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Robotic Vaginal Natural Orifice Transluminal Endoscopic Hysterectomy for Benign Indications

  • Lior Lowenstein
    Correspondence
    Corresponding author: Lior Lowenstein MD, MS, MHA, MBA, Department of Obstetrics and Gynecology, Rambam Health Care Campus, Haifa, Israel.
    Affiliations
    Department of Obstetrics and Gynecology, Rambam Health Care Campus, and Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel (Drs. Lowenstein, Mor, Matanes, Lauterbach, Boulus, Weiner)
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  • Omer Mor
    Affiliations
    Department of Obstetrics and Gynecology, Rambam Health Care Campus, and Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel (Drs. Lowenstein, Mor, Matanes, Lauterbach, Boulus, Weiner)
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  • Emad Matanes
    Affiliations
    Department of Obstetrics and Gynecology, Rambam Health Care Campus, and Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel (Drs. Lowenstein, Mor, Matanes, Lauterbach, Boulus, Weiner)
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  • Roy Lauterbach
    Affiliations
    Department of Obstetrics and Gynecology, Rambam Health Care Campus, and Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel (Drs. Lowenstein, Mor, Matanes, Lauterbach, Boulus, Weiner)
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  • Sari Boulus
    Affiliations
    Department of Obstetrics and Gynecology, Rambam Health Care Campus, and Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel (Drs. Lowenstein, Mor, Matanes, Lauterbach, Boulus, Weiner)
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  • Zeev Weiner
    Affiliations
    Department of Obstetrics and Gynecology, Rambam Health Care Campus, and Ruth and Bruce Rappaport Faculty of Medicine, Technion Israel Institute of Technology, Haifa, Israel (Drs. Lowenstein, Mor, Matanes, Lauterbach, Boulus, Weiner)
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  • Jan Baekelandt
    Affiliations
    Department of Gynecological Oncology and Endoscopy, Imelda Hospital, Bonheiden, Antwerpen, Belgium (Dr. Baekelandt)
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Published:October 31, 2020DOI:https://doi.org/10.1016/j.jmig.2020.10.021

      ABSTRACT

      Study Objective

      The Hominis surgical system is a novel robot-assisted system, designed specifically for robotic vaginal natural orifice transluminal endoscopic surgery (RvNOTES). We presented our experience of the first 30 RvNOTES hysterectomies assessing the feasibility and safety of this technology.

      Design

      A two-center prospective study.

      Setting

      Academic tertiary referral centers. The ethics committees approved the study in both centers.

      Patients

      Thirty women with benign indication for hysterectomy.

      Intervention

      RvNOTES hysterectomy performed by the Hominis surgical system.

      Measurements and Main Results

      The primary outcome of the study was the rate of conversion to open or conventional laparoscopic approaches. Secondary outcomes included intra- and postoperative adverse events, operative time, estimated blood loss, length of hospital stay, and 6-week follow-up assessment. A total of 15 women were enrolled at each site. The median age was 59 years (range: 37–79) and the median body mass index was 25.4 kg/m2 (range: 17.6–40.0). Twenty-four women (80%) had comorbidities. All the procedures were completed successfully without conversion to open abdominal, traditional vaginal, or conventional laparoscopic surgery. No intraoperative complications were observed. Median blood loss and procedure duration were 50 mL (range: 20–400) and 57 minutes (range: 24–88), respectively. Postoperative pain was minimal, with a median visual analog scale of 3 (range: 1–5) for the first 24 hours following surgery. The median hospital stay was 3 days (range: 2–8). According to the treating physicians’ evaluations, the vaginal cuff was fully healed in all patients at the 6-week postoperative follow-up visit.

      Conclusions

      This is the first publication of robot-assisted vaginal hysterectomy using the Hominis surgical system. The positive results of this study show this new technology to be a safe and effective tool for vaginal natural orifice transluminal endoscopic surgery, enabling surgeons to operate vaginally with the known advantages of robotic modality.

