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Obstetrics & Gynecology 1999;94:94-98
© 1999 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Major Complications of Laparoscopy: A Follow-Up Finnish Study

PÄIVI HÄRKKI-SIREN, MD, JARI SJÖBERG, MD, PhD and TAPIO KURKI, MD, PhD

From the Department of Obstetrics and Gynecology, Helsinki University Central Hospital, Helsinki; the Department of Obstetrics and Gynecology, Jorvi Hospital, Espoo; and the Patient Insurance Association, Helsinki, Finland.

Address reprint requests to: Päivi Härkki-Siren, MD, Department of Obstetrics and Gynecology, Helsinki University Central Hospital, PL 140, HYKS, Helsinki FIN-00029, Finland


   Abstract
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Abstract
Materials and Methods
 Results
 Discussion
 References
 
Objective: To examine recent figures on major laparoscopic complications in Finland.

Methods: This was a nationwide record-linkage study from January 1995 through December 1996 including all Finnish hospitals performing gynecologic laparoscopies. Data files of the National Patient Insurance Association and the Finnish Hospital Discharge Register were used. Data were compared with previous results from 1990 to 1994.

Results: Among 32,205 gynecologic laparoscopies, 130 major complications were noted. The total complication rate was 4.0 per 1000 procedures: 0.6 per 1000 in diagnostic laparoscopies, 0.5 per 1000 in sterilization, and 12.6 per 1000 in operative laparoscopies. Intestinal injuries were reported in 0.7 per 1000, incisional hernias in 0.3 per 1000, urinary tract injuries in 2.5 per 1000, major vascular injuries in 0.1 per 1000, and other injuries in 0.5 per 1000 gynecologic laparoscopic procedures. Seventy-five percent (88 of 118) of the major complications in operative laparoscopies occurred during hysterectomies. The total major complication rate decreased from 4.9% in 1993 to 2.3% in 1996 ({chi}2 = 8.55, P = .003), but the incidence of ureteral injuries remained stable, at about 1% of laparoscopic hysterectomies. Ureteral injuries were most common in local hospitals (2.6%), followed by central (1.1%) and university hospitals (0.9%). From 1990 through 1996, the relative risk for ureteral injury in laparoscopic hysterectomies, compared with other operative laparoscopies was 29.0 (95% confidence interval [CI] 13.3, 63.0), for bladder injury 13.0 (95% CI 6.0, 28.2), for intestinal injury 1.3 (95% CI 0.6, 2.5), and for major vascular injury 0.4 (95% CI 0.1, 3.6). Compared with the figures for 1990–1994, all major complications in operative laparoscopies increased, from 0 per 1000 in 1990 to 14.0 per 1000 in 1996 ({chi}2 = 20.28, P < .001), but part of this increase was due to the increased proportion of laparoscopic hysterectomies.

Conclusion: Laparoscopic hysterectomies are still associated with a stable 1% risk of ureteral injury, whereas other major complications were decreasing until 1996. Complications in other laparoscopic procedures generally are rare.

Previous findings have suggested that laparoscopic complications may be increasing worldwide as more demanding procedures are being performed laparoscopically.1–3 We reported that diagnostic and sterilization laparoscopies are safe, but serious complications can occur with operative laparoscopies, especially with laparoscopic hysterectomies.4,5 Thereafter, we have continued to study the trends in laparoscopic complications.


   Materials and Methods
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Abstract
 Materials and Methods
Results
 Discussion
 References
 
Two of the most reliable Finnish register databases were used in this study. We first acquired the numbers of various gynecologic laparoscopies performed from the Finnish Hospital Discharge Register, in which data are collected on diagnosis, dates of admission and discharge, and surgical procedures for each inpatient.6 All major complications are reported to the National Patient Insurance Association to obtain nonfault compensation for patient injury; all patient records and surgical reports are sent there for investigations. Major complications included injuries to the intestine, urinary tract, and large vessels, plus nerve paresis, deep venous thrombosis, and unintended laparotomies due to massive hemorrhage, as described previously.4 The laparoscopies were divided into three groups: diagnostic laparoscopies, sterilization laparoscopies, and operative laparoscopies. Operative laparoscopies were defined as procedures done for endometriosis, ectopic pregnancy, adhesions, ovarian cysts, and incontinence; they included myomectomy and hysterectomy. We collected and analyzed data on all major complications that occurred during gynecologic laparoscopies and were reported to the Patient Insurance Association from January 1995 through December 1996. We compared the present results with the rates of complications in our previous survey from 1990 through 1994.4

Relative risk (RR) and 95% confidence interval (CI) were applied between complications following various operative laparoscopies; 95% CIs were also applied when reporting percentages (Medstat; Astra, Albertslund, Denmark).7 Differences between complication rates were analyzed by the {chi}2 test, in which P < .05 was considered statistically significant.


