwyer et al28 Miklos et al30 Dwyer et al28 Harris et al31 Pettit and Petrou4 Councell et al32 Timmons and Addison33 Total
1995 1999 1997 1999 1997 1999 1997 1994 1994 1990
Major gynecologic surgery* Open Burch colposuspension Open Burch colposuspension Laparoscopic Burch colposuspension Laparoscopic Burch colposuspension Stamey needle suspension Reconstructive pelvic floor surgery† Major vaginal surgery‡ Laparoscopic hysterectomy Abdominal gynecologic surgery§
No. of No. of injuries No. of injuries ureteral No. of recognized recognized ureteral injuries/1000 No. of intraoperatively postoperatively operations operations injuries 1270 925 112 178 21 61 224 236 171 37 3235
5 0 0 3 0 0 6 5 1 0 20
3.9 0 0 16.9 0 0 26.8 21.2 5.8 0
5 0 0 2 0 0 6 5 1 0 19
0 0 0 1 0 0 0 0 0 0 1
* Including total abdominal hysterectomy (with/without adnexectomy), total vaginal hysterectomy (with/without vaginal repairs), and stress incontinence surgery.27 † Including abdominal and vaginal colpopexies, colpectomy or colpocleisis, colpoplastic repairs, needle urethropexy, retropubic urethropexy, and pubovaginal sling.31 ‡ Including culdoplasties, sacrospinous ligament fixation, anterior repair, modified Pereyra procedure, pubovaginal slings, vaginal paravaginal defect repair, fistula repair, and vaginal hysterectomy.4 § Including total abdominal hysterectomy (with/without adnexectomy), retropubic urethropexy (with/without hysterectomy, posterior repair, or sacral colpopexy), and exploratory laparotomy.33
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Table 4. Frequency of Bladder Injuries Diagnosed With the Use of Routine Cystoscopy During Major Gynecologic Surgery
Study 28
Dwyer et al Pace et al29 Dwyer et al28 Miklos et al30 Dwyer et al28 Harris et al31 Pettit and Petrou4 Councell et al32 Total
Year
Operation
1999 1997 1999 1997 1999 1997 1994 1994
Open Burch colposuspension Open Burch colposuspension Laparoscopic Burch colposuspension Laparoscopic Burch colposuspension Stamey needle suspension Reconstructive pelvic floor surgery* Major vaginal surgery† Laparoscopic hysterectomy
No. of operations
No. of bladder injuries
925 112 178 21 61 224 236 171 1928
3 3 3 0 1 3 2 5 20
No. of bladder injuries/1000 operations 3.2 26.8 16.9 0 16.4 13.4 8.5 29.2
No. of injuries recognized intraoperatively
No. of injuries recognized postoperatively
1 3 3 0 1 3 2 4 17
2 0 0 0 0 0 0 1 3
* Including abdominal and vaginal colpopexies, colpectomy or colpocleisis, colpoplastic repairs, needle urethropexy, retropubic urethropexy, and pubovaginal sling.31 † Including culdoplasties, sacrospinous ligament fixation, anterior repair, modified Pereyra procedure, pubovaginal slings, vaginal paravaginal defect repair, fistula repair, and vaginal hysterectomy.4
tive cystoscopy but deferred repair with a ureteroneocystostomy until postoperative day 1.27 In a second case, despite negative intraoperative cystoscopy findings after a laparoscopic Burch colposuspension, a symptomatic unilateral ureteral ligation was detected 2 days postoperatively and required management with a ureteroneocystostomy.28 In the studies involving intraoperative cystoscopy, there were 20 unsuspected bladder injuries (Table 4). Seventeen (85%) of the 20 unsuspected bladder injuries were identified and managed successfully intraoperatively. Management consisted of removal and appropriate replacement of sutures in ten (59%) of the 17 cases, repair of unintentional cystotomy in four (24%), and removal and appropriate replacement of a sling in one. No details were provided on intraoperative management in two cases (12%) or on final functional outcome in any cases. Despite the use of intraoperative cystoscopy during primary surgery, three (15%) of the 20 unsuspected bladder injuries were not diagnosed (Table 4). Two of those women had open Burch colposuspensions and subsequently presented with lower urinary tract symptoms. Nonabsorbable suture was found in the bladder by repeat cystoscopy 3– 4 years after the primary surgery.28 The intravesical sutures might have been missed at the time of the primary cystoscopy or might have eroded subsequently through the bladder mucosa. In the third woman, a difficult bladder flap dissection was accomplished with unipolar coagulation during laparoscopic hysterectomy.32 On postoperative day 10, this patient experienced continuous urine drainage from the vagina and a vesicovaginal fistula was diagnosed (presumably caused by ischemia and necrosis, resulting from the difficult dissection).32 VOL. 94, NO. 5, PART 2, NOVEMBER 1999
Use of routine intraoperative cystoscopy did allow unsuspected lower urinary tract injuries to be recognized and managed at the primary surgery in 35 (88%) of 40 cases. In at least 24 (69%) of these 35 cases, intraoperative management did not involve advanced urologic surgery and consisted only of removing and replacing sutures or repairing unintentional cystotomies.
