Surgical management of uterine fibroids in Hesse, Germany, between 1998 and 2004

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1 UTERINE FIBROIDS Surgical management of uterine fibroids in Hesse, Germany, between 1998 and 2004 Andreas Hackethal, M.D., a D orthe Br uggmann, M.D., a Anne Leis, M.D., a Swapnil Langde, M.D., a,b Rosi Stillger, B.Sc., c and Karsten M unstedt, M.D., Ph.D. a a Department of Obstetrics and Gynecology, Justus-Liebig-University of Giessen, Giessen, Germany; b Galaxy Laparoscopy Institute, Pune, India; and c Institute of Quality Assurance, Hesse, Germany Objective: To identify and evaluate surgical management of women with uterine fibroids. Design: Retrospective analysis of mandatory surgical data sent to the Institute for Quality Assurance. Setting: Data collection from 1998 to 2004 in Hesse, Germany. Patient(s): 34,814 women who underwent surgery for uterine fibroids. Intervention(s): Patients were treated with either myomectomy or hysterectomy. Main Outcome Measure(s): Statistical analysis of mandatory surgical parameters. Result(s): Altogether, 4975 (14.3%) women had myomectomies, and 29,839 (85.7%) had hysterectomies. Age was an important determinant of surgical procedure; hysterectomy was preferred for patients over 40 (odds ratio 4.3; 95% confidence interval: ). Laparoscopic myomectomy rates increased from 25.9% in 1998 to 41.9% in 2004; during the same period, the proportion of conversion procedures and abdominal approaches fell from 15.6% to 2.9% and 38.9% to 30.9%, respectively. Intraoperative complication rates were similar for myomectomy (1.1%) and hysterectomy (1.0%), but postoperative complication rates were higher for hysterectomy (5.8%) than myomectomy (3.2%). Conclusion(s): The increasing use of endoscopic procedures was an important feature in this series and appeared to be safe. The reduction of conversion rates and intraoperative complications might be related to improvements in surgical skill. Acceptance of the benefits of endoscopic approaches seems to have promoted its steady growth as a primary surgical approach. (Fertil Steril Ò 2009;91: Ó2009 by American Society for Reproductive Medicine.) Key Words: Uterine fibroids, myomectomy, hysterectomy, quality assurance About 30% of all women of childbearing age present with uterine fibroids. Although it is generally agreed that women with asymptomatic fibroids do not require treatment (1), symptomatic patients do. Fibroids may cause bleeding disorders and pain, including dysmenorrhea and pelvic pressure. They also result in infertility through distortion of the uterine cavity, obstruction of the tubal ostia, and changes in the endometrium that affect embryo implantation and growth. Patients may present with one or more of these symptoms when they consult their gynecologist, who then has to consider the most appropriate treatment for them. In general, there are three approaches in symptomatic women: use of gonadotropin-releasing hormone analogues, uterine artery embolization, and surgery (2, 3). The surgical options are either a uterus-conserving approach via myomectomy (by Received August 23, 2007; revised and accepted December 5, A.K. has nothing to disclose. D.B. has nothing to disclose. A.L. has nothing to disclose. S.L. has nothing to disclose. R.S. has nothing to disclose. K.M. has nothing to disclose. Reprint requests: Andreas Hackethal, M.D., Universit atsfrauenklinik Giessen, Klinikstrasse 32, Giessen, Germany (FAX: þ ; andreas.hackethal@gyn.med.uni-giessen.de). laparoscopy, laparotomy, or hysteroscopy) or complete or subtotal removal of the uterus, which can also be achieved by a number of surgical approaches (4 6). In surgery for uterine fibroids, the therapeutic decision is mainly influenced by the patient s choice and desire to bear children. In 1997, the German state of Hesse introduced the first statewide survey of surgical data in gynecology (the GQH survey). Information was collected and monitored by the Institute of Quality Assurance, Hesse. The population of Hesse is around 6,089,000, of which 3,111,000 