Original Article
Risk of Morcellation of Uterine Leiomyosacomas in Laparoscopic Supracervical Hysterectomy and Laparoscopic Myomectomy, a Retrospective Trial Including 4791 Women Marit Lieng, MD, PhD*, Espen Berner, MD, and Bjorn Busund, MD From the Department of Gynecology, Oslo University Hospital, Oslo, Norway (Drs. Lieng, Berner, and Busund), and Institute of Clinical Medicine, University of Oslo, Oslo, Norway (Dr. Lieng).
ABSTRACT Study Objective: To evaluate the incidence of uterine leiomyosarcomas (LMSs). To identify the risk of morcellating LMS in a gynecological department that offers laparoscopic supracervical hysterectomy (LSH) and laparoscopic myomectomy as primary surgical treatments. Design: A retrospective trial. Design Classification: Canadian Task Force Classification III. Setting: Norwegian university teaching hospital. Patients: Women diagnosed with uterine LMS and the total population of women who were referred for surgical treatment of uterine fibroids from January 1, 2000 to December 31, 2013. Interventions: Surgical treatment of fibroids, including LSH, abdominal supracervical hysterectomy, total laparoscopic hysterectomy, total abdominal hysterectomy, laparoscopic myomectomy, and hysteroscopic resection of fibroids. Measurements and Main Results: A total of 4791 women were included in this trial; 1957 laparoscopic procedures were performed, and a morcellator was used in 1846 of the procedures. Twenty-six women were diagnosed with uterine LMS specimens after surgery. The mean 6 SD age of women with LMS was 61.2 6 12.3 years, and the mean 6 SD of the tumor size at time of diagnosis was 90.9 6 45.4 mm. Of these 26 women, 6 were diagnosed with uterine LMS by endometrial biopsy before surgical treatment, and 14 women were treated by open hysterectomy and bilateral salpingo-oophorectomy due to a clinical preoperative suspicion of a malignant condition. Consequently, 6 women with uterine LMS were treated according to the protocol for anticipated benign fibroids. Five of these women underwent laparotomy due to tumor size. LSH was performed in 1 woman, and a morcellator was used for tissue extraction. The incidence of uterine LMS in the population of women referred for anticipated benign fibroids was 0.0054 (1 in 183 women). The rate of unintended morcellation of a LMS at our department between January 1, 2000 and December 31, 2013 was 0.0002 (1 in 4791 women). Conclusion: The incidence of uterine LMS was comparable with the incidence reported in the literature. The risk of unintended morcellation of uterine LMS after a preoperative selection of women with fibroids appears to be very low. Journal of Minimally Invasive Gynecology (2015) -, -–- Ó 2014 AAGL. All rights reserved. Keywords:
DISCUSS
Laparoscopic myomectomy; Laparoscopic supracervical hysterectomy; Leiomyosarcoma; Power morcellation; Uterine leiomyosarcoma; Uterine tissue extraction
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-22-2-JMIG-D-14-00408
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Corresponding author: Marit Lieng, MD, PhD, Department of Gynecology, Oslo University Hospital, P. O. Box 4950 Nydalen, N-0424 Oslo, Norway. E-mail: [email protected] Submitted August 12, 2014. Accepted for publication October 29, 2014. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2014 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2014.10.022
Recently, there has been an increasing focus on the use of the electromechanical morcellators for tissue extraction during laparoscopic supracervical hysterectomy (LSH) and laparoscopic myomectomy [1–10]. This has become a controversial object of discussion, both in United States and Europe [11–14]. Mainly, there is concern regarding the risk of unintended morcellation of leiomyosarcomas
2
(LMSs) [10,12,15]. This may lead to spread of the cancerous tissue in the abdominal and pelvic cavity, and consequently, to worsening of the patient’s prognosis [16]. Therefore, in April 2014, the U.S. Food and Drug Administration (FDA) issued a communication discouraging the use of laparoscopic power morcellation of fibroids [12]. If a morcellator should be used during hysterectomy or myomectomy, the FDA has instructed all health care providers in the United States to inform patients that fibroids may contain unexpected cancerous tissue, and that the morcellator may spread the cancer and significantly worsen their prognosis. In addition, the FDA has recommended a thorough discussion of benefits and risk of all treatments with patients. During the last decade, LSH has been the preferred surgical treatment in women with symptomatic fibroids who require hysterectomy at our department. Laparoscopic myomectomy may be performed in women who want to preserve the uterus, if feasible. Preoperative evaluation before LSH includes cervical cytology, endometrial biopsy, gynecological examination, and transvaginal sonography. LSH is not performed in women with previous or current cervical dysplasia, or