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Role of robotic surgery on pelvic floor reconstruction

Andrea Giannini M.D., Eleonora Russo M.D., Malacarne E. M.D., Cecchi E. M.D., Paolo Mannella M.D., Ph.D, and Tommaso Simoncini M.D., Ph.D

Department of Experimental and Clinical Medicine, Division of Obstetrics and Gynecology, University of Pisa, Italy

Send Correspondences to:

Prof. Tommaso Simoncini: tommaso.simoncini@med.unipi.it Department of Clinical and Experimental Medicine

Division of Obstetrics and Gynecology University of Pisa

Via Roma, 67 56126, Pisa, Italy Tel +39.050.993523 Fax +39.050.553410

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Abstract

Over the past two decades, minimally invasive surgery (MIS) abdominal surgery has

increasingly been used to treat pelvic organ prolapse. Besides the several advantages associated with minimal invasiveness, this approach bridged the gap between the benefits of vaginal surgery with the surgical success rates of open abdominal procedures. The most commonly performed procedure for suspension of the vaginal apex for postoperative vaginal prolapse by robotic-assisted laparoscopy is the sacrocolpopexy. Conventional laparoscopic application of this procedure was first reported in 1994 by Nezhat et al. and had not gained widespread adoption due to lengthy learning curve associated with laparoscopic suturing. Since FDA approval of the da Vinci® robot for gynecologic surgery in 2005, minimally invasive abdominal surgery for pelvic organ prolapse has become increasingly popular, as robotic-assisted

laparoscopic sacrocolpopexy is an option for those surgeons without experience or training in the conventional route. Robotic surgery has made its way into the armamentarium of POP treatment and has allowed pelvic surgeons to adapt the 'gold standard' technique of abdominal sacrocolpopexy to a minimally invasive approach with improved intraoperative morbidity and decreased convalescence. In fact, repair of pelvic organ prolapse can be performed robotically, and sometimes surgeons can feel suturing and dissection during the procedures less challenging with the assistance of the robot. However, even if robotic surgery may confer many benefits over conventional laparoscopy, these advantages should continue to be weighed against the cost of the technology. To date, as long-term outcomes, evidence about robotic sacrocolpopexy for a repair of pelvic organ prolapse are not conclusive, and much more investigations are needed to evaluate subjective and objective outcomes, perioperative and postoperative adverse events, and costs associated with these procedures. It is plausible to think that the main advantage is that robotics may lead to a widespread adoption of minimally invasive techniques in the field of pelvic floor reconstructive surgery.

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The following review will address the development and current state of robotic assistance in treating pelvic floor reconstruction discussing available data about the techniques of robotic prolapse repair as well as morbidity, cost and clinical outcomes.

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Introduction

Pelvic organ prolapse (POP) is a common female pelvic floor disorder that has significant impact on quality of life. A recent study estimated that by the year 2050, 43.8 million women, or nearly one-third of the adult female population in the US, would be affected by at least one troublesome pelvic floor disorder1. A woman's lifetime risk of surgery for pelvic organ prolapse (POP) is

12-19% with over 300 000 prolapse surgeries performed annually in the US alone. POP accounts for about 15-18% of hysterectomies, and uterovaginal prolapse is the most common indication for hysterectomy in postmenopausal women. About one in 12 women living in the community in the UK report symptoms of pelvic organ prolapse2,3. With the aging and increasing activity of the

population, the need for prolapse operation is growing. Prolapse surgery has historically been plagued with high rates of women requiring salvage repair after their initial attempts at surgical correction fail4. Decreasing the need for salvage procedures decreases the lifetime cost of the

condition more than any other factor.

Actually, the development of robotic-assisted surgery has subsequently brought further benefits to minimally invasive gynecological surgery, allowing to overcome some difficulties found by surgeons in laparoscopy, including tremor amplification, ergonomic difficulty or limited movements of instruments. The use of the Da Vinci System (Intuitive Surgery Inc., CA, USA), since the approval of FDA in 2005 for gynecological surgery, has become increasingly widespread thanks to its evident advantages: three-dimensional optics, more comfortable working position for the surgeon, more flexibile movements, wirst-like motion, tremor filtering and motion scaling thus resulting in more dexterity and accuracy during surgery5-7.

In consideration of the advantages presented above, the learning curve results faster than in

conventional laparoscopy in different surgical tasks such as dissection in narrow spaces or suturing8

thus, robotic surgery has been adopted widely as the operative treatment of pelvic floor reconstruction.

