National learning curve for laparoscopic hysterectomy and trends in hysterectomy in Finland

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1 Human Reproduction Vol.23, No.4 pp , 2008 Advance Access publication on January 31, 2008 doi: /humrep/den006 National learning curve for laparoscopic hysterectomy and trends in hysterectomy in Finland Tea H.I. Brummer 1,3, Tomi T. Seppälä 2 and Päivi S.M. Härkki 1 1 Department of Obstetrics and Gynecology, Helsinki University Central Hospital, PO Box 140, Helsinki, HUS, Finland; 2 Helsinki School of Economics, PO Box 1210, Helsinki, Finland 3 Correspondence address. tea.brummer@hus.fi BACKGROUND: Complications of laparoscopic hysterectomy (LH) have been evaluated with particular focus on quantities of urinary tract injuries. An earlier survey in the 1990s on LH in Finland indicated a decreasing trend in complications; our aim was to evaluate the current complications and hysterectomy trends. METHODS: All hysterectomies in Finland performed for benign indication from 2000 to 2005 (n ) were included, data were obtained from the Finnish hospital care register. All major complications reported on LH were analysed; the data were collected retrospectively from the Patient Insurance Centre. RESULTS: In 2000, the proportion of abdominal hysterectomy (AH) was 38%, vaginal hysterectomy (VH) 37% and LH 25%, whereas in 2005, the proportions were 26%, 45% and 29%, respectively. The overall incidence of major complications in LHs from 1992 to 1999 (LH n ) was 1.8% and from 2000 to 2005 (LH n ) it decreased to 1.0%. During the same time, urinary tract injuries decreased from 1.4% to 0.7%; in detail ureteral injuries decreased from 0.9% to 0.3%. CONCLUSIONS: Laparoscopic and VHs have become more common in Finland than AH. Continuous instruction and training of the Finnish gynaecological surgeons has helped to diminish major complication rates and it seems that in LH, a plateau on the learning curve has been reached. Keywords: hysterectomy; laparoscopic hysterectomy; learning curve; complication; ureteral injuries Introduction Laparoscopy became popular in gynaecological surgery in the 1990s. Cholecystectomy is still more commonly performed by laparoscopic route than is hysterectomy. Laparoscopic hysterectomy (LH) is divided into three main subgroups: laparoscopically assisted vaginal hysterectomy (LAVH) where VH is preceded by laparoscopic procedures excluding uterine artery ligation; LH where the laparoscopic procedures include uterine artery ligation [abbreviated to LH(a) in most recent publications]; and total LH (TLH) where a vaginal component is absent and the vaginal vault is sutured laparoscopically (Johnson et al., 2006). The era of LH began in 1988 (Reich et al., 1989). The first operation in Scandinavia was performed in Norway in 1991 (Langebrekke et al., 1992) and the first in Finland in 1992 (Mäkinen and Sjöberg, 1994), with the proportion having risen to 24% of all hysterectomies by 1996 (Mäkinen et al., 2001). Its introduction was not as rapid elsewhere: in France in 1996, it was 13.2% (Chapron et al., 1999); in the USA in 1997, 9.9% (Farquhar and Steiner, 2002); in the UK from 1994 to 1995, 3% (Maresh et al., 2002); and in Denmark between 1998 and 2000, it was 6% (Møller et al., 2002). The proportion for the vaginal route in the same studies was reported as 46.8% in France, 27.1% in the USA, 30% in the UK, and 14% in Denmark; abdominal hysterectomy (AH) has thus been reported as the most performed in all except the French university clinics. Has the new millennium made LH more common? In 2002 in the Netherlands, a national report of 108 hospitals showed that LAVH was performed in 25, and in such clinics comprised 7% of hysterectomies (Kolkman et al., 2007). In 2003 in California, the rate of LAVH was 3.9%, in a follow-up of hysterectomies performed between 1994 and 2003 (Jacobson et al., 2006). In 2003 in Western Australia, the proportion of LAVH was 15% (Spilsbury et al., 2006). In 2004 in France, the rates of LH and LAVH were 19.1% and 8.2%, respectively; this study of 634 patients included only university hospitals (David-Montefiore et al., 2007). The proportion for VH from these more recent studies was between 21.9% and 27.1% in the USA, 45% in Australia and 48.3% in France. Urinary tract injury, in particular ureteral injury, has remained the main fear for the laparoscopic approach. In a 2006 meta-analysis of 27 trials, there was a statistically significantly higher rate of urinary tract injuries for LH versus AH, but it was non-significant versus VH, and likewise nonsignificant for LH(a) versus LAVH. The meta-analysis pooled bladder and ureter injuries together as urinary tract 840 # The Author Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please journals.permissions@oxfordjournals.org

