key: cord-0981304-sf3av1gk authors: MISAL, Meenal; MAGTIBAY, Paul M.; YI, Johnny title: Robotic laparoendoscopic single-site (LESS) and reduced port hysterectomy using the da Vinci SP® Surgical System: a single institution case series date: 2020-08-20 journal: J Minim Invasive Gynecol DOI: 10.1016/j.jmig.2020.08.009 sha: c6334c3ae371029f04e19f96b7537710c5022834 doc_id: 981304 cord_uid: sf3av1gk Abstract Study objective : To present a series of robotic laparoendoscopic single-site (LESS) and reduced port hysterectomy cases and discuss the surgical technique required for successful use on this new platform Design Retrospective case series Setting Academic medical center Patients All patients undergoing robotic LESS or reduced port hysterectomy with the SP1098 da Vinci SP® Surgical System from December 2019 to March 2020 Interventions Robotic LESS or reduced port hysterectomy Measurements and main results A total of 8 cases of hysterectomy were performed successfully. 4 cases included concomitant resection of endometriosis. 5 cases required placement of an additional port. Average uterine weight was 136.1 ± 61.5 grams (range 87 – 246). Average estimated blood loss was 37.5 ± 27 mL (range: 20 – 100). Average operative time was 86.5 ± 27.1 minutes (range 60 – 132). Time required for vaginal cuff closure was available for patients #5 – #8 and ranged from 10 – 13 minutes. All patients had same day discharge. There were no conversions to alternate surgical modality, complications, or readmissions. Conclusion Our preliminary experience with the SP1098 da Vinci SP® Surgical System demonstrates the technical feasibility and safety of this surgical modality for gynecologic surgery. Additional studies examining postoperative outcomes and prospective studies comparing this modality to traditional robotic surgery are indicated. Minimally invasive surgery has been shown to have significant benefits to patients in gynecology. 1 Multiple studies show that endoscopic approaches to gynecologic procedures have comparable or improved outcomes when compared to laparotomic approaches. Multi-port approaches to laparoscopy and robotic surgery are currently most common in the United States. Laparoendoscopic single-site surgery (LESS) has emerged as a potentially less invasive alternative to multiport laparoscopy. LESS refers to a spectrum of surgical techniques that allows performance of laparoscopic surgery through consolidation of all ports into one surgical incision. 2 LESS has been shown to be comparable with traditional laparoscopy in terms of efficacy and safety in gynecologic surgery 3 , though the approach does require alteration in surgical technique and may be more challenging to adopt. In the last decade, as robotics became more popular in gynecologic surgery, single-site robotic platforms were developed. Multiple studies show that robotic LESS is a safe and effective platform, comparable to traditional robotics with respect to operative time, complications, and postoperative pain. 4, 5 However, this surgical modality also has challenges, including reduced extracorporeal triangulation and a limited array of non-articulating instruments. Significant alteration in surgical technique is required for successful use of the system. 6 The SP1098 da Vinci SP® Surgical System (Intuitive Surgical, Sunnyvale, CA) is a newer robotic system, with articulating instruments and camera that allow for intracorporeal triangulation, which may circumvent some of the weaknesses of previous single-site robotic systems. It was approved for urologic procedures and transoral otolaryngology by the Food and Drug Administration (FDA) in March of 2019. 7 However, it is not currently FDA approved for gynecologic surgery. Thus far, one Korean group has published their experience with gynecologic surgery with this platform. 8 They found that use of the da Vinci SP1098 platform was feasible for a variety of gynecologic surgeries including hysterectomy, myomectomy, and sacrocolpopexy without conversion to alternate surgical modality. The objective of this case series is to present our surgical technique and discuss the feasibility of performing robotic LESS hysterectomy using the SP1098 da Vinci SP® Surgical System. From December 2019 to March 2020, 8 patients underwent robotic LESS or reduced port hysterectomy at Mayo Clinic Arizona in Phoenix, Arizona. All patients were counseled that the SP1098 da Vinci SP® Surgical System is not FDA approved for gynecologic surgery. In addition to the standard discussion of surgical risks, patients were counseled that off-label use of the da Vinci SP1098 may incur additional risks, such as intraoperative conversion to multiport robotics or laparotomy. All patients were offered performance of their surgery via standard multiport robotic approach. Furthermore, all patients were aware that their surgeon had minimal direct experience with the da Vinci SP1098 platform. All patient records were reviewed to identify demographics and preoperative