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In this field of gynecological surgery, robotic approach is still a matter of debated in term of indications and type of surgeries because literature is not conclusive. However, evidences regarding robotic sacrocolpopexy are growing and detailed and robotic sacrocolpopexy has gained increasing popularity. Parallel, novel robotic treatments for the management of advanced pelvic organ prolapse are emerging. Interestingly, concomitant procedures for urinary incontinence, for the management of posterior compartment or to treat pelvic fistula may be performed during robotic surgeries for the pelvic floor reconstruction, though the literature about these mutlicompartment operations is still poor. A review of the literature restricted to the exclusive robotic-approach to pelvic floor

reconstructive surgery was undertaken, in particular focusing our attention on technical differences and alternatives, operative parameters, clinical outcomes and costs.

ROBOTIC SACRCOLPOPEXY (RASC)

Background, preoperative and technical considerations

Indications for sacrocolpopexy may consider several factors. Despite the promising outcomes with laparoscopic sacrocolpopexy (LSC), this technique has not been promptly adopted. Operators often affirmed that the dissection of the rectovaginal and presacral areas, placement of the mesh,

positioning of sutures and the intracorporeal knotting may be really challenging.

RASC is considered the gold standard surgical procedure for stage 2-4 vaginal apex prolapse according on different randomized clinical trials and reviews of the literature 9,10 when compared

with vaginal approaches. Moreover, RASC is the most commonly performed procedure for the treatment of the vaginal apex suspension after relapse of postoperative vaginal prolapse. Finally, patient with a foreshortened vagina may benefit of this minimally invasive abdominal procedure11,12.

Uterine preservation is associated with decreased morbidity and a lower rate of vaginal mesh extrusion compared with concomitant hysterectomy despite concerns exists about unexpected uterine pathology. Thus, the management of the uterus in patients who still have it must be discussed before surgery and different options for total or subtotal hysterectomy are possible. If a

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hysterectomy is planned before a sacrocolpopexy with permanent mesh, a supracervical

hysterectomy should be preferred because the risk of mesh erosion at vaginal level ay be reduced conserving the cervix12-14. Considering that the risk of occult malignant uterine pathology is not

negligible15 and that postoperative treatment may be difficult, preoperative endometrial evaluation

should be considered on all patients in postmenopausal period undergoing intra-abdominal uterine morcellation. When patients have surgical indication of hysterectomy, we suggest to perform a double layered closured of the vaginal cuff. Moreover, during placement and anchorage of the mesh, care should be taken to avoid suturing the mesh to the vaginal apex suture line in order to reduce the risk of mesh erosion. The choice of the mesh is another key element. The best type of material debated in the literature, synthetic non-absorbable mesh consistently outperforms

autologous, allogenic, and xenograft in terms of anatomic and symptom correction in randomized trials. These benefits, however, come at the expense of higher mesh exposure rates 12,16,17.In patients

who wish to preserve their uterus, hysteropexy may be performed. The sacrohysteropexy with uterus and vaginal suspension by mesh fixed to the sacral promontory is a technical option but it is infrequently used18. Different surgical techniques for RASC have been accurately descripted in

literature however, there is no general agreement concerning how this robotic procedure should be performed for an ideal outcome. Herein we describe one of the most used robotic technique according to the review of the current literature and our institution experience.

Surgical technique

After appropriate antibiotic prophylaxis and general anesthesia is achieved, the patient is prepped and draped in the low lithotomy position and stabilized with all pressure points protected. Urinary bladder catheterization is done. Insufflation is achieved with a Veress needle in umbilical site. A supra-umbilical camera port (12 mm), three 8 mm robotic ports (two on left side and one on right side) and an additional 12-mm assistant port are placed. The principal left and right working ports are placed as high as possible in the abdomen to assure optimal arm mobility for dissection of the

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sacral promontory which can be deceptively high in some patients. The patient is placed in the steep Trendelenburg position and the robot docked from the side or between legs. A self-retaining

adjustable sacrocolpopexy retractor is placed inside the vagina and is controlled by the assistant during the surgery. It is essential that all intraperitoneal adhesions be released in order to create the space to the retroperitoneal structures for reparation. Concerning the use of robotic tools, the most frequently used in the right arm is the monopolar scissors (Da Vinci Si setting: 25 W, Da Vinci Xi setting: 2)/Needle driver and in the left arm the bipolar forceps/Needle driver. Few operator need the fourth arm using the prograsp forceps. The robotic scope is usually a 30° down lens camera. It is relevant the application of intravaginal self-retaining, adjustable sacrocolpopexy or retractor by the assistant.