Discussion Overall frequency of ureteral and bladder injuries was four-fold higher in studies that involved routine cystoscopy than in studies that did not. However, data from those reports might be biased because of underestimation of injuries in studies not involving cystoscopy or overestimation of injuries in studies involving routine intraoperative cystoscopy. Injury rates in reports of studies not involving routine cystoscopy could be lower than the true rates because asymptomatic injuries would not be detected and symptomatic injuries presenting later in the postoperative period or at another center might not be included in the reports. Injury rates in reports of studies involving routine cystoscopy might be higher than the true rates because those surgeons might have been less rigorous or careful in identifying lower urinary tract structures during surgery; performing more difficult surgery, closer to the lower urinary tract; recognizing injuries that may have spontaneously resolved (eg, partially obstructed ureter or absorbable sutures in the bladder); or recognizing injuries that may have remained asymptomatic (eg, unilateral silent renal death or nonabsorbable sutures in the bladder). Although many authors recommended use of routine intraoperative cystoscopy after high-risk urogynecologic or pelvic reconstructive surgery, there was no Gilmour et al
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consensus concerning whether cystoscopy should be done after all major gynecologic surgery.4,31 Wiskind et al27 recommended use of cystoscopy “at every operation that places the ureter at risk.” However, because of the proximity of the reproductive and lower urinary tracts, the ureters and bladder are at risk of injury in most major gynecologic operations. Another option is performing selective cystoscopy, only after complicated or difficult surgery, when the surgeon wishes to confirm the integrity of the lower urinary tract at the end of the operation. In their review of clinical records from symptomatic ureteral injuries, Goodno et al14 could not find documented factors that might have accounted for ureteral injuries in eight (42%) of 19 cases. In a larger retrospective series,9 19 (51%) of 37 symptomatic ureteral injuries after laparoscopic hysterectomy and four (24%) of 17 after total abdominal hysterectomy had occurred during “simple” or “uncomplicated” hysterectomies. Although those data are retrospective, if a policy of selective cystoscopy had been in place, those symptomatic injuries still might have occurred. There are advantages and disadvantages to performing routine intraoperative cystoscopy after all major gynecologic surgeries. In addition to increased recognition and intraoperative management of occult lower urinary tract injuries, benefits include accurate suprapubic catheter placement and possibly earlier recognition of coexisting bladder disease. Disadvantages of routine cystoscopy include increased operating time and cost per surgical case, increased morbidity from cystoscopy per se (mostly from urinary tract infection), and extra required training and skills. As shown in two reports, routine cystoscopy does not guarantee recognition of all lower urinary tract injuries28 and nonobstructive, partially obstructive, or late injuries secondary to ischemia and necrosis also can be missed.32 Before a recommendation can be made that routine intraoperative cystoscopy be performed after all major gynecologic surgeries, more research is needed on the accuracy of diagnosis of lower urinary tract injuries with the use of cystoscopy by gynecologists and on the cost-effectiveness of intraoperative cystoscopy (and the intraoperative management of abnormalities) versus postoperative diagnosis and management of lower urinary tract injuries.
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tract in urethral suspension procedures for stress incontinence. Int Urogynecol J Pelvic Floor Dysfunct 1999;10:15–21. Pace J, Ballard CA, Klutke J, Klutke C, Kobak W. Intraoperative transvesical cystoscopy for urogynecologic procedures. Int Urogynecol J Pelvic Floor Dysfunct 1997;8:265–9. Miklos JR, Kohli N, Sze EHM, Saye WB. Percutaneous suprapubic teloscopy: A minimally invasive cystoscopic technique. Obstet Gynecol 1997;89:476 – 8. Harris RL, Cundiff GW, Theofrastous JP, Yoon H, Bump RC, Addison WA. The value of intraoperative cystoscopy in urogynecologic and reconstructive pelvic surgery. Am J Obstet Gynecol 1997;177:1367–9. Councell RB, Thorp JM, Sandridge DA, Hill ST. Assessments of laparoscopic-assisted vaginal hysterectomy. J Am Assoc Gynecol Laparosc 1994;2:49 –56. Timmons MC, Addison WA. Suprapubic teloscopy: Extraperitoneal intraoperative technique to demonstrate ureteral patency. Obstet Gynecol 1990;75:137–9.
Screening for squamous intraepithelial lesions with fluorescence spectroscopy Michele Follen Mitchell, MD, MS, Scott B. Cantor, PhD, Carrie Brookner, MS, Urs Utzinger, PhD, David Schottenfeld, MD, and Rebecca Richards-Kortum, PhD Objective: To evaluate the accuracy of fluorescence spectroscopy in screening for squamous intraepithelial lesions (SILs) and to compare its performance with that of Papanicolaou smear screening, colposcopy, cervicoscopy, cervicography, and human papillomavirus (HPV) testing. Data Sources: Receiver operating characteristic (ROC) curve analysis was used to analyze performance by fluorescence spectroscopy (primary data) and other methods (secondary data). Methods of Study Selection: In our search, 275 articles were identified in MEDLINE (1966 –1996). Articles were included if the investigators had studied a population in whom low disease prevalence was expected; used either Papanicolaou smear screening and colposcopy or colposcopically directed biopsy as a standard against which the screening technique was measured, and included enough data for recalculation of reported sensitivities and specificities. Tabulation, Integration, and Results: Receiver operating characteristic curves for fluorescence spectroscopy were cal-
From the Department of Gynecologic Oncology, Section of General Internal Medicine, and the Department of Medical Specialties, University of Texas M. D. Anderson Cancer Center, Houston, Texas; the Department of Electrical and Computer Engineering, University of Texas at Austin, Austin, Texas; and the Department of Epidemiology, University of Michigan, Ann Arbor, Michigan. This study was supported by the National Science Foundation and the Whitaker Foundation. The contributions of E. Neely Atkinson, PhD, and Judy Sandella, CNP, MS, are gratefully acknowledged.
