Human Reproduction, Vol. 14, No. 1, 44-48,
January 1999
© 1999 European Society of Human Reproduction and Embryology
Laparoscopic myomectomy in premenopausal women with and without preoperative treatment using gonadotrophin-releasing hormone analogues
Department of Obstetrics and Gynaecology, Catholic University of The Sacred Heart, Largo A. Gemelli 8, 00168, Rome, Italy
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Abstract |
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The present study was undertaken in order to evaluate the usefulness or otherwise of preoperative gonadotrophin-releasing hormone (GnRH) analogue treatment prior to laparoscopic myomectomy. From June 1993 through December 1996, 60 premenopausal women aged between 25 and 42 years and with a sonographic diagnosis of intramural or subserous myomas were selected for laparoscopic myomectomy at the Department of Obstetrics and Gynaecology of the Catholic University of The Sacred Heart, Rome. According to a computer-generated sequence, 30 patients were submitted to three cycles of GnRH analogue treatment prior to surgery, whereas no preoperative treatment was prescribed to the other 30 patients. Laparoscopic myomectomy was successfully performed in all patients for a total of 174 myomas excised laparoscopically. The patients' mean age, the number of myomas per patient, the mean diameter of the myomas, parity and estimated blood loss were similar in both groups. The operative time was significantly longer in the group of patients submitted to GnRH analogue treatment than that of the group of patients not submitted to any preoperative medical therapy (157.5±74.71 versus 112.33±54.71 min; P = 0.01). No intra-operative complications occurred. In no case was blood transfusion necessary. Two patients developed post-operative fever (temperature >38°C.). The mean length of hospital stay was 2.39 days and was similar in both groups. Thirteen spontaneous pregnancies occurred among 24 infertile patients (54.1%). The pregnancy rate for these patients was similar in both groups. The viable term delivery rate was 45.8%. The authors conclude that laparoscopic myomectomy is a feasible and safe procedure. The post-operative pregnancy rate for infertile patients is similar to that following laparotomic myomectomy. The present study suggests that preoperative GnRH analogue treatment does not offer any significant advantages for laparoscopic myomectomy.
Key words: GnRH analogue/myomectomy/operative laparoscopy/pregnancy
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Introduction |
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Uterine myoma is the most frequent benign solid tumour of the female genital tract and is diagnosed in about 25–30% of women. The incidence increases in the later years of reproductive age (Buttram and Reiter, 1981
). Uterine leiomyomas may be asymptomatic but are often a cause of metrorrhagia, pelvic pain and infertility. Until the 1950s, abdominal hysterectomy was the most common treatment employed for this pathology, particularly in women beyond reproductive age. In recent years, the remarkable social and cultural changes as well as the widespread use of contraceptives have led to a delay in pregnancy onset and consequently to the necessity of uterine preservation when symptomatic myomas are diagnosed during reproductive age. Therefore, in such patients, conservative surgery should include myomectomy and anatomic uterine reconstruction with the aim of maintaining the patients' reproductive potential.
Abdominal myomectomy is associated with an acceptable morbidity rate, comparable to that of hysterectomy (LaMorte et al., 1993). The introduction of minimally invasive surgical techniques and video laparoscopy for the treatment of numerous benign gynaecological pathologies, such as ovarian cysts, tubal pregnancies and endometriosis, has resulted in remarkable advantages both for the patient (reduced intra-operative and post-operative morbidity) as well as in social and economic terms, since minimally invasive surgery necessitates a shorter hospitalization and allows an earlier resumption of normal activities (Saidi et al., 1994; Damiani et al., 1998).
The first laparoscopic myomectomy was performed by Semm and Mettler (1980). Recently, the technique has also been employed for the excision of large intramural fibroids (Daniell and Gurley, 1991; Dubuisson et al., 1991; Nezhat et al., 1991; Hasson et al., 1992; Mettler et al., 1995). Gonadotrophin-releasing hormone (GnRH) analogue treatment has been shown to result in a decrease in the dimensions of uterine myomas (Filicori et al., 1983). A maximum effect is observed following three or four cycles of such treatment (Golan et al., 1989; Friedman, 1993). However, the usefulness of such therapy prior to laparoscopic myomectomy is still the subject of debate. In the present study, the outcome of laparoscopic myomectomy in patients submitted to preoperative GnRH analogue treatment is compared with that observed in patients not submitted to such therapy prior to surgery.
