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A Nationwide Analysis of Laparoscopic Complications

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A Nationwide Analysis of Laparoscopic Complications
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  A Nationwide Analysis of Laparoscopic Complications PiiIVI H~RKKI-SIR&, MD, AND TAP10 KURKI, MD, PhD Objective: To evaluate the nationwide incidence of laparo- scopic complications, as the number of demanding gyneco- logic laparoscopic procedures increases worldwide. Methods: The National Patient Insurance Association was founded in 1987 in Finland. All major complications are reported to the Association because it handles financial compensation for patients’ injuries without proof of mal- practice. We analyzed 256 complications following laparo- scopic procedures occurring in 1990-1994. There were 160 minor complications, which were defined as mild infections, mild hemorrhages, and failed sterilization. In all, 96 major complications occurred, including intestinal, urinary tract, and vascular injuries. The number of gynecologic laparos- copies 70,607 procedures) was obtained from the Finnish Hospital Discharge Register. Results: The total complication rate was 3.6/1000 proce- dures, and the rate of major complications was 1.4/1000 procedures. In diagnostic laparoscopies, the annual major complication rate was constantly below 0.6/1000, and in sterilization, it was below 0.8/1000. In operative laparosco- pies, major complications increased from O/1000 in 1990 to 10.5/1000 in 1993 and leveled to lO.l/lOOO in 1994. In all, intestinal injuries occurred in 0.6/1000, ureteral injuries in 0.3/1000, bladder injuries in 0.3/1000, and vascular injuries in O.l/lOOO laparoscopic procedures. Conclusiolzs: Diagnostic and sterilization laparoscopies appear to be safe, but more complex laparoscopies are associated with an unacceptably high number of serious complications requiring continuous follow-up and exper- tise. Obstet Gynecol 1997;89:108-22. Copyright 0 1997 by The Alnerican College of Obstetricians and Gynecologists.1 Surveys of laparoscopic complications have been avail- able from the United States and the United Kingdom since 1972.’ The development of laparoscopic instru- mentation has made it possible to decrease the compli- cation rate in diagnostic and sterilization procedures and to perform more complex operations laparoscopi- cally.lm4 Hence, laparoscopic surgery has gained global popularity in the last few years and replaced many traditional laparotomies.“,” Nevertheless, this technique requires a certain learning period and may thus be prone to many serious complications.‘,x However, in practice it has proved to be difficult to obtain reliable information of the true complication rate in gynecologic laparoscopies. In some surveys only 13 of respon- dents have answered the questionnaires, which is bound to bias the results.” However, this is not a problem in Finland because every patient is insured by the National Patient Insurance Association, to which all major and most minor medical complications are re- ported. The Patient Injury Act was brought into force on the first of May 1987 in Finland. To obtain full compensa- tion for patient injury, proof of malpractice is no longer required. The Patient Injury Act ensures compensation for patient injury that 1) probably has arisen as a consequence of examination or treatment, 2) has been caused by n nfection or inflammation, and 3) has been caused by an accident connected with examination or treatment. Most importantly, Patient Insurance effec- tively decreases the number of malpractice trials in courts. Thus, during the existence of the National Patient Insurance Association only 114 (0.3 ) malprac- tice trials h ve arisen from 32,216 claims. Every Finnish hospital has an official patient ombudsman who helps the patient prepare a claim when necessary. Thus, it is the patient who reports the injury to the Association. When coming to the hospital, patients are well in- formed of the Patient Injury Act and of the Association, which will ensure th t all major and most minor com- plications are reported. As a result of having a solid data base, the register of the National Patient Insurance Association otiers a reliable source of information for the analysis of com- plications associated with gynecologic laparoscopy. 