in women with atypical endometrial hyperplasia or endometrial cancer. Furthermore, open surgery is performed in cases in whom symptoms or preoperative findings are suggestive of possible malignant pelvic tumors. Consequently, LSH is rarely performed in postmenopausal women with symptoms related to uterine fibroids. The recent FDA safety communication and the subsequent debate encouraged us to review the treatment performed in women with presumed benign fibroids at our department [12]. The objective of this study was to evaluate the occurrence of uterine LMS in our patient population. In addition, we wanted to identify the risk of unintended morcellation of LMS in a gynecological department that offers LSH or laparoscopic myomectomy as primary surgical procedures in women with fibroids who require surgical treatment. Materials and Methods This is a retrospective study carried out in a university teaching hospital during May and June 2014. The Scientific Advisory Board and the Advisory Committee on the Protection of Patient Records at Oslo University Hospital approved the study. Approval from the Regional Committee for Medical Research Ethics was not necessary. All specimens with a histopathological diagnosis of uterine LMS at the Department of Pathology at our institution from January 1, 2000 to December 31, 2013 were retrieved, and the medical records of all women with LMS were searched. The following variables were retrieved from the medical records of the women diagnosed with LMS: patient age; body mass index; symptoms; size of the tumor (LMS); any preoperative investigations and results of such investigations; surgical treatment; and outcome (alive or deceased). To calculate the prevalence of LMS in women with presumed benign fibroids at our department, all procedures per-
Journal of Minimally Invasive Gynecology, Vol -, No -, -/- 2015
formed due to fibroids at our department from January 1, 2000 to December 31, 2013 were registered, as well as the type of surgical procedure and surgical approach used. The demographic data were not available for the total population of women studied. The data were analyzed using SPSS 18.0 (IBM, Armonk, New York). Results Of all the women referred to our department between January 1, 2000 and December 31, 2013 for surgical treatment of fibroids, 27 were diagnosed with uterine LMS (Fig. 1). In addition, the histopathological diagnosis of the specimen after surgery in 1 woman was inconclusive (whether the tumor was malignant or benign). This woman was treated and followed up according to the treatment protocol for uterine LMS. This woman was included in this study as a case of LMS. Two of the women with LMS had a relapse of previously diagnosed disease. Consequently, 26 new cases of women with LMS were identified. The mean 6 SD age of women with LMS at time for diagnosis was 61.2 6 12.3 years, and the mean 6 SD body mass index was 26.5 6 6.5 kg/m2. The majority of women with LMS were postmenopausal (74.0%), and the dominant symptom in this group of women was postmenopausal bleeding. Most premenopausal women experienced pelvic pressure or pain and/or menorrhagia. Two asymptomatic women were referred because they had a rapid growing fibroid diagnosed by transvaginal ultrasound, according to the referring gynecologist. Three of the women had previously had surgery due to benign fibroids confirmed by histopathological examination of the specimen (1 supracervical abdominal hysterectomy, 1 open myomectomy, and 1 transcervical resection of a submuceous fibroid). The mean 6 SD size of the tumor at the time of LMS diagnosis was 90.9 6 45.4 mm. Figure 2 shows the distribution of new cases of LMS for the study (2000– 2013) and the outcome in each case. LMSs were diagnosed preoperatively by endometrial biopsy in 6 of the 26 women. One of these women was 84 years of age and had an advanced stage of the condition with multiple metastasis to the lungs at the time of diagnosis. After a thorough evaluation, and informed consent was obtained, no surgical treatment was performed and the patient received palliative treatment. The other 5 women were treated and followed up according to the treatment protocol for LMS at the national cancer institution (open hysterectomy and bilateral salpingoo-oophorectomy). The diagnosis of LMS was not established when the surgical treatment was performed in 20 women. Nevertheless, 14 of these women (70.0%) were treated by surgical procedures according to the protocol for uterine LMS (total abdominal hysterectomy and bilateral salpingooophorectomy) due to a clinical suspicion of possible malignant conditions. In most cases, the suspicion of possible malignant conditions was based on large tumors with irregular sonographic apperance in postmenopausal women.
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Fig. 1 Study flowchart. BSOE 5 bilateral salpingo-oophorectomy; LSH 5 laparoscopic supracervical hysterectomy; SAH 5 supracervical abdominal hysterectomy.