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Materials and methods |
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From June 1993 through December 1996, 60 patients were selected for laparoscopic myomectomy. The patients' mean age was 33.89±4.28 years (range: 25–42 years). Criteria for laparoscopic myomectomy included the presence of symptomatic subserosal or intramural myomas and the presence of uterine myomas as the only plausible explanation for a history of recurrent abortion (six cases) or infertility (18 cases). In all cases, the number of myomas as well as their dimensions were determined at transvaginal sonography. Indications for transvaginal sonography included metrorrhagia resistant to medical therapy (21 patients), pelvic pain (eight patients), dysmenorrhoea (seven patients) and primary (16 patients) or secondary infertility (eight patients). Amongst the latter, six had a history of recurrent abortion.
In all infertile patients, myomectomy was performed when the myoma exceeded 3 cm in diameter or when serial sonography revealed the presence of a rapidly growing myoma and when all other possible causes of infertility were excluded at ovulation studies, hysterosalpingography, post-coital test and semen analysis. The location of the myoma was not considered as an exclusion criterion. All patients with submucous myomas were submitted to hysteroscopic myomectomy and were excluded from the present series. Patients with myomas >10 cm in diameter (Dubuisson et al., 1991) as well as those with more than three myomas >4cm in diameter were excluded from the present series and submitted to laparotomic myomectomy.
Patients included in the present series were randomized according to a computer-generated sequence: 30 patients were submitted to three cycles of preoperative GnRH analogue treatment (Decapeptyl, 3.75 mg; IPSEN Biotech, Paris, France) administered intramuscularly and 30 were not submitted to any preoperative medical therapy. All patients treated using preoperative GnRH analogues were also submitted to monthly sonography in order to evaluate any variations in myoma dimensions. Informed consent, including the possibility of necessarily resorting to laparotomy, was obtained in all cases according to the local Ethics Committee criteria.
Patient age, parity, number and size of the myomas excised, operative time, blood losses, intra- and post-operative complications, length of hospitalization as well as pregnancy outcome were analysed using the Student's t-test and Fisher exact test. A P-value 
0.05 was considered statistically significant.
Surgical procedure
Videolaparoscopy was performed with the patient under general anaesthesia and with endotracheal intubation. A pneumoperitoneum at a pressure of 15 mm Hg was established using a carbon dioxide insufflator (Electronic Laparoflator; Storz, Germany) and was maintained constantly throughout surgery. The laparoscopic trocar was inserted through an umbilical incision. Two ancillary trocars (5 and 10–12 mm) were inserted lateral to the right and left epigastric vessels for the operating instruments. When necessary, a medial supra-pubic trocar was also inserted.
Pedunculated myomas were excised using bipolar forceps and scissors. In cases of intramural myomas more than 3 cm in diameter, 20 ml of a vasoconstrictor solution containing 50 µg of terlipressine acetate (Glipressina®; Ferring, Milano, Italy) were injected into the uterine serosa overlying the myoma using a long spinal needle inserted, under laparoscopic vision, directly through the abdominal wall. A monopolar needle was used to incise the uterine serosa. The myoma was then excised by means of a combination of blunt dissection and activated energy using bipolar forceps. The uterine lesion was repaired by applying a single or double layer of interrupted or running 2–0 Polyglactin sutures. Removal of the myomas from the abdominal cavity was achieved using a manual S.E.M.M. macro-morcellator (Wisap, Sauerlach-Munchen, Germany) introduced into the pelvis through a trocar sleeve.
Blood losses were estimated by calculating the difference between the volumes of aspirated and irrigated fluids. The operating time was considered to be the time elapsed between endotracheal intubation and complete suturing of the abdominal incisions.
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Results |
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Laparoscopic myomectomy was successfully performed in all cases (Table I
). A total of 174 myomas were excised with a mean of 2.91±2.13 myomas per patient (range: 1–8) (Table I). A total of 107 myomas were intramural, whereas 67 were subserous. Amongst the latter, 21 were pedunculated. The average diameter of the myomas excised was 4.8±1.75 cm (range 2–10). In 15 patients (25%) additional laparoscopic surgical procedures were performed: electrocoagulation of endometriotic implants in seven patients, adhesiolysis in five patients and ovarian cystectomy in three patients. Two patients were also submitted to hysteroscopic resection of endometrial polyps. Preoperative GnRH analogue treatment resulted in a mean 33% reduction in myoma dimensions. The patients' mean age, their parity, the number of myomas per patient as well as the preoperative dimensions of the myomas were similar in both groups of patients.