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Address reprint requests to:
Donna Gilmour, MD Department of Obstetrics and Gynecology Dalhousie University IWK Grace Health Centre 5850/5980 University Avenue Halifax NS B3J 3G9 Canada E-mail: [email protected] Received March 12, 1999. Received in revised form May 17, 1999. Accepted June 17, 1999.
Copyright © 1999 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
culated using a Bayesian algorithm, and ROC curves for the other screening methods were constructed using metaanalytic techniques. Areas under the ROC curves and Q points were calculated. Screening colposcopy had the highest area under the curve (0.95), followed by screening cervicography (0.90), HPV testing (0.88), cervicoscopy (0.85), fluorescence spectroscopy (0.76), and Papanicolaou smear screening (0.70). Conclusion: In terms of screening for SILs, fluorescence spectroscopy performed better than the standard technique, Papanicolaou smear screening, and less well than screening colposcopy, cervicography, HPV testing, and cervicoscopy. The promise of this research technique warrants further investigation. (Obstet Gynecol 1999;94:889 –96. © 1999 by The American College of Obstetricians and Gynecologists.)
Although use of Papanicolaou smear screening has led to a substantial decrease in cervical cancer–related mortality over the last 50 years, this screening method still has disadvantages: a high false-positive rate and a typically week-long wait for results. Therefore, new technologies for screening for and diagnosis of cervical cancer and squamous intraepithelial lesions (SILs) are being evaluated. One of those, laser-induced fluorescence spectroscopy, is a noninvasive real-time technique for screening for and diagnosis of neoplasia,1 in which a fiberoptic probe is placed on the cervix, illuminating the tissue with low-power, monochromatic light and collecting fluorescent light emitted by the tissue. The fluorescence spectrum is recorded. The shape of the spectrum is based on the number of fluorophores in the tissue.1 Different levels of fluorescence are seen in normal, preneoplastic, and neoplastic tissue.2 We have been developing and testing algorithms for SIL diagnosis and screening using fluorescence spectroscopy.3,4 For the diagnosis of SIL, we reported sensitivities of 87% for squamous epithelium, 96% for 0029-7844/99/$20.00 PII S0029-7844(99)00408-1
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17.
18.
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after intravaginal prostaglandin E2 during preinduction cervical ripening. Am J Obstet Gynecol 1991;165:1006 –9. Smith CV, Rayburn WF, Miller AM. Intravaginal prostaglandin E2 for cervical ripening and initiation of labor. Comparison of a multidose gel and single, controlled-release pessary. J Reprod Med 1994;39:381– 6. Chyu JK, Strassner HT. Prostaglandin E2 for cervical ripening: A randomized comparison of Cervidil versus Prepidil. Am J Obstet Gynecol 1997;177:606 –11. Wing DA, Ortiz-Omphroy G, Paul RH. A comparison of intermittent vaginal administration of misoprostol with continuous dinoprostone for cervical ripening and labor induction. Am J Obstet Gynecol 1997;177:612– 8. Sanchez-Ramos L, Peterson DE, Delke I, Gaudier FL, Kaunitz AM. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: A randomized trial. Obstet Gynecol 1998;91:401–5. Ottinger WS, Menard MK, Brost BC. A randomized clinical trial of prostaglandin E2 intracervical gel and a slow release vaginal pessary for preinduction cervical ripening. Am J Obstet Gynecol 1998;179:349 –53. Stewart JD, Rayburn WF, Farmer FC, Liles EM, Schipul AH Jr, Stanley JR. Effectiveness of prostaglandin E2 intracervical gel (Prepidil), with immediate oxytocin, versus vaginal insert (Cervidil) for induction of labor. Am J Obstet Gynecol 1998;179:1175– 80. Hennessey MH, Rayburn WF, Stewart JD, Liles EC. Preeclampsia and induction of labor: A randomized comparison of prostaglandin E2 as an intracervical gel, with oxytocin immediately, or as a sustained-release vaginal insert. Am J Obstet Gynecol 1998;179:1204–9. Moher D, Jadad AR, Nichol G, Penman M, Tugwell P, Walsh S. Assessing the quality of randomized controlled trials: An annotated bibliography of scales and checklists. Control Clin Trials 1995;16:62–73. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies. J Natl Cancer Inst 1959;22:719 – 48. Breslow NE, Day NE. Statistical methods in cancer research. Vol 1, no. 32. The analysis of case control studies. Lyon, France: IARC Scientific Publications, 1980. L’Abbe KA, Detsky AS, O’Rourke K. Meta-analysis in clinical research. Ann Intern Med 1987;107:224 –33. Follmann D, Elliott P, Suh I, Cutler J. Variance imputation for overviews of clinical trials with continuous response. J Clin Epidemiol 1992;45:769 –73.
Lower urinary tract injury during gynecologic surgery and its detection by intraoperative cystoscopy D. T. Gilmour, MD, FRCSC, P. L. Dwyer, MBBS, FRACOG, and M. P. Carey, MD, FRACOG Objective: To review the frequency of lower urinary tract injuries after major gynecologic surgery and the role of From the Royal Women’s Hospital and the Mercy Hospital for Women, Melbourne, Australia.