   Results
Top
Abstract
 Materials and Methods
 Results
Discussion
 References
 
A total of 32,205 gynecologic laparoscopies were done from 1995 through 1996. During the same time, 130 major complications associated with gynecologic laparoscopy were reported to the National Patient Insurance Association. The incidence of major complications was 0.6 per 1000 procedures in diagnostic laparoscopies, 0.5 per 1000 in sterilization laparoscopies, and 12.6 per 1000 in operative laparoscopies. Of complications following operative laparoscopies, 48% were ureteral injuries, 19% bladder injuries, 13% intestinal injuries, 7% incisional hernias, 2% large-vessel injuries, and 11% other injuries. In total, 75% (88 of 118) of the major complications in operative laparoscopies occurred during laparoscopic hysterectomies; 42% (3928 of 9337) of all operative laparoscopies consisted of laparoscopic hysterectomies (Table 1Go).


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  		Table 1. Major Complications in Gynecologic Laparoscopies, 1995–1996
 
Twenty-four bowel injuries were reported during the study (Tables 1Go and 2Go). Injury to the small intestine was most common (13 women, 54%), followed by the large intestine (seven women, 29%) and rectum (four women, 17%). The bowel injury was caused by electrocoagulation in 13 cases (54%), during entry into the abdominal cavity with a Veress needle or a trocar in 10 cases (42%), and in one case with a grasping forceps. Only four bowel injuries were noted during the primary operation. All intestinal injuries but one were treated by laparotomy; one rectovaginal fistula healed without any procedure.


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  		Table 2. Laparoscopic Procedures in Which Major Complications Occurred, 1995–1996
 
Eight incisional hernias were reported (Tables 1Go and 2Go). Diagnoses were made between the second and 14th postoperative days. The size of the trocars ranged from 5 to 12 mm (one 5 mm, five 10 mm, and two 12 mm), and 5–30 cm of small intestine was herniated. Small-bowel resection was needed in three patients (38%).

Seventy-nine urinary tract injuries were reported, 22 of which were bladder injuries (12 simple bladder perforations and ten vesicovaginal fistulas) (Tables 1Go and 2Go). Three of the seven simple bladder perforations in laparoscopic hysterectomies occurred during an intravaginal part of the operation, and the rest during a laparoscopic part of the operation. Twelve simple bladder perforations were sutured: by laparotomy in nine, laparoscopically in two, and vaginally in one case. All ten vesicovaginal fistulas occurred during laparoscopic hysterectomies, seven during laparoscopic and three during intravaginal parts of the operations. Seven fistulas were repaired by one procedure, but three women required two operations to treat the fistulas.

Fifty-seven ureteral injuries were reported, and all occurred after operative laparoscopies (Table 1Go). Most (51 of 57, 89%) of the ureteral injuries occurred during laparoscopic hysterectomies (Table 2Go). All injuries took place during laparoscopic parts of the hysterectomy and were caused by electrocoagulation in 44, scissors in three, clips with electrocoagulation in three, and Endo-GIA stapler (United States Surgical Corp., Norwalk, CT) in one patient. The incidence of ureteral injury after laparoscopic hysterectomy was lowest in university hospitals in 1996 (0.6%), followed by central hospitals (1.1%) and local hospitals (2.2%) (Table 3Go). Three bilateral injuries occurred during hysterectomies and were treated by bilateral ureteral anastomosis (one patient), ureteroneocystostomy and suture of the ureter (one patient), and ureteroneocystostomy and percutaneous nephrostomy (one patient). The other ureteral injuries were treated as follows: 32 cases with ureteroneocystostomy, eight with ureteral stenting, four with reanastomosis, two with transureteroureterostomy, two with suture followed by ureteroneocystostomy, two by splitting of the stricture with ureteroscopy, and one with ureterolysis followed by dilation.


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  		Table 3. Major Complications in Laparoscopic Hysterectomies, 1992–1996
 
Four vascular injuries to the large vessels were reported (one aorta and three iliac vessels) (Tables 1Go and 2Go). Injuries were caused by a trocar in two patients, by electrocoagulation in one, and by laparoscopic scissors in one. All injuries were treated by laparotomy without further complications.

Fifteen other major complications were reported (Tables 1Go and 2Go). Eight hemorrhages from the smaller vessels occurred (epigastric, mesenteric, uterine, vaginal cuff, and retroperitoneal small vessels) and were treated as follows: laparoscopy (one patient), laparoscopy and laparotomy (one patient), laparotomy (five patients), and three different laparotomies (one patient). In addition, three women had paresis of the brachial plexus because of overextension of the arm after one laparoscopic Burch operation and two laparoscopic hysterectomies. Two women also had to undergo laparotomies for abdominal abscesses, and one woman had deep venous thrombosis. The only death among these women was due to a massive pulmonary embolism after laparoscopic supracervical hysterectomy. The patient had received no anticoagulant medication. After the operation, a positive family history of thrombosis was reported. The death rate was 19.6 per 100,000 laparoscopic hysterectomies and 1.0 per 100,000 of all laparoscopies from 1990 through 1996.