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The global mean operative time was 126.74±66.01 min. The operative time was significantly longer in the group of patients submitted to preoperative GnRH analogue treatment than in the group of patients not submitted to any preoperative medical therapy (157.5±74.61 versus 112.33±54.71 min.; P = 0.01). In no case did intraoperative complications occur. The estimated blood losses were 198.5±98 ml for the group of patients submitted to preoperative GnRH therapy and 235.3±84 ml for the group of patients not submitted to any preoperative medical therapy. This difference was not statistically significant. In no case was blood transfusion necessary.
The average length of hospitalization was 2.39±1.24 days (range: 1–6 days) and was similar for both groups. Only two patients developed post-operative fever. They were both treated using cephalosporins (2 g/day) for 5 days and were discharged on the 5th and 6th post-operative days respectively.
Twenty-four infertile patients had a mean follow-up of 13 months (range: 6–32 months). Eight spontaneous pregnancies occurred among 16 patients with a history of primary infertility (50%) whereas five spontaneous pregnancies occurred among eight patients with a history of secondary infertility (62.5%). In particular, amongst the latter group, three pregnancies occurred in patients with a history of recurrent abortion and two in patients with a history of secondary infertility. There was no significant difference between the pregnancy outcome of the two groups of patients. Thus, the global pregnancy rate was 13/24 (54.1%). Ten pregnancies (76.9%) occurred within 1 year of surgery. The pregnancy outcome included vaginal delivery in six cases (46.1%), Caesarean section in five cases (38.4%) and spontaneous abortion in two cases (15.3%). Thus, the delivery rate was 45.8%. In no case did ectopic pregnancy occur. Caesarean section revealed the presence of uterine adhesions in one patient.
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Discussion |
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The indications for laparoscopic myomectomy in women of reproductive age are similar to those for laparotomic myomectomy and include menorrhagia, pelvic pain and primary or secondary infertility. It should be borne in mind that, in spite of undoubted economic and social advantages, laparoscopic myomectomy is not always feasible. Limitations depend on the number and size of myomas, on the excessively long operative time, on the necessity of accurate repair of the uterine lesion and of adhesion prevention, and on the patient's desire to maintain fertility. Criteria for laparoscopic myomectomy have changed during recent years and candidates for this technique have included women with a maximum of four myomas
3 cm in diameter and/or women with myomas up to 10 cm in diameter (Dubuisson et al., 1991) and even women with myomas up to 16 cm in diameter (Hasson et al., 1992).
In the present study, laparoscopic myomectomy was performed on patients with a maximum of eight myomas each not exceeding 10 cm in diameter. In accordance with other studies published in the literature (Daniell, 1995; Mettler et al., 1995), preoperative GnRH analogue therapy was administered to 30 women included in the present study. Such therapy resulted in a mean 33% reduction in the dimensions of the myomas. This observation is similar to that made by other authors (Fridman et al., 1989; Kiltz et al., 1994). The rationale for preoperative GnRH medical therapy includes the presumed facilitation of laparoscopic myomectomy as well as a reduction of blood losses (Fridman et al., 1989; Golan et al., 1993). In the present study, the mean global estimated blood loss was 223 ml. In no case was blood transfusion necessary. Blood losses for the group of patients treated preoperatively using GnRH analogues did not significantly differ from those observed for the group of patients not submitted to any preoperative medical therapy. This observation is similar to that reported by other authors for abdominal myomectomy (Fedele et al., 1990; Kiltz et al., 1994). We would like to stress that, in case of large myomas (>3 cm), we have utilized a vasoconstrictor and that adequate haemostasis using bipolar coagulation was performed prior to suturing of the uterine lesion.
In our cases the mean operative time was 126 min, which is comparable to that reported by other authors for laparoscopic myomectomy (Table II) and similar to (Smith and Uhlir, 1990; Diamond, 1996) or slightly longer than that reported in the literature for abdominal myomectomy (Fridman et al., 1989; Fedele et al., 1990; Ginsburg et al., 1993; Mais et al., 1996). Suturing of the uterine incisions and removal of large myomas from the pelvic cavity take up most of the time of laparoscopic myomectomy. The authors of the present study have employed the manual Semm macro-morcellator. However, the Steiner electric morcellator (Steiner et al., 1993) allows a significant reduction in the operative time without having to resort to culdotomy or mini-laparotomy.