2 Laparoscopic hysterectomy in Finland injuries to detect a significance, which was absent if each organ injury was analysed alone (Johnson et al., 2005, 2006). A randomized multicentre study carried out between 1996 and 2000 in the UK and South Africa included 920 LHs and detected ureteral damage in 0.7% and bladder damage in 1.6% of the cases (Garry et al., 2004). In a recent French study, a review from 13 earlier studies revealed a variation in the rate of ureteral injuries from 0.00% to 3.39%; their own study of 1300 LHs presented a ureteral injury rate of 0.3% (Léonard et al., 2007). Another French study from university clinics in 2004, including both LH and LAVH groups, had an overall urinary tract injury incidence of 1.2% (David-Montefiore et al., 2007). The laparoscopic route was rapidly implemented in the s throughout Finland with operations performed from 1992 to 1999 but this was overshadowed by urinary tract injuries: 0.9% ureteral and 0.5% bladder injuries. The ureteral complications were more common in Finnish local (2.7%) hospitals than in central (1.1%) and university (0.9%) hospitals (Härkki et al., 2001). Education and training helps in reducing unwanted damage: in the prospective FINHYST 1996 study, surgeons who had performed over 30 LHs reported significantly fewer complications (Mäkinen et al., 2001). A reduction in complications could also be seen throughout the years in the previous Finnish follow-up of LHs; ureteral injury incidence was reduced from 1.9% in 1993 to 0.4% in 1999 (Härkki et al., 2001). The learning curve refers to a relationship between experience and surgical performance which in our study is measured by the proportion of complications. A national learning curve can be observed as a new surgical technique is spread across a whole nation. The aim of this study is to investigate by which approach, vaginal, laparoscopic or abdominal, hysterectomies are performed in Finland and to do a follow-up study of complications in LH, thus exploring the national learning curve of Finnish gynaecological surgeons. Materials and Methods The numbers of hysterectomies from 2000 to 2005 were obtained from the Finnish hospital care register which is maintained by the National Research and Development Centre for Welfare and Health (STAKES), which is a research centre working under the Ministry of Social Affairs and Health in Finland. Operations performed due to malignant indications were excluded based on C-codes referring to cancer in the International Classification of Diseases (ICD-10). The LH-group represents all LHs: LH(a)s, LAVHs, TLHs and laparoscopic subtotal hysterectomies (LSH). The AH-group includes AHs as well as supracervical, i.e. subtotal AHs. The VH-group comprises all VHs, due to uterine prolapse or not, and with or without colpoperineoplasty. The Patient Injuries Act is a law that came into force in Finland as early as 1 May 1987 and was revised on 1 May 1999 (Mikkola, 2004); it defines in detail the terms in which a bodily injury sustained in connection with treatment provided by health and medical care is compensated. The institution handling the compensation procedures is the Patient Insurance Centre. All hospitals have authorized agents helping patients to get into contact with the Centre, which in addition has a PDF form on their website, to make the filing of a claim as easy as possible. The patients are motivated to report complications to seek economic compensation; this also reduces malpractice trials, yet an injury where no actual malpractice is involved can also be compensated. Statements from the patient, the hospital records from the institution of treatment and statements from medical advisors are carefully evaluated to decide whether the claim is accepted and the compensation paid. The data on complications were collected retrospectively from the files of the Patient Insurance Centre, focusing on LH on benign disease and major complications, such as injuries to organs, i.e. urinary tract or bowel injuries and fistulas from these systems to the vagina, and infections, hernias, haemorrhagic complications or other conditions where it was necessary to intervene by a re-operation. Surgery induced thrombosis, embolus or death were also considered as a major complication. We have modelled the learning curve for the whole period of with generalized linear modelling (GLM) technique. The analysis was performed with SPSS. The response function indicating the number of complications follows a binomial probability distribution. For the shape of the learning curve, we have tried several alternative link functions, which all give very similar results. For the sake of simplicity, we thus report the results based on the logistic model, which is most commonly used in practice. Results The total number of hysterectomies on benign indications