are women, and its demographics fit those of the German population (7, 8). Data collected for the GQH survey were evaluated using general indicators of treatment quality, which had been identified in an earlier work (9). Our study identified and evaluated surgical management of patients with uterine fibroids treated in hospitals in Hesse, Germany, between 1998 and Data on the surgical procedures performed were evaluated in relation to the patients characteristics, surgical approach, intraoperative and postoperative complications, mean operation times, and mean hospital stay. 862 Fertility and Sterility â Vol. 91, No. 3, March /09/$36.00 Copyright ª2009 American Society for Reproductive Medicine, Published by Elsevier Inc. doi: /j.fertnstert

2 MATERIALS AND METHODS Data Collection Between January 1, 1998 and December 31, 2004, approximately 280,000 gynecologic surgical procedures performed at all 87 gynecologic departments in the state were recorded on a standardized form for the GQH survey. The data were collected at the Institute of Quality Assurance Hesse. The instrument for data assessment consisted of 57 items grouped into 12 sections as follows (10): Identification of patient and hospital Diagnosis on admission to hospital Medical history Interim diagnosis Prophylactic measures Surgical procedure data, including approach Peculiarities of surgical procedures Intraoperative complications (bleeding and injuries to neighboring organs) Postoperative complications (surgical revision, infection, blood transfusion, pneumonia, deep vein thrombosis and embolism, seroma and hematoma formation, disturbed wound healing, ileus, and others) Histology Postoperative diagnostic investigations Hospital discharge Final diagnosis Database We generated an anonymous database of all cases coded for a final diagnosis of uterine fibroids according to the International Classification of Diseases (ICD 9: 218, ICD 10: D25). Cases of patients with histologic evidence for malignancy were excluded. Fibroid recurrences could not be distinguished from primary occurrences. Surgical treatment options were classified according to the International Code of Procedures in Medicine (ICPM 1.1 and 2.0; Hysterectomy 5-683, Myomectomy ). Statistical Analyses We used SPSS 12.0 software (SPSS, Chicago, IL) for Windows for data management and statistical analysis. The dependent group variables, myomectomy and hysterectomy, were assessed in relation to the following independent variables: surgical approach, age, patients physical status (classified according to the American Society of Anesthesiologists grade), complication rates, mean operation time, and mean length of hospital stay. Independent and dependent group variables were tested by cross-tabulation and chisquare test. In addition, multifactorial logistic regression and analysis of variance (ANOVA) were applied. P<.05 was considered statistically significant. RESULTS Uterine fibroids were diagnosed in 40,521 women discharged from Hessian hospitals between 1998 and In 34,814 (86%) cases, the fibroids were treated surgically, either by myomectomy (4,975, 14.3%) or hysterectomy (29,839, 85.7%). During the observed time period, the incidence of myomectomy versus hysterectomy as treatment for uterine fibroids showed a statistically significant change. Patient characteristics in relation to surgical approach are summarized in Table 1. For obvious reasons (conservation of fertility), younger patients underwent myomectomy more often than older patients, who more likely were treated by hysterectomy (odds ratio [OR] 4.3; 95% confidence interval [CI], ). Myomectomy The proportion of myomectomies increased steadily from 11.7% in 1988 to 17.6% in Four surgical approaches to myomectomy were differentiated on the standardized GQS form. These were laparoscopy, laparotomy, conversion from laparoscopy to laparotomy, and other (e.g., myomectomy by hysteroscopy). During the study period, the percentage of myomectomies performed by laparoscopy (25.9% to 41.9%) and hysteroscopy (19.6% to 24.2%) continually increased while