      Keywords

      Hysterectomy is the most common gynecologic surgery performed in the United States, with over 600 000 surgeries carried out annually, including 200 000 for outpatients [
      • Whiteman MK
      • Hillis SD
      • Jamieson DJ
      • et al.
      Inpatient hysterectomy surveillance in the United States, 2000–2004.
      ,
      • Cohen SL
      • Ajao MO
      • Clark NV
      • Vitonis AF
      • Einarsson JI
      Outpatient hysterectomy volume in the United States.
      ]. For benign indications, vaginal hysterectomy has been recommended by the American College of Obstetricians and Gynecologists as the preferred approach, when feasible, because of its proven advantages, including low complication rates, short surgical time, fast recovery, reduced postoperative pain, and low costs [
      Committee on Gynecologic Practice
      Committee opinion no 701: choosing the route of hysterectomy for benign disease.
      ,
      • Mäkinen J
      • Johansson J
      • Tomás C
      • et al.
      Morbidity of 10 110 hysterectomies by type of approach.
      ,
      • Aarts JW
      • Nieboer TE
      • Johnson N
      • et al.
      Surgical approach to hysterectomy for benign gynaecological disease.
      ].
      Despite the American College of Obstetricians and Gynecologists recommendation, the popularity of vaginal hysterectomy has decreased over the past 3 decades. In the United States, the use of this approach decreased from 25% in 1990 to 17% in 2010 [
      • Aarts JW
      • Nieboer TE
      • Johnson N
      • et al.
      Surgical approach to hysterectomy for benign gynaecological disease.
      ]. Reasons for this trend include limited training, a lower rate of hysterectomies being performed by individual surgeons, and greater diversity of operative approaches. The latter further decreases the number of vaginal surgeries performed in training and in practice. Moreover, anatomic challenges such as obesity, a large uterus and previous pelvic surgeries, including a history of cesarean deliveries, may increase surgical difficulty [
      • King CR
      • Giles D
      Total laparoscopic hysterectomy and laparoscopic-assisted vaginal hysterectomy.
      ].
      The use of a surgical robotic system for hysterectomy has rapidly increased. Some of the described advantages in the literature include elimination of the surgeon's hand tremor, a rapid learning curve and the increased agility obtained by the robot's joints. The latter enables the surgeon to perform complex procedures with minimal strain [
      • Sandberg EM
      • Twijnstra ARH
      • Driessen SRC
      • Jansen FW
      Total laparoscopic hysterectomy versus vaginal hysterectomy: a systematic review and meta-analysis.
      ,
      • Paraiso MF
      • Ridgeway B
      • Park AJ
      • et al.
      A randomized trial comparing conventional and robotically assisted total laparoscopic hysterectomy.
      ].
      Vaginal natural orifice transluminal endoscopic surgery (vNOTES) has shown much promise in a wide variety of gynecologic and nongynecologic procedures. These include hysterectomy, myomectomy, adnexectomy, omentectomy, uterosacral ligament suspension, and appendectomy [
      • Lowenstein L
      • Baekelandt J
      • Paz Y
      • Lauterbach R
      • Matanes E
      Transvaginal natural orifice transluminal endoscopic hysterectomy and apical suspension of the vaginal cuff to the uterosacral ligament.
      ,
      • Baekelandt JF
      • De Mulder PA
      • Le Roy I
      • et al.
      Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial.
      ,
      • Xu B
      • Xu B
      • Zheng WY
      • et al.
      Transvaginal cholecystectomy vs conventional laparoscopic cholecystectomy for gallbladder disease: a meta-analysis.
      ,
      • Lowenstein L
      • Matanes E
      • Lauterbach R
      • et al.
      Feasibility and learning curve of transvaginal natural orifice transluminal endoscopic surgery for hysterectomy and uterosacral ligament suspension in apical compartment prolapse.
      ,
      • Goldenberg M
      • Burke YZ
      • Matanes E
      • Lowenstein L
      Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) for prophylactic bilateral salpingo-oophorectomy.
      ,
      • Lowenstein L
      • Matanes E
      • Lauterbach R
      • Boulus S
      • Amit A
      • Baekelandt J
      Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) for omentectomy – a case series.
      ]. vNOTES hysterectomies account for a small fraction of all the hysterectomies performed. This is despite the minimally invasive surgical footprint, which results in faster recovery and lower postoperative pain. This is mainly because of its technical difficulty and the demand of both laparoscopic and vaginal surgical skills [
      • Li CB
      • Hua KQ
      Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) in gynecologic surgeries: a systematic review.
      ].
      In the light of the advantages of the 3 aforementioned approaches (vaginal, vNOTES, and robotic), the Hominis surgical system (Memic Innovative Surgery Ltd., Or Yehuda, Israel) was developed as an integrative system that enables robot-assisted surgery through vaginal access. In this article, we present our experience with the first 30 cases of robot-assisted vNOTES (RvNOTES) hysterectomies using the Hominis surgical system and assess the feasibility and safety of this revolutionary technology.