decreased in Finland from 2000 (n ¼ ) to 2005 (n ¼ 7909) by 26%. In 2005, the Finnish gynaecological surgeons performed more laparoscopic than AHs. The number of VHs exceeded those by the abdominal route in In the beginning of the study period in 2000, the proportions of hysterectomies by the approaches abdominal, vaginal and laparoscopic were 38%, 37% and 25% and in 2005 the proportions were 26%, 45% and 29%, respectively (Fig. 1). The 6-year period was composed of LHs. The overall incidence of major complications was 9.7 per 1000 operations. The yearly numbers of complications along with the estimated learning curve are shown in Fig. 2a. The likelihood ratio test for the model is highly significant statistically (x 2 ¼ 55.84, P, 0.001) showing a good model fit. The incidence of major complications has been reasonably steady in this century, indicating that a national learning curve plateau has been formed. The types of major complications of LH from 1992 to 1999 and from 2000 to 2005 are shown in Table I. The yearly Figure 1: Hysterectomies (n) for benign indication in Finland from 1992 to

3 Brummer et al. Table I. Major complications of LH versus Years Laparoscopic hysterectomies (n) Ureteral injury 125 (0.90%) 47 (0.34%) Bladder injury and VVFs 68 (0.49%) 45 (0.32%) Bowel injury 20 (0.14%) 12 (0.09%) Major vascular injury 2 (0.01%) 0 (0%) Death 1 (0.01%) 0 (0%) Other* 29 (0.21%) 31 (0.22%) Total 245 (1.76%) 134 (0.96%) *Including re-operations (due to other cause than specific organ injury) and thromboses. Figure 2: (a) Learning curve, the number of major complications in LH, (b) learning curve, the number of urinary tract injuries in LH and (c) learning curve, the number of ureteral injuries in LH incidences of these complications from 2000 to 2005 are presented in Table II. Urinary tract injuries In , the overall incidence of urinary tract injuries was 0.66%. There were altogether 92 injuries, of which 22 were vesicovaginal fistulas (VVFs), 23 bladder injuries and 47 ureteral injuries. The total numbers of complications were reported, and it should be noted that there were five patients having both ureteral injury and VVF, and three patients having ureteral and bladder injuries simultaneously. The yearly numbers of urinary tract injuries and the estimated learning curve are shown in Fig. 2b. The likelihood ratio test for the 842 model is highly significant statistically (x 2 ¼ 59.67, P, 0.001) showing a good fit. The incidence of urinary tract injuries has been steady in , indicating that a learning curve plateau has been reached. The overall incidence of ureteral injuries during was 0.34%. Of the 47 patients having ureteral damage, 43 (91%) went through ureteroneocystostomy, and one of them was preceded by an attempt of ureteranastomosis. Three patients were treated with stenting of the ureter and one recovered spontaneously. All lesions were unilateral. The injury was on the right side in 60% (28/47) of cases. The modalities to perform the haemostasis during LH were bipolar coagulation in 29 cases, ultrasonic scalpel in 10 cases, combination of bipolar coagulation and ultrasonic scalpel in 3 cases, bipolar instrument Ligasurew in 4 cases and in one case, the haemostasis method was not reported. Bipolar coagulation is the most common method of haemostasis for uterine vessels in Finland. The estimated learning curve and year by year incidence are given in Fig. 2c, which shows a very good fit, with the likelihood ratio test being highly significant statistically (x 2 ¼ 49.68, P, 0.001). Also the incidence of ureteral injuries has been steady in the current century, indicating that a learning curve plateau has been reached. The overall incidence of bladder injuries during was 0.16%. There were 23 bladder injuries and they were most commonly approached by laparotomy to perform suturing of the lesion. This occurred in 13 (56%) cases: five lesions were repaired in the primary operation and in the rest of the cases, between the first and 27th post-operative day. Six patients (26%) were treated by laparoscopic suturing: five in the primary operation and one on the first post-operative day. Suturing by the vaginal route was performed in three lesions and one was treated only by a Foley-catheter insertion. The overall incidence of VVFs during was 0.16%. There were 22 reported VVFs of which two minor fistulas were treated by insertion of Foley catheter drainage and by electrocoagulation via cystoscopy and 20 were repaired by laparotomy. Four patients had multiple laparotomies to secure closure: three patients required a second laparotomy and one patient was exposed to three laparotomies as an unsuccessful bladder repair lead to a pair of VVF repairs. Unsuccessful vaginal closure was attempted twice and both patients were later treated by the abdominal route.