the proportion approached via laparotomy (38.9% to 30.9%) declined. Although the proportion of conversions from laparoscopy to laparotomy fell during the observation period (from 15.6% to 2.9%), the assessment instrument changed in 2003, so no firm conclusions can be drawn in this respect. Information on intraoperative complication rates, postoperative complication rates, mean operation times, and the duration of hospital stay for each myomectomy approach is summarized in Table 2. Complication rates during myomectomy were low, with an average of 1.12% (56 out of 4975 patients). They were lowest for laparoscopic procedures and highest in cases of conversion from laparoscopy to laparotomy. Perhaps complications were the reason for conversion in some patients, but this does not seem to be generally true as in more than 98% of the cases no intraoperative complications were noted. As shown in Table 3, the intraoperative and postoperative complication rates for myomectomy were low. Injuries to neighboring organs accounted for only about half of the complications. Unfortunately, most intraoperative complications were not specified clearly. The rate of infections was statistically significantly higher for the abdominal approach; and it was highest in the case of classic open surgery (OR 5.2; 95% CI, ). On average, the postoperative complication rate was 3.21%. In cases of hysterosresectoscopy, the postoperative complication rate was 1.31%, but it was higher for laparoscopy (2.05%), conversion (4.21%), and laparotomy (5.25%). A third of postoperative complications were unspecified, but another third were caused by infections of the urinary system or the wound. Laparoscopic myomectomy showed the lowest perioperative complication rates. It is interesting that the mean operation time for the laparoscopic approach fell from 96 to 85 minutes over the Fertility and Sterility â 863

3 TABLE 1 Age, physical status, and surgical characteristics in women undergoing surgery for uterine fibroids in hospitals in Hesse, Germany, between 1998 and Variable Myomectomy (n [ 4975) Hysterectomy (n [ 29,839) Age (years) < (11.5) 135 (0.5) (60.8) 4985 (16.7) (22.1) 16,862 (56.5) > (5.6) 7857 (26.3) American Society of Anesthesiologists physical status grade I 3546 (71.3) 17,199 (57.6) II 1344 (27.0) 11,353 (38.0) III 82 (1.6) 1257 (4.2) IV 3 (0.1) 23 (0.1) V 7 (0.0) Surgical approach Laparoscopic 1807 (36.3) 2310 (7.7) Conversion 428 (8.6) 0 Abdominal 1751 (35.2) 14,731 (49.4) Vaginal 12,140 (40.7) Other (e.g., hysteroscopy)/combinations 989 (19.9) 658 (2.2) Note: Value in parentheses is percentage. study period, but this did not reach statistical significance (P¼.054). Operation duration remained the same for all other surgical approaches. As expected, the mean hospital stay for myomectomy procedures was the lowest for hysteroresectoscopic and highest for the abdominal approaches. Hysterectomy We observed a steady decline in the proportion of hysterectomies from 88.3% in 1998 to 82.4% in During the study, the proportions of abdominal hysterectomies fell from 51.6% to 45.4%. However, the proportion of hysterectomies performed via laparoscopic, vaginal, and other approaches increased from 5.5% to 8.9%, 41.3% to 43.0%, and 1.6% to 2.6%, respectively. Because of a change in the assessment scheme in 2003, these data may show a bias in favor of laparoscopic and other approaches. The mean duration of surgery and of hospital admission in patients who underwent hysterectomy is summarized in Table 2. Intraoperative complication rates, postoperative complication rates, and mean operation time as well as the duration of hospital stay for each surgical approach are summarized in Table 2. The overall intraoperative complication rate was 1% (310 out of 29,839 patients). The lowest documented rate was 0.8% for the vaginal approach (99 out of 12,140 patients). Our data analysis showed a slightly higher complication rate for laparoscopic hysterectomy compared with abdominal hysterectomy (1.56% versus 1.07%). Bladder injuries were the most common intraoperative