Review of Robotic Surgery in Gynecology-The Future Is Here.

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This review compared robotic, laparoscopic, abdominal, and vaginal surgery for gynecologic conditions, finding robotic surgery associated with shorter hospitalizations and often less blood loss than open surgery.

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This review synthesizes data from fifty-five studies to evaluate the efficacy and safety of robotic surgery for various benign gynecologic conditions, including myomectomy, hysterectomy, and sacrocolpopexy. The authors found that while robotic approaches often result in reduced blood loss, shorter hospital stays, and fewer minor complications compared to open or laparoscopic techniques, they are significantly more expensive and do not always demonstrate superior clinical outcomes regarding major morbidity or operative time. A key limitation noted is the lack of long-term data on fertility and recurrence rates, as well as the urgent need for more randomized clinical trials to validate these findings. Relevance to endometriosis: listed as one indication for GnRH antagonists, though the paper's main focus is uterine fibroids.

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Abstract

The authors present a systematic review of randomized and observational, retrospective and prospective studies to compare between robotic surgery as opposed to laparoscopic, abdominal, and vaginal surgery for the treatment of both benign and malignant gynecologic indications. The comparison focuses on operative times, surgical outcomes, and surgical complications associated with the various surgical techniques. PubMed was the main search engine utilized in search of study data. The review included studies of various designs that included at least 25 women who had undergone robotic gynecologic surgery. Fifty-five studies (42 comparative and 13 non-comparative) met eligibility criteria. After careful analysis, we found that robotic surgery was consistently connected to shorter post-surgical hospitalization when compared to open surgery, a difference less significant when compared to laparoscopic surgery. Also, it seems that robotic surgery is highly feasible in gynecology. There are quite a few inconsistencies regarding operative times and estimated blood loss between the different approaches, though in the majority of studies estimated blood loss was lower in the robotic surgery group. The high variance in operative times resulted from the difference in surgeon's experience. The decision whether robotic surgery should become mainstream in gynecological surgery or remain another surgical technique in the gynecological surgeon's toolbox requires quite a few more randomized controlled clinical trials. In any case, in order to bring robotic surgery down to the front row of surgery, training surgeons is by far the most important goal for the next few years.
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Study

We performed a systematic search to identify studies regarding robotic gynecologic surgery. PubMed was searched from inception to January 2017 for English-language studies, using the search terms “robotic surgery,” “gynecology,” “intuitive,” as well as various benign and malignant gynecologic conditions and surgical procedures. We also used a website named “All About Robotic Surgery” to review robotic surgery history ( http://www.allaboutroboticsurgery.com/ ). The review includes studies of various designs that include at least 25 women who had undergone robotic gynecologic surgery. Fifty-five studies (42 comparative and 13 non-comparative) met eligibility criteria.

