Surgical Results of Myomectomy Using Laparoscopic and Minilaparotomic Access

Abstract

Evaluation of: Palombo S, Zupi E, Russo T et al.: A multicentric randomized, controlled study comparing laparoscopic versus minilaparotomic myomectomy: short-term outcomes. Fertil. Steril. (2007) (In Press) [1]. There has been significant debate regarding the best route to myomectomy in symptomatic and infertile women. In this study, 136 premenopausal women wishing to conceive were randomly allocated to two groups and these were compared. The patients were assigned to one of the surgical procedures (i.e., laparoscopic or minilaparotomic). Fibroid enucleation and suturing times were significantly shorter after minilaparotomic myomectomy, whereas the degree of surgical difficulty was significantly higher when using laparoscopic myomectomy. The surgical results were significantly influenced by specific investigational centers involved, and also by fibroid dimension and localization. This last variable was the strongest predictor of surgical outcome.

During the past several years, various options have been proposed for the surgical treatment of uterine myomas. Moreover, the best approach for women in reproductive age, desiring to preserve childbearing potential, has been the myomectomy [1].

Once the decision is made to proceed with myomectomy by an abdominal approach, the physician must decide whether the patient is an appropriate candidate for a laparoscopic route [2]. Prospective, randomized studies have shown that laparoscopic myomectomy has clear advantages in terms of hospital stay and recovery. Mais et al. compared laparoscopic myomectomy (LM) with abdominal myomectomy (AM) in 40 women with respect to pain relief and recovery time, and found that there was a quicker recovery in the laparoscopic arm compared with the laparotomy group [3]. The operative time was comparable between the two groups. One of the primary goals of myomectomy is the preservation of the uterus for future fertility. Unfortunately, the adhesion formation rate after myomectomy by laparotomy is over 90%, compromising the primary goal of retaining fertility [4]. Laparoscopy has been proven, both in experimental and human models, to be associated with a reduction in adhesion formation. The reduction of adhesions by laparoscopic myomectomy was confirmed by Takeuchi and Kinoshita [5]. The risk of a future uterine rupture is a major concern following any myomectomy. The difficulties of adequately closing all layers laparoscopically and using electrocoagulation for hemostasis may contribute to the risk of uterine rupture. A combination of laparoscopy and minilaparotomy (<5 cm incision) may reduce some of these problems. The laparoscopic-assisted myomectomy (LAM) was introduced to clinical practice by Nezhat et al. [6]. Three major objectives of LAM were mentioned: minimizing blood loss, preventing postoperative adhesions, and maintaining uterine-wall integrity. As such, a laparoscopy-assisted approach may allow the superior repair of the uterus and, possibly, improve obstetrics outcome. Several authors independently worked on a variant of laparoscopic myomectomy in which the dominant myoma was removed laparoscopically and the uterus was delivered via colpotomy into the vagina for removal of secondary uterine myomas and for uterine closure [7–10]. The results of these studies confirm the feasibility of laparoscopic-assisted vaginal myomectomy (LAVM). Despite the small number of patients in the Czech pilot study [10], the operating time was significantly shorter with LAVM than with LM. Koh and Janik have lamented the impossibility of achieving full visual control in the course of myoma enuclation in LAM and or LAVM [4]. These authors suggested that, in both procedures, exteriorizing and handling the uterus reproduces the very factors that cause de novo adhesion formation or introduce infection.

One study, reported that myomectomies performed by laparotomy were associated with a greater blood loss, longer length of stay, and longer recovery when prospectively compared with either a minilaparotomy or laparoscopic-assisted minilaparotomy, with no difference in operating time [11]. Another variation has been described employing an ‘ultraminilaparotomy’ incision along with concomitant embolization of the myomas [12]. This procedure has been advocated for the minimally invasive treatment of large myomas. Hand-assisted laparoscopy has also been described. This technique is well established in other surgical specialties [13].

Recently, minilaparotomic access was proposed as an alternative procedure to reduce the rate of laparotomies in the treatment of several pelvic gynecologic diseases [14–16]. Minila-parotomic myomectomy seems to associate the advantage of laparotomy with that of a minimal access. To date, only one randomized, controlled trial compared both laparoscopic and minila-parotomic approaches for myomectomy [17]. Significant advantage was observed using the laparoscopy in terms of hemoglobin decline, pain intensity and hospital discharge. On the other hand, operative time was shorter using minilaparotomic access, and no clinical relevant conclusion was provided with respect to the predictors to be used regarding the choice of the different surgical approaches [1].

