Robotic Surgery in Benign Gynecologic Indications

Gynecologic surgery has undergone a significant evolution over the past few centuries.

The first planned hysterectomy was a vaginal hysterectomy performed by Osiander of Gottingen in Lower Saxony in Germany in 1801. ^[1] Since then, the techniques of gynecologic surgery have been significantly enhanced and the complications reduced.

Laparoscopy was introduced in gynecology in the 1940s. It was not until 1988 that the first laparoscopic-assisted vaginal hysterectomy was performed by Harry Reich in Pennsylvania. ^[1] Many criticized this procedure because of the complexity of the technique, along with the lengthy operating time. Eventually, technology evolved, and the laparoscopic approach led to decreased hospital length of stay and faster postoperative recovery with minimal differences in postoperative morbidity or mortality. 

Robotic surgery in gynecologic procedures began when the da Vinci surgical system was approved by the US Food and Drug Administration (FDA), and the first gynecologic surgery was performed in 2005. Since then, the number of minimally invasive gynecologic procedures has increased dramatically, with the number of robotically assisted hysterectomies surpassing the number of hysterectomies performed with conventional laparoscopy. ^[2]

Since the inception of a robot by Leonardo da Vinci in 1495, the field of robotics has expanded into many areas, including the automobile industry, space exploration, military, and medicine. The evolution of robotic systems in surgery began in 1985 with the use of a robotic arm called the PUMA 560 for a stereotactic brain biopsy. Different models based on inputting preoperative designs for surgery into the robotic device were then developed and applied in the fields of general surgery for transurethral resection of the prostate (PROBOT) and orthopedics for hip replacements (ROBODOC). ^[3] Robotic telepresence technology was then conceived to provide immediate operative care remotely to wounded soldiers on the battlefield.

In 1994, AESOP was the first FDA-approved surgical robot, which consisted of a voice-activated system and robotic arm for endoscopic camera control to replace a surgical assistant in laparoscopy. HERMES was then developed to give the surgeon voice-activated control over the camera, light source, insufflation, printer, phone, operating room lights, and the patient table position. Two robotic arms and a surgeon console were implemented in the ZEUS surgical system that was used in 1999 for cardiac surgery and then FDA approved for laparoscopic surgery in 2001. In 2005, the FDA approved the current robotic platform, the da Vinci surgical system. The advancements of the previous devices were incorporated into this system, along with many others.

2020 ACOG guidelines on robot-assisted gynecologic surgery

The American College of Obstetricians and Gynecologists (ACOG) released guidelines on robot-assisted gynecologic surgery that include the following ^[4] :

• Robot-assisted cases should be appropriately selected based on the available data and expert opinion. In addition to the didactic and hands-on training necessary for any new technology, ongoing quality assurance is essential to ensure appropriate use of the technology and, most importantly, patient safety.

• Adoption of new surgical techniques should be driven by what is best for the patient, as determined by evidence-based medicine rather than external pressures.

• Adequate informed consent should be obtained from patients before surgery. In the case of robotic procedures, this includes a discussion of the indications for surgery and risks and benefits associated with the robotic technique compared with alternative approaches and other therapeutic options.

• Surgeons should describe their experience with robotic-assisted surgery or any new technology when counseling patients regarding these procedures.

• Surgeons should be skilled at abdominal and laparoscopic approaches for a specific procedure before undertaking robotic approaches.

• Surgeon training, competency guidelines, and quality metrics should be developed at the institutional level.

• Reporting of adverse events is currently voluntary and unstandardized, and the true rate of complications is not known. The American College of Obstetricians and Gynecologists and the Society of Gynecologic Surgeons recommend the development of a registry of robot-assisted gynecologic procedures and the use of the Manufacturer and User Facility Device Experience Database to report adverse events.

Robotic gynecologic surgery has indications similar to conventional laparoscopy.

Because of the increased setup time, indications for robotic gynecologic surgery are primarily operative, as opposed to a diagnostic laparoscopy. Many procedures can be performed as “combined cases” with other surgical services, including general surgery and urology. Robotic-assisted gynecologic surgery has been implemented in all fields of gynecology, including reproductive endocrinology and infertility, urogynecology, and gynecologic oncology.