Therefore, 6 of the 26 women with LMS were treated surgically according to the treatment for a benign condition. Four of these women underwent supracervical abdominal hysterectomy (SAH), and 1 had an open myomectomy due to large fibroids. One woman underwent LSH with tissue extraction performed by an electromechanical morcellator. All 6 women underwent a second surgical procedure when the diagnosis of LMS was established by histopathological examination of the specimen from the original surgical procedure (removal of cervix uteri and adnexa in women with previous SAH and LSH, and removal of uterus and adnexa in a woman with a previous myomectomy). A total of 4791 women were referred to our department for surgical treatment of fibroids between January 1, 2000 and December 31, 2013. The total occurrence of LMSs in women admitted for surgical treatment of a presumed benign uterine tumor was 0.0054. Open surgery (abdominal total or supracervical hysterectomy and abdominal myomectomy) was the dominant surgical approach used during the first years of the study (Fig. 3). Laparoscopic procedures,
including laparoscopic total or supracervical hysterectomy and laparoscopic myomectomy, were gradually implemented at our department during the study period, and laparoscopy was the dominant surgical approach used in women with fibroids from 2004 onward (Fig. 3). A total of 1957 laparoscopic procedures were performed on women with fibroids during the study period. The laparoscopic procedures consisted of 1134 LSH procedures (57.9%), 712 laparoscopic myomectomies (36.4%), and 111 total laparoscopic hysterectomies (TLHs) (5.7%). Only 1 of the 1846 women treated by laparoscopy, including tissue extraction by morcellation, had LMS morcellated (0.0005). The total rate of unintended morcellation of a LMS at our department between January 1, 2000 and December 31, 2013 was 1 of 4791 operative procedures (0.0002). Discussion The results of this trial indicate that the risk of unintended morcellation of a uterine LMS is very low, even in a
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Fig. 2 Distribution and outcomes of new cases of uterine leiomyosarcoma during 2000 to 2013.
department that offers LSH with morcellation as the standard surgical treatment in women with fibroids. Although we found a relatively high rate of LMS compared with previous studies (0.54%), the risk of unintended morcellation of a LMS was very low (0.02%) [6–8,10,15,17,18]. The importance of preoperative evaluation of women before hysterectomy is clearly demonstrated in this study. Although we mainly perform laparoscopic hysterectomies at our department, most women with LMS were treated by open hysterectomy and bilateral salpingo-oophorectomy due to a clinical suspicion of a potential malignant uterine tumor. According to the medical records, the important clinical factors during the preoperative decisionmaking of the surgical approach and procedure were patient age, occurrence of new fibroid-related symptoms in postmenopausal women, tumor size, and irregular tumor appearance found by transvaginal ultrasound. Minimal invasive surgery such as TLH or LSH have well-documented benefits compared with open hysterectomy [19–21]. These benefits include fewer perioperative complications, shorter hospital stays, less pain, better
Fig. 3 Surgical treatment of women with uterine fibroids during 2000 to 2013. LSH 5 laparoscopic supracervical hysterectomy; SAH 5 supracervical abdominal hysterectomy; TAH 5 total abdominal hysterectomy; TLH 5 total laparoscopic hysterectomy.