On occasion, with a small enterocoele, the sac can be plicated with permanent sutures to the vaginal apex or the lax anterior wall may need plication with the pubovesical fascia being attached to it. Larger enterocoeles should be resected, with removal of excessive vaginal epithelium and a permanent Y-mesh applied to provide the necessary support. In women with diverticulosis, it is helpful to suture the appendices epiploicae to the anterior abdominal wall to help with retraction. The sigmoid colon and retroperitoneum are retracted to left by fourth arm when used by surgeon. The next crucial step is identification of the sacral promontory and its relationship to the right ureter and the right common iliac vein. Deeper to the proposed peritoneal dissection lie the middle sacral vessels. A longitudinal incision of the peritoneum over the sacral promontory is carried out, extending to the cul-de-sac. The pneumoperitoneum helps expose underlying tissues – blunt

dissection is then used to expose the anterior longitudinal ligament over the sacral promontory. The right ureter and iliac vessels are identified and protected. Peritoneum overlying the sacral

promontory is opened to expose anterior longitudinal ligament (ALL) of the sacrum. Care is taken to avoid injuring the iliac vessels and right ureter crossing iliac artery lateral to the sacral

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dissected to maintain a clean, bloodless field. Two Gore-Tex sutures, tied together to create a double arm suture of correct length, are placed through ALL.

injuring the iliac vessels and right ureter crossing iliac artery lateral to the sacral promontory. The middle sacral artery and the sacral plexus of veins must also be accurately dissected to preserve a free, bloodless operative area. Two non-absorbable sutures, tied together to create a double arm suture of correct length, are placed through ALL.

Right parietal peritoneum is incised from the promontory to the vaginal vault avoiding injuries to the right ureter. Some operators prefer to create a tunnel underneath the right parietal peritoneum. Later, this peritoneal flap/ tunnel will be used for the retroperitonealization of the mesh. The dissection and the opening in the retroperitoneum should be adequate to allow for a tension free closure. This step not only assures that no mesh is left exposed to bowel, but it also serves as a proper enterocele repair.

A self-retaining sacrocolpopexy retractor is inserted into the vagina, stretching it towards sacral promontory for easy identification and dissection. Peritoneum overlying the vaginal apex is dissected in pouch of Douglas. The avascular plane between anterior vaginal wall and bladder is dissected until bladder trigone is reached. To facilitate this surgical step, bladder can be filled with normal saline to identify its limits. Posteriorly, peritoneum and rectum is freed from the posterior vaginal wall, avoiding damage to haemorrhoidal vessels or rectal nerves. The space should be sufficiently broad and long to accommodate the mesh placement and allow for ease of suturing. The length of the anterior and posterior sections is measured with the open width of the dissecting forceps. In general, 5–8 cm of anterior and posterior walls is dissected. A 23 × 4 cm wide pore polypropylene ‘Y’ shaped mesh is selected and trimmed to size. A Y-shaped monofilament polypropylene mesh is then sutured in a tension-free manner to the vaginal vault using

non-absorbable sutures, with the vagina being placed in an anterior and cephalad direction. The free end of the Y-shaped mesh is then fixed to the anterior longitudinal ligament with non-absorbable

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sutures, titanium tacks or staples. In our institution, we customarily use pre-formed a Y-shaped large-pore polypropylene graft (Alyte® Bard, Inc. Covington, U.S.A).

It is critically important at this point that the assistant has the prolapse reduced at the correct vaginal axis and to the desired tension. Any excess mesh is cut. The bottom end of the ‘Y’ mesh is anchored to the sacrum with the two preplaced non-adsorbable sutures. It is usual to add several more sites of fixation to the ALL after the initial two sites are secured. The parietal peritoneum over the vaginal vault and the sacral promontory is sutured with 2-0 vicryl in running fashion in order to complete peritoneal re-approximation which helps cover the mesh internally. The mesh is entirely

retroperitonealized thus preventing any future sites of enterocele formation or small bowel

obstruction due to mesh adhesion. Care is taken to make sure that no mesh is left exposed, no sites of herniation are left and complete hemostasis is achieved. The urinary catheter is removed the following morning. Some operators prefer to perform a cystoscopy with vaginoscopy to assess for efflux from each ureter and to ensure that there was no occult bladder or vaginal injury during the surgery. However, this procedure is not routinely adopted and widely accepted as necessary (Figure 1).