      Materials and Methods

       Study Design and Patients

      The current prospective study was approved by the local ethics committees of the 2 participating institutions: Rambam Health Care Campus, Haifa, Israel (0422-18-RMB) and Imelda Hospital, Bonheiden, Belgium (Imelda:180625). The study was conducted between November 2018 and November 2019. The surgeries were performed by senior gynecologic surgeons with 2 levels of experience: 1-highly experienced surgeons with hundreds of vaginal hysterectomies including vNOTES and 5-10 BSO surgeries using the Hominis platform. Two less experienced surgeons with tens of vaginal hysterectomies, including a handful of vNOTES procedures and no prior experience with the Hominis surgical system. Each surgery was performed by a primary surgeon who was assisted by one resident who held the camera. Before the study, training sessions on the system were carried out for all participating surgeons to standardize the surgical technique and to implement the robot functions. Women older than 18 years with benign indications for hysterectomy were offered participation in the study. Exclusion criteria included women with anatomic hazards for laparoscopy and/or vaginal and/or pouch of Douglas access (such as diagnosis of Crohn's disease, active pelvic inflammatory disease, active diverticulitis, severe peritoneal adhesions, frozen pelvis, obliterated vagina or severe recto-vaginal endometriosis), women after pelvic radiation, women diagnosed with active intra-abdominal malignancy, women with general conditions or illness incompatible for surgery, and pregnancy.
      The participation included a 6-week postoperative follow-up visit. The postoperative course, including adverse events and symptoms of rectal or bladder injury, was documented.

       The Hominis Surgical System

      The Hominis surgical system is a humanoid-shaped robotic system that was designed for transvaginal surgical procedures (Supplemental Video 1). The system consists of sterile (disposable and reusable) components including the Hominis Arms and the Vaginal Access Kit, and nonsterile capital equipment such as the Hominis Surgeon Console and the Hominis robotic control unit.
      The surgeon controls the arms with 2 joysticks, which also have shoulder, elbow, and wrist joints. The arms are inserted transvaginally through the posterior fornix into the pelvic cavity, and retroflexed toward the point of entry. This enables access to the structures in the pelvic cavity (Fig. 1). For accuracy and usability, each robotic arm corresponds to the respective hand of the surgeon and is controlled by the right and left joysticks. The arms include a rigid section (shaft) and a flexible section; the latter is composed of 3 joints, based on the design of the human arm with a shoulder, an elbow, and a wrist. Both shoulder and elbow joints can rotate and flex (Fig. 2), while the wrist joint can rotate about its axis. Each joystick has 3 corresponding joints with a shoulder, an elbow, and a wrist, such that each Hominis arm moves according to its analogous joystick movement. End-effectors at the distal ends of the arms enable grasping, blunt dissection, approximation, and electrocautery.
      Fig 1
      Fig. 1The gynecological trocar kit and the Hominis arms are inserted transvaginally through the posterior fornix to the pelvic cavity.
      Fig 2
      Fig. 2The Hominis arms are retroflexed toward the point of entry, thereby enabling performing the procedure with a laparoscopic point of view and reaching various structures in the pelvic cavity.
      The Hominis Surgeon console (Fig. 3) is the main human machine interface for the Hominis surgical system. While seated, the surgeon controls the robotic arms through the robotic control unit. The robotic control unit drives the arms and connects them to an electrosurgical generator through 2 connectors, one for monopolar energy and another for bipolar energy.
      Fig 3
      Fig. 3Hominis surgical arms and control console.