108 0029.7~4~/97/817.00 PII SOO29-7s~4 9h)o ~3Yr,-O  Materials and Methods The material consisted of 256 gynecologic laparoscopic complications reported to the Patient Insurance Associ- ation from January 1990 through December 1994. Com- plications were divided into minor and major compli- cations. The total of 160 minor complications included mild infections, mild hemorrhages, and failed steriliza- tion The 96 major complications consisted of injuries to the intestine, urinary tract, or large vessels, in addition, some women experienced severe nerve paresis and deep venous thrombosis. The numbers of different laparoscopic procedures were acquired from the Finnish Hospital Discharge Register, which has collected information regarding diagnosis, dates of admission and discharge, and sur- gical procedures on each inpatient. The purpose of this Register is research, administration, and planning, and it is maintained by the National Board of Health.’ Every hospital collects data that are automatically sent to the Register at the end of each year. In the analysis, we divided laparoscopic procedures into three categories: diagnostic laparoscopies, laparoscopic sterilization, and operative laparoscopies. Diagnostic laparoscopies in- volved only procedures carried out in connection with sterility or dysmenorrhea without any extra procedure. Placement of Filshie clips is the main technique used for laparoscopic sterilization, but sometimes Hulka clips or tubal electrocoagulation are used. Operative laparos- copy was defined as procedures carried out in connec- tion with endometriosis, ectopic pregnancy, adhesions, and ovarian cysts, as well as myomectomy and laparo- scopic hysterectomy. The complication rate was ana- lyzed separately in different procedures and according to different organs. Differences between complication rates were ana- lyzed by the 2 test. P I .05 was considered statistically significant. Results From 1990 through 1994, 70,607 gynecologic laparosco- pies were carried out (Table 1). During that time 160 Table 1. The Number of Gynecologic Laparoscopic Procedures in 1990-l YY4 YeFIr 1990 1991 1992 1993 1994 All Diagnostic Laparoscopic Operative ICplrOSCOp~ sterilization I~pXOSCOp~ Total 3054 869 1 1437 13,182 3248 8870 1977 14,095 3806 iY79 2100 13,885 4089 7800 2578 14,467 4182 7461 3335 14,978 18,379 40,801 11,427 70,607 Table 2. Annual Number of Complications Associated With Gynecologic Laparoscopies Reported to the Patient Insurance Association in Finland Year 1990 1991 1992 1993 1994 All MillOr complications* 33 (2.5) 32 (2.3) 39 (2.8) 28 (1.9) 28 (1.9) 160 (2.3) Major complicatrons* All complications* 6 (0.5) 39 (3.0) 6 (0.4) 38 (2.7) 12 (0.9) 51 (3.7) 29 (2.0)’ 57 (3.9) 43 (2.9) 71 (4.7) 96 (1.4) 256 (3.6) * Number of patients (number of patients/l000 procedures). The change in the rate of major complications from 1992 to 1993 was statistically significant (, = 6.38, P = .012). minor and 96 major complications associated with gynecologic laparoscopy were reported to the Patient Insurance Association (Table 2). The total complication rate was 3.6/ 1000 procedures. The average incidence of major complication was 1.4/1000 procedures, but the incidence increased 5.8-fold from 1990 through 1994. No death in connection with gynecologic laparoscopy was reported during these years. Complications of diagnostic laparoscopy were rare, the annual frequency of major complications being between 0 and 0.6/ 1000 procedures from 1990 through 1994 (Table 3). Major complications of laparoscopic sterilization fluctuated between 0.3 and 0.8/ 1000 proce- dures during this period (Table 3). The most common minor complication was unexpected pregnancy after sterilization, which varied between I.2 and 2.0/1000 sterilizations, when the follow-up time was at least 1.5 years. None of the annual changes in major complica- tions during these procedures were statistically signifi- cant. The major complications of operative laparoscopies increased from 0 in 1990 to 10.5/1000 in 1993, but leveled to 10.1 / 1000 in 1994 (Table 3). The increase in major complications from 1992 to 1993 was statistically significant (, = 11.6, P = .OOl); the others were not. Most of the major complications occurred in laparo- scopic hysterectomies (64% in 1993 and 61% in 1994). Table 3. Major Complications in Gynecologic Laparoscopy in 1990-1994 Procedure” Injury Diagnostic Sterilization Operative Total* Intestinal 4 (0.2) 16 (0.4) 24 (2.1) 44 (0.6) Bladder 1 (0.1) 1 (0.1) 18 (1.6) 20 (0.3) Ureteral 0 2 (0.1) I6 (1.4) 18 (0.3) Vascular 0 2 (0.1) 5 (0.4) 7 (0.3) Other 0 I (0.1) 6 (0.5) 