Keywords
robotics - robotic surgical procedures/adverse effects - gynecologic surgical procedures/methods
- endometriosis/surgery - gynecology
Palavras-chave
robótica - procedimentos cirúrgicos robóticos/efeitos adversos - procedimentos cirúrgicos
em ginecologia/métodos - endometriose/cirurgia - ginecologia
Introduction
In the 1990s, laparoscopy, previously relegated to diagnostic procedures, gained prominence
in surgeries on the female reproductive system.[1] The evolution from open surgery to laparoscopy brought benefits for patients, and
robotics represents a technological advancement in minimally invasive surgery.[1] The word robot refers to compulsory or mandatory work, and the term was created
and first used by Karel Capek in 1920, in his play Rossum Universal Robots. The Robotics Institute of America defines a robot as a machine that has a human
form of performing tasks, possibly with more precise skills.[2]
Robotic surgery models emerged in the 1980s at the request of the United States Army,
which sought alternatives for the surgical treatment of soldiers wounded on the battlefield.[3] Robotic systems were continually created until the development of the da Vinci System
(Intuitive Surgical, Sunnyvale, California, USA), which is now widely used for procedures
in different specialties, including gynecology.[4] In Brazil, the Hospital Israelita Albert Einstein (HIAE) has pioneered the practice
of robot-assisted laparoscopy in several specialties, including gynecology, and has
performed a growing number of procedures since 2008.
Studies have compared the perioperative results of conventional, laparoscopic, and
robotic surgeries in the field of gynecology, including benign and malignant surgeries,
mainly hysterectomies.[5]
[6] The disadvantages of conventional surgery over laparoscopy are clear in terms of
abdominal incisions, length of stay, greater need for postoperative analgesia, and
higher complication rates.[5]
[6]
[7] On the other hand, when robot-assisted laparoscopy is compared with conventional
laparoscopy, it would be expected that complex procedures become safer and more reproducible,
as certain difficulties would be overcome. These include limitations on instruments
range of motion, two-dimensional vision, tremor, ability to perform laparoscopic sutures,
the need for an assistant to hold the camera, and a steep learning curve in the laparoscopy.[4]
[7]
Robot-assisted laparoscopy can be used in many gynecological procedures, including
myomectomies, hysterectomies, adnexal surgeries, treatment of endometriosis, sacrocolpopexies,
tubal reanastomosis, and oncological surgeries, including pelvic and para-aortic lymphadenectomies.[8]
[9]
[10]
[11]
[12]
[13] However, technological implementation in a surgical environment, especially when
it involves several or many teams, with different levels of training and skills, is
a great challenge and responsibility because patient safety can never be put at risk,
otherwise the use of those tools should be strongly discouraged. Proctors in our hospital
are designated by a multidisciplinary surgical committee. They need to be experienced
in laparoscopy and recognized as proficient in robotics, with a minimum of 20 robotics
cases (usually more than that). Those proctors have the function of supporting other
less experienced teams throughout the surgery and handling the robot, with the role
of intervening and even performing some steps of the procedure, if necessary. At the
end, they evaluate the surgeons' skills in the different tasks of operations. It is
also the proctor who formally enables other surgeons to perform procedures on their
own after proven proficiency, thus ensuring good surgical results while always prioritizing
patient safety.
The objective of this study was to analyze the perioperative results and safety of
performing gynecological surgeries using robot-assisted laparoscopy during implementation
of the technique over a 6-year period, considering procedures performed with and without
a proctor.
Methods
This retrospective, observational and cross-sectional study was approved by the Institutional
Medical Ethics Committee, CAAE: 38045414.7.0000.0071. We analyzed the medical records
of 274 patients who underwent gynecological surgeries for benign or malignant diseases
at the Hospital Israelita Albert Einstein (HIAE), São Paulo, Brazil, from September
2008 to December 2014. Patients with surgical indication for the treatment of gynecological
diseases were included, and patients with non-gynecological procedures were excluded,
even if there was a gynecological procedure for them as well.
The study considered each patient age, BMI, ASA classification, and diagnosis. We
evaluated the procedures performed, operative time, length of stay, perioperative
complications, blood transfusion, conversions (laparoscopy or laparotomy), transfer
to the intensive care unit, and mortality. The data were descriptively analyzed using
absolute frequency and percentages for qualitative variables and averages, standard
deviations, or medians and quartiles for quantitative variables. The median was selected
in cases of asymmetric sample distribution. The analyses were performed using SPSS
statistical program, version 17.0 (SPSS Inc., Chicago, USA) to compare complications,
transfusion rate and surgical conversion between experienced robotic surgeons without
proctor and beginner robotic surgeons with proctor assistance.
Results
The number of surgeries was found to have increased over the course of the study period,
with 16 (5.8%) surgeries in 2009, 22 (8.0%) in 2010, 45 (16.4%) in 2011, 38 (13.9%)
in 2012, 63 (23%) in 2013, and 87 (31.8%) in 2014. In 2008, three (1.1%) surgeries
were performed from September to December. Three teams performed the procedures in
187 patients (68.2%), with a mean of 62.33 cases per surgeon (range: 27–126). Twenty
teams still in their initial robotics learning curve were responsible for 87 cases
(31.8%), with a mean of 4.35 cases per surgeon (range: 1–14), always with the participation
of a proctor.