       The Surgical Procedure

      First, an abdominal GelPOINT access platform (Applied Medical, Rancho Santa Margarita, CA) was used for insertion of the camera and accessory trocars through the umbilicus site (Fig. 4). If needed, an accessory trocar was used for suction and irrigation. A 10-mm scope with a 30-degree angle was used. The 2 robotic Hominis arms were inserted through the posterior fornix and the hysterectomy proceeded as per standard of care. Using the robotic arms, the round ligament was cauterized and cut, followed by a division of the broad ligament leaves. The anterior leaf was bluntly dissected and the vesicovaginal space was exposed, separating the cervix and the anterior vaginal wall from the upper lying bladder. The suspensory ligament and the uterine arteries were sealed and cut. On uterine detachment, the robot was undocked, and the uterus was extracted through the vagina. The enlarged uteri were placed in a bag, cut and extracted from the vagina in small pieces. For manual vaginal closure, Vicryl 0 (Ethicon Inc.) continuous suture was used. The total operating time was defined as the time interval from the first incision to the last suture and the hysterectomy time was defined as the duration between insertion of the robotic arms and their removal.

       Data Collection and Outcome Measures

      Surgical data were collected prospectively during the procedures. Postoperative care was in accordance with local protocols. The primary outcome of the study was the rate of conversion to open abdominal, traditional vaginal, or conventional abdominal laparoscopic approaches. Secondary outcomes included intraoperative blood loss estimation, length of hospitalization, pain during the first postoperative 24 hours (according to a 0–10 visual analog scale [VAS]), and the need for analgesia. Perioperative complications and complications through the sixth postoperative week were documented. Participants were asked to rate their pain on the Surgical Pain Scale every 8 hours during the 24 hours following surgery. For these VAS, pain was rated between “0 - no pain sensation” and “10 - most intense pain imaginable,” at rest and with normal activity. The amounts of narcotic and nonsteroidal anti-inflammatory drugs used during the hospitalization were also assessed daily.