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28. Egger M, Davey Smith G, Schneider M, Minder C. Bias in metaanalysis detected by a simple, graphical test. BMJ 1997;315:629 –34. 29. Blair FC, Tassone SA, Pearman CR, St Cyr MB, Rayburn WF. Inducing labor with a sustained-release PGE2 vaginal insert. Experience at a community hospital. J Reprod Med 1998;43:408 –12. 30. Taylor AV, Boland J, Bernal AL, MacKenzie IZ. Prostaglandin metabolite levels during cervical ripening with a controlled-release hydrogel polymer prostaglandin E2 pessary. Prostaglandins 1991;41:585–94. 31. Taylor AV, Boland J, MacKenzie IZ. The concurrent in vitro and in vivo release of PGE2 from a controlled-release hydrogel polymer pessary for cervical ripening. Prostaglandins 1990;40:89 –98. 32. Lyndrup J, Nickelsen C, Guldbaek E, Weber T. Induction of labor by prostaglandin E2: Intracervical gel or vaginal pessaries? Eur J Obstet Gynecol Reprod Biol 1991;42:101–9. 33. Orhue AA. Induction of labour at term in primigravidae with low Bishop’s score: A comparison of three methods. Eur J Obstet Gynecol Reprod Biol 1995;58:119 –25. 34. Stampe Sorensen S, Palmgren Colov N, Andreasson B, Bock JE, Berget A, Schmidt T. Induction of labor by vaginal prostaglandin E2. A randomized study comparing pessaries with vaginal tablets. Acta Obstet Gynecol Scand 1992;71:201– 6. 35. Keirse MJ. Prostaglandins in preinduction cervical ripening. Metaanalysis of worldwide clinical experience. J Reprod Med 1993;38: 89 –100. 36. Owen J, Winkler CL, Harris BA Jr, Hauth JC, Smith MC. A randomized, double-blind trial of prostaglandin E2 gel for cervical ripening and meta-analysis. Am J Obstet Gynecol 1991;165:991– 6.
Address reprint requests to:
Luis Sanchez-Ramos, MD Department of Obstetrics and Gynecology University of Florida Health Science Center 653-1 West 8th Street Jacksonville, FL 32209 E-mail: [email protected] Received November 2, 1998. Received in revised form February 18, 1999. Accepted March 4, 1999. Copyright © 1999 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
routine intraoperative cystoscopy during major gynecologic surgery in the detection of lower urinary tract injuries. Data Sources: We combined a MEDLINE search for reports from 1966 to October 1998, using the terms “urinary tract injury,” “ureter/ureteric/ureteral obstruction/fistula/injury,” “bladder fistula/injury,” and “vesico-vaginal fistula,” with a second search for all reports of gynecologic surgical procedures. Additional references were obtained from relevant articles and review articles. Methods of Study Selection: Included were all English language articles on the frequency of unintentional urinary tract injuries identified during or after benign gynecologic surgery. There were 22 reports on the frequency of lower urinary tract injuries after gynecologic surgery and eight on the use of routine cystoscopy during gynecologic surgery to diagnose unsuspected injuries.
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Tabulation, Integration, and Results: In the reports of studies not involving routine cystoscopy, the frequency of ureteral injury varied from 0 to 14.6 injuries per 1000 operations, with an overall frequency of 1.6 per 1000. The frequency of bladder injury varied from 0.2 to 19.5 per 1000, with an overall frequency of 2.6 per 1000. Only 11.5% of ureteral injuries and 51.6% of bladder injuries were identified and managed intraoperatively. In the reports of studies involving routine cystoscopy, the frequency of ureteral injury varied from 0 to 26.8 per 1000, with an overall frequency of 6.2 per 1000. The frequency of bladder injury varied from 0 to 29.2 per 1000, with an overall frequency of 10.4 per 1000. Up to 90% of unsuspected ureteral injuries and 85% of unsuspected bladder injuries were identified with the use of cystoscopy and were managed successfully intraoperatively. In 69% of the unsuspected ureteral and bladder injuries, the intraoperative management consisted of removing and replacing sutures or repairing unintentional cystotomies. Conclusion: Use of routine intraoperative cystoscopy during major gynecologic and urogynecologic surgery might prevent sequelae from lower urinary tract injuries. (Obstet Gynecol 1999;94:883–9. © 1999 by The American College of Obstetricians and Gynecologists.)
There is potential for lower urinary tract injuries during gynecologic surgery because of the anatomic proximity of the reproductive and lower urinary tracts. Almost every major gynecologic operation has been reported to lead to a lower urinary tract injury.1 Unrecognized lower urinary tract injuries after gynecologic surgery can be asymptomatic or can present with immediate postoperative pain, fever, peritonitis, ileus, or other morbidity and lead to further surgery. Long-term sequelae of bladder and ureteral injuries include urine leakage from fistulas and loss of renal function. More recently, medicolegal sequelae are becoming more of a concern because surgeons are being found negligent increasingly for lower urinary tract injuries, even when surgery is documented as anything but straightforward.2 The best approach is to avoid lower urinary tract injury, by meticulous and careful surgical technique— identifying, dissecting, and reflecting contiguous lower urinary tract structures during gynecologic surgery.3 If injury occurs despite those efforts, the next best approach is intraoperative recognition and repair. Routine intraoperative cystoscopy after all major gynecologic operations may facilitate the recognition of a real or potential injury, allowing intraoperative repair. Repair at the primary surgery often is easier, more successful, less morbid for the patient, and advantageous for the surgeon from a legal point of view.4 The objectives of this study were to review the frequency of lower urinary tract injuries after major gynecologic surgery and the role of routine intraoperative cystoscopy after major gynecologic surgery in the 884 Gilmour et al
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diagnosis of unsuspected lower urinary tract injuries and, as a consequence, in the prevention or limitation of their sequelae.
