Introducing the Hugo RAS System in Urogynecology: Preliminary Data on Feasibility, Settings, and Perioperative Outcomes of Robotic Sacrocolpopexy

Panico G1, Campagna G1, Mastrovito S1, Vacca L1, Caramazza D1, Lombisani A1, Natale F1, Marturano M1, Pierro M1, Ferraro C1, Ercoli A2, Scambia G1

Research Type

Clinical

Abstract Category

Pelvic Organ Prolapse

Abstract 612
Open Discussion ePosters
Scientific Open Discussion Session 33
Friday 29th September 2023
13:15 - 13:20 (ePoster Station 2)
Exhibit Hall
New Devices Pelvic Organ Prolapse Surgery Robotic-assisted genitourinary reconstruction
1. Università Cattolica del Sacro Cuore, Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Chirurgia Ginecologica, Dipartimento di Scienze della Salute della Donna e del Bambino e di Sanità Pubblica, Roma, Italia, 2. PID Ginecologia Oncologica e Chirurgia Ginecologica Miniinvasiva, Università degli studi di Messina, Policlinico G.Martino, Messina, Italia
Presenter
Links

Abstract

Hypothesis / aims of study
Minimally invasive sacrocolpopexy is now considered the gold standard for surgical treatment of apical and multi-compartmental prolapse. Over the past decade, the goal of minimally invasive surgery has been to reduce complications associated with open abdominal surgery. Nowadays, robotic-assisted surgery (RAS) has become well-established for major urologic and gynecologic surgery. Although the daVinci system has emerged as the predominant platform in RAS and is currently the most widely available, other robotic platforms have been released on the market in recent years, including the Hugo RAS system (MEDTRONIC Inc, USA). This novel platform was introduced in Europe in March 2022 and received CE (Conformité Européenne) approval for gynecological and urological procedures. As early adopters of this technology, we report our initial experiences of robotic sacrocolpopexy (RSCP) using the HUGO RAS system.
Study design, materials and methods
We prospectively collected data of the first 60 patients who underwent RSCP with the new Hugo RAS system. All patients were affected by multicompartmental prolapse. Before surgery, patients underwent clinical examination and preoperative instrumental workup, which included a detailed history, physical examination, pelvic and urinary ultrasound, PAP TEST, and urodynamic evaluation. Two senior surgeons with experience of more than 50 minimally invasive sacralcolpopexy per-year performed all the procedures. Patient demographic, intra and post-operative data were collected. During surgery, specific time parameters were also measured (Docking time was defined as the time to change and adapt the robotic setting to the patient; Operative time was defined as the interval from the start of procedure to the suture of surgical incisions; Console time was considered from the moment the first operator started the procedure at the robotic console, until the end of its usage).
Results
All patients had POP-Q stage 3-4 multicompartmental prolapse. The median operative time (OT) was 185 minutes (range 95 - 305). The median docking time was 4 minutes (range 2-12). Estimated median blood loss was 15 mL (range 10-100). For all procedures performed, no conversion to laparotomy was recorded. Four patients had adhesions requiring laparoscopic adhesiolysis before robotic docking. Fifty-six patients had associated procedures, including 49 subtotal hysterectomies, 1 total hysterectomy, 49 salpingo-oophorectomies. Four patients had combined nerve-sparing sacrocolpopexy and ventral rectopexy for associated rectal prolapse and obstructed defecation syndrome. 
One minor intraoperative complication was reported, specifically a small opening of the anterior vaginal wall repaired intraoperatively with no postoperative consequences. Four 30-day postoperative complications were registered. Specifically, 1 mild fever treated with oral analgesics, 2 lower urinary tract infections treated with oral antibiotics, 1 umbilical infection treated with oral antibiotics.  Median time to discharge was 3 days (2-4). Pain VAS score decreased after surgery, with a 24h median of 3 (range 1–4).
Median follow-up was 8 months (6-10) and demonstrated statistically significant improvement in outcome parameters using POP-Q classification (table 1). No cases of mesh extrusion were reported. Of the 23 patients who complained of stress urinary incontinence before surgery, 10 did not complain of the symptom after surgery (43.5%). Two de novo stress urinary incontinence were reported, while no patients developed postoperative urge incontinence. Anatomical cure rate at six months was 96.7% with only two cases of anterior recurrence (POP-Q stage 2 and 3 respectively). Subjective cure rate was 98.3%. Patient-reported outcome data at 6 months showed that all 59 women (98.3%) had PGI-I 1-2 scores.
Interpretation of results
Accepting a new surgical robot in clinical practice mandates the demonstration of technical feasibility, efficacy and clinical safety. Our results showed that surgery did not differ from laparoscopic in terms of intra- and postoperative complications, hospital stay, and blood loss. The only aspect that differed was the OT (operative time), which was inevitably longer than standard laparoscopy, but similar to the times described for RSCP. Trocar placement was similar to that used in standard laparoscopic sacrocolpopexy. The separate arm design allowed a wide variety of modifications during docking.
Concluding message
This is the first series to analyze RSCP results for POP using the new Hugo RAS system. Our results suggest both objective and subjective efficacy, with minimal intra- and postoperative complications, comparable to standard minimally invasive techniques. Our case series may provide the basis for future studies to confirm the safety, efficacy, and feasibility of the technique. This was a pilot study, with the idea of pre-analyzing patient data while planning a prospective study with a larger sample.
Figure 1
References
  1. Monterossi G, Pedone Anchora L, Gueli Alletti S, Fagotti A, Fanfani F, Scambia G. The first European gynaecological procedure with the new surgical robot HugoTM RAS. A total hysterectomy and salpingo-oophorectomy in a woman affected by BRCA-1 mutation. Facts Views Vis Obgyn. 2022 Mar;14(1):91–4
  2. Serati M, Bogani G, Sorice P, Braga A, Torella M, Salvatore S, et al. Robot-assisted sacrocolpopexy for pelvic organ prolapse: a systematic review and meta-analysis of comparative studies. Eur Urol. 2014 Aug;66(2):303–18.
Disclosures
Funding No funding/grant Clinical Trial No Subjects Human Ethics Committee Fondazione Policlinico Universitario Agostino Gemelli IRCSS Helsinki Yes Informed Consent Yes
23/11/2024 07:36:52