comorbidities. Primary outcomes reported included operative time (defined as time between incision start and closure) and perioperative outcomes, including emergency room visits and re-admissions. Data collection also included estimated blood loss, conversion to multiport robotic surgery or laparotomy, pathology, uterine weight, length of hospital stay, and perioperative complications. Time required to complete vaginal cuff closure was also noted, if the procedure was recorded. This retrospective case series was deemed exempt by the Mayo Clinic Arizona Institutional review board (IRB#: 20-000440). The SP1098 da Vinci SP® Surgical System consists of the surgeon console, vision cart, and patient side cart, which are the same as the previous da Vinci surgical platforms. A single instrument arm is attached to the patient side cart. This contains 4 instrument drives that control the articulating camera and up to 3 robotic instruments, which are inserted into the abdomen through a 25-mm SP multichannel port. The surgeon can control up to three 6mm fully-wristed, elbowed instruments that have between 20 -25 lives. The instruments most likely to be used in gynecologic surgery include the monopolar curved scissors, Maryland bipolar forceps, fenestrated bipolar forceps, needle driver, Cadiere forceps, and monopolar scissors. The elbow joints allow the surgeon to maintain intracorporeal triangulation. The 10mm oval EndoWrist SP camera has a 73 degree field of view and has 12 lives. The camera can be moved in a traditional fashion, or the cobra mode can be utilized. When the cobra function is used, the camera retracts and moves above or below the instruments, which can help prevent instrument collision and optimizes visualization. An instrument guidance system displays the locations of the camera and instruments within the operative field. (Table 1) . With respect to comorbidities, none of the patients in this series was a smoker or had a diagnosis of diabetes. One patient had a diagnosis of asthma. Indication for surgery for all cases was benign and included abnormal uterine bleeding (n = 5, 62.5%), post-menopausal bleeding (n = 2, 25%), and risk reduction (n = 1, 12.5%). 5 of the women had history of abdominal surgery, including cesarean section, ablation of endometriosis, salpingectomy for sterilization and ectopic pregnancy, and uterine artery embolization for fibroids. Patient clinical characteristics are summarized in Table 1 . Operative characteristics are displayed in Table 2 . Seven cases were robotic-assisted total laparoscopic hysterectomy. Four cases included concomitant resection of endometriosis. Due to presence of endometriosis and adhesions, one case was performed as a robot-assisted modified radical hysterectomy, with resection of parametrium and mobilization of the ureters. A 5mm assist port was placed in the first five cases, which included the four cases with concomitant resection of endometriosis. Average uterine weight was 136.1 ± 61.5 grams (range 87 -246). Average estimated blood loss was 37.5 ± 27 mL (range: 20 -100). Average operative time was 86.5 ± 27.1 minutes (range 60 -132). Time required for vaginal cuff closure was recorded for patients #5 -#8 and ranged from 10 -13 minutes. All patients had same day discharge. Six patients experienced a completely benign postoperative course. One patient developed upper abdominal pain and a CT of the abdomen and pelvis was obtained for work up. This revealed moderate inflammatory changes within the pelvis with thickened loops of ileum. She was managed expectantly and her symptoms resolved; her upper abdominal pain was felt to be unrelated to surgery. Another patient reported vaginal bleeding in postoperative week #3, which did not require any intervention. At her subsequent 6week postoperative exam she was found to have granulation tissue of the vaginal cuff, which was cauterized with silver nitrate. There were no emergency room visits during the 6-week postoperative period and no readmissions. Six patients had an in-person 6-week postoperative evaluation. There were no clinical or physical exam findings suggestive of hernia or concern for delayed wound healing at the umbilicus. Because all non-urgent in-person care was deferred during COVID-19 social distancing protocols, the last two patients included in this series had video postoperative visits. They reported no concerns. Interest in single-incision laparoendoscopic surgery continues to grow. Previously established robotic LESS platforms faced several obstacles to widespread adoption because of technical challenges. The newer single port system enjoy several advantages including increased dexterity and range of motion, camera mobility, and intracorporeal instrument triangulation. The additional benefits of robotic LESS surgery can be preserved, including a single scar with improved cosmesis and the potential for decreased pain. Our preliminary experience with the SP1098 da Vinci SP® Surgical System demonstrates the technical