The most common procedures performed are a hysterectomy, myomectomy, sacrocolpopexy, and excision of endometriosis.

Hysterectomy

The hysterectomy is the most commonly performed gynecologic surgery, with approximately 600,000 performed annually. ^[5] Ninety percent of these are performed for benign indications, including fibroids, abnormal uterine bleeding, endometriosis, and chronic pelvic pain. Several approaches are available, including abdominal, vaginal, laparoscopic (total laparoscopic hysterectomy [TLH], laparoscopic-assisted vaginal hysterectomy [LAVH], laparoscopic supracervical hysterectomy [LSH]), and robotic-assisted laparoscopic hysterectomy (RALH).

In 2002, only 10% of hysterectomies were performed in a minimally invasive fashion. Wu et al evaluated 538,722 hysterectomies performed during this year for benign indications. Of these, 66.1% were performed abdominally, 21.8% were performed vaginally, and only 11.8% were performed laparoscopically. ^[6]

The American Association of Gynecologic Laparoscopists (AAGL) released a statement in November 2010 stating that hysterectomies should be performed in as minimally invasive a manner as possible. ^[7]

Several reasons for the lack of laparoscopic hysterectomies have been proposed. One is the steep learning curve required to overcome a deficit in surgical skills when faced with a large uterus or adhesive disease. Another barrier is the lack of training during Obstetrics and Gynecology residencies. The same limitations exist for robotic surgery. A published survey by Gobern et al displayed that, of the one third of their respondents, 82% had a robotic platform readily available. Of these, 78% performed gynecologic procedures and only 58% had a training curriculum in place. ^[8] A standardized curriculum in residency programs for minimally invasive surgery is still being established.

Myomectomy

Women with symptomatic fibroids may choose to undergo a myomectomy to preserve fertility, as well as to achieve fertility. The robotic approach can be used to treat symptoms in a minimally invasive manner in reproductive aged women. It is associated with a shorter recovery time and a quicker return to work.

Obstacles with robotic myomectomy include difficulty enucleating leiomyomas, difficulty performing adequate multilayer closure, and the concern for uterine rupture with subsequent pregnancies, as well as a steep learning curve. Nonetheless, a review of articles regarding robotic-assisted laparoscopic myomectomy reports favorable outcomes (see Outcomes).

Sacrocolpopexy

Pelvic organ prolapse is an increasing concern as the female life expectancy increases. Sacrocolpopexy for prolapse is an advanced surgery that requires significant suturing with dissection of the presacral space and suturing of mesh from the vagina to the sacral promontory, which has prohibited its popularity in conventional laparoscopy. Traditionally, this procedure has been performed abdominally owing to the technical difficulty associated with dissection of these spaces.

Robotic-assisted sacrocolpopexy provides an alternative to the abdominal approach and conventional laparoscopy. It is a means to more effectively and efficiently dissect these spaces and suture while providing a minimally invasive modality with faster recovery time.

Endometriosis

Endometriosis affects approximately 10% of reproductive-aged women. The disease significantly impairs a women's quality of life, owing to chronic pelvic pain, dysmenorrhea, dyspareunia, and bowel disorders. Superficial, ovarian, and deep infiltrating endometriosis can be treated with surgical resection. Laparoscopy is the criterion standard for diagnosis of this condition. Robotic surgery provides a means to perform difficult procedures in deep infiltrating endometriosis and a frozen pelvis.

While robotic surgery has no absolute contraindications, it has relative contraindications and limitations.

Obesity

Obesity is defined as a BMI greater than 30 kg/m². It presents several difficulties associated with robotic surgery. Obesity distorts anatomy and complicates placement of the ports. In addition, the increased retroperitoneal fat may distort the operative field and may make the procedures more difficult owing to the bowel continuously moving into the operative field.

Obese patients may also have difficulty tolerating the steep Trendelenburg position.

On the other hand, robotic surgery decreases the surgeon's fatigue, resulting in decreased conversions to open surgery, as well as fewer postoperative obesity-related complications related to open surgery (eg, wound infections). ^[9]

Adhesive disease

As with conventional laparoscopy, robotic-assisted procedures can be associated with complications in patients with intraabdominal adhesive disease. Prior abdominal surgery or diseases such as endometriosis or pelvic inflammatory disease are associated with increased adhesion formation and place the patient at higher risk for complications associated with entry. Methods to decrease these complications include the Hasson open-entry technique, ^[10] as well as using ultrasonography to determine placement of the initial trocar. ^[11]

Cost

Increased costs associated with robotic-assisted gynecologic surgery are a concern.

