A survey of current practices and opinions amongst surgeons on fibroid management published by R Fusun Sirkeci et al, reported that 81% surgeons perform some type of myomectomy [8]. Of these, open myomectomy, hysteroscopic procedures and laparoscopic myomectomy was performed by 74%, 56% and 32% of the respondents respectively [8]. Although laparoscopy has been advocated for gynecological procedures since 1979 [9] there is still a lot of gap in availability of laparoscopic myomectomy as an option to women seeking conservative treatment for fibroids. This gap is primarily due to steep learning curve, limited degree of freedom of the instruments and the difficulty in performing sutures in narrow pelvic spaces by surgeons. The Robotic technology is more intuitive than standard laparoscopy. It exactly simulates the surgeon’s movements performed at the masters on the console and perfectly translates it on to the patient’s pelvis. The ten times magnification with 3-D vision, wrist like movements and the physiologic tremor filtration are key features of Robotic technology. These features can help surgeon reduce their learning curve. A recent publication on learning curve for gasterectomy by Kim M et al [10], reported that twenty-five cases were needed to gain proficiency and additional 23 cases were needed to progress from proficiency to mastery.
The first Robotic-assisted myomectomy was reported by Advincula et al in the year 2004 [11]. In India, there is a paucity of data on the surgical outcomes of laparoscopic, and Robotic myomectomy. To the best of our knowledge, the present study is the first study from a tertiary care centre in India that has compared the outcomes of these two surgical techniques in patients with uterine myomas. The general criticism is that Robotic myomectomy takes more time and does not give superior clinical outcomes when compared to laparoscopic myomectomy. This study is mainly to focus in comparing these two procedures once the learning curve of Robotic myomectomy was achieved at our centre.
In a study by Göçmen et al the mean age reported for the Robotic and laparoscopic groups was 34.20 ± 5.65 years and 35.65 ± 6.13 years (p = .202) respectively [12]. In another study comparing the surgical outcomes of Robotic-assisted, laparoscopic, and abdominal myomectomy from a total of 575 myomectomies the mean age reported for the Robotic and laparoscopic groups was 37.00 ± 5.19 years, 38.00 ± 6.67 years and 37.00 ± 5.93 years respectively [13]. Pluchino et al reported the mean age of 34.72 ± 5.95 years and 36.40 ± 7.14 years respectively for the Robotic and laparoscopic groups [14]. In our study, mean age of 34.31 ± 5.40 years and 33.54 ± 4.96 years respectively for the RM and LM group (p = .355) was comparable. The women needing myomectomy are of similar ages across multiple studies and countries.
It is reported across specialities that robot gives an advantage in performing surgery in obese patients. Similar to this, in our study, patients in the RM group had a significantly higher mean BMI as compared to the LM group (27.35 ± 4.54 kg/m2 vs. 25.23 ± 4.17 kg/m2, p = .003). Both Gocmen and Chen in fact reported the opposite findings and their LM group had higher BMI than the RM group although the difference was not statistically significantly [12.15]. However, Geppert et al concluded that Robotic hysterectomy in obese women (BMI > 30) was associated with similar operating time when compared with the abdominal hysterectomy once the learning curve was over [16]. An interesting study by Moss EL et al, recorded the real-time information on the muscle movement/activity in surgeons to perform exercises in simulated in normal and high BMI models. They found that the time to complete all exercises was significantly lower for Robotically assisted surgery as compared with straight-stick laparoscopy (p < 0.05 or better). Further, the movement of the surgeons' core and muscle usage was significantly greater in high BMI straight-stick laparoscopy as compared to the Robotically assisted surgery [17]. Our study was not a randomised trial, but it did suggest that Robotic surgery is offered more to obese women as pelvic surgery is easy with robot in such women. This may be attributed to the fact that in morbidly overweight patients, Robotic myomectomy can be a safe and effective minimally invasive method.
Although not statistically significant, in our study the mean number of fibroids removed were more in RM group as compared with LM groups (2.38 ± 2.47 vs. 1.97 ± 1.75 respectively, p = .251). This observation is consistent with the findings (2.73 ± 3.10 vs. 2.09 ± 1.85, p = .573) of Gocmen et al [12]. Further, in our study, the mean size of the largest fibroid for the RM and LM groups was 9.13 ± 3.17 cm and 9.20 ± 4.11 cm respectively (p = .900). The mean size of the largest fibroid in our study was way higher than the previously published report by Gocmen et al (6.00 ± 1.50 cm vs. 5.53 ± 1.40 cm, p = .307), Barakat et al (7.7 ± 0.73 cm vs. 6.7 ± 0.93 cm), Pluchino et al (4.76 ± 1.71 cm vs. 4.2 ± 2.38 cm) and Hsiao et al (6.3 ± 0.23 cm vs. 6.4 ± 0.33 cm) respectively [12–14, 18]. The mean fibroid weight for the RM and LM groups (382.53 ± 270.64 gm vs. 418.38 ± 336.86 gm, p = .443) in our study was higher than the previously published report by Bedient et al (210 ± 270 gm vs. 350 ± 330 gm, p = .13) [19]. This is again consistent with the observation that robot assisted surgery is useful in performing more complex myomectomies and can be instrumental in preventing open myomectomies.