feasibility of this surgical modality for gynecologic surgery. The mean operative time of 86.5 minutes and low estimated blood loss are consistent with our practice experience with standard multiport robotic hysterectomy. Vaginal cuff closure times ranged from 10 -13 minutes, which is also consistent with times achieved on a multiport robotics platform. These results suggest that standard robotic skills are highly transferrable to the robotic single port platform. However, at this point, little can be concluded about the surgeon learning curve with this platform. Although operative times did decrease between case #1 and case #8, the surgeries performed were heterogeneous and are difficult to compare directly. Further information regarding surgeon learning curve will be collected as our institution's experience with this surgical platform progresses. Hysterectomy with the single port platform appears to be safe as well. None of the patients experienced a conversion to alternate surgical modality, surgical complication, or required readmission. Only one patient required an unscheduled office visit for evaluation of vaginal bleeding, but no intervention or treatment was indicated. Despite several advantages of the da Vinci SP1098 system as compared to previous robotic single-site systems, some alteration to surgical technique is required. For example, obtaining traction of tissue is limited with the da Vinci SP1098. Medial traction and cephalad traction along the axis of the trocar is not restricted; however, adequate lateral or anterior traction is more challenging to obtain. Secondly, the bedside assistant can play a very limited role. Although a laparoscopic instrument can be inserted through the fourth aperture of the trocar if not in use, movement is restricted to the axis of the single port trocar. Thus, the bedside assistant is best used to retrieve specimens and operate a suction irrigator. In the first 5 of the 8 cases an additional 5mm port was placed in the left lower quadrant. Of note, 4 of these 5 cases included resection of endometriosis. The 5mm assist port was placed due to difficulty obtaining adequate tissue traction during ureterolysis, Our practice does not routinely use an intra-uterine manipulator with standard multiport robotics. However, an intra-uterine manipulator with a colpotomy cup was used in one case and was very helpful with anteversion, lateral traction, and colpotomy. It is likely that routine use of a uterine manipulator may eliminate the need for an additional assistant port for traction purposes. Another option, as described by Shin, et al., is to use a GelPass One-port System (Meden, Seoul, Korea) or similar product at the umbilicus. The SP cannula as well as an additional assistant trocar can be inserted through the GelSeal cap. The use of this method likely allows for additional intraoperative flexibility, but also adds to total surgical cost. In future cases, optimal surgical technique at our institution will continue to be refined. This case series includes a small number of cases, however, the characteristics of the patients and types of procedures performed are reflective of high volume gynecology practices. The BMI of the patients included ranged from normal to Class II obese. Of the 8 patients, 5 had history of previous abdominal procedures. Of note, the previously published case series reported an average patient length of stay of 4.6 days. 8 This difference may be due to different institutional discharge criteria; however, our case series supports the feasibility of same day discharge for patients undergoing surgery with the robotic single port modality. In conclusion, hysterectomy with the SP1098 da Vinci SP® Surgical System is technically feasible for the well-selected patient with minimal alteration in technique. In addition, the da Vinci SP1098 robotic platform appears to be safe for gynecologic surgery. Additional studies examining postoperative outcomes and prospective studies comparing this modality to traditional robotic surgery are indicated. Video. Surgical technique for robotic single port surgery. Surgical approach to hysterectomy for benign gynaecological disease Is robotics the future of laparoendoscopic single-site surgery (LESS)? Laparoendoscopic single-site versus conventional laparoscopic gynecologic surgery: a metaanalysis of randomized controlled trials Single-site Versus Multiport Robotic Hysterectomy in Benign Gynecologic Diseases: A Retrospective Evaluation of Surgical Outcomes and Cost Analysis Robotic single-site versus laparoendoscopic singlesite hysterectomy: a propensity score matching study Gynecologic robotic laparoendoscopic single-site surgery: prospective analysis of feasibility, safety, and technique Administration FaD. Indications for Use. 510(k) Summary for TORS Labeling Robotic single-port surgery using the da Vinci SP(R) surgical system for benign gynecologic disease: A preliminary report Figure 1 . Robot arm docked to SP cannula without instruments.