7 (0.1) All 5 (0.3) 22 (0.5) 69 (6.0) 96 (1.4) * Number of patients (number of patients/ 1000 procedures). VOL. 89, NO. 1, IANUARY lYY7 HErkki-Sir& and Kurki Lnpnrosro/~ir CoriydicL7hJrzs 109  Table 4. Laparoscopic Procedures, Where Major Complications Occurred N = 96) Type of injury il II Intestinal injury II = 44) Diagnostic laparoscopy Sterilization laparoscopy Operative laparoscopy Endometriosis Lysis of adhesion Ovarian cystectomy Hysterectomy Oophorectomy Salpingostomy Ovarian resection Ectopic pregnancy Bladder injury n = 20) Diagnostic laparoscopy Sterilization laparoscopy Operative laparoscopy Hysterectomy Ovarian cystectomy Ureteral injury n = 18) Sterilization laparoscopy Operative laparoscopy Hysterectomy Endometriosis Vascular injury 12 = 7) Sterilization laparoscopy Operative laparoscopy Ectopic pregnancy Salpingo-oophorectomy Hysterectomy Other injury II = 7) Sterilization laparoscopy Operative laparoscopy Hysterectomy Ectopic pregnancy Ovarian puncture Salpingectomy 16 24 4 2 (44 ) were diagnosed during the primary laparoscopy. There were nine injuries caused by electrocoagulation and six injuries caused by a trocar or Veress needle. The average time from injury to diagnosis was 10.4 days (range O-38 days) in the former cases and 1.3 days (range O-4 days) in the latter. All damage was treated by laparotomy. Two stomach injuries were caused by Veress needles. In one case immediate laparotomy and suture of the perforation was performed. In another case the patient was placed under observation, and no further surgery was needed. 1 1 18 17 2 16 15 1 2 2 6 Forty-four bowel injuries were reported during the study period (Table 4). Damage of the small intestine was the most common complication (26 patients, 59 ) followed by damage of the large bowel (16 patients, 36 ). Two patients (5 ) had injury of the stomach. The injury was caused by electrocoagulation in 23 cases, by a trocar or Veress needle in 20 cases, and by a clip in one case. Only one (3.9 ) of the 26 small bowel perforations was noticed during primary laparoscopy. Immediate laparotomy was performed and the bowel was sutured. The average time from primary laparoscopy to the diagnosis of small intestine perforation was 3.3 days. This time was longer (4.8 days, range l-10 days) in 14 cases in which the injury was caused by the effect of electrocoagulation than in I2 cases in which injury was caused by a trocar or Veress needle (1.7 days, range O-5 days). All injuries were treated by laparotomy. Large bowel injury occurred in 16 patients; seven of them Thirty-eight urinary tract injuries (20 to the bladder and 18 to the ureter) were reported from 1990 through 1994 (Table 4). The diagnosis of bladder damage was made on average 1.1 days (range O-8 days) after injury. In six cases laparotomy was carried out, ten perfora- tions were sutured laparoscopically, two perforations were sutured vaginally, and two patients were treated by the use of a Foley catheter. Four ureteral injuries were caused by clips and 14 by electrocoagulation. Diagnosis of ureteral damage was made on average 29.4 days (range O-154 days) after injury. Only one of the injuries was discovered during the primary operation: a sterilization clip was placed accidentally on the ureter, the mistake was noticed, and the clip was removed without damage to the ureter. The rest of the injuries were treated as follows: two cases by retrograde ure- teral stenting without laparotomy, two by percutaneous nephrostomy, three by end-to-end anastomosis, eight by ureteroneocystostomy, and two by nephrectomy. Seven vascular injuries were reported during the 5-year period: six iliac vessels (four arteries, two artery and vein) and one aorta (Table 4). A trocar or Veress needle caused the injury in five cases (67 ) and unipo- lar electrocoagulation in three cases (33 ). All compli- cations were discovered immediately, and all patients were treated by laparotomy. Seven other major complications were reported. One patient developed chronic pelvic pain after laparoscopic sterilization. The clip was attached to the ovarian liga- ment. Subtotal hysterectomy was performed 3 years later and the pain disappeared. Another laparoscopic puncture and aspiration of an ovarian cyst resulted in a serious postoperative infection treated by salpingo- oophorectomy. Thirdly, pain continued following lapa- roscopic operation of an ectopic pregnancy, trophoblas- tic tissue was encountered in the large bowel and laparotomy was necessary. Fourthly, a paresis of bra- chial plexus occurred after salpingectomy for hydrosal- pinx. Finally, after two prolonged laparoscopic hyster- ectomies (5 and 6 hours), one patient had a deep venous thrombosis and paresis of the peroneal nerve and the other patient had paresis of the brachial plexus. 