Pasic et al performed a retrospective analysis comparing outcomes and costs of conventional laparoscopic hysterectomies with robotic-assisted hysterectomies. They demonstrated no difference in postoperative complications or hospital stay. However, they stated that an inpatient procedure with robotic assistance cost $9,640, while an inpatient procedure without robotic assistance cost $6,973. Outpatient procedures with robotic assistance cost $7,920, while outpatient procedures without robotic assistance cost $5,949. They also demonstrated a significant difference in the length of procedures. Robotic assistance took significantly longer, resulting in higher hospital charges. ^[2]

Another concern is the cost of the robotic unit. It costs between $1 million and $2.3 million and is associated with a high maintenance cost. Instruments and accessories range from $1,300-$2,200 per 10 procedures. Additionally, the annual service agreement ranges from $100,000-$170,000 per year. Despite these significant costs, the number of robotic surgeries being performed is increasing. Approximately 278,000 da Vinci procedures were performed in 2011, which is up 35% from 2009 and 30% from 2010. ^[12]

Wright et al compared the cost of laparoscopic versus robotic hysterectomies. The authors reviewed 264,758 hysterectomies for benign indications at 411 hospitals. They concluded there were no differences in perioperative outcomes, but the robotic hysterectomies had an additional cost of $2189. ^[13]

Training/credentialing

Robotic surgery requires training. Many studies have demonstrated improvement in laparoscopic skills with simulation and laboratory drills. This improvement has also been shown in robotics. Laboratory drills improve accuracy, decrease errors, result in a shorter learning curve, and increase the speed of intracorporeal suturing and knot tying. ^[14]

Sandadi et al evaluated the number of robotic hysterectomies a gynecological fellow needs to decrease their operative time by half to be approximately 33. Most obstetrics/gynecolody residents are graduating with few robotic surgeries, which emphasizes the need for a curriculum on minimally invasive procedures. ^[15]

In addition, issues exist regarding how to appropriately train and credential robotic surgeons. In general, the credentialing can be granted only by the institution where the surgeon is employed and is based on the concepts of technical training, capability, and documented robotic surgery cases. In addition, training should incorporate how to respond to technical malfunctions and how to rapidly remove the device in case of an emergency. ^[16]

Hysterectomy

In a large retrospective review of robotic versus laparoscopic hysterectomies published in 2010, few clinical differences in perioperative or postoperative events were observed. This study reviewed data from 358 hospitals for a total of 36,188 hysterectomies, 95% (34,527) of which were performed with conventional laparoscopy. Although there were few clinical differences, the cost of the robotic approach was significantly increased. ^[2]

Paraiso et al performed a randomized controlled trial comparing laparoscopic versus robotic hysterectomies for benign indications. They compared 27 women undergoing a laparoscopic hysterectomy and 26 women undergoing a robotic hysterectomy. They concluded that conventional laparoscopy has a significantly shorter operating room time versus robotic (171.6 +/- 75.8 minutes vs 245.8 +/- 117.1 minutes, respectively). In addition, they concluded there was no difference in perioperative complications or postoperative pain and return to work. ^[17]

Myomectomy

In 2004, Advincula et al reported a series of 35 patients with an average of 1.6 myomas who underwent robotic myomectomy. The mean operating time was 230.8 minutes, the estimated blood loss (EBL) was 169 mL, and the conversion rate was 8.6%. Two conversions were due to difficult enucleations caused by absent haptic feedback. ^[18]

In 2007, a retrospective case analysis by Advincula et al compared myomectomies performed robotically or via a laparotomy. They had 29 patients in both the robotic and open arms. Robotic myomectomy resulted in decreased EBL, length of stay, and complications. However, a longer operative time was reported. ^[19]

No major advantage of robotic over laparoscopic myomectomy was identified in a retrospective case study by Nezhat et al in 2009, but the operative time was 234 minutes for robotic cases versus 203 minutes for standard laparoscopic myomectomies. This study compared 15 robotic versus 35 laparoscopic myomectomies. ^[20]