Robotic

Twenty-one studies compared robotic surgery for endometrial cancer with either laparoscopic or abdominal approaches; 14 studies included a comparison to laparoscopic approaches, 29 – 42 while 11 studies included a comparison to open approaches, 30 , 31 , 34 , 36 , 43 – 49 and one was a randomized clinical trial. 42 One study was a prospective study 50 regarding single-site approach for endometrial cancer staging. Fourteen observational studies assessed operative time and length of post-surgical hospitalization comparing robotic and laparoscopic surgery for endometrial cancer. 29 – 42 Length of post-surgical hospitalization was reduced in the robotic groups. There was some inconsistency in the finding of shorter operative times in the laparoscopic surgery groups. The largest study reporting operative times was by Barrie et al. 40 ( n =1,433), pointing to shorter operative times in the robotic surgery group whether the procedure included hysterectomy alone or addition of pelvic/para-aortic lymph node dissection. Statistically significantly shorter times were observed in the patients undergoing hysterectomy alone (125 min [108–151] versus 136 min [111–171], P =0.02) and the patients undergoing hysterectomy, pelvic lymph node dissection, and para-aortic lymph node dissection (186 min [154–232] versus 244 min [205–279], P <0.01). These results were supported by the only RCT conducted in this context until now, performed by Mäenpää et al., 42 in which 99 patients were randomly assigned to two groups: robotic and laparoscopic surgery. Operative times in the robotic surgery group were shorter (139 min [range 86–197] versus 170 min [range 126–259], P <0.001). Furthermore, there were no differences in the number of lymph nodes removed, estimated blood loss, and length of post-surgical hospitalization between the two groups. In the laparoscopic surgery group five conversions to open surgery occurred as opposed to zero conversions in the robotic surgery group ( P =0.027). There were more major postoperative complications in the robotic surgery group (11 versus 5, P =0.111). Thus, Mäenpää et al. 42 concluded that robotic surgery offers an effective and safe alternative in the surgical treatment of endometrial cancer. The majority of studies found that estimated blood loss was significantly lower in the robotic surgery groups. When comparing robotic surgery with laparoscopic surgery regarding the total number of lymph nodes removed, four studies reported robotic superiority, three studies reported robotic inferiority, and four studies showed no difference. Eleven studies compared robotic and open surgery for the treatment/staging of endometrial cancer. 30 , 31 , 34 , 36 , 43 – 49 Robotic surgery was by far superior to open surgery regarding estimated blood loss and post-surgical hospitalization. Except for two studies (one by El Sahwi et al. 45 that showed shorter operative times for the robotic surgery group, and the other by Hinshaw et al. 49 that showed similar operative times in both surgical groups), all found operative times to be longer in the robotic surgery groups. The total number of lymph nodes retrieved (which is considered a surgery quality indicator) was different in both groups, with five studies reporting robotic superiority, two studies reporting robotic inferiority, and five studies reporting no difference. From an economic aspect, robotic surgery has a reputation of being costly compared to other surgical approaches because of the high cost of robotic surgical sets and disposable parts, but after stratification and review of costs of extended post-surgical hospitalization in the open surgery groups compared to the robotic surgery groups, it is inferred 30 , 47 that robotic surgery is less costly than open surgery ( P <0.001). Corrado et al. 50 evaluated the feasibility and safety of robotic single-site hysterectomy either with or without pelvic lymph node dissection. The investigators prospectively collected clinical and operative data, as well as data on length of stay, on all patients who had undergone the afore-mentioned surgery for clinical International Federation of Gynecology and Obstetrics (FIGO) stage I or occult stage II endometrial carcinoma. A total of 125 patients were included in the study. Median docking, console, and total operative times were 11 min (range 4–40 min), 80 min (range 20–240 min), and 122 min (range 35–282 min), respectively. Median estimated blood loss was 50 mL (range 10–250 mL). The only conversion to a different surgical approach was in one patient who was converted to vaginal surgery due to the patient’s pulmonary baseline morbidity. Pelvic lymphadenectomy was performed in 16.8% of the patients, while the median number of lymph nodes retrieved was 13 (range 3–32). Median post-surgical hospitalization was 2 days (range 1–3 days). No intraoperative complications were documented. The investigators concluded that robotic surgery is technically feasible, safe, and reproducible for this indication and grade of disease, and has the potential to become the treatment of choice for patients affected by FIGO stage I–II endometrial cancer. However, randomized controlled trials are needed to confirm these results. A total of seven studies compared robotic radical hysterectomy with either laparoscopic hysterectomy 51 or open radical hysterectomy. 52 – 57 In addition, we chose to include two more studies: one summary of 3 years of robotic radical hysterectomy experience 58 and one prospective non-randomized phase II study. 59 Soliman et al. 51 conducted the only study that compared laparoscopic and robotic radical hysterectomy approaches. The investigators found that both approaches showed similar operative times, length of post-surgical hospitalization, and total number of lymph nodes retrieved. Estimated blood loss was significantly lower in the robotic surgery group (115.5 mL versus 171 mL, P <0.001). Seven studies evaluated and compared operative times, length of post-surgical hospitalization, and estimated blood loss between robotic and open radical hysterectomy. 52 – 57 All of the studies found similar results regarding significantly shorter length of post-surgical hospitalization after robotic surgery, ranging from 1 to 3.7 days for robotic-assisted procedures and 2.8 to 5 days for open surgery. Nam et al. 55 reported longer hospitalization periods, nearly 3-fold the reported average (robotic, 11.6 days; open, 16.9 days), most likely due to different practice patterns. All seven studies reported significantly lower estimated blood loss, with decreases of 49% to 77% in the robotic surgery groups. Some inconsistencies were found between the different studies regarding operative times. Two studies 54 , 55 found no significant differences between the two surgical approaches. Three studies 51 , 53 , 57 found that robotic surgery required longer operative times ( P <0.001). The two remaining studies 52 , 58 showed the exact opposite results regarding operative times, reporting that robotic surgery had shorter operative times ( P =0.002). These inconsistencies are probably but not solely the result of surgeon’s experience. Cantrell et al. 58 evaluated the 3-year survival of patients who had undergone radical hysterectomy, whether robotic, laparoscopic, or open. No difference in overall survival was observed between the different groups. Recurrence was rare and similar between groups. Pelvic lymph nodes were dissected in 98% of patients, and were found to be positive for disease in 8.5%–10.9% of patients. The mean number of pelvic lymph nodes retrieved was higher in the minimally invasive group (19.4 versus 16.0, P <0.001). There was no difference in the rate of post-operative chemotherapy ( P =0.32) or radiation therapy ( P =0.28). Gallotta et al. 59 conducted a prospective non-randomized controlled trial (Canadian Task Force classification level 2) enrolling patients with stage IB2–III cervical cancer who underwent robotic radical hysterectomy plus pelvic and/or aortic lymph node dissection within 6 weeks after chemotherapy/radiation therapy. Surgery feasibility and complications were analyzed. Pelvic lymph node dissection was performed in all cases. Robotic surgery was successful in 97.5% of cases. Median operative time was 185 min (range 100–330 min), and median estimated blood loss was 100 mL (range 50–300 mL). Median length of post-surgical hospitalization was 2 days (range 1–4 days). No intraoperative complications were recorded. During the observation period, 30% of the patients had complications. Recurrence was documented in 12.5% of patients. The one study published to date comparing robotic and laparoscopic approaches found no statistically significant difference between the two approaches with regard to final FIGO stage, histology, and tumor grade. 60 In addition, 15.6% of the patients were upstaged, with no statistically significant difference between the two groups. Median number of pelvic lymph nodes retrieved was 14 (range 3–42) and 11 (range 2–29) in the robotic and the laparoscopic groups ( P =0.235), respectively. Median number of aortic lymph nodes retrieved was 11 (range 3–26) and 12 (range 1–39) in the robotic and the laparoscopic groups ( P =0.263), respectively. Operative time was significantly shorter in the robotic group ( P =0.043). Estimated blood loss was similar ( P =0.691). No difference was found in terms of surgical complications.