      Results

      A total of 30 women were enrolled, 15 women at each site. Table 1 presents baseline characteristics of the study population. The median age was 59 years (range: 37–79) and the median body mass index was 25.4 kg/m2 (range: 17.6–40). Twenty-four women (80%) had comorbidities. The indications for the surgeries are listed in Table 1.
      Table 1Sociodemographic data, medical history and indications for surgery
      CharacteristicValue
      Age (yrs), median and range59 (37–79)
      Parity, median and range2 (0–10)
      Previous cesarean section, n (%)2 (7)
      BMI (kg/m2), median and range25.4 (17.6–40.0)
      Hypertension, n (%)9 (30)
      Hyperlipidemia, n (%)8 (27)
      Cardiac disease, n (%)3 (10)
      Diabetes, n (%)3 (10)
      Previous pelvic/abdominal surgery, n (%)12 (40)
      POPQ score:
      Stage I, n (%)9 (30)
      Stage II, n (%)9 (30)
      Stage III, n (%)12 (40)
      Stage IV, n (%)0
      Indications for surgeries:
      Pelvic organ prolapse, n (%)12 (40)
      Myomatous uterus, n (%)4 (13)
      Endometrial hyperplasia, n (%)2 (7)
      Menorrhagia, metrorrhagia, n (%)7 (23)
      Cervical dysplasia, n (%)3 (10)
      Ovarian cyst, n (%)2 (7)
      BMI = body mass index; POPQ = pelvic organ prolapse quantification.
      Table 2 shows intraoperative and postoperative data and presents the concomitant procedures that were performed in addition to hysterectomy. All the surgeries were carried out to completion through vaginal access, without conversion to abdominal, conventional vaginal, or laparoscopic approaches and without any major complications. The median hysterectomy time was 57 minutes (range: 24–88) and the median blood loss was 50 mL (range: 20–400). Twenty women (67%) underwent bilateral salpingo-oophorectomy, 9 (30%) underwent bilateral salpingectomy and 1 (3%) woman underwent unilateral salpingo-oophorectomy. Eleven women (37%) underwent uterosacral ligament suspensions for advance apical prolapse and 2 women (7%) underwent tension-free vaginal tape-obturator for stress urinary incontinence. Three (10%) enlarged uteri were extracted in bag.
      Table 2Intraoperative and postoperative data
      OutcomeValue
      Hysterectomy time, min, median (range)57 (24–88)
      Total operating time, min, median (range)156 (83–267)
      Uterus size, gestational wk, median (range)5.5 (4–15)
      Concomitant surgeries:
      Bilateral salpingo-oophorectomy, n (%)20 (67)
      Bilateral salpingectomy, n (%)9 (30)
      Unilateral salpingo-oophorectomy and unilateral salpingectomy, n (%)1 (3)
      Uterosacral ligament suspension, n (%)11 (37)
      SUI repair surgery-TVT-O, n (%)2 (7)
      Bleeding, mL, median (range)50 (20–400)
      In bag uterine extraction, n (%)3 (10)
      Pain assessment at 24 h postoperative (VAS: 0–10), median (range)3 (1–5)
      Demand for analgesics:
       PO paracetamol, n (%)14 (47)
       PO dipyrone, n (%)8 (27)
       Opioids, n (%)0 (0)
       IV analgesics (paracetamol), n (%)5 (17)
       Number of times analgesics were used, median (range)2 (0–4)
      Length of hospital stay, d, median (range)3 (2–8)
      Baseline hemoglobin level, mean, SD (g/dL),12.9 (1.57)
      Hemoglobin level 24 h after the surgery, mean (SD), (g/dL)11.5 (1.17)
      Mean drop in hemoglobin level, (g/dL)1.4
      Short-term outcomes:
      Urinary tract infection, n (%)3 (10)
      Re-hospitalization0
      Re-operation0
      IV = intravenous; PO = per-os; SD = standard deviation; SUI = stress urinary incontinence; TVT = tension-free vaginal tape-obturator; VAS = visual analog scale.
      The median postoperative hospital stay was 3 days (range: 2–8). The median VAS score for the first 24 hours after surgery was 3 (range: 1–5). None of the women requested analgesia beyond the routinely administered postoperative protocol (oral/intravenous paracetamol, oral ibuprofen or oral dipyrone by demand) (Table 2). None of the women required oral or intravenous opioids. One woman developed a urinary tract infection and was treated with ambulatory oral antibiotics. No additional postoperative adverse events were reported. According to the evaluation of the treating physicians, the vaginal cuff was healed, as expected, in all the women at the 6-weeks postoperative follow-up visit.