cosmetic results, improved quality of life, and faster return to work. In most women with symptomatic fibroids who require hysterectomy at our department, electromechanical morcellation or division of the specimen is necessary to be able to retrieve the uterine tissue through a laparoscopic incision. Although different ‘‘in-bag morcellation techniques’’ have been described to increase safety during power morcellation of fibroids, no such validated system for closed electromechanical morcellation is currently available [22–24]. Consequently, a strategy of complete avoidance of unintended morcellation of a LMS at our department requires that most women with symptomatic fibroids who require hysterectomy must be treated by abdominal hysterectomy. An abundance of morcellation for uterine tissue extraction to avoid morcellation and spread of a LMS will probably increase morbidity related to laparotomy. Therefore, according to the results of the present trial, we have no reason to change our current practice regarding surgical treatment of women with fibroids. Although morcellation has been a widely used technique for tissue extraction during laparoscopic hysterectomy and myomectomy for the last 2 decades, there are few studies that have described the prevalence of unexpected LMS among women who undergo morcellation. A recently published research letter evaluated the occurrence of all types of uterine cancers in women who underwent minimally invasive hysterectomy using morcellation [25]. However, the occurrence of LMS was not evaluated in this report. The main limitations of our study were the retrospective design and the lack of demographic data for the total population studied. The objectives of this trial were to evaluate the occurrence of uterine LMSs and to identify the risk of unintended morcellation of LMSs in our patient population. Therefore, the lack of demographic data for the total population did not influence the conclusion of this trial. A prospective design, including complete preoperative demographic data, would have strengthened the validity of the study. However, the local registry both on histopathological diagnosis of uterine LMS and the surgical procedures at the department are of high quality. Therefore, the data in this study were most likely correct and complete. In addition, the strength of the study was the relatively large sample size. The findings of our study support the conclusion of the American Association of Gynecologic Laparoscopists expert group report, which was published on May 6, 2014 [14]. According to this report, ‘‘Morcellation should only be considered in patients if the appropriate evaluation of the myometrium (with or without fibroids) is reassuring, and appropriate evaluation of the cervix and endometrium is also reassuring. For patients in whom preoperative evaluation results in an increased suspicion for malignancy, alternatives to morcellation should be employed, including laparotomy. As the risk of malignancy, including undetectable malignancy, is increased in postmenopausal women, alternatives to morcellation should be considered in this patient population.’’
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Conclusion The risk of unintended morcellation of a LMS in a population of women with symptomatic fibroids who undergo thorough preoperative evaluation appears to be very low. To decrease the risk of unintended morcellation of uterine LMS, women who have clinical findings that are suspicious of malignant disease found on endometrial biopsy or transvaginal ultrasound should be treated according to the prococol for that malignancy.
11.
12.
13.
Acknowledgments Bjorn Risberg, MD, Department of Pathology, Oslo University Hospital, contributed to the study. The Department of Gynecology, Oslo University Hospital, covered all expenses of the study. No additional funding was required.
14.
15.
References 1. Andy UU, Nosti PA, Kane S, et al. Incidence of unanticipated uterine pathology at the time of minimally invasive abdominal sacrocolpopexy. J Minim Invasive Gynecol. 2014;21:97–100. 2. Della BC, Karini H. Endometrial stromal sarcoma diagnosed after uterine morcellation in laparoscopic supracervical hysterectomy. J Minim Invasive Gynecol. 2010;17:791–793. 3. Einstein MH, Barakat RR, Chi DS, et al. Management of uterine malignancy found incidentally after supracervical hysterectomy or uterine morcellation for presumed benign disease. Int J Gynecol Cancer. 2008;18:1065–1070. 4. Frick AC, Walters MD, Larkin KS, Barber MD. Risk of unanticipated abnormal gynecologic pathology at the time of hysterectomy for uterovaginal prolapse. Am J Obstet Gynecol. 2010;202:507.e1–507.e4. 5. Hagemann IS, Hagemann AR, LiVolsi VA, Montone KT, Chu CS. Risk of occult malignancy in morcellated hysterectomy: a case series. Int J Gynecol Pathol. 2011;30:476–483. 6. Kho KA, Nezhat CH. Evaluating the risks of electric uterine morcellation. JAMA. 2014;311:905–906. 7. Milad MP, Milad EA. Laparoscopic morcellator-related complications. J Minim Invasive Gynecol. 2014;21:486–491. 8. Ramm O, Gleason JL, Segal S, Antosh DD, Kenton KS. Utility of preoperative endometrial assessment in asymptomatic women undergoing hysterectomy for pelvic floor dysfunction. Int Urogynecol J. 2012;23: 913–917. 9. Seidman MA, Oduyebo T, Muto MG, Crum CP, Nucci MR, Quade BJ. Peritoneal dissemination complicating morcellation of uterine mesenchymal neoplasms. PLoS One. 2012;7:e50058. 10. Theben JU, Schellong AR, Altgassen C, Kelling K, Schneider S, Grosse-Drieling D. Unexpected malignancies after laparoscopic-