complication in all cases. It is interesting that postoperative complication rates for abdominal, vaginal, and laparoscopic surgical approaches fell during the study (Table 4). Again, some patients had more than one complication, which means that there were 1733 (5.81%) patients with 1902 (6.41%) different complications. Laparoscopic hysterectomy was associated with a statistically significantly lower postoperative complication rate than abdominal hysterectomy. Infections of the urinary tract and wound accounted for approximately half of the postoperative complications. The most common combinations of complications were fever >38 C on day 3 after surgery and either urinary tract or wound infections. There was an association between increased prophylactic administration of antibiotics and the reduction of postoperative wound infections rate, fever, and septicemia (OR 2.0; 95% CI, , adjusted for age, American Society of Anesthesiologists physical status grade and surgical approach). DISCUSSION This study shows that during the past few years there has been a change in surgical treatment preferences for patients with uterine fibroids. We found a clear trend toward the use of the minimally invasive procedures laparoscopy and hysteroscopy. In addition, we noted a steady decline in complication rates. The reasons behind the trend toward organ preservation are unclear. These may reflect patients demands or the popularity of newer and more advanced surgical techniques that allow the conservation of the uterus. Thus, the proportion 864 Hackethal et al. Surgical management uterine fibroids Vol. 91, No. 3, March 2009

4 TABLE 2 Myomectomy and hysterectomy: surgical complications, mean hospital stay, and mean operation time in relation to surgical approach in women with uterine fibroids treated in hospitals in Hesse, Germany, between 1998 and Myomectomy: surgical approach All Laparoscopy Conversion Abdominal Others (e.g., hysteroscopy) Number of myomectomies (%) Intraoperative Postoperative Mean operation time (minutes) Mean hospital stay (days) 4975 (100) 1807 (36.3) 428 (8.6) 1751 (35.2) 989 (19.9) 1.12 (56) 0.55 (10) 1.87 (8) 1.25 (22) 1.62 (16) 3.21 (160) 2.05 (37) 4.21 (18) 5.25 (92) 1.31 (13) Hysterectomy: surgical approach All Laparoscopy Vaginal Abdominal Other (combinations) Number of hysterectomies (%) Intraoperative Postoperative Mean operation time (minutes) Mean hospital stay (days) 29,839 (100) 2310 (7.7) 12,140 (40.7) 14,731 (49.4) 658 (2.2) 1.04 (310) 1.56 (36) 0.82 (99) 1.07 (158) 2.58 (17) 5.81 (1733) 4.68 (108) 4.66 (566) 6.95 (1024) 5.32 (35) of endoscopically performed myomectomy procedures in relation to the total number of myomectomies performed increased continuously during the study. As might be expected, uterus-conserving treatment was more frequent in younger patients. This reflects their desire to remove any possible obstacles to becoming pregnant. In this group, an abdominal myomectomy was performed in almost half of the cases. One explanation may be the fear of uterine rupture in case of pregnancy. However, uterine rupture seems to be a rare complication; in a large clinical series, it occurred in about 1% of patients when the uterotomy was repaired appropriately (11). A systematic literature review on the surgical management of uterine fibroids failed to show any randomized trials supporting the superiority of one treatment over the other in respect of uterine ruptures (2). Earlier studies clearly showed the superiority of laparoscopic myomectomy in respect of postoperative pain, adhesion formation, hospital stay, and time until return to work (12, 13). Changes made to the survey instrument in 2003 affected the procedure for assessing the surgical approach. Defined approach selections such as Combination of vaginal and abdominal were changed to Vaginal and Abdominal, which subsequently had to be cross-checked for approach assessment. However, these changes would not have affected the end results for surgical approach assessment. We did not identify any age-related differences in the surgical approaches