      Discussion

      This is the first report of RvNOTES hysterectomy using robot-assisted instrumentation developed for this purpose. We present a total of 30 RvNOTES hysterectomies performed using the Hominis system. All the procedures were completed according to the study protocol, with no perioperative or postoperative serious adverse events and no conversions to open or conventional laparoscopic surgery. The median hysterectomy time was 57 minutes, which is in the same range as that reported for our initial experience of hysterectomy performed with other surgical approaches. Further, the operative time in the current study corroborates times reported by others [
      • Matanes E
      • Lauterbach R
      • Mustafa-Mikhail S
      • Amit A
      • Wiener Z
      • Lowenstein L
      Single port robotic assisted sacrocolpopexy: our experience with the first 25 cases.
      ,
      • Awad N
      • Mustafa S
      • Amit A
      • Deutsch M
      • Eldor-Itskovitz J
      • Lowenstein L
      Implementation of a new procedure: laparoscopic versus robotic sacrocolpopexy.
      ,
      • Geller EJ
      • Lin FC
      • Matthews CA
      Analysis of robotic performance times to improve operative efficiency.
      ]. Blood loss among our patients was minimal, and concurs with other reports on robotic and vNOTES approaches [
      • Baekelandt JF
      • De Mulder PA
      • Le Roy I
      • et al.
      Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a day-care procedure: a randomised controlled trial.
      ,
      • Matanes E
      • Lauterbach R
      • Mustafa-Mikhail S
      • Amit A
      • Wiener Z
      • Lowenstein L
      Single port robotic assisted sacrocolpopexy: our experience with the first 25 cases.
      ,
      • Sarlos D
      • Kots L
      • Stevanovic N
      • von Felten S
      • Schär G
      Robotic compared with conventional laparoscopic hysterectomy: a randomized controlled trial.
      ]. The normal length of hospital stay in both participating centers were 2 days for minimally invasive surgery and 4 days for open surgery; these are comparable with the median hospitalization length of the current study.
      Hysterectomy dates back to ancient times when vaginal hysterectomy was performed by Soranus of Ephesus in 120 A.D and later during the middle ages owing to an inverted uterus. Patients rarely survived [
      • Sutton C
      Hysterectomy: a historical perspective.
      ]. The first abdominal hysterectomy was performed by Charles Clay in 1843 [
      • Sutton C
      Hysterectomy: a historical perspective.
      ]. The first conventional laparoscopic and robot-assisted hysterectomies were performed in 1988 [
      • reich H
      • DeCAPRIO J
      • McGLYNN F
      Laparoscopic hysterectomy.
      ] and 2001 [
      • Diaz-Arrastia C
      • Jurnalov C
      • Gomez G
      • Townsend Jr, C
      Laparoscopic hysterectomy using a computer-enhanced surgical robot.
      ], respectively. More recently, vNOTES hysterectomy was performed by Su et al [
      • Su H
      • Yen CF
      • Wu KY
      • Han CM
      • Lee CL
      Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES): feasibility of an innovative approach.
      ]and reported in 2012. The first human cases of transvaginal robotic surgery were presented by Dr J Baekelandt [

      Baekelandt J. Robotic vaginally assisted NOTES hysterectomy: a case series. Sergs Meeting on Robotic Gynaecological Surgery, organized by the Society of European Robotic Gyneacological Surgery Istanbul, Turkey 2015.