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Another possible advantage of preoperative GnRH analogue treatment is that such treatment may result in a softening of the uterine myomas, thus facilitating morcellation (Dubuisson et al., 1995a
). However, in our experience, the operative time was significantly longer in the group of patients submitted to preoperative GnRH therapy than in the group of patients in whom no medical treatment was administered preoperatively. This may be due to the fact that GnRH analogue therapy may soften uterine fibroids, rendering identification of the cleavage plane more difficult and hence lengthening the operative time. Such a possibility was also proposed by other authors for abdominal myomectomy (Beyth, 1990; Acién and Quereda, 1996). Recently, Deligdisch et al. (1997) has suggested that the obliteration of the myoma–myometrial interface may explain the difficulty encountered during enucleation of myomatous nodules in patients in whom preoperative GnRH analogue therapy was administered. Besides, preoperative GnRH analogue therapy has been reported to be associated with an increased short-term risk of myoma recurrence (Golan et al., 1993). This observation, however, has not been confirmed by other authors (Sudik et al., 1996).
Several studies have reported on the successful pregnancy outcome following abdominal myomectomy. Pregnancy rates ranging from 40 to 65% have been reported following this procedure (Buttram and Reiter, 1981; Starks, 1988; Verkauf, 1992). The pregnancy rates reported in the literature following laparoscopic myomectomy range from 17 to 100% (Table III). In the present series, 13 spontaneous pregnancies occurred among 24 infertile patients submitted to laparoscopic myomectomy. A delivery rate of 45.8% was observed. A spontaneous pregnancy is most likely to occur within 1 year of abdominal (Verkauf, 1992; Gehlbach et al., 1993; Tulandi et al., 1993; Sudik et al., 1996) or laparoscopic myomectomy (Dubuisson et al., 1996). Ten of the 13 spontaneous pregnancies observed in the present study (76.9%) occurred within 1 year of surgery, with no significant difference between the two groups of patients. In a retrospective study including 67 patients, Sudik et al. (1996) did not report any difference in the post-operative pregnancy rates between a group of patients submitted to preoperative GnRH analogue treatment and another group of patients in whom such therapy was not administered.
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Four cases of spontaneous uterine rupture during pregnancy following laparoscopic myomectomy are reported in the literature (Harris, 1992
; Dubuisson et al., 1995b; Mecke et al., 1995; Friedman et al., 1996). However, spontaneous uterine rupture has also been reported to occur following abdominal myomectomy (Rubin, 1942; Finn and Muller, 1950; Garnet, 1964; Georgakopoulos and Bersis, 1981; Roopnarinesingh and Ramsewak, 1985; Golan et al., 1990). Roopnarinesingh and Ramsewak (1985) have reported three cases of uterine rupture prior to the onset of labour among 41 women with a history of abdominal myomectomy in whom the uterine incision extended through the endometrial mucosa (7.3%). This author suggested that the main cause of uterine rupture was the opening of the endometrial cavity. Another such case was reported by Friedmann et al. (1996) following laparoscopic myomectomy. No case of spontaneous uterine rupture occurred in the present series, probably because incision of the endometrial lining was not necessary in any of the patients included in this study. Besides, the widespread use of monopolar electrodes, which extensively damage the myometrium, may also result in defective healing of the uterine lesions. In the present study haemostasis was achieved using bipolar current which results in less extensive tissue damage. The average length of hospitalization (2.39 days) was similar to that reported in the literature (Dubuisson et al., 1995a; Seinera et al., 1997) and did not differ between the two groups of patients.
Routine second-look laparoscopy for post-operative adhesion evaluation was not performed in this series. Among five patients submitted to Caesarean section, only one presented with uterine adhesions. Bulletti et al. (1996), in a case-controlled study, showed that laparoscopic myomectomy resulted in less post-operative adhesion formation than abdominal myomectomy. Absorbable or non-absorbable barriers (Mais et al., 1995; Myomectomy Adhesion Multicenter Study Group, 1995; Diamond, 1996) seem to be effective in significantly reducing post-operative adhesion formation even though the risk is not completely eliminated. Moreover, such barriers are not effective unless adequate haemostasis is achieved.
In conclusion, laparoscopic myomectomy can be successfully and safely performed in all patients who wish to avoid laparotomy and retain their fertile status. However, the surgeon must have a vast experience in laparoscopic surgery and must be particularly familiar with laparoscopic suturing. The pregnancy outcome observed in the present study is encouraging. However, further studies evaluating the risk of post-operative adhesion formation and of uterine rupture during pregnancy or labour are required in order to reach definite conclusions regarding the efficacy of this technique. Preoperative GnRH analogue treatment is effective in reducing the size of myomatous nodules, but does not seem to offer any significant advantages for laparoscopic myomectomy. More studies including larger series of patients are necessary in order to evaluate this aspect further.
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1 To whom correspondence should be addressed
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Submitted on April 22, 1998; accepted on October 1, 1998.
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