Perioperative and clinical outcomes

The first described RASC patient’s series performed in five patients was described in 2004 by Di Marco et al. The mean operative time was 210 min and LOS was one day with no relapses after a mean of 4 months’ follow-up19. In terms of objective cumulative cure rate for all compartments,

Serati et al. performed a systematic review of the literature and found that 84-100% of patients were cured after RASC. When they performed a meta-analysis of the data from 27 studies, the overall recurrence rate was 6.4% (3.4%, 0.4% and 2.6% for anterior, apical, and posterior compartments, respectively). The reoperation rate was approximately 3% with 63.6% of those being posterior colporrhaphie. Based on 4 studies with follow-up longer than 24 months, Serati et al. quoted an

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apical recurrence rate of 0.8% in a total of 246 patients. The meta-analysis reported an overall conversion rate to open surgery of <1%, with a 3% rate of intraoperative complications and a 2% rate of severe postoperative complications; the overall vaginal mesh extrusion rate was 2%. The mesh extrusion rates in series with hysteropexies and supracervical-hysterectomies with

sacrocervicopexies are lower than rates in series with RASC or total hysterectomy with RASC. A systematic review of 65 studies showed that the average rate of synthetic mesh erosion was 3.4%, the lowest rate was for polypropylene (0.5%) compared with other types of synthetic mesh, such as polyethylene or polytetrafluoroethylene (3.1–5.0%)12. This group reported robotic malfunction

occurs in up to 3.5% of cases20.

However, information regarding subjective cure rates is scarce, with significant heterogeneity in definitions of subjective cure. Culligan et al. reported a very high patient satisfaction rate of 97%, with 96% of patients who would recommend the surgery to other people. The same author reported a 95% cure rate defined as the absence of prolapse symptoms in the Pelvic Floor Distress Inventory-20 questionnaire, no prolapse beyond the hymen, and the C point ≤−521. Other authors reported

similar results in terms of subjective improvement (range 90-100%)22,23. Significant heterogeneity

also exists in operation time in the studies, as most surgeons allowed concomitant procedures. Hence, total hysterectomy or SCH, concomitant transvaginal prolapse reparation or

anti-incontinence procedures, the rates of which varied greatly, can contribute to variability in operation time.

Considering papers reporting outcomes of series of patients undergone only RASC we considered 10 recent and significant papers. These studies were usually small, with a mean sample size of 88 patients, although most possessed a duration of follow-up >24 months. Recently Gupta et al. reported on the largest series of patients (195) a higher mean operative time (242 min) with short duration of medium follow-up (9 months) showing a 1% conversion rate and non-negligible estimated blood loss (EBL<200 ml). Subjective cure rate was seen in 90% of patients, but the limit of this study is the lack of objective cure rate24.

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Salamon et al. reported a series of 120 patients undergoing RASC with a 12-months duration of follow up. Mean operative time was 161 min with a 0% conversion rate and minimal EBL (<100 ml). Objective cure was seen in 89% of patients. Postoperative SUI was identified in five patients (4%). Two patients (2%) experienced dyspareunia25. These results are mirrored by the other smaller

series, such as those reported by Moreno Sierra et al.26, Linder et al.27 and Hach et al.28 that reported

0% of conversion rate, and those reported by Ploumidis et al. and Germain et al. that noted, 3%, and 4% of conversion rates, respectively22,29,30. Decreases in RASC operative time were reported by

Moreno Sierra et al. (200–179 min)29, Germain et al. (222–183 min)22, and Elliott et al. (285–186

min),23 with increasing surgical experience.

Objective success rates were ≥89%, with subjective success rates in a similar range (90–100%) across all of the series. Interestingly, however, length of stay (LOS) varied widely between the series based on geography. US-based series showed a LOS from 1 to 1.7 days23,31; those from

Europe were 4 days26. No isolated series of patients undergoing robotic hysteropexy could be

identified, although 60% of the patients in the series reported by Ploumidis et al. did undergo uterine sparing; their clinical outcomes could not be separated from other patients in the study30.