Sources We did a MEDLINE search covering 1966 to October 1998 using a combination of thesaurus and single-term search strategies. The initial search was for all reports with any of the following key words: “urinary tract injury,” “ureter/ureteric/ureteral obstruction/fistula/injury,” “bladder fistula/injury,” or “vesico-vaginal fistula.” That search was combined with a second search for all reports involving gynecologic surgical procedures. Our review was limited to articles published in English.
Study Selection We retrieved 272 abstracts. The reference sections of all relevant articles and review articles were scrutinized for articles not found with our search. A total of 135 articles were reviewed in detail. Considered were all reports on the frequency of unintentional urinary tract injuries identified during or after benign gynecologic surgery. Because lower urinary tract injuries after gynecologic surgery are relatively rare, only reports of studies with more than 500 patients were included. We excluded letters to the editor, case reports, small case series, and reports in which injuries secondary to radical pelvic surgery or obstetric complications could not be separated from injuries secondary to benign gynecologic surgery. Because reports of studies involving routine intraoperative cystoscopy during gynecologic surgery were scarce and these studies involved fewer women, all of those reports were included in our review, even if fewer than 500 subjects were studied. We identified 30 reports that fit our criteria, 22 on the frequency of lower urinary tract injuries after gynecologic surgery and eight on the use of routine cystoscopy during gynecologic surgery to diagnose unsuspected injuries.
Results Frequencies of ureteral and bladder injuries are summarized from studies involving and those not involving routine intraoperative cystoscopy. Overall frequency was determined by dividing the number of ureteral or bladder injuries by the number of operations. To facilitate comparisons, we have converted all frequencies of ureteral and bladder injuries to frequencies per 1000 operations. Types of operations are listed as accurately as could be determined from each study. With the exception of Dicker et al,5 the studies were retrospective. Newell6 included injuries recognized postoperatively and those recognized at autopsy. Obstetrics & Gynecology
Table 1. Frequency of Ureteral Injuries After Major Gynecologic Surgery
Study 7
Rosen et al Saidi et al8 Harkki-Siren et al9 Liu and Reich10 Stanhope et al11 Daly and Higgins12 Falk and Bunkin13 Harkki-Siren et al9 Goodno et al14 Kunz15 Dicker et al5 Amirikia and Evans16 Thompson and Benigno17 Falk and Bunkin13 Holloway18 Newell6 Harkki-Siren et al9 Falk and Bunkin13 Newell6 Stanhope et al11 Harkki-Siren et al9 Goodno et al14 Kudo et al19 Dicker et al5 Amirikia and Evans16 Thompson and Benigno17 Falk and Bunkin13 Copenhauer20 Edwards and Beebe21 Total
Year
Operation
1996 1996 1998 1994 1991 1988 1954 1998 1995 1984 1982 1979 1971 1954 1950 1939 1998 1954 1939 1991 1998 1995 1990 1982 1979 1971 1954 1962 1949
Open Burch colposuspension Major laparoscopic surgery* Laparoscopic hysterectomy Laparoscopic hysterectomy Major abdominal surgery† Major abdominal surgery† Adnexal surgery Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Subtotal abdominal hysterectomy Subtotal abdominal hysterectomy Subtotal abdominal hysterectomy Major vaginal surgery‡ Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy
No. of operations
No. of ureteral injuries
929 953 2741 518 2833 1093 567 43,149 2469 737 1283 4228 2287 1114 808 944 10,854 1577 2072 2546 5636 1054 9230 568 2111 1533 1664 1000 570 107,068
4 4 37 1 2 16 1 17 8 3 3 5 9 1 6 8 3 1 5 16 1 5 3 0 2 1 2 2 2 168
No. of ureteral injuries/1000 operations 4.3 4.2 13.5 1.9 0.7 14.6 1.8 0.4 3.2 4.1 2.3 1.2 3.9 0.9 7.4 8.5 0.3 0.6 2.4 6.3 0.2 4.7 0.3 0 0.9 0.7 1.2 2.0 3.5
No. of injuries recognized intraoperatively
No. of injuries recognized postoperatively
0 0 2 0 0 8 0 0 NE 1 0 NE NE 0 1 0 1 1 1 0 0 NE NE 0 NE NE 0 0 0 15
4 4 35 1 2 8 1 17 NE 2 3 NE NE 1 5 5 2 0 2 16 1 NE NE 0 NE NE 2 2 2 115
NE ⫽ not able to elicit information about whether ureteric injury was diagnosed intraoperatively or postoperatively from the details provided in the report. * Including laparoscopic hysterectomy (with/without adnexectomy), ovarian cystectomy, and ablation of severe (grade 4) endometriosis.6 † Including total abdominal hysterectomy and/or other abdominal gynecologic operations for the treatment of pelvic conditions.9,10 ‡ Including vaginal hysterectomy and/or other vaginal operations for the correction of vaginal prolapse.9
Seventeen reports contained frequencies of ureteral injuries after various major gynecologic surgeries (Table 1). The frequency of ureteral injury in those studies varied from 0 to 14.6 injuries per 1000 operations, with an overall frequency of 1.6 per 1000. In 13 of the 17 reports, we ascertained times of identification and management of ureteral injuries. Of 130 injuries in those 13 studies, only 15 ureteral injuries (11.5%) were identified and managed during the primary operation, and 115 (88.5%) were diagnosed and managed postoperatively. Fourteen reports contained frequencies of bladder injuries after various major gynecologic surgeries (Table 2). The frequency of bladder injuries varied from 0.2 to 19.5 per 1000, with an overall frequency of 2.6 per 1000. In 11 reports, we ascertained times of identification and management of bladder injuries. Of 157 injuries in those 11 studies, 81 bladder injuries (51.6%) were recorded as identified and successfully managed intraoperatively and 76 (48.4%) were recorded as identified and manVOL. 94, NO. 5, PART 2, NOVEMBER 1999