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assisted supracervical hysterectomies (LASH): an analysis of 1,584 LASH cases. Arch Gynecol Obstet. 2013;287:455–462. European Society for Gynaecological Endoscopy. Statement on Morcellation. Available at: http://www.esge.org/article/218. Accessed July 9, 2014. U.S Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication, issued April 17, 2014. Available at: http://www.fda.gov/ MedicalDevices/Safety/AlertsandNotices/ucm393576.htm. Accessed July 9, 2014. American Congress of Obstreticians and Gynecologists. Power Morcellation and Occult Malignancy in Gynecological Surgery. A Special Report 2014. Available at: http://www.acog.org/Resources-AndPublications/Task-Force-and-Work-Group-Reports/Power-Morcellationand-Occult-Malignancy-in-Gynecologic-Surgery. Accessed July 9, 2014. American Association of Gynecologic Laparoscopists. Advancing Minimally Invasive Gynecology Worldwide. Available at: http:// www.aagl.org/wp-content/uploads/2014/05/Tissue_Extraction_TFR.pdf. Accessed July 9, 2014. Leibsohn S, d’Ablaing G, Mishell DR Jr, Schlaerth JB. Leiomyosarcoma in a series of hysterectomies performed for presumed uterine leiomyomas. Am J Obstet Gynecol. 1990;162:968–974. Park JY, Park SK, Kim DY, et al. The impact of tumor morcellation during surgery on the prognosis of patients with apparently early uterine leiomyosarcoma. Gynecol Oncol. 2011;122:255–259. Parker WH, Fu YS, Berek JS. Uterine sarcoma in patients operated on for presumed leiomyoma and rapidly growing leiomyoma. Obstet Gynecol. 1994;83:414–418. Takamizawa S, Minakami H, Usui R, et al. Risk of complications and uterine malignancies in women undergoing hysterectomy for presumed benign leiomyomas. Gynecol Obstet Invest. 1999;48:193–196. ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009;114:1156–1158. AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011;18:1–3. Nieboer TE, Johnson N, Lethaby A, et al. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009;(3):CD003677. Cohen SL, Greenberg JA, Wang KC, et al. Risk of leakage and tissue dissemination with various contained tissue extraction (cte) techniques: an in vitro pilot study. J Minim Invasive Gynecol. 2014;21:935–939. Einarsson JI, Cohen SL, Fuchs N, Wang KC. In-bag morcellation. J Minim Invasive Gynecol. 2014;21:951–953. Senapati S, Tu FF, Magrina JF. Power morcellators: a review of current practice and assessment of risk. Am J Obstet Gynecol. 2014 Jul 26. pii: S0002-9378(14)00795-9. doi:10.1016/j.ajog.2014.07.046. [Epub ahead of print]. Wright JD, Tergas AI, Burke WM, et al. Uterine pathology in women undergoing minimally invasive hysterectomy using morcellation. JAMA. 2014;312:1253–1255.
Risk of Morcellation of Uterine Leiomyosacomas in Laparoscopic Supracervical Hysterectomy and Laparoscopic Myomectomy, a Retrospective Trial Including 4791 Women Marit Lieng, MD, PhD*, Espen Berner, MD, and Bjorn Busund, MD From the Department of Gynecology, Oslo University Hospital, Oslo, Norway (Drs. Lieng, Berner, and Busund), and Institute of Clinical Medicine, University of Oslo, Oslo, Norway (Dr. Lieng).
ABSTRACT Study Objective: To evaluate the incidence of uterine leiomyosarcomas (LMSs). To identify the risk of morcellating LMS in a gynecological department that offers laparoscopic supracervical hysterectomy (LSH) and laparoscopic myomectomy as primary surgical treatments. Design: A retrospective trial. Design Classification: Canadian Task Force Classification III. Setting: Norwegian university teaching hospital. Patients: Women diagnosed with uterine LMS and the total population of women who were referred for surgical treatment of uterine fibroids from January 1, 2000 to December 31, 2013. Interventions: Surgical treatment of fibroids, including LSH, abdominal supracervical hysterectomy, total laparoscopic hysterectomy, total abdominal hysterectomy, laparoscopic myomectomy, and hysteroscopic resection of fibroids. Measurements and Main Results: A total of 4791 women were included in this trial; 1957 laparoscopic procedures were performed, and a morcellator was used in 1846 of the procedures. Twenty-six women were diagnosed with uterine LMS specimens after surgery. The mean 6 SD age of women with LMS was 61.2 6 12.3 years, and the mean 6 SD of the tumor size at time of diagnosis was 90.9 6 45.4 mm. Of these 26 women, 6 were diagnosed with uterine LMS by endometrial biopsy before surgical treatment, and 14 women were treated by open hysterectomy and bilateral salpingo-oophorectomy due to a clinical preoperative suspicion of a malignant condition. Consequently, 6 women with uterine LMS were treated according to the protocol for anticipated benign fibroids. Five of these women underwent laparotomy due to tumor size. LSH was performed in 1 woman, and a morcellator was used for tissue extraction. The incidence of uterine LMS in the population of women referred for anticipated benign fibroids was 0.0054 (1 in 183 women). The rate of unintended morcellation of a LMS at our department between January 1, 2000 and December 31, 2013 was 0.0002 (1 in 4791 women). Conclusion: The incidence of uterine LMS was comparable with the incidence reported in the literature. The risk of unintended morcellation of uterine LMS after a preoperative selection of women with fibroids appears to be very low. Journal of Minimally Invasive Gynecology (2015) -, -–- Ó 2014 AAGL. All rights reserved. Keywords:
DISCUSS
Laparoscopic myomectomy; Laparoscopic supracervical hysterectomy; Leiomyosarcoma; Power morcellation; Uterine leiomyosarcoma; Uterine tissue extraction
You can discuss this article with its authors and with other AAGL members at http://www.AAGL.org/jmig-22-2-JMIG-D-14-00408
Use your Smartphone to scan this QR code and connect to the discussion forum for this article now* * Download a free QR Code scanner by searching for ‘‘QR scanner’’ in your smartphone’s app store or app marketplace.