One case report of robot-assisted hysteropexy was identified without reported outcomes32.

Overall, review of the ten-series included a total of 879 patients with a mean duration of follow-up of 27 months. Mean operative time was 176 min. The conversion rate to ASC was low, averaging <1%. SUI procedures were performed concurrently in 58% of patients. Objective cure was achieved in 95.5% of the patients, with 89% of subjective cure rate. A review of the outcomes of RASC can be seen in Table 1.

Considering papers which compare different approaches, two main retrospective studies compared RASC (198 cases) and ASC (413 cases). Similar objective and subjective cure rates were found33,34.

A multicentre retrospective cohort compared “minimally invasive” sacrocolpopexies ([MISC], including both RASC and LSC) with ASC in 1,124 patients and found that for MISC the rate of complications was lower, blood loss was less and hospital LOS was shorter; in addition, anatomic

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success was significantly higher for MISC than for ASC (93% versus 85%, P <0.001)35. Nine

papers compared RASC with LSC, involving 1,157 subjects were recently reviewed by De Gouveia De Sa. No significant difference was found between approaches for anatomical outcomes,

mortality, hospital stay (MD: -0.72/95 % CI 1.72, 0.28], p = 0.16), and postoperative quality of life. However, RASC had more postoperative pain and longer operating times, although fewer overall complications when performed concomitantly with hysterectomy (OR 0.35; 95 % CI 0.19-0.64)36.

Learning curve

Robotic surgery traditionally has a shorter learning curve than laparoscopic surgery. The use of more intuitive robotic technology allows surgeons without advanced laparoscopic skills to perform a challenging procedure via a minimally invasive approach. A learning curve for RSC also exists. Lenihan et al. also reported that the learning curve for RSC comprised about 50 cases37. Geller et al.

suggested that after 20 procedures the overall time needed to perform RASC decreases

significantly. In particular, they reported that time of cuff closure, anterior and posterior sacral dissection, sacral mesh attachment, peritoneal closure, total docked time, and total incision time decrease after the first 20 procedures38. Mourik et al. described that operative time decreased after

12 sacrocolpopexy and after successive 12 procedures39.

Germain et al. reported an 18% decrease in operating times after 10 procedures in a series of 52 patients undergoing RSC over a 7-yr period. In details, mean operative time decreased from 222 min during the first 10 cases to 183 for the next 10 cases22. Similarly, Akl et al. reported that in their

experience after the execution of the first 10 cases, operative time decreased by 25.4%40.

Costs

One of the first cost analysis about RASC was published by Paraiso et al. in 2006.This group verified that RASC ($16,278) was significantly more expensive than LSC ($14,342), although the cost difference was smaller (P = 0.008)41.

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In 2011 Judd et al. in a cost-minimization analysis, evaluated that ASC was the cheapest ($5,792) compared with costs of laparoscopic ($7,353) and robotic approach ($8,508), assuming equal efficacy42.

In a retrospective cohort, Tan-Kim et al. reported significantly higher costs for RASC than for LSC (P <0.01), without reporting actual costs for institutional and proprietary motivations43.

In 2012 both Hoyte34 and Elliott groups demonstrated that RASC was cheaper than abdominal

sacrocolpopexy, with the latter study demonstrating that the number of robotic cases performed at an institution and LOS are major drivers of cost44.

In the meta-analysis by Serati (2014), RASC was described to be cheaper than abdominal sacrocolpopexy ($7,910 versus $8,409, respectively, P <0.001) but $1,936 more expensive than laparoscopic procedure, on average20. Anger revealed 6-week costs of RASC to be significantly

more expensive than 6-week costs of laparoscopic sacrocolpopexy ($20,898 versus $12,170, P <0.001)45. The increased cost of RASC compared with laparoscopic sacrocolpopexy is generally

attributable to robotic purchase, maintenance costs and increased operative time,41 while the

increased cost of ASC compared with RASC is attributable to increased hospital LOS34,44.

It is interestingly to highlight that the cost analysis of robotic sacrocolpopexy must comprise consideration of both the cost of robotic platform acquisition (over US$1.8 million) and the maintenance amounts which average $153,000 per year45. Moreover, the high cost of robotic

approach encompasses disposable robotic tools as well as surgical, hospital and health-care. Additionally, the need of specialized personnel and peculiar engineering assistance are key factors that should be considered. Finally, the lack of a competitor for the da Vinci® robotic system may be a relevant cause in the high cost of purchase and technical assistance18.