      ] at the seventh Annual SERGS meeting on Robotic Gynaecological Surgery in Istanbul in June 2015. The first cases of robotic vNOTES hysterectomy using a Da Vinci Xi system showed increased setup time and problems with instrument and robotic arm collision and, therefore, a longer surgical time [
      • Baekelandt J
      Robotic vaginally assisted NOTES hysterectomy: the first case series demonstrating a new surgical technique.
      ,
      • Baekelandt J
      Robotic vaginal NOTES hysterectomy: two new surgical techniques.
      ,
      • Lee CL
      • Wu KY
      • Su H
      • Han CM
      • Huang CY
      • Yen CF
      Robot-assisted natural orifice transluminal endoscopic surgery for hysterectomy.
      ].
      Several factors make the vaginal approach more challenging and consequently lower its worldwide usage, despite its recognized clinical advantages. These factors include a narrow vagina, restricted vision, a narrow pubic arch, uterine immobility, pelvic adhesions, bulky uteri and adnexal masses [
      • Berek JS
      Berek & Novak's Gynecology.
      ]. Good exposure provided by a laparoscopic camera may help overcome these challenges by enabling the surgeon to better respect the anatomy and avoid possible complications. Overall, vNOTES was expected to enable more women undergo hysterectomy by a vaginal rather than an abdominal approach. However, since the first documented vNOTES hysterectomy in 2012 [
      • Su H
      • Yen CF
      • Wu KY
      • Han CM
      • Lee CL
      Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES): feasibility of an innovative approach.
      ], this approach has not gained momentum and most hysterectomies are still performed abdominally [
      Committee on Gynecologic Practice
      Committee opinion no 701: choosing the route of hysterectomy for benign disease.
      ]. The robotic Hominis surgical system enables entrance to the cul-de sac of a narrow habitus. Moreover, the broad range of motion facilitates uterine mobilization and adhesiolysis, safely and effectively [
      • Lowenstein L
      • Matanes E
      • Weiner Z
      • Baekelandt J
      Robotic transvaginal natural orifice transluminal endoscopic surgery for bilateral salpingo oophorectomy.
      ]. The size, because of multiple myomas, of some of the uteri that were removed during the study at 15 weeks gestation was 13.5 × 10 cm with a weight of 509 g. Three enlarged uteri were placed in a bag, cut using a scalpel and then extracted vaginally in smaller pieces. In addition, one-third of the women in our study had undergone at least one previous pelvic surgery. Both these conditions render the traditional vaginal approach less appealing to most surgeons [
      • Veronikis DK
      Vaginal hysterectomy: the present past.
      ]. Therefore, RvNOTES may potentially assist in shifting the trend from abdominal laparoscopic/robotic hysterectomies to the previously preferred vaginal approach. This is because of the low complication rate, short surgical time, fast recovery, reduced postoperative pain, and low costs of vaginal hysterectomy [
      Committee on Gynecologic Practice
      Committee opinion no 701: choosing the route of hysterectomy for benign disease.
      ]. Additional advantages of the Hominis robot are its light weight and small footprint (12 pounds), which ensures easy mobility, short setup time, and fast docking [
      • Lowenstein L
      • Matanes E
      • Weiner Z
      • Baekelandt J
      Robotic transvaginal natural orifice transluminal endoscopic surgery for bilateral salpingo oophorectomy.
      ].
      Future studies are required to assess the benefits of RvNOTES for patients with various characteristics and different indications, and long-term safety compared with standard approaches for hysterectomy.
      Strengths of this study include the prospective and multi-institution design. Furthermore, all the procedures were performed by 2 surgical teams, with varying experience (residents and experienced surgeons), who employed the same technique. This study is limited by its short follow-up period and relatively small population, which may affect the true incidence of adverse events related to the procedure and approach. In addition, as with any single-arm prospective study, our findings might be influenced by patient selection bias and not represent the larger population of women who undergo hysterectomy for benign indications. However, this was addressed with a study population of a wide diversity of patient characteristics, medical backgrounds, and anatomic conditions.

      Conclusion

      This is the first report of RvNOTES hysterectomy using a robotic system specifically designed for this purpose. RvNOTES enables surgeons to operate vaginally with the known advantages of robotic modality. Our experience offers evidence of the feasibility of conducting hysterectomy by RvNOTES with no conversions to an open or conventional laparoscopic approach. The safety of this approach was also demonstrated, as no serious adverse events or device-related adverse events occurred, and all procedure-related adverse events were common to any vaginal procedure. This novel technology is promising for the high volume of hysterectomies performed, and potentially for other gynecologic procedures. Future randomized studies, comparing RvNOTES to traditional vaginal, laparoscopic and robot-assisted abdominal approaches are needed to determine the ultimate utility of this modality.

      Appendix. Supplementary materials

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