The mean total operative time reported in our study was slightly more for the RM group when compared with the LM group (127.37 ± 110.67 min and 120.66 ± 44.27 min respectively (p = .650). This difference is not statistically significant. We consider this as an important finding as it contradicts the previously reported studies showing significantly higher operative time in Robotic myomectomies. An increase of surgical time (coefficient = 51.9 min, P < .001) was reported by Chen et al [15]. Wang et al reported a significantly prolonged operative time (weighted mean difference 84.88, p < .00001) in RM cases when compared to abdominal myomectomy cases [20]. This is an important conclusion of our study, that beyond the initial learning curve, there is no difference in the operative time between LM and RM cases. However, Robotic surgery can help in better operative outcomes as discussed further in this study.
A multiple regression analysis was performed on log operative time considering all the variables as independent variables. The regression model had the number of fibroids and the size of the fibroids as significant predictors. The result revealed that the total operative time was significantly affected by the number of fibroids (P < .0001) and the size of the fibroids (P = .005) without any significant association with the type of surgery (P = .953). The model power was low so we performed the stepwise regression where we found the same two variables as significant (P < .0001) but with the higher power. Considering that no significant difference is seen by adding additional independent variables the number of fibroids and the size of the fibroids turn out to be significant in the regression model at a 1% level of significance. To confirm this, we also performed the analysis of covariance in order to see if there is any effect of covariates on the dependent variable and again, we found that the type of surgery was not significant although the dependent variable was significant at a 1% level of significance.
In our study, mean blood loss was significantly less in the RM group as compared to the LM group (115.43 ± 79.43 vs. 340.98 ± 453.09 ml, p = < .0001). Four previous studies by Gocmen et al (101.33 ± 39.84 ml vs. 119.78 ± 43.70 ml), Barakat et al (100 ± 120.4 ml vs. 150 ± 74.1 ml), Pluchino et al (138.42 ± 67.66 ml vs. 232.74 ± 183.14 ml), and Qin et al (68.2 ± 28.9 ml vs. 102 ± 25.7 ml) have reported similar observations [12–14, 21]. Among all these studies, the mean blood loss in the RM group was lowest in the study by Qin et al whereas the same for the laparoscopic group was highest in our study. Reduction in total blood loss and the need for lesser IV analgesia in the post op periods has significant impact on post-operative recovery. This further contributed in reducing the length of stay even allowing patient to undergo this procedure as day care.
The duration of hospital stay in our study was significantly less for patients in the RM group as compared to the patients in the LM group (1.28 ± 0.49 vs. 1.92 ± 1.05 days, p = < .0001). This observation is consistent with the findings of the previously published reports by Gocmen et al (1.67 ± 0.58 days vs. 1.87 ± 0.67 days) and Barakat et al (1 ± 0.001 days vs. 1 ± 0.67 days) [12–13]. Two other studies by Pluchino et al (2.03 ± 1.08 days vs. 1.94 ± 0.37 days) and Qin et al (3.12 ± 0.82 days vs. 4.98 ± 0.83 days) have reported a higher duration of hospital stay as compared to our study but the difference between the RM and LM group in these studies also was statistically significant [14–21]. A meta-analysis reported no statistical significance for the length of hospital stays between RM and LM group (OR 0.04, 95% CI, 0.09–0.18, p = .56) [22].
In our study, 93.97% of patients in the RM group required no blood transfusion as compared to 81.97% of patients in the LM group (p = .031). Two previous studies by Pluchino et al (97.67% vs. 90.7%) and Bedient et al (95% vs. 95.12%) reported a relatively higher percentage of patients that require no blood transfusion in both RM and LM groups [14, 19]. The number of blood transfusions in the RM group of our study was significantly less than the LM group (6.03% vs. 18.03%) and the finding is contrary to the observations of a pooled analysis of 6 studies [20] where there was no significant difference in the number of transfusions between RM and LM group (OR 1.16, 95% CI, 0.61–2.18, p = .66). Another meta-analysis comprising eight studies of Robotic versus laparoscopic myomectomy reported no statistical significance for the transfusion needed between RM and LM group (OR 1.13, 95% CI, 0.42–3.07, p = .15) [22].
Post-operative pain felt by the patient is important criteria to determine early discharge and less dependence on IV analgesia can help achieve this. In our study, 41.38% of patients in the RM group, and 34.43% of patients in the LM group did not require any IV analgesia (p = .368) once they were out of the operating room. Further, 56.03% and 2.59% of patients in the RM group and 50.82% and 13.11% patients in the LM group required IV analgesia for up to 24 hrs. (p = .509) and 48 hrs. (p = .006) respectively. The requirement of IV analgesia was significantly less for patients in the RM group as compared to the LM group (p = .019). This significant difference in IV analgesia requirement helped in reducing the length of stay in our study population. A previous study by Mangalath AS et al comparing the analgesic requirements in robot-assisted versus conventional laparoscopic abdominal surgeries also reported the similar finding [23].
In our study, the symptoms (dysmenorrhoea, heavy menstrual bleeding, abdominal mass, and frequency of urine) were significantly higher in the RM group as compared to the LM group (p = .006). A study by Chen YC et al, also reported higher symptoms (mass effect, bladder symptoms, dysmenorrhea, pelvic pain and abnormal uterine bleeding) in the RM group as compared to the LM group although the difference was not statically significant [24].