ROBOTIC-ABDOMINAL LATERAL SUSPENSION Background, preoperative and technical considerations

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Development of new strategies to suspend the apex that avoid the challenges of RASC and are technically easier is therefore key to permit broader dissemination of minimally-invasive abdominal procedures for advanced apical POP. Abdominal lateral suspension (ALS) is a recently developed surgical approach that fulfills these concepts. This technique has been proposed by Dubuisson et al. in the 90’s46,47 . The technique requires a deep dissection of the vesical-vaginal space up to the level

of the bladder trigon and the placement of a mesh that is sutured to the anterior vaginal wall, uterine cervix and isthmus. Two long lateral arms are then retracted through retroperitoneal tunnels to reach the lateral abdominal wall. This allows lateral traction on the apex, that is thus not displaced

posteriorly as in ASC, but rather centrally, which is more anatomically correct. This procedure does not require posterior dissection of the recto-vaginal space or isolation of the sacral promontory nor the placement of sutures at this level. It thus skips the two most complex and potentially dangerous steps of sacrocolpopexy.

Laparoscopic ALS (L-ALS) is easier that L-ASC due to the reduced dissection and to the lower number of sutures required. Dubuisson at al. have published a long personal series of patients treated with L-ALS for early/intermediate POP, showing feasibility, safety and high rates of anatomical success emphasizing the importance of maintaining the uterus even in presence of advanced apical prolapse48-51.

Robotic assistance may be potentially useful to further facilitate this procedure, and may combine the advantages of minimally invasive technique with higher efficacy due to enhanced dissection and suturing ability. Robotic-ALS (R-ALS) may thus allow safe and effective treatment of patients with advanced anterior-apical prolapse without entero-rectocele52.

In 2014 Dällenbach reported the first robotic experience performing ALS on ten patients with symptomatic anterior and apical POP stage II or more. At present, the lack of study comparing vis-a-vis the outcomes of RASC and RALS on the high stage apical prolapse let to consider this novel technique as a merely and safe alternative to RASC. In this view, future comparative studies about the perioperative and clinical outcomes of these two abdominal treatments for advanced POP are

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mandatory and they will demonstrate the superiority of one technique over the other or the equivalence of the cure rate.

Surgical technique

The uterine cervix is vertically grasped with two tenacula on the right and left sides and a hysterometer is then inserted in the uterine cavity to allow manipulation.

Pneumoperitoneum is obtained with a Veress needle inserted through the umbilicus. A 12-mm trocar is introduced intraumbilically. After introducing the Da Vinci 30° optic, a robotic 8-mm trocar is placed under direct vision in each iliac fossa, about 10 cm laterally and 2 cm caudally to the umbilical trocar. A 12-mm trocar is inserted in the left upper abdominal quadrant for the field assistant. Fig. 1A shows the entry sites on the abdomen. After diagnostic laparoscopy, the patient is positioned in a 20° Trendelenburg position and the Da Vinci robot is laterally docked from the left side of the patient.

A T-shaped titanized polypropylene mesh (TiLOOP® “Prof. Dubuisson”® 9 x 41.5 cm, 65 g/m2) with an anterior vaginal part of 6 cm length and 5 cm width and two lateral arms of 3 cm width and 18 cm length each is used. The mesh is prepared by rolling and stitching the two lateral arms to facilitate introduction through the 12-mm left paraumbilical port and intracorporeal mesh manipulation.

The procedure starts with the opening of the utero-vesical peritoneum and its dissection up to the right and left round ligaments with Da Vinci bipolar Maryland forceps and monopolar curved scissors. The vesical-vaginal septum is identified and incised. Dissection is facilitated by the assistant pushing and slightly lifting the cervix while orienting the uterine body in a mildly retroverted position. A malleable straight retractor is used to expose the anterior vaginal wall and the anterior fornix during dissection. The bladder is grasped and pulled towards the anterior abdominal wall to allow dissection of the vesical-vaginal septum up to the bladder trigone.

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achieving deep vesical-vaginal dissection. The pre-vesical peritoneum is then suspended with a suture to the lower anterior abdominal wall to expose the anterior vaginal wall.