Compared with our previous survey,4 we found that major complications occurred annually at rates below 1.0 per 1000 procedures after diagnostic and sterilization laparoscopies during the 7-year follow-up from 1990 through 1996. However, major complications after operative laparoscopies increased yearly from 0 per 1000 in 1990 to 14.0 per 1000 procedures in 1996, a highly statistically significant increase ({chi}2 = 20.28, P < .001). The only statistically significant annual change occurred during 1992–1993 ({chi}2 = 11.6, P = .001), when laparoscopic hysterectomy was performed for the first time in Finland. Intestinal injuries were the most frequent complications in 1990–1994 (3.6 per 1000 in 1994) in operative laparoscopy, followed by urinary tract and vascular injuries. In 1995, ureteral injuries increased rapidly to 6.4 per 1000 and then decreased to 5.8 per 1000 in 1996; intestinal injuries decreased to 1.0 per 1000 in 1995 and then increased to 2.1 per 1000 in 1996 after operative laparoscopy.

Because three quarters of the complications of operative laparoscopy occurred during laparoscopic hysterectomies, we subtracted the number of laparoscopic hysterectomies from the number of operative laparoscopies. The annual rates of ureteral and bladder injuries after operative laparoscopies without laparoscopic hysterectomies in 1990–1996 were always below 1.4 per 1000, whereas the highest annual incidence of intestinal injury was 3.5 per 1000 in 1994. We also compared the incidences of major complications in laparoscopic hysterectomies with other operative laparoscopies in 1990–1996: intestinal injuries 2.2 per 1000 versus 1.7 per 1000 (RR 1.3; 95% CI 0.6, 2.5), ureteral injuries 12.9 per 1000 versus 0.4 per 1000 (RR 29.0; 95% CI 13.3, 63.0), bladder injuries 6.7 per 1000 versus 0.5 per 1000 (RR 13.0; 95% CI 6.0, 28.2), and major vascular injuries 0.2 per 1000 versus 0.4 per 1000 procedures (RR 0.4; 95% CI 0.1, 3.6), respectively. However, the incidence of all major complications in laparoscopic hysterectomies decreased significantly from 1993 to 1995 and to 1996, although the rate of ureteral injuries was 1% throughout these years. The incidence of ureteral injuries decreased somewhat in university and central hospitals from 1993 through 1996, but this was not statistically significant. Only the decrease in ureteral complications in local hospitals was significant during these years (Table 3Go).


   Discussion
Top
Abstract
 Materials and Methods
 Results
 Discussion
References
 
According to our 7-year data, diagnostic and sterilization laparoscopies are quite safe, as shown in previous studies.2,3,8 The new finding was the year-by-year increase in major complications in operative laparoscopies, which is due at least in part to the increased proportion of hysterectomies among operative laparoscopies. The incidence of ureteral injuries was stable, even as the incidence of all major complications decreased from 1993 to 1996 in laparoscopic hysterectomies. Major complications during other operative laparoscopies did not increase either. Only one death occurred, from a massive pulmonary embolism, and our mortality rate is in accordance with other reports.1,2 In a French study,2 the complication rate for advanced laparoscopic procedures, including laparoscopic hysterectomies, was no higher than that for standard operative laparoscopies; however, these operations were done by highly experienced physicians. The highest risks of complications occurred during laparoscopic hysterectomies (15% of all operative laparoscopies) also in the Netherlands multicentral survey.3 The experience of the surgeon was a significant predictor of complications.3

Of the complications occurring after operative laparoscopies, three quarters were in laparoscopic hysterectomies, which is the main source of laparoscopic complications in Finland. The first laparoscopic hysterectomy was done in Finland in 1992.9 In our nationwide survey of laparoscopic hysterectomies in 1993–1994, the total complication rate was 10%,5 which is in accordance with other reports.10–12 The overall risk of ureteral injury, however, was continuously about 1%, which is higher than after other types of hysterectomy.13 These injuries tended to be more common in smaller local hospitals where laparoscopic expertise is not as extensive as in university hospitals. Residents in training programs usually become skilled at advanced laparoscopy under the supervision of experts, but personnel at smaller hospitals must acquire their skills by attending courses or by visiting training centers. In an American survey of laparoscopy-assisted vaginal hysterectomies in 1995, 49% of the uterine arteries were secured vaginally, and the incidence of ureteral injuries was only 0.3%.14 According to the Finnish survey during 1993 and 1994, 86% of the uterine vessels were cut laparoscopically,5 and during this survey, all ureters were injured during laparoscopic parts of the operations. In most cases, electrocoagulation was the main cause of ureteral injuries due to the thermal effect; therefore, one way to decrease ureteral injuries is to cut the uterine vessels vaginally, especially during the learning phase.