110 HIrkki-Sir&n and Kurki Lapnuoscopic Complications Obstetrics 6 Gynecology  Discussion Our main goal was to obtain reliable nationwide data on gynecologic laparoscopic complications during a representative time period. According to the results of an American survey, the rate of complications increase when more complex laparoscopic procedures are per- formed.3Z5 The launch of the Patient Insurance Associ- ation in Finland offered a good starting point to study these complications. We believe that all major compli- cations are reported to the Patient Insurance Associa- tion because there is no fear of claims of malpractice or loss of reputation. The Association does not punish the surgeon, and the decision is not reported on the curric- ulum vitae. Nevertheless, cases of indemnity can al- ways be taken to a public court. We are also aware of the possible risk of incomplete reporting of minor complications that do not have any long-term harm to the patient. Some complications also might have been overlooked during the very first years of the Associa- tion, before the expansion of laparoscopic surgery, but now the Association is well-known by patients and physicians. To our knowledge, this amount of data is one of the largest, covering the whole country, which contrasts with reports from some specialized centers.‘” From 1990 through 1994, the annual major complica- tion rate in diagnostic and sterilization laparoscopies has been constantly less than l/1000. This figure is comparable to those in the American Association of Gynecologic Laparoscopists’ Membership Survey” and a French multicenter collaborative study.” On the other hand, the number of major complications in operative laparoscopies increased from 0 in 1990 to 10.5/1000 in 1993 as observed also in the other surveys.3 The average major complication rate in operative laparoscopy in our material was 12-fold higher as compared with the rates in diagnostic and sterilization laparoscopy. Most of the complications occurred during laparoscopic hysterecto- mies. However, no death was associated with gyneco- logic laparoscopy in Finland during the 5-year study period, which contrasts with other studies.3,7” During the same time period, two deaths after laparoscopic cholecystectomy and one death after laparoscopic re- pair of inguinal hernia were reported. The incidence of intestinal injury during gynecologic surgery has been reported to be on average 0.7 : 1.1 in vaginal surgery, 0.8 in laparotomy, and 0.4 in laparoscopy.” In our material laparoscopy was associ- ated with bowel perforation in about 0.1 of proce- dures, which is lower than previously reported.i2 Seventy-five percent of all ureteral injuries occur in gynecologic operations, with an incidence of O.l- 2.5 .13,14 The figure in abdominal hysterectomies is 0.2 i5 and 0.1 in vaginal hysterectomies.” In a recent Finnish survey the risk of bladder and ureteral injury was also 0.2 in abdominal hysterectomies.17 Occa- sional ureteral injuries have been reported in minor laparoscopic procedures,” but the ureters are particu- larly vulnerable during major operative laparoscopy.‘” The total amount of major complications in laparo- scopic hysterectomy is 3.5 in Finland,20 which is comparable to other results2i However, the incidence of ureteral injuries is 1.2 , which is twice as high as previously reported.20,2’ Vascular injuries seem to be rare, and only a few cases have been reported during laparoscopic proce- dures.23J24 The most commonly injured vessels are the terminal aorta and the iliac vessels as in our material, in which the incidence of vascular injuries was 0.1 / 1000. All deaths have been related to a delay in diagnosis2’ All our patients were treated immediately, by laparot- omy. All patients survived. We assume that the number of gynecologic laparo- scopic procedures is increasing and even more difficult operations will be done. Thus, it is important to ascer- tain the true complication rates and outcomes, to eval- uate the risks and benefits of these procedures. Accord- ing to our results, complications during sterilization and diagnostic laparoscopy seem to be rare. In contrast, great attention should be paid to the unacceptably high number of complications, especially ureteral injuries, in operative gynecologic laparoscopy. Everyone perform- ing these demanding laparoscopic procedures should have a proper training period because only with expe- rience will the number of complications decrease.