The mesh is fashioned over the anterior vaginal wall with the help of the vaginal retractor and sutured to the vagina with six sutures of 2-0 long-term absorbable synthetic monofilament suture of Glycolide and Trimetheylene carbonate (Maxon®, Covidien). A row of three sutures is placed on the apex of the mesh at the level of the bladder trigon. A second row of three stiches is placed at half-distance from the first row and the cervix. A third row of three non-absorbable 2-0

polypropylene stitches (Prolene®, Ethicon) is then placed on the anterior and right and left sides of the cervix. Finally, a last polypropylene stitch is placed to suture the mesh centrally to the uterine isthmus.

The lateral arms of the mesh are then freed by removing the blocking sutures. A 3-mm skin incision is made 2 cm above and 2 cm laterally to the anterior superior iliac spine, bilaterally. A

laparoscopic dissector is introduced through the incision and is pushed perpendicularly through the fascia to enter the retroperitoneal space. The dissector is then oriented towards the pelvis and a retroperitoneal tunnel is created up to the round ligament to reach the lateral arm of the mesh. The mesh is grasped and laterally pulled out slowly by retracting the dissector up to the abdominal surface. Care must be taken during the introduction and retraction of the laparoscopic instrument not to injure the external iliac vessels bilaterally. The two lateral arms provide horizontal side traction on the uterine cervix, which turns into a very predictable tension, which is extremely consistent and cannot be excessive. The lateral arms of the mesh are not sutured to the fascia

according to the ‘‘tension-free’’ repair principle. The mesh is then cut at the level of the skin before closure of the incision. Finally, the pre-vesical peritoneum is closed over the mesh to completely peritonealize the graft with a continuous 2-0 glyconate suture (Monosyn®, B-Braun Melsungen AG). After cleaning the abdominal cavity, the robotic arms are undocked and the surgical accesses are closed (Figure 2). Notably, for both RASC and RALS trocar placement slightly changes according to the choice of the robotic systems (Figure 3).

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Perioperative and clinical outcomes

Only two series reporting RALS outcomes are described in the literature. In the first series of RALS reported by Dällenbach, POP repair was successfully completed in all ten patients. There was no intra- or postoperative complication. The median total duration time of the operation was 206.5 min (interquartile range 190.3–251.0). Mean blood loss was 8 (SD 16.2) ml (range 0–50 ml). All patients returned home between the third and fifth postoperative days. There was no recurrence, erosion, de novo urgency, or urinary incontinence at short-term follow-up [mean 52.8 (SD 20.2) days]53. The largest worldwide series is reported by Simoncini et al.in 2016. 40 consecutive patients

with IIIrd or IVth stage symptomatic anterior and apical pelvic organ prolapse underwent R-ALS. All surgeries were completed by full robotic technique without complications. Mean operative time was 117 ± 26 min. The procedure resulted in complete resolution of POP-associated symptoms and in improvements of POP- and incontinence-related quality of life scores (PQOL and IIQ7) at 1 month from surgery52. Interestingly, one year after the publication of the aforementioned series our

group published the first worldwide case of single-site RALS (SS-RALS). A 71-year-old female with advanced symptomatic anterior and apical prolapse (POP-Q stage III/III) was treated by a single umbilical incision. The procedure was successfully completed in 155 min performing the procedure by full robotic technique without any complication54.

Further robotic procedures for pelvic floor surgery

Although the majority of pelvic floor surgeons limit their robotic pelvic floor reconstruction to RASC, and the emerging RALS, robotic surgery has been used for various pelvic surgeries. The sacral colpoperineopexy is used in patients with rectocele with perineal descent. In this procedure, a posterior piece of mesh is attached to the perineal body and the rectovaginal septum while a second mesh attached to the anterior vaginal wall. Both of these mesh arms are then attached to the anterior longitudinal ligament. Although this is an option for rectocele repair, the majority of surgeons prefer to repair a rectocele through an open vaginal approach55. Another well-described procedure