Results

Women who suffered symptomatic fibroids or unexplained fertility were offered enrolment in the study. In total, 162 ambulatory premenopausal women with uterine leiomyomas were chosen as candidates for myomectomy. They were consecutively screened in three university departments of obstetrics and gynecology. Randomization was carried out using software of randomization to generate a random allocation sequence in single blocks as a method of restriction. The two groups of 68 patients in each group were obtained from randomization of 136 patients. Unexplained infertility was diagnosed after exclusion of endocrine and tubal abnormalities, and male-factor fertility. At study design, authors considered the effect of the two procedures on fertility as the primary point of the present randomized, pilot, clinical trial and, specifically, on the cumulative livebirth rate. After 15 months of follow-up on myomectomy and an interim analysis of their initial data, the differences between the groups on reproductive outcome were considered too little or clinically irrelevant to continue the study in order to obtain an adequate power [18]. Thus, their patient enrolment was discontinued.

Major medical conditions, current or past history of chronic physical illness, use of hormonal drugs, vigilance and history of alcohol abuse were all considered as exclusion criteria. In addition, the following specific exclusion criteria were included: no desire to conceive, presence of more than three uterine leiomyomas and of leiomyomas with a main diameter of less than 3 cm or more than 10 cm, calcified leiomyomas, presence or alteration of the uterine cavity and other uterine or adnexal abnormalities, pattern of hyperplasia in the endometrial biopsy, an abnormal Papanicolau smear and a positive pregnancy test. Unfortunately, in the study of Palomba et al., no information was provided regarding the proportion of the intramural and subserosal myomas [1].

At study entry, age, parity and BMI, work and socioeconomic status, leiomyoma-related symptoms, quality of life and previous laparotomies were assessed in each patient by the same clinician for each from three investigational centers. The average BMI in both groups was found to be at 26 only, and varied between 21 and 29. No obese women were assessed. The explanation for this finding is probably related to race of the women and geographical characteristics. The absence of obese women is the main limitation of the study. The feasibility of surgery is often limited by obesity; laparoscopic and especially minilaparotomic procedures are difficult in women weighing 180 pounds or more [19]. This knowledge is important because every third woman in the USA, Germany and the Czech Republic who is aged over 30 years is obese. Critical considerations are not only absolute body weight but symmetry and distribution of subcutaneous fat in the anterior abdominal wall and retroperitoneum. Based on the above-mentioned reason, future study should verify how obesity changes perioperative parameters and affects the feasibility of myomectomy performed through various accesses. Obese women should be selected for surgery with reference to optimal access, efficacy and safety.

Leiomyoma-related symptoms, such as menorrhagia, pelvic pressure and pain, were assessed using a visual analog scale. During each surgical procedure, total operative time, enucleation time of each leiomyoma and repairing time of the uterine defect after hysterectomy were recorded. Intraoperative blood loss, intraoperative and postoperative complications, and degree of surgical difficulty were also evaluated and recorded in both groups.

Significance of the results

The results confirm that minilaparotomic myomectomy is related to a lower global degree of surgical difficulty, and leiomyoma enucleation and hysterectomy suture time were significantly shorter after this one. These parameters could be the main criteria in the surgeon's decision for the choice of the best approach to myomectomy. Surprisingly, no intraoperative complications were observed during laparoscopy, whereas six cases of laparotomic conversion were recorded during the minilaparotomy (p = 0.012). The laparotomic conversions, equally distributed in all three investigational centers, were due to posterior isthmic and intraligamentary leiomyomas. These results are not in accordance with the results of Allessandri et al. [17]; there were two laparoconversions caused by difficulties of hemostasis and ileal perforation in the laparoscopy group. The evaluated paper demonstrates significant influence of the specific investigational center, dimension and localization of the largest fibroid. The minilaparotomic approach looses all its advantage over laparoscopy, in the presence of the main fibroid located at a posterior site. No influence of BMI on the surgical results was detected. The absence of obese women is the main limitation of the study. We may assume that in a large population including a representative proportion of obese women, BMI could significantly influence the surgical results, especially in the minilaparotomic group.

Future perspective

Further long-term multicentric trials are needed to compare the laparoscopic and minila-parotomic approaches to myomectomy for symptomatic uterine leiomyomas in terms of feasibility and possibility to improve fertility outcome. A larger, randomized, controlled study of myomectomy via different routes (LAM and LAVM) and of alternative procedures and technologies (uterine artery embolization, uterine artery occlusion and myolysis) is also necessary.