for hysterectomy. Even though rates of abdominal hysterectomy fell by 6% during the study, it still remained the preferred approach. Although this finding corresponds well with earlier studies (14), it is worth mentioning that in this analysis the high rate of abdominal hysterectomies might also be explained with the main diagnosis of uterine fibroids. In general, the vaginal or laparoscopic assisted approaches have clear advantages regarding postoperative complaints. The intraoperative and postoperative complication rates are more difficult to evaluate. In our study, the rates of major complications such as injuries to the bladder and Fertility and Sterility â 865

5 TABLE 3 Myomectomy: intraoperative and postoperative complications in relation to surgical approach in women with uterine fibroids treated in hospitals in Hesse, Germany, between 1998 and Myomectomy: surgical approach All n [ 4975 Laparoscopic n [ 1807 Conversion n [ 428 Abdominal n [ 1751 Other (e.g. hysteroscopy) n [ 989 Intraoperative complications Organ injuries (%) Bladder 5 (0.10) 0 (0) 1 (0.23) 3 (0.17) 1 (0.10) Bowel 5 (0.10) 3 (0.17) 0 (0) 1 (0.05) 1 (0.10) Nerve/vessel 2 (0.04) 0 (0) 1 (0.23) 1 (0.05) 0 (0) Uterus 13 (0.23) 3 (0.17) 1 (0.23) 1 (0.05) 8 (0.81) Events related to anesthesia (%) 2 (0.04) 0 (0) 0 (0) 1 (0.05) 1 (0.10) Other (%) 29 (0.58) 4 (0.22) 5 (1.16) 15 (0.86) 5 (0.51) Total (%) 56 (1.12) 10 (0.55) 8 (1.87) 22 (1.25) 16 (1.62) Postoperative complications Infections of: Urinary tract (%) 33 (0.73) 8 (21.61) 3 (16.67) 22 (23.91) 0 Wound (%) 33 (0.73) 5 (13.51) 2 (11.11) 22 (23.91) 4 (30.77) Surgery after secondary 24 (0.48) 4 (10.81) 4 (22.22) 15 (16.30) 1 (7.69) hemorrhage (%) Abscess (%) 15 (0.30) 1 (2.70) 1 (5.56) 10 (10.87) 3 (23.08) Temperature >38 C 3 days 9 (0.19) 4 (10.81) 1 (5.56) 4 (4.35) 0 after operation Seroma/hematoma 5 (0.10) 3 (8.11) 0 2 (2.17) 0 Secondary wound dehiscence 3 (0.06) 2 (5.41) 0 1 (1.09) 0 Other (%) 38 (0.76) 10 (27.03) 7 (38.89) 16 (17.31) 5 (38.46) Total postoperative diagnosed complications a 160 (3.21) 37 (2.05) 18 (4.21) 92 (5.25) 13 (1.31) a Individual patients could have more than one complication. bowel were within the known range; however, most complications were classified as other within the GQS survey (15, 16). Complications need to be more clearly defined as does surgery-related information (i.e., size, number, and position of myomas), and the GQS survey instrument should be adapted to allow better future classification and documentation. Conversely, some data presentation might not be congruent with clinical features, especially in rare occasions. In spite of these shortcomings, we can clearly state that the complication rate fell over time. This may be due to the fact that the GQS study not only analyzed data on surgical procedures but continually fed back the results of analyses to each contributing department, showing the anonymized results of other departments, too. This ongoing quality-assurance feedback might have resulted in improvement over the course of the study (9). In our opinion, it might have meant that departments increased the use of perioperative antibiotic cover, which might then have improved the postoperative complication rates. The comparably long mean hospital stay as well as its decline, especially from 2003 to 2004 (P<.001), is probably not due to quality assurance or any medical rational background. It is more likely a result of the introduction of the Diagnosis Related Groups System, which changed hospital financing in the German healthcare system. It is understood that the mean hospital stay in Germany is longer compared with many other industrialized states. The GQH study provided data from a large statewide standardized survey on gynecologic surgery. After a thorough literature review, we concluded that this is the largest published data collection. There was an increase of endoscopic approaches in the treatment of uterine fibroids as well as a decline in the complication rate. Because participation in the survey became mandatory in 1998, there is little bias in the dataset, which covers all surgical interventions in the state of Hesse. Unfortunately, changes were made to the GQH assessment instrument in 2003, which had to be considered; more importantly, the assessment instrument is not specific enough to provide 866 Hackethal et al. Surgical management uterine fibroids Vol. 91, No. 3, March 2009