aged postoperatively. Most postoperatively recognized bladder injuries presented as vesicovaginal fistulas (74 of 76, 97%). Eight reports contained frequencies of unsuspected ureteral and/or bladder injuries diagnosed with the use of intraoperative cystoscopy during major gynecologic and urogynecologic surgeries (Tables 3 and 4). All of those studies were retrospective. Cystoscopy was performed transurethrally or transvesically with or without the use of intravenous indigo carmine to help confirm ureteral patency. In the studies involving routine cystoscopy, the frequency of ureteral injuries varied from 0 to 26.8 per 1000, with an overall frequency of 6.2 per 1000. The frequency of bladder injuries varied from 0 to 29.2 per 1000, with an overall frequency of 10.4 per 1000. In the studies involving intraoperative cystoscopy, there were 20 unsuspected ureteral injuries (Table 3). Eighteen (90%) of the 20 unsuspected ureteral injuries Gilmour et al
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Table 2. Frequency of Bladder Injuries After Major Gynecologic Surgery
Study 8
Saidi et al Harkki-Siren et al9 Ou et al22 Liu and Reich10 Harkki-Siren et al9 Kunz15 Dicker et al5 Amirikia and Evans16 Falk23 Graber et al24 Howkins25 Holloway18 Harkki-Siren et al9 Harkki-Siren et al9 Kudo et al19 Dicker et al5 Amirikia and Evans16 Copenhauer20 Allen and Peterson26 Total
Year
Operation
1996 1998 1994 1994 1998 1984 1982 1979 1967 1964 1963 1950 1998 1998 1990 1982 1979 1962 1954
Major laparoscopic surgery* Laparoscopic hysterectomy Laparoscopic hysterectomy Laparoscopic hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Total abdominal hysterectomy Subtotal abdominal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy Vaginal hysterectomy
No. of operations
No. of bladder injuries
953 2741 839 518 43,149 737 1283 4228 1000 819 1000 808 10,854 5636 9230 568 2111 1000 2280 89,754
11 24 8 6 54 1 4 18 5 16 2 8 3 1 44 9 4 11 2 231
No. of bladder injuries/1000 operations 11.5 8.8 9.5 11.6 1.3 1.4 3.1 4.3 5.0 19.5 2.0 9.9 0.3 0.2 4.8 15.8 1.9 11.0 0.9
No. of injuries recognized intraoperatively
No. of injuries recognized postoperatively
8 14 NE 5 9 1 4 NE 2 11 1 6 2 0 NE 8 NE 10 0 81
3 10 NE 1 45 0 0 NE 3 5 1 2 1 1 NE 1 NE 1 2 76
Abbreviation as in Table 1. * Including laparoscopic hysterectomy (with/without adnexectomy), ovarian cystectomy, and ablation of severe (grade 4) endometriosis.6
were diagnosed and managed successfully during the primary surgery. In ten (56%) of the 18 cases, obstructing sutures were removed and absence of obstruction was confirmed with repeat cystoscopy. In three (17%) of the 18 cases, women required cystotomies, ureteral stents, or ureteral reimplantation during primary surgery. No details were provided on intraoperative man-
agement of ureteral obstructions in five cases (28%) or on final functional outcome in any of the cases. Two (10%) of the 20 unsuspected ureteral injuries were not diagnosed and managed intraoperatively (Table 3). In one case, after a vaginal hysterectomy, culdoplasty, and anterior and posterior repair, the surgeon identified a ureteral injury with the use of intraopera-
Table 3. Frequency of Ureteral Injuries Diagnosed With the Use of Routine Cystoscopy During Major Gynecologic Surgery
Study
Year
Operation
Wiskind and Thompson27 Dwyer et al28 Pace et al29 Dwyer et al28 Miklos et al30 Dwyer et al28 Harris et al31 Pettit and Petrou4 Councell et al32 Timmons and Addison33 Total
1995 1999 1997 1999 1997 1999 1997 1994 1994 1990
Major gynecologic surgery* Open Burch colposuspension Open Burch colposuspension Laparoscopic Burch colposuspension Laparoscopic Burch colposuspension Stamey needle suspension Reconstructive pelvic floor surgery† Major vaginal surgery‡ Laparoscopic hysterectomy Abdominal gynecologic surgery§
No. of No. of injuries No. of injuries ureteral No. of recognized recognized ureteral injuries/1000 No. of intraoperatively postoperatively operations operations injuries 1270 925 112 178 21 61 224 236 171 37 3235
5 0 0 3 0 0 6 5 1 0 20
3.9 0 0 16.9 0 0 26.8 21.2 5.8 0
5 0 0 2 0 0 6 5 1 0 19
0 0 0 1 0 0 0 0 0 0 1
* Including total abdominal hysterectomy (with/without adnexectomy), total vaginal hysterectomy (with/without vaginal repairs), and stress incontinence surgery.27 † Including abdominal and vaginal colpopexies, colpectomy or colpocleisis, colpoplastic repairs, needle urethropexy, retropubic urethropexy, and pubovaginal sling.31 ‡ Including culdoplasties, sacrospinous ligament fixation, anterior repair, modified Pereyra procedure, pubovaginal slings, vaginal paravaginal defect repair, fistula repair, and vaginal hysterectomy.4 § Including total abdominal hysterectomy (with/without adnexectomy), retropubic urethropexy (with/without hysterectomy, posterior repair, or sacral colpopexy), and exploratory laparotomy.33
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Obstetrics & Gynecology
Table 4. Frequency of Bladder Injuries Diagnosed With the Use of Routine Cystoscopy During Major Gynecologic Surgery
Study 28
Dwyer et al Pace et al29 Dwyer et al28 Miklos et al30 Dwyer et al28 Harris et al31 Pettit and Petrou4 Councell et al32 Total
Year
Operation
1999 1997 1999 1997 1999 1997 1994 1994
Open Burch colposuspension Open Burch colposuspension Laparoscopic Burch colposuspension Laparoscopic Burch colposuspension Stamey needle suspension Reconstructive pelvic floor surgery* Major vaginal surgery† Laparoscopic hysterectomy
No. of operations
No. of bladder injuries
925 112 178 21 61 224 236 171 1928
3 3 3 0 1 3 2 5 20
No. of bladder injuries/1000 operations 3.2 26.8 16.9 0 16.4 13.4 8.5 29.2
No. of injuries recognized intraoperatively
No. of injuries recognized postoperatively
1 3 3 0 1 3 2 4 17
2 0 0 0 0 0 0 1 3
* Including abdominal and vaginal colpopexies, colpectomy or colpocleisis, colpoplastic repairs, needle urethropexy, retropubic urethropexy, and pubovaginal sling.31 † Including culdoplasties, sacrospinous ligament fixation, anterior repair, modified Pereyra procedure, pubovaginal slings, vaginal paravaginal defect repair, fistula repair, and vaginal hysterectomy.4