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includes ventral rectopexy. This is utilized for patients with full thickness prolapse of the rectum through the anal muscles. It may occur in up to 38% of women with urogenital prolapse56. Burch

colposuspension is an effective procedure for the treatment and prevention of SUI. Because of the increased operative duration and risk of complications for a Burch procedure compared with a midurethral sling, this procedure has now been largely replaced by midurethral sling procedures. Burch colposuspension is typically performed mostly in combination with an abdominal

sacrocolpopexy in women with symptomatic stress urinary incontinence (SUI) or as a prophylactic procedure in women with advanced prolapse who are likely to develop SUI after sacrocolpopexy. Burch colposuspension can be performed laparoscopically. There is no difference in efficacy between the open and laparoscopic approaches to the Burch procedure, but laparoscopic procedures have somewhat lower complication rates57. In the presence of a surgeon with the appropriate

laparoscopic skills, robotic Burch colposuspension may be performed during other pelvic floor procedures. However, there are any data regarding the feasibility and the outcomes of this procedure when performed by robotic approach. Robotic-assisted laparoscopic

utero-sacrocolpopexy is not a commonly performed procedure but may be very useful at the time of concomitant robotic-assisted laparoscopic hysterectomy, especially if additional transvaginal reconstruction is not necessary. An advantage of robotic suspension compared with the transvaginal approach is that the risk of rectal and ureteral injury at the time of placement of the suspension sutures may be reduced, as these structures are more easily delineated with robotic surgery. There is not a substantial amount of data on outcomes after uterosacral ligament suspension performed via a minimally invasive abdominal route, but the reported cure rates are range from 76% to 90% 58,59.

There are very few data on the use of robotic assistance for laparoscopic paravaginal defect repair to corrects lateral cystoceles. A case report exists demonstrating the feasibility of the robotic

approach60; otherwise, the data are limited. A retrospective study by Behnia-Willison et al. reported

a 76% objective cure rate in women undergoing bilateral paravaginal defect repair at the time of laparoscopic uterosacral ligament suspension61, though there are no studies evaluating long-term

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outcomes after robotic-assisted paravaginal defect repair. Pelvic fistulae are a far less common medical problem in the USA than POP; however, when they occur they are typically the result of a surgical injury. There are a few case reports or series of robotic repair of various pelvic fistulas including vesical-vaginal fistulae (VVF), vesical-uterine fistulae (VUF) and ureterovaginal fistulae (UVF). Although pelvic fistulae are uncommon in developed countries, they do occasionally occur and if they are not approachable vaginally then a robot-assisted repair can decrease morbidity with successful outcomes. Although difficult to obtain due to the low incidence of pelvic fistulae, outcome data based on larger patient numbers would be helpful to better understand the role of robotic assistance in the repair of pelvic fistulae62.

Conclusions

After its introduction in 2005 in gynecology, robotic surgery has become a mainstay of POP repair. The decision to proceed with a robotic technique depends on many patient, individual surgeon’s experience, and institutional reasons. Moreover, the choice of robotic technique must take into account comorbidities that may affect the ability to perform minimally invasive surgery, such as severe chronic obstructive pulmonary disease, morbid obesity, prior abdominopelvic surgery, and pelvic fibrosis. The literature has demonstrated that the learning curve for robotic techniques for POP is short requiring approximately 10-20 cases, however, surgeons should accurately evaluate the comfort with a particular surgical technique in combination with the potential complexity of each case. Excellent outcomes with minimally invasive approach with decreased intraoperative blood loss, decreased hospital stays, and lower overall cost compared with the open surgery have been previously described. However, since that the cost effectiveness is currently unclear in the field of robotic surgery and considering the heterogeneity of current reports, further prospective RCTs are required for conclusive results about the clinical performance of robotic approach for pelvic reconstructive surgery.

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Founding: None

Authors’ contribution: AG writing, ER writing, EM and EC table and figures content, PM and TS supervision and editing.

Table 1 – Clinical outcomes and complications of patient series undergone robot-assisted sacrocolpopexy.

Legend to figures Figure 1

Surgical steps of robotic-assisted sacral colpopexy.

A: vesical-vaginal space dissection; B: recto-vaginal space dissection; C: pre-sacral area dissection; D-E: mesh fixation; F: closing the peritoneum over the mesh.

Figure 2

Surgical steps of robotic-assisted lateral suspension.

A: opening of the utero-vesical peritoneum; B: dissection of the vesical-vaginal septum up to the bladder trigon and placement of the mesh over the anterior vaginal wall; C: suture of the mesh to the vagina, the cervix and the uterine isthmus; D: the mesh is grasped and laterally pulled out by a dissector through a retroperitoneal tunnel; E: correct mesh positioning; F: closing of the pre-vesical peritoneum over the mesh.

Figure 3

Trocars placement in robotic sacrocolpopexy and robotic abdominal lateral suspension with different robotic systems. A: da Vinci Si Surgical System; B: da Vinci Xi Surgical System.

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