The safety of advanced laparoscopies is highest in experienced hands;15 complications are usually related to inexperience of the surgeon.16 Laparoscopic hysterectomy is still a new procedure that should be done with adequate supervision until experience is gained. The ureters should be identified carefully during surgery, and it is essential to follow safety guidelines during the learning phase17 to decrease serious complications.18


   Footnotes
 
Supported by a grant from the Clinical Research Institution of Helsinki University Central Hospital and Jorvi Hospital and the Research Foundation of Obstetrics and Gynecology.

PII S0029-7844(98)00566-3

Received September 21, 1998. Received in revised form November 30, 1998. Accepted December 17, 1998.


   References
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Abstract
 Materials and Methods
 Results
 Discussion
 References
 
1. Hulka J, Peterson HB, Philips JM, Surrey MW. Operative laparoscopy: American Association of Gynecologic Laparoscopists’ 1993 membership survey. J Am Assoc Gynecol Laparosc 1995;2:133–6.[Medline]

2. Querleu D, Chapron C. Complications of gynecologic laparoscopic surgery. Curr Opin Obstet Gynecol 1995;7:257–61.[Medline]

3. Jansen FW, Kapiteyn K, Trimbos-Kemper T, Herman J, Trimbos JB. Complications of laparoscopy: A prospective multicentre observational study. Br J Obstet Gynaecol 1997;104:595–600.[Medline]

4. Härkki-Siren P, Kurki T. A nationwide analysis of laparoscopic complications. Obstet Gynecol 1997;89:108–12.[Abstract]

5. Härkki-Siren P, Sjöberg J, Mäkinen J, Heinonen PK, Kauko M, Tomas E, et al. Finnish National Register of laparoscopic hysterectomies: A review and complications of 1165 operations. Am J Obstet Gynecol 1997;176:118–22.[Medline]

6. Keskimäki I, Aro S. Accuracy of data on diagnosis, procedures and accidents in the Finnish Hospital Register. Int J Health Sci 1991;2: 15–21.

7. Morris JA, Gardner MJ. Calculating confidence intervals for relative risks (odds ratios) and standardised ratio and rates. BMJ 1988;296:1313–6.

8. Hulka JF, Phillips JM, Peterson HB, Surrey MW. Laparoscopic sterilization: American Association of Gynecologic Laparoscopists’ 1993 membership survey. J Am Assoc Gynecol Laparosc 1995;2: 137–8.[Medline]

9. Mäkinen J, Sjöberg J. First experiences from laparoscopically assisted hysterectomy in Finland 1994. Ann Chir Gynaecol 1994; 83:59–61.

10. Garry R, Phillips G. How safe is the laparoscopic approach to hysterectomy? Gynaecol Endosc 1995;4:77–9.

11. Harris JH, Daniell JF. Early complications of laparoscopic hysterectomy. Obstet Gynecol Surv 1996;51:559–67.[Medline]

12. Meikle SF, Nugent EW, Orleans M. Complications and recovery from laparoscopy-assisted vaginal hysterectomy compared with abdominal and vaginal hysterectomy. Obstet Gynecol 1997;89: 304–11.[Abstract]

13. Härkki-Sirén P, Sjöberg J, Tiitinen A. Urinary tract injuries after hysterectomy. Obstet Gynecol 1998;92:113–8.[Abstract]

14. Hulka JF, Levy BS, Parker WH, Phillips JM. Laparoscopic-assisted vaginal hysterectomy: American Association of Gynecologic Laparoscopists’ 1995 membership survey. J Am Assoc Gynecol Laparosc 1997;4:167–71.[Medline]

15. Chapron C, Dubuisson J-P, Querleu D, Pierre F. Complications of laparoscopy: A prospective multicentre observational study. Br J Obstet Gynaecol 1997;104:1419–20.

16. See W, Cooper C, Fisher R. Predictors of laparoscopic complications after formal training in laparoscopic surgery, JAMA 1993;270: 2689–92.[Abstract]

17. Chapron C, Devroey P, Dubuisson JB, Pouly JL, Vercellini P. ESHRE guidelines for training, accreditation and monitoring in gynaecological endoscopy. Hum Reprod 1997;12:867–8.[Free Full Text]

18. Phipps JH. Avoidance of complications of laparoscopic hysterectomy. Baillieres Clin Obstet Gynaecol 1995;9:729–48.[Medline]




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