‘,” References 1. Hulka J. Complications of laparoscopy. Curr Prob Obstet Gynecol 1980;1:1-63. 2. Rock JA, Warshaw JR. The history and future of operative lapa- roscopy. Am J Obstet Gynecol 1994;170:7-11. 3 Hulka J, Peterson H, Phillips J, Surrey M. Operative laparoscopy: American Association of Gynecologic Laparoscopists’ 1993 Mem- bership Survey. J Am Assoc Gynecol Laparosc 1995;2:133-6. 4. Ville Y, Hyett J, Hecher K, Nicolaides K. Preliminary experience with endoscopic laser surgery for severe twin-twin transfusion syndrome. N Engl J Med 1995;332:224-7. 5. Sutton C. Operative laparoscopy. Curr Opin Obstet Gynecol 1992;4:430-8. 6. Grimes DA. Frontiers of operative laparoscopy: A review and critique of the evidence. Am J Obstet Gynecol 1992;166:1062-71. 7. Querleu D, Chapron C. Complications of gynecologic laparoscopic surgery. Cm-r Opin Obstet Gynecol 1995;7:257-61. 8. Harkki-Siren I’, Sjoberg J. Evaluation and the learning curve of the first one hundred laparoscopic hysterectomies. Acta Obstet Gy- necol Stand 1995;74:638-41. 9. Keskimaki I, Aro S. Accuracy of data on diagnosis, procedures and accidents in the Finnish hospital register. Int J Health Sciences 1991;2:15-21. 10. Querleu D, Chapron C, Chevaler L, Bruhat M. Complications of VOL. 89, NO. 1, JANUARY 1997 HIrkki-Sir& and Kurki Laparoscopic Cornplicafions 111  gynaecologic surgery. A French multicentre collaborative study. Gynaecol Endosc 1993;2:3-6. 1. Hulka J, Phillips J, Peterson H, Suttey M. Laparoscopic steriliza- tion: American Association of Gynecologic Laparoscopists’ 1993 Membership Survey. J Am Assoc Gynecol Laparosc 1995;2:137-8. 12. Krebs H-B. Intestinal injury in gynecologic surgery: A ten-year experience. Am J Obstet Gynecol 1986;155:509-14. 13. Symmonds RE. Ureteral injuries associated with gynecological surgery: Prevention and management. Clin Obstet Gynecol 1976; 19:623-43. 14. Goodno J, Powers T, Harris V. Ureteral injury in gynecologic surgery: A ten-year review in a community hospital. Am J Obstet Gynecol 1995;172:1817-22. 15. White SC, Wartel LJ, Wade ME. Comparison of abdominal and vaginal hysterectomies. A review of 600 operations. Obstet Gy- necol 1971;37:530-7. 16. Copenhaver EH. Vaginal hysterectomy: An analysis of indications and complications among 1000 operations. Am J Obstet Gynecol 1962;84:123-8. 17. Virtanen H, Makinen J, Kiilholma I’, Hirvonen T, Nurmi M. Urological injuries in conjunction with gynecologic surgery-10 years’ experience. Int Urogynecol J 1995;6:26-30. 18. Grainger D, Soderstrom R, Schiff S, Glickman M, DeCherney A, Diamond M. Ureteral injuries at laparoscopy: Insights into diag- nosis, management, and prevention. Obstet Gynecol 1990;75:839- 45. 19. Saidi MH, Sadler RK, Vancaillie TG, Akright BD, Farhart SA, White AJ. Diagnosis and management of serious urinary compli- cations after major operative laparoscopy. Obstet Gynecol 1996;87: 272-6. 20. Harkki-Siren P, Sjoberg J, Makinen J, Heinonen PK, Kauko M, Tomas E, et al. Finnish national register of laparoscopic hysterec- tomies: A review and complications of 1165 operations. Am J Obstet Gynecol 1997, in press. 21. Liu C, Reich H. Complications of total laparoscopic hysterectomy in 518 cases. Gynecol Endosc 1994;3:203-8. 22. Garry R, Phillips G. How safe is the laparoscopic approach to hysterectomy? Gynecol Endosc 1995;4:77-9. 23. Baadsgaard S, Bille S, Egeblad K. Major vascular injury during gynecologic laparoscopy. Acta Obstet Gynecol Stand 1989;68: 283-5. 24. Noordestgaard AG, Bodily KC, Osborne RW, Buttorff JD. Major vascular injuries during laparoscopic procedures. Am J Surg 1995;169:543-5. 25. See WA, Cooper CS, Fisher RJ. Predictors of laparoscopic compli- cations after formal training in laparoscopic surgery. JAMA 1993; 270:2689-92. Address reprint requests to: Paivi Harkki-Siren MD Department of Obstetrics and Gynecology Jorvi Hospital Turuntie 250 FIN-02740 Espoo Finland Received June 24, 1996. Received in revised form September 17, 1996. Accepted September 22, 1996. Copyright 0 1997 by The American College of Obstetricians and Gynecologists. Published by Elsevier Science Inc. 112 HIrkki-Sir and Kurki Laparosro~?ic Complications Obstetrics Gynecology
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