6 TABLE 4 Hysterectomy: intraoperative and postoperative complications in relation to the surgical approach in women with uterine fibroids treated in hospitals in Hesse, Germany, between 1998 and Hysterectomy: surgical approach All n [ Laparoscopic n [ 2310 Vaginal n [ Abdominal n [ Other (combinations) n [ 658 Intraoperative complications Organ injuries (%) Bladder 142 (0.48) 17 (0.74) 58 (0.48) 73 (0.50) 3 (0.46) Ureter 28 (0.09) 4 (0.17) 5 (0.04) 17 (0.12) 0 (0) Urethra 3 (0.01) 1 (0.04) 0 (0) 2 (0.01) 0 (0) Bowel 39 (0.23) 3 (0.13) 10 (0.8) 21 (0.14) 1 (0.15) Nerves/vessel 18 (0.06) 0 (0) 6 (0.06) 11 (0.07) 3 (0.46) Uterus 7 (0.02) 0 (0) 7 (0.06) 3 (0.02) 1 (0.15) Other 1 (0.00) 0 (0) 1 (0.01) 0 (0) 0 (0) Events related to anesthesia (%) 4 (0.01) 0 (0) 2 (0.02) 2 (0.01) 0 (0) Other (%) 68 (0.23) 11 (0.48) 10 (0.08) 29 (0.20) 9 (1.36) Total (%) 310 (1.04) 36 (1.56) 99 (0.82) 158 (1.07) 17 (2.58) Postoperative complications Infections of (%) Urinary tract 551 (1.85) 36 (33.33) 221 (36.65) 287 (25.65) 8 (11.11) Wound 441 (1.51) 20 (18.52) 104 (17.25) 311 (27.81) 6 (8.31) Surgery after secondary 215 (0.72) 8 (7.41) 87 (14.43) 110 (9.83) 10 (13.91) hemorrhage (%) Abscess (%) 163 (0.55) 11 (10.70) 62 (10.32) 85 (7.61) 5 (6.94) Temperature >38 C 3 days 67 (0.22) 1 (0.93) 28 (4.64) 23 (2.11) 15 (20.83) after operation Seroma/hematoma 67 (0.22) 5 (4.63) 17 (2.86) 44 (3.93) 1 (1.49) Secondary wound dehiscence 51 (0.17) 2 (1.92) 3 (0.58) 45 (4.02) 1 (1.49) Other (%) 346 (1.21) 25 (23.44) 81 (13.43) 214 (19.12) 26 (36.11) Total postoperative diagnosed complications a 1902 (6.41) 108 (4.68) 603 (4.97) 1119 (7.60) 72 (10.94) a Individual patients could have more than one complication. information on all points of interest regarding uterine fibroids, such as the number and location of fibroids within the uterus. However, in spite of its shortcomings, the GQH instrument is able to document improvements in surgical outcome and identify decisional criteria in the treatment of fibroids. Acknowledgments: The authors thank Bj orn Misselwitz, head of the GQH project in Eschborn, Hesse, for his support on this project. REFERENCES 1. American College of Obstetricians and Gynecologists. Quality assessment and improvement in obstetrics and gynecology. Washington, DC: ACOG;1994: Myers ER, Barber MD, Gustilo-Ashby T, Couchman G, Matachar DB, McCrory DC. Management of uterine leiomyomata: what do we really know? Obstet Gynecol 2002;100: Lethaby A, Vollenhoven B, Sowter M. Pre-operative gonadotropinreleasing hormone analogue before hysterectomy or myomectomy for uterine fibroids [update in Cochrane Database Syst Rev 2001;2: CD000547]. Cochrane Database Syst Rev 2000;2:CD Semm K, Mettler L. New methods of pelviscopy for myomectomy, ovariectomy, tubectomy and adnexectomy. Endoscopy 1979;11: Hasson HM, Rotman C, Rana N, Sistos F, Dmowski WP. Laparoscopic myomectomy. Obstet Gynecol 1992;80: Daniell JF, Guerly LD. Laparoscopic treatment of clinically significant symptomatic uterine fibroids. J Gynecol Surg 1991: Federal Statistics Office. Regional breakdown of German population. Available at: Retrieved October 23, Statistisches Bundesamt. Statistisches Jahrbuch 2004 f ur die Bundesrepublik Deutschland. Wiesbaden: Statistisches Bundesamt, 2004: Geraedts M, Berg D, Koester H, Rauskolb R, Scheidel P, Selbmann HK. Qualit atssicherung in der operativen Gyn akologie. (Bundesministerium f ur Gesundheit ed.). Baden Baden: Nomos Verlag, M unstedt K, von Georgi R, Zygmunt M, Misselwitz B, Stillger R, K unzel W. Shortcomings and deficits in surgical treatment of gynecological cancers: a German problem only? Gynecol Oncol 2002;86: Fertility and Sterility â 867

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