4 Laparoscopic hysterectomy in Finland Table II. Major complications, n (%), of LH in Finland. Year LH (n) Ureteral injury 8 (0.31%) 10 (0.45%) 7 (0.28%) 7 (0.31%) 6 (0.28%) 9 (0.40%) Bladder injury 3 (0.12%) 3 (0.13%) 5 (0.20%) 3 (0.13%) 5 (0.23%) 4 (0.18%) Vesicovaginal fistulas 6 (0.23%) 4 (0.18%) 2 (0.08%) 4 (0.18%) 3 (0.14%) 3 (0.13%) Bowel injury 2 (0.08%) 1 (0.04%) 1 (0.04%) 1 (0.04%) 1 (0.05%) 6 (0.27%) Re-operation other 8 (0.31%) 2 (0.09%) 3 (0.12%) 1 (0.04%) 6 (0.28%) 5 (0.22%) Thrombosis 1 (0.04%) 0 (0.00%) 0 (0.00%) 0 (0.00%) 2 (0.09%) 2 (0.09%) Bowel injuries The overall incidence of bowel injuries during was 0.09%. All injuries were repaired by laparotomy. There were 12 perforations reported: six occurred in the small and six in the large intestines. A single patient had injuries in both: at the primary operation the suturing to the small intestines was performed, and a later peritonitis revealed a sigmoid colonic perforation discovered in the relaparotomy where a Hartmann procedure was performed. All injuries to the small intestines were diagnosed within nine post-operative days. Four injuries were sutured and a single perforation was treated by resection of the ileum; this patient still required a relaparotomy due to an abcess. When the perforation occurred in the large intestines, it led to fistulation to the vagina in four cases: a single rectovaginal fistula was treated only by closure, without any bowel resection; two cases of sigmavaginal fistulas were treated by Hartmann procedures, and one of them required a second laparotomy due to necrosis of the bowel; and a single sigmoid perforation was treated by an unsuccessful suturing leading to vaginal fistulation, which was treated by anterior resection of the rectum including closure of the fistula. The remaining two sigmoid colonic perforations where fistulation was absent were treated by Hartmann procedures. All injuries of the large intestines were detected between 3 days and 3 months post-operatively. Vascular injuries No major vessels (aorta, cava or iliac vessels) were injured. The overall incidence of re-operations due to haemorrhage was 0.11%. There were 16 cases, of which eight were dealt with by laparotomy, laparoscopy was used in five cases and the remaining cases were treated by vaginal exploration and evacuation of the haematoma. A single case was reported to be treated by vaginal sutures combined with angiographic embolization therapy. The most common method of haemostasis during LH in Finland is bipolar coagulation, which was used in 13 of the above operations, whereas ultrasonic scalpel was used in three operations prior a vascular injury. Other major complications There were no deaths. A single pulmonary embolus and four cases of deep venous thrombosis of the lower limb were reported. Infections requiring operative treatment were two abcesses drained vaginally and two treated by laparoscopic lavation. In three cases, an operation was done due to an incisional hernia and one laparotomy was performed due to postoperative ileus. There was a single case of compartment syndrome requiring fasciotomy. Discussion The overall number of hysterectomies for benign causes diminished by 26% from 2000 to 2005 possibly due to conservative methods of treatment for dysfunctional uterine bleeding, such as various endometrial resection or ablation techniques and such as the levonorgestrel-releasing intrauterine system, a Finnish invention (Nilsson et al., 1981). Since 2002 of all hysterectomies VH has been performed most commonly in Finland. The abdominal route has become least common as VH exceeded it in 2002 and LH exceeded it in This allows speedier recovery to our patients as it is known that the hospital stay is shorter and return to normal activities is faster after VH and LH compared with AH (Johnson et al., 2005, 2006). The choice of the approach in the end lies in the hands of the individual surgeon and is determined by personal preferences and experience, along with some patientrelated factors such as uterine size, a possible prolapse or other comorbitities such as endometrioses or ovarian pathology. But why is LH so popular in Finland? The population density of Finland is the fourth sparsest in Europe thus we are not centralizing our hysterectomies to just a few hospitals as geographical conditions force us to perform surgery all over Finland to ensure that patients receive treatment within a reasonable distance from home. Health care in Finland is financed by the state but organized by the local governments, and common operations such as hysterectomies are performed in 46 different communal hospitals. Communal does not refer to the private hospitals, but to university, central and local hospitals all over Finland. So the reason for the popularity of laparoscopy lies not merely in the hands of a few experienced gynaecological surgeons, who would favour LH. On the basis of the Finnish hospital care register, not only LH, but laparoscopy in itself is popular in Finland; in % of operations due to ectopic pregnancy were performed by laparoscopy, as were 88% of removal of ovarian cysts, 66% of salpingo-ophorectomies and 43% of tubal re-anastomosis after sterilization. Among uterine operations, hysteroscopic procedures excluded, 24% of the myomectomies were laparoscopic. The follow-up of complications is essential and their evaluation is necessary if the rates are undesirably high. Our nationwide study plays an important role as a large number of operations and complications are analysed, unlike in 843