tive cystoscopy but deferred repair with a ureteroneocystostomy until postoperative day 1.27 In a second case, despite negative intraoperative cystoscopy findings after a laparoscopic Burch colposuspension, a symptomatic unilateral ureteral ligation was detected 2 days postoperatively and required management with a ureteroneocystostomy.28 In the studies involving intraoperative cystoscopy, there were 20 unsuspected bladder injuries (Table 4). Seventeen (85%) of the 20 unsuspected bladder injuries were identified and managed successfully intraoperatively. Management consisted of removal and appropriate replacement of sutures in ten (59%) of the 17 cases, repair of unintentional cystotomy in four (24%), and removal and appropriate replacement of a sling in one. No details were provided on intraoperative management in two cases (12%) or on final functional outcome in any cases. Despite the use of intraoperative cystoscopy during primary surgery, three (15%) of the 20 unsuspected bladder injuries were not diagnosed (Table 4). Two of those women had open Burch colposuspensions and subsequently presented with lower urinary tract symptoms. Nonabsorbable suture was found in the bladder by repeat cystoscopy 3– 4 years after the primary surgery.28 The intravesical sutures might have been missed at the time of the primary cystoscopy or might have eroded subsequently through the bladder mucosa. In the third woman, a difficult bladder flap dissection was accomplished with unipolar coagulation during laparoscopic hysterectomy.32 On postoperative day 10, this patient experienced continuous urine drainage from the vagina and a vesicovaginal fistula was diagnosed (presumably caused by ischemia and necrosis, resulting from the difficult dissection).32 VOL. 94, NO. 5, PART 2, NOVEMBER 1999
Use of routine intraoperative cystoscopy did allow unsuspected lower urinary tract injuries to be recognized and managed at the primary surgery in 35 (88%) of 40 cases. In at least 24 (69%) of these 35 cases, intraoperative management did not involve advanced urologic surgery and consisted only of removing and replacing sutures or repairing unintentional cystotomies.
Discussion Overall frequency of ureteral and bladder injuries was four-fold higher in studies that involved routine cystoscopy than in studies that did not. However, data from those reports might be biased because of underestimation of injuries in studies not involving cystoscopy or overestimation of injuries in studies involving routine intraoperative cystoscopy. Injury rates in reports of studies not involving routine cystoscopy could be lower than the true rates because asymptomatic injuries would not be detected and symptomatic injuries presenting later in the postoperative period or at another center might not be included in the reports. Injury rates in reports of studies involving routine cystoscopy might be higher than the true rates because those surgeons might have been less rigorous or careful in identifying lower urinary tract structures during surgery; performing more difficult surgery, closer to the lower urinary tract; recognizing injuries that may have spontaneously resolved (eg, partially obstructed ureter or absorbable sutures in the bladder); or recognizing injuries that may have remained asymptomatic (eg, unilateral silent renal death or nonabsorbable sutures in the bladder). Although many authors recommended use of routine intraoperative cystoscopy after high-risk urogynecologic or pelvic reconstructive surgery, there was no Gilmour et al
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consensus concerning whether cystoscopy should be done after all major gynecologic surgery.4,31 Wiskind et al27 recommended use of cystoscopy “at every operation that places the ureter at risk.” However, because of the proximity of the reproductive and lower urinary tracts, the ureters and bladder are at risk of injury in most major gynecologic operations. Another option is performing selective cystoscopy, only after complicated or difficult surgery, when the surgeon wishes to confirm the integrity of the lower urinary tract at the end of the operation. In their review of clinical records from symptomatic ureteral injuries, Goodno et al14 could not find documented factors that might have accounted for ureteral injuries in eight (42%) of 19 cases. In a larger retrospective series,9 19 (51%) of 37 symptomatic ureteral injuries after laparoscopic hysterectomy and four (24%) of 17 after total abdominal hysterectomy had occurred during “simple” or “uncomplicated” hysterectomies. Although those data are retrospective, if a policy of selective cystoscopy had been in place, those symptomatic injuries still might have occurred. There are advantages and disadvantages to performing routine intraoperative cystoscopy after all major gynecologic surgeries. In addition to increased recognition and intraoperative management of occult lower urinary tract injuries, benefits include accurate suprapubic catheter placement and possibly earlier recognition of coexisting bladder disease. Disadvantages of routine cystoscopy include increased operating time and cost per surgical case, increased morbidity from cystoscopy per se (mostly from urinary tract infection), and extra required training and skills. As shown in two reports, routine cystoscopy does not guarantee recognition of all lower urinary tract injuries28 and nonobstructive, partially obstructive, or late injuries secondary to ischemia and necrosis also can be missed.32 Before a recommendation can be made that routine intraoperative cystoscopy be performed after all major gynecologic surgeries, more research is needed on the accuracy of diagnosis of lower urinary tract injuries with the use of cystoscopy by gynecologists and on the cost-effectiveness of intraoperative cystoscopy (and the intraoperative management of abnormalities) versus postoperative diagnosis and management of lower urinary tract injuries.