Corresponding author: Marit Lieng, MD, PhD, Department of Gynecology, Oslo University Hospital, P. O. Box 4950 Nydalen, N-0424 Oslo, Norway. E-mail: [email protected] Submitted August 12, 2014. Accepted for publication October 29, 2014. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2014 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2014.10.022
Recently, there has been an increasing focus on the use of the electromechanical morcellators for tissue extraction during laparoscopic supracervical hysterectomy (LSH) and laparoscopic myomectomy [1–10]. This has become a controversial object of discussion, both in United States and Europe [11–14]. Mainly, there is concern regarding the risk of unintended morcellation of leiomyosarcomas
2
(LMSs) [10,12,15]. This may lead to spread of the cancerous tissue in the abdominal and pelvic cavity, and consequently, to worsening of the patient’s prognosis [16]. Therefore, in April 2014, the U.S. Food and Drug Administration (FDA) issued a communication discouraging the use of laparoscopic power morcellation of fibroids [12]. If a morcellator should be used during hysterectomy or myomectomy, the FDA has instructed all health care providers in the United States to inform patients that fibroids may contain unexpected cancerous tissue, and that the morcellator may spread the cancer and significantly worsen their prognosis. In addition, the FDA has recommended a thorough discussion of benefits and risk of all treatments with patients. During the last decade, LSH has been the preferred surgical treatment in women with symptomatic fibroids who require hysterectomy at our department. Laparoscopic myomectomy may be performed in women who want to preserve the uterus, if feasible. Preoperative evaluation before LSH includes cervical cytology, endometrial biopsy, gynecological examination, and transvaginal sonography. LSH is not performed in women with previous or current cervical dysplasia, or in women with atypical endometrial hyperplasia or endometrial cancer. Furthermore, open surgery is performed in cases in whom symptoms or preoperative findings are suggestive of possible malignant pelvic tumors. Consequently, LSH is rarely performed in postmenopausal women with symptoms related to uterine fibroids. The recent FDA safety communication and the subsequent debate encouraged us to review the treatment performed in women with presumed benign fibroids at our department [12]. The objective of this study was to evaluate the occurrence of uterine LMS in our patient population. In addition, we wanted to identify the risk of unintended morcellation of LMS in a gynecological department that offers LSH or laparoscopic myomectomy as primary surgical procedures in women with fibroids who require surgical treatment. Materials and Methods This is a retrospective study carried out in a university teaching hospital during May and June 2014. The Scientific Advisory Board and the Advisory Committee on the Protection of Patient Records at Oslo University Hospital approved the study. Approval from the Regional Committee for Medical Research Ethics was not necessary. All specimens with a histopathological diagnosis of uterine LMS at the Department of Pathology at our institution from January 1, 2000 to December 31, 2013 were retrieved, and the medical records of all women with LMS were searched. The following variables were retrieved from the medical records of the women diagnosed with LMS: patient age; body mass index; symptoms; size of the tumor (LMS); any preoperative investigations and results of such investigations; surgical treatment; and outcome (alive or deceased). To calculate the prevalence of LMS in women with presumed benign fibroids at our department, all procedures per-
Journal of Minimally Invasive Gynecology, Vol -, No -, -/- 2015
formed due to fibroids at our department from January 1, 2000 to December 31, 2013 were registered, as well as the type of surgical procedure and surgical approach used. The demographic data were not available for the total population of women studied. The data were analyzed using SPSS 18.0 (IBM, Armonk, New York). Results Of all the women referred to our department between January 1, 2000 and December 31, 2013 for surgical treatment of fibroids, 27 were diagnosed with uterine LMS (Fig. 1). In addition, the histopathological diagnosis of the specimen after surgery in 1 woman was inconclusive (whether the tumor was malignant or benign). This woman was treated and followed up according to the treatment protocol for uterine LMS. This woman