Discussion

The experience of the last 12 years has been documented meticulously in the various studies reviewed above. The evolution of robotic surgery is quite phenomenal for such a young technology, perhaps in part due to the obvious advantages of robotic surgery in general. The majority of studies available today regarding robotic surgery are retrospective and based on a single surgeon’s/center’s experience. The number of RCTs available is extremely limited, thus making it difficult for administrators, reviewers, or health care givers to assimilate and create clear clinical guidelines regarding the use of this new technology. The majority of studies available suggest that in most benign indications the robotic approach is non-inferior or superior to the laparoscopic approach and consistently proves to be superior to the open approach. When it comes to malignant indications, the results are quite similar, though robotic surgery for the treatment of endometrial cancer has been receiving excellent reviews in the field and in clinical studies. Most of the reviewed studies compared three main aspects of robotic surgery including operative time, estimated blood loss, and length of post-surgical hospitalization. Robotic surgery was by far superior to both abdominal and laparoscopic approaches regarding both estimated blood loss and length of post-surgical hospitalization. On the other hand, the results regarding operative times were inconsistent, most probably due to the variance in surgeon experience, likely a factor in the high cost of surgery. The learning curve described in the reviewed studies points to between 20 and 30 surgeries being required to begin mastering the robotic technique. In the investigators’ experience, previous experience in laparoscopic surgery is a relative advantage before embarking on the robotic surgery adventure. Previous gaming (video-game) experience may also be a relative advantage in this context. This review has several limitations, most of which result from the quality of evidence-based medicine available regarding robotic surgery in gynecology. Indicators of poor-quality studies include factors such as small number of patients included, generalization of robotic procedures in the same study due to low surgery volume, and very few RCTs. This review is the most comprehensive and most up-to-date review available today regarding robotic surgery. That being said, RCTs regarding comparisons between different minimally invasive surgery techniques are required. Since cost-effectiveness is the greatest limitation of robotic surgery, future studies must include cost evaluations including calculations regarding length of hospitalization, post-surgical complications, and return to regular routine and recuperation. Based on current knowledge and in light of the data reported in this review, in the case of gynecological surgery, the choice regarding surgical approach should be individualized based on patient background, surgeon’s experience, and availability of robotic instrumentation. When the time comes and robotic surgery is as common as laparoscopic surgery, there is no doubt that the abdominal approach will be abandoned, although, like with other important skills, surgeons will have to master open surgery before mastering minimally invasive surgery techniques, just in case of occurrence of complications or clinical situations requiring conversion to open surgery. When reviewing the literature, we found quite a few case reports that described unique surgeries performed in a variety of gynecological indications, including ovarian indications requiring surgery, 60 and the next step in robotic surgery aims at surgical site minimization—single-port robotic surgery. 26 , 61 , 62 As proved by these publications, robotic surgery is still evolving, and the future is wide and unknown. Currently (according to ClinicalTrials.gov) there are 11 RCTs being conducted worldwide, eight regarding robotic sacrocolpopexy or robotic pelvic organ prolapse repair (including NCT01535833 , NCT02367235 , NCT01346436 , NCT03034499 , NCT02676973 , NCT02741830 , NCT02852512 , NCT02800512 ), four of which are comparative studies meant to compare robotic and either laparoscopic or vaginal approaches. One study regarding robotic uterine transplantation ( NCT02987023 ) is being conducted. Two oncological studies are being conducted utilizing robotic surgery, one regarding cervical cancer, a comparative study meant to compare robotic and other minimally invasive approaches for the treatment cervical cancer ( NCT00614211 ), and the other meant to evaluate the use of robotic surgery in gynecologic oncology ( NCT00671827 ). The data from the afore-mentioned studies will help evaluate the role of robotic surgery in gynecology and forge the future of robotic surgery in the field of gynecology.

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