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26. 1. Drake MJ, Noble JG. Ureteric trauma in gynecologic surgery. Int Urogynecol J Pelvic Floor Dysfunct 1998;9:108 –17. 2. Brudenell M. Medico-legal aspects of ureteric damage during abdominal hysterectomy. Br J Obstet Gynaecol 1996;103:1180 –3. 3. Symmonds RE. Ureteral injuries associated with gynecologic sur-
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Screening for squamous intraepithelial lesions with fluorescence spectroscopy Michele Follen Mitchell, MD, MS, Scott B. Cantor, PhD, Carrie Brookner, MS, Urs Utzinger, PhD, David Schottenfeld, MD, and Rebecca Richards-Kortum, PhD Objective: To evaluate the accuracy of fluorescence spectroscopy in screening for squamous intraepithelial lesions (SILs) and to compare its performance with that of Papanicolaou smear screening, colposcopy, cervicoscopy, cervicography, and human papillomavirus (HPV) testing. Data Sources: Receiver operating characteristic (ROC) curve analysis was used to analyze performance by fluorescence spectroscopy (primary data) and other methods (secondary data). Methods of Study Selection: In our search, 275 articles were identified in MEDLINE (1966 –1996). Articles were included if the investigators had studied a population in whom low disease prevalence was expected; used either Papanicolaou smear screening and colposcopy or colposcopically directed biopsy as a standard against which the screening technique was measured, and included enough data for recalculation of reported sensitivities and specificities. Tabulation, Integration, and Results: Receiver operating characteristic curves for fluorescence spectroscopy were cal-
From the Department of Gynecologic Oncology, Section of General Internal Medicine, and the Department of Medical Specialties, University of Texas M. D. Anderson Cancer Center, Houston, Texas; the Department of Electrical and Computer Engineering, University of Texas at Austin, Austin, Texas; and the Department of Epidemiology, University of Michigan, Ann Arbor, Michigan. This study was supported by the National Science Foundation and the Whitaker Foundation. The contributions of E. Neely Atkinson, PhD, and Judy Sandella, CNP, MS, are gratefully acknowledged.
VOL. 94, NO. 5, PART 2, NOVEMBER 1999
Address reprint requests to:
Donna Gilmour, MD Department of Obstetrics and Gynecology Dalhousie University IWK Grace Health Centre 5850/5980 University Avenue Halifax NS B3J 3G9 Canada E-mail: [email protected] Received March 12, 1999. Received in revised form May 17, 1999. Accepted June 17, 1999.
Copyright © 1999 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc.
culated using a Bayesian algorithm, and ROC curves for the other screening methods were constructed using metaanalytic techniques. Areas under the ROC curves and Q points were calculated. Screening colposcopy had the highest area under the curve (0.95), followed by screening cervicography (0.90), HPV testing (0.88), cervicoscopy (0.85), fluorescence spectroscopy (0.76), and Papanicolaou smear screening (0.70). Conclusion: In terms of screening for SILs, fluorescence spectroscopy performed better than the standard technique, Papanicolaou smear screening, and less well than screening colposcopy, cervicography, HPV testing, and cervicoscopy. The promise of this research technique warrants further investigation. (Obstet Gynecol 1999;94:889 –96. © 1999 by The American College of Obstetricians and Gynecologists.)
Although use of Papanicolaou smear screening has led to a substantial decrease in cervical cancer–related mortality over the last 50 years, this screening method still has disadvantages: a high false-positive rate and a typically week-long wait for results. Therefore, new technologies for screening for and diagnosis of cervical cancer and squamous intraepithelial lesions (SILs) are being evaluated. One of those, laser-induced fluorescence spectroscopy, is a noninvasive real-time technique for screening for and diagnosis of neoplasia,1 in which a fiberoptic probe is placed on the cervix, illuminating the tissue with low-power, monochromatic light and collecting fluorescent light emitted by the tissue. The fluorescence spectrum is recorded. The shape of the spectrum is based on the number of fluorophores in the tissue.1 Different levels of fluorescence are seen in normal, preneoplastic, and neoplastic tissue.2 We have been developing and testing algorithms for SIL diagnosis and screening using fluorescence spectroscopy.3,4 For the diagnosis of SIL, we reported sensitivities of 87% for squamous epithelium, 96% for 0029-7844/99/$20.00 PII S0029-7844(99)00408-1
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