was included in this study as a case of LMS. Two of the women with LMS had a relapse of previously diagnosed disease. Consequently, 26 new cases of women with LMS were identified. The mean 6 SD age of women with LMS at time for diagnosis was 61.2 6 12.3 years, and the mean 6 SD body mass index was 26.5 6 6.5 kg/m2. The majority of women with LMS were postmenopausal (74.0%), and the dominant symptom in this group of women was postmenopausal bleeding. Most premenopausal women experienced pelvic pressure or pain and/or menorrhagia. Two asymptomatic women were referred because they had a rapid growing fibroid diagnosed by transvaginal ultrasound, according to the referring gynecologist. Three of the women had previously had surgery due to benign fibroids confirmed by histopathological examination of the specimen (1 supracervical abdominal hysterectomy, 1 open myomectomy, and 1 transcervical resection of a submuceous fibroid). The mean 6 SD size of the tumor at the time of LMS diagnosis was 90.9 6 45.4 mm. Figure 2 shows the distribution of new cases of LMS for the study (2000– 2013) and the outcome in each case. LMSs were diagnosed preoperatively by endometrial biopsy in 6 of the 26 women. One of these women was 84 years of age and had an advanced stage of the condition with multiple metastasis to the lungs at the time of diagnosis. After a thorough evaluation, and informed consent was obtained, no surgical treatment was performed and the patient received palliative treatment. The other 5 women were treated and followed up according to the treatment protocol for LMS at the national cancer institution (open hysterectomy and bilateral salpingoo-oophorectomy). The diagnosis of LMS was not established when the surgical treatment was performed in 20 women. Nevertheless, 14 of these women (70.0%) were treated by surgical procedures according to the protocol for uterine LMS (total abdominal hysterectomy and bilateral salpingooophorectomy) due to a clinical suspicion of possible malignant conditions. In most cases, the suspicion of possible malignant conditions was based on large tumors with irregular sonographic apperance in postmenopausal women.
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Fig. 1 Study flowchart. BSOE 5 bilateral salpingo-oophorectomy; LSH 5 laparoscopic supracervical hysterectomy; SAH 5 supracervical abdominal hysterectomy.
Therefore, 6 of the 26 women with LMS were treated surgically according to the treatment for a benign condition. Four of these women underwent supracervical abdominal hysterectomy (SAH), and 1 had an open myomectomy due to large fibroids. One woman underwent LSH with tissue extraction performed by an electromechanical morcellator. All 6 women underwent a second surgical procedure when the diagnosis of LMS was established by histopathological examination of the specimen from the original surgical procedure (removal of cervix uteri and adnexa in women with previous SAH and LSH, and removal of uterus and adnexa in a woman with a previous myomectomy). A total of 4791 women were referred to our department for surgical treatment of fibroids between January 1, 2000 and December 31, 2013. The total occurrence of LMSs in women admitted for surgical treatment of a presumed benign uterine tumor was 0.0054. Open surgery (abdominal total or supracervical hysterectomy and abdominal myomectomy) was the dominant surgical approach used during the first years of the study (Fig. 3). Laparoscopic procedures,
including laparoscopic total or supracervical hysterectomy and laparoscopic myomectomy, were gradually implemented at our department during the study period, and laparoscopy was the dominant surgical approach used in women with fibroids from 2004 onward (Fig. 3). A total of 1957 laparoscopic procedures were performed on women with fibroids during the study period. The laparoscopic procedures consisted of 1134 LSH procedures (57.9%), 712 laparoscopic myomectomies (36.4%), and 111 total laparoscopic hysterectomies (TLHs) (5.7%). Only 1 of the 1846 women treated by laparoscopy, including tissue extraction by morcellation, had LMS morcellated (0.0005). The total rate of unintended morcellation of a LMS at our department between January 1, 2000 and December 31, 2013 was 1 of 4791 operative procedures (0.0002). Discussion The results of this trial indicate that the risk of unintended morcellation of a uterine LMS is very low, even in a
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Fig. 2 Distribution and outcomes of new cases of uterine leiomyosarcoma during 2000 to 2013.