5 Brummer et al. small, yet randomized, trials which might give selected data from highly specialized centres. The incidence of major complications of LHs has been highly reduced in Finland, during the 8-year period from 1992 to 1999, it was 1.8%, and during the 6-year period from 2000 to 2005, it was 1.0%; similarly the incidence of urinary tract injury decreased from 1.4% to 0.7% and in more detail, ureteral damage decreased from 0.9% to 0.3%. None of the ureteral complications from 2000 to 2005 resulted to nephrectomy, whereas during the previous decade three kidneys were lost due to this complication (Härkki et al., 2001). This means that from 1992 to 2005 the incidence of all complications has decreased by 74% (in average 11% per year), urinary tract injuries by 83% (in average 13% per year) and ureteral injuries by 79% (in average 11% per year) (Fig. 2a c). Since 1999 the complication rate has been reasonably stable, thus a national learning curve plateau seems to have been reached. A learning curve study of 1647 LHs from a centre of endoscopic surgery between and had a decrease of major complications from 5.6% to 1.3% and of urinary tract injuries from 2.2% to 0.9%, respectively (Wattiez et al., 2002), somewhat similar to the national learning curve in Finland. This study does not give a detailed view on different subgroups of LH the surgical procedures are registered by the Nordic Medico-Statistical Committee (NOMESCO) Classification of Surgical procedures (NCSP) and LH(a)s, LAVHs, TLHs and LSHs each do have their own NCSP code. Nevertheless, in our study the LH represents all of these laparoscopic approaches together because we suspect that the nationwide usage of the LH codes have been non-coherent as they have been added to the NCSP-classification later than other hysterectomy codes. This study neither gives information on hysterectomy indications nor concomitant procedures, both of which might be of interest when evaluating complications. Hysterectomy was number six in the list of injuries compensated by the Finnish Patient Insurance Centre , the top five consisting of different orthopaedic procedures and laparoscopic cholecystectomy. But are the numbers of complications received from the Patient Insurance Centre accurate since they are reported by our patients? The accuracy was tested in two different hysterectomy studies, where the complications reported by patients to the centre were compared with the complication rates achieved directly from gynaecological surgeons. The first one was a prospective survey where a national register of LHs was founded The rate of the major complications matched those of the Patient Insurance Centre, but some bladder perforations sutured during the primary operation were not reported by the patients (Härkki-Sirén et al., 1997). The second study was FINHYST 1996, a prospective national study of hysterectomies (Mäkinen et al., 2001). The rate of the major complications in LHs reported by the gynaecological surgeons to FINHYST 1996 was later compared with the numbers reported to the Patient Insurance Centre. Again, the number of bladder injuries reported by the patients was lower than those by the gynaecological surgeons. The amount of ureteral injuries reported by the patients was higher than the number reported to FINHYST 1996 (Härkki et al., 2001). This may be due to 844 diagnostic delay; thus the retrospective register analysis from the Patient Insurance Centre seems to be most accurate in ureteral injuries. The number of intestinal injuries was equal in both. It seems likely that some bladder injuries repaired in the primary operation itself might be lost, as in such there may be no actual subjective harm experienced by the patient. A national cross-section of LH gives a real-life picture of its complications. This may be unlike reports from laparoscopy specializing centres. Continuous instruction and training of the Finnish gynaecological surgeons has helped to diminish complication rates and it seems a plateau on the learning curve has been reached; LH is a good and safe option for hysterectomy in Finland. More detailed information on the causalities of occurring complications of hysterectomy is still needed. Acknowledgements We are grateful to Reima Palonen and Saija Lehtinen in Patient Insurance Centre for their collaboration with patient injury files. Simo Pelanteri in National Research and Development Centre for Welfare and Health is also thanked for finding the numbers of benign hysterectomies for us. References Chapron C, Laforest L, Ansquer Y, Fauconnier A, Fernandez B, Breart G, Dubuisson JB. Hysterectomy techniques used for benign pathologies: results of a French multicentre study. 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