Another large retrospective data review that compared 575 myomectomies performed abdominally (68.3%), laparoscopically (16.2%), and robotically (15.5%) showed decreased length of stay and decreased EBL in the robotic-assisted group. In this review, heavier myomas were removed more often via abdominal (average, 263 g) than robotic-assisted (average, 223 g) and laparoscopic approaches (average, 96.65 g). EBL was highest in abdominal myomectomy (200 mL vs 150 mL robotic vs 100 mL laparoscopic). Operative time was the longest in the robotic group (181 min vs 155 min laparoscopic vs 125 min abdominal). ^[21]

A retrospective data review in a community-based hospital compared surgical outcomes in 77 patients who underwent robotic-assisted laparoscopic myomectomy to those in 30 patients who underwent open myomectomy. The body mass index (BMI) and specimen weight were comparable, but the robotic modality resulted in significantly less EBL (125 ± 106 mL vs 353 ± 373 mL), a shorter hospital stay (1.4 vs 2.69 days), and a longer operative time for robotic myomectomy than open myomectomy (212 ± 88 min vs 136 ± 53 min). ^[22]

A 2012 retrospective chart review of robotic-assisted laparoscopic myomectomy versus abdominal myomectomy showed less intravenous hydromorphone use, shorter hospital stays, and equivalent clinical outcomes in robotic-assisted laparoscopic myomectomy cases. In this review, 27 robotic myomectomies were compared to 54 abdominal myomectomies. The authors did not find a decreased EBL with robotic myomectomy. In addition, as the specimen size increased, the efficiency of robotic myomectomy decreased. Because of the increased operative time with the robotic approach, the average hospital charge was significantly higher, even with the shorter hospital stay ($47,478 vs $26,720). ^[23]

There is concern regarding laparoscopic myomectomies increasing the risk of uterine rupture. A retrospective analysis of robotic-assisted myomectomy compared to abdominal myomectomy demonstrated less blood loss and less complication rates with the robotic approach. Postoperative hospital stay was also significantly less in the robotic group. ^[19]

Although additional data are needed, the first case report of an uncomplicated full-term pregnancy after laparoscopic myomectomy with the assistance of the da Vinci robotic system was published in 2007 and supports the suturing capabilities of the robot. ^[24]

Sacrocolpopexy

Gellar et al compared 73 robotic sacrocolpopexies versus 108 open sacrocolpopexies and demonstrated increased operative times, decreased EBL, decreased length of hospital stays, and similar vaginal vault support in the robotic arm after a 6-week postoperative follow-up. ^[25]

Elliott et al reported high patient satisfaction with the robotic approach and one recurrent vaginal vault prolapse in 12 months of follow-up of patients with posthysterectomy vaginal vault prolapse who underwent robotic sacrocolpopexy. ^[26]

Paraiso et al performed a randomized controlled trial comparing conventional versus robotic sacrocolpopexies. They included 38 in the laparoscopic group and 40 in the robotic group. The robotic group had a longer operating time, procedure time, and total suturing time. They also suggested that robotic procedures had more postoperative pain, requiring more NSAID use. In addition, the robotic group had a greater cost, with a mean difference of $1,936. Both groups had improvement in their vaginal support, and there were no differences in functional outcomes after 1 year. ^[27]

Endometriosis

There are limited studies evaluating the role of robotic-assisted surgery for endometriosis.

Siesta et al performed a 5-year retrospective cohort study to assess the feasibility of using robotic surgery to resect deep infiltrating endometriosis. They evaluated 19 bowel resections, 23 removals of rectovaginal septum nodules, and 5 bladder resections. They did not have any intraoperative complications and reported one anastomotic leak. ^[28]

In addition, Nezhat et al compared robotic versus conventional laparoscopy for the treatment of endometriosis. Forty patients were in the robotic group and 38 were in the conventional group. Both groups had similar age, BMI, and stage of endometriosis. There were no significant differences in the 2 groups in terms of blood loss, days in the hospital, and perioperative complications. The mean operating time of the robotic group was slightly higher than the conventional laparoscopy group (191 minutes vs 159 minutes). ^[29]