department that offers LSH with morcellation as the standard surgical treatment in women with fibroids. Although we found a relatively high rate of LMS compared with previous studies (0.54%), the risk of unintended morcellation of a LMS was very low (0.02%) [6–8,10,15,17,18]. The importance of preoperative evaluation of women before hysterectomy is clearly demonstrated in this study. Although we mainly perform laparoscopic hysterectomies at our department, most women with LMS were treated by open hysterectomy and bilateral salpingo-oophorectomy due to a clinical suspicion of a potential malignant uterine tumor. According to the medical records, the important clinical factors during the preoperative decisionmaking of the surgical approach and procedure were patient age, occurrence of new fibroid-related symptoms in postmenopausal women, tumor size, and irregular tumor appearance found by transvaginal ultrasound. Minimal invasive surgery such as TLH or LSH have well-documented benefits compared with open hysterectomy [19–21]. These benefits include fewer perioperative complications, shorter hospital stays, less pain, better
Fig. 3 Surgical treatment of women with uterine fibroids during 2000 to 2013. LSH 5 laparoscopic supracervical hysterectomy; SAH 5 supracervical abdominal hysterectomy; TAH 5 total abdominal hysterectomy; TLH 5 total laparoscopic hysterectomy.
cosmetic results, improved quality of life, and faster return to work. In most women with symptomatic fibroids who require hysterectomy at our department, electromechanical morcellation or division of the specimen is necessary to be able to retrieve the uterine tissue through a laparoscopic incision. Although different ‘‘in-bag morcellation techniques’’ have been described to increase safety during power morcellation of fibroids, no such validated system for closed electromechanical morcellation is currently available [22–24]. Consequently, a strategy of complete avoidance of unintended morcellation of a LMS at our department requires that most women with symptomatic fibroids who require hysterectomy must be treated by abdominal hysterectomy. An abundance of morcellation for uterine tissue extraction to avoid morcellation and spread of a LMS will probably increase morbidity related to laparotomy. Therefore, according to the results of the present trial, we have no reason to change our current practice regarding surgical treatment of women with fibroids. Although morcellation has been a widely used technique for tissue extraction during laparoscopic hysterectomy and myomectomy for the last 2 decades, there are few studies that have described the prevalence of unexpected LMS among women who undergo morcellation. A recently published research letter evaluated the occurrence of all types of uterine cancers in women who underwent minimally invasive hysterectomy using morcellation [25]. However, the occurrence of LMS was not evaluated in this report. The main limitations of our study were the retrospective design and the lack of demographic data for the total population studied. The objectives of this trial were to evaluate the occurrence of uterine LMSs and to identify the risk of unintended morcellation of LMSs in our patient population. Therefore, the lack of demographic data for the total population did not influence the conclusion of this trial. A prospective design, including complete preoperative demographic data, would have strengthened the validity of the study. However, the local registry both on histopathological diagnosis of uterine LMS and the surgical procedures at the department are of high quality. Therefore, the data in this study were most likely correct and complete. In addition, the strength of the study was the relatively large sample size. The findings of our study support the conclusion of the American Association of Gynecologic Laparoscopists expert group report, which was published on May 6, 2014 [14]. According to this report, ‘‘Morcellation should only be considered in patients if the appropriate evaluation of the myometrium (with or without fibroids) is reassuring, and appropriate evaluation of the cervix and endometrium is also reassuring. For patients in whom preoperative evaluation results in an increased suspicion for malignancy, alternatives to morcellation should be employed, including laparotomy. As the risk of malignancy, including undetectable malignancy, is increased in postmenopausal women, alternatives to morcellation should be considered in this patient population.’’
Lieng et al.
Morcellation of Uterine Leiomyosarcomas
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Conclusion The risk of unintended morcellation of a LMS in a population of women with symptomatic fibroids who undergo thorough preoperative evaluation appears to be very low. To decrease the risk of unintended morcellation of uterine LMS, women who have clinical findings that are suspicious of malignant disease found on endometrial biopsy or transvaginal ultrasound should be treated according to the prococol for that malignancy.
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Acknowledgments Bjorn Risberg, MD, Department of Pathology, Oslo University Hospital, contributed to the study. The Department of Gynecology, Oslo University Hospital, covered all expenses of the study. No additional funding was required.
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