The patients were aged 20 to 84 years, with a median age of 38 years, and the BMI
range was 16 to 46.7 kg/m2, with a median of 23.3 kg/m2. In the surgical risk evaluation, only one patient had a preoperative ASA score of
III (0.4%). The others were classified as ASA I or ASA II, indicating low clinical-surgical
risk. The following preoperative diagnoses were found: endometriosis, uterine myoma,
endometrial cancer, adenomyosis, and benign ovarian tumor. The following procedures
were performed: ovarian cystectomy, treatment of intestinal endometriosis, hysterectomy,
treatment of deep endometriosis (other than intestinal), myomectomy, oophorectomy,
lymphadenectomy and sacrocolpopexy. The most frequent diagnosis was endometriosis,
which occurred in 192 patients (70.1%). The most frequent procedures were ovarian
cystectomy (22%) and treatment of intestinal endometriosis (20%) ([Tables 1] and [2]).
Table 1
Distribution of surgeries by the preoperative diagnosis (n = 338)
|
Diagnosis
|
n (%)
|
|
Endometriosis
|
193 (57)
|
|
Uterine myoma
|
120 (35.5)
|
|
Endometrial cancer
|
10 (3)
|
|
Adenomyosis
|
10 (3)
|
|
Benign ovarian tumor
|
5 (1.5)
|
Table 2
Distribution of procedures performed (n = 501)
|
Procedures
|
n (%)
|
|
Ovarian cystectomy
|
110 (22)
|
|
Treatment of intestinal endometriosis
|
101 (20)
|
|
Hysterectomy
|
89 (17.8)
|
|
Treatment of deep endometriosis (other than intestinal)
|
85 (17)
|
|
Myomectomy
|
66 (13.2)
|
|
Oophorectomy
|
40 (8)
|
|
Lymphadenectomy
|
9 (1.8)
|
|
Sacrocolpopexy
|
1 (0.2)
|
The diagnoses were included in the study as individual occurrences, given that each
patient might have more than one diagnosis at the time of surgical decision. The same
was considered for the procedures performed, as different procedures could be necessary
during a single patient surgery. The operative time was 55 to 600 minutes, with a
median time of 225 minutes (interquartile range [IQR]: 150–280 minute). The postoperative
length of stay was 0.5 to 12 days, with a median time of 2 days (IQR: 2–3 days). Transfusions
were required in 5.8% of the surgeries (1–3 red blood cell concentrates). There were
complications in 2.6% of the surgeries and conversion to laparotomy or laparoscopy
in 1.1% of the cases. There were no transfers to the ICU and no deaths ([Table 3]). There were no differences in complication rates between the group of surgeons
with less experience in robotics (who were always assisted by a proctor) and the group
of more experienced surgeons ([Table 4]).
Table 3
Distribution of surgeries by parameters analyzed in the case series (n = 274)
|
Distribution of surgeries
|
|
|
Operative time
|
Minutes
|
|
Median (IQR)
|
225 (150–280)
|
|
Minimum–Maximum
|
55–600
|
|
Postoperative length of stay
|
Days
|
|
Median (IQR)
|
2(2–3)
|
|
Minimum–Maximum
|
0.5–12
|
|
Need for transfusion
|
n (%)
|
|
No
|
258 (94.2)
|
|
Yes
|
16 (5.8)
|
|
Amount transfused
|
n (%)
|
|
None
|
258 (94.2)
|
|
1
|
7 (2.6)
|
|
2
|
7 (2.6)
|
|
3
|
2 (0.7)
|
|
Description of perioperative complications
|
n (%)
|
|
No complications
|
272 (99.2)
|
|
Ureteral reconstruction due to ureteral injury
|
1 (0.4)
|
|
Colonic fistula, with colostomy performed
|
1 (0.4)
|
|
Surgical conversion (laparoscopy/laparotomy)
|
n (%)
|
|
No conversion
|
271 (98.9)
|
|
Laparoscopy
|
2 (0.7)
|
|
Laparotomy
|
1 (0.4)
|
|
Intra-hospital mortality/Transfer to ICU
|
n (%)
|
|
None
|
0 (0)
|
Abbreviation: IQR, interquartile range.
Table 4
Comparison of complication, conversion and transfusion rates between surgeries performed
with and without proctor (n = 274)
|
Variables
|
Without proctor
|
With proctor
|
|
Need for transfusion n (%)
|
|
No
|
177 (94.7)
|
81 (93.1)
|
|
Yes
|
10 (5.3)
|
6 (6.9)
|
|
p
1 = 0.611
|
|
Complications n (%)
|
|
No
|
186 (99.5)
|
86 (98.9)
|
|
Yes
|
1 (0.5)
colonic fistula requiring colostomy
|
1 (1.1)
ureter injury requiring reconstruction
|
|
p
2 = 0.535
|
|
Surgical conversion n (%) (laparoscopy/laparotomy)
|
|
No
|
185 (98.9)
|
86 (98.9)
|
|
Yes
|
2 (1.1)
laparoscopy
|
1 (1.1)
laparotomy
|
|
p
2 > 0.999
|
p1, chi-squared test; p2, Fisher exact test.
Discussion
A 2010 review showed that robotic surgery has gradually become a frequent choice,
and this modality has demonstrated good results in terms of reducing trauma and shortening
the length of stay, with fewer complications, as evidenced by the extent to which
it has been more present in several specialties every day.[14] Although most gynecological procedures could be done by robotics, and this technology
has been recently made available in more than 30 hospitals in Brazil, the number of
procedures is still low even in those hospitals, demonstrating the difficulty in qualifying
a good number of surgeons to use this technology safely and effectively.
In this study, we focused on safety-related outcomes, evaluating two distinct groups
of surgeons: 20 with little experience in robotics (mean: 4.35 cases per surgeon;
range: 1–14) and 3 experienced robotic surgeons (mean: 62.33 cases per surgeon; range:
27–126). The results demonstrated low rates of complications, transfusion and conversion,
even when surgeons less experienced in robotics did the procedures, always assisted
by an experienced proctor. However, we emphasize that our results have limitations
related to study design, because it is retrospective and observational, with convenience
sample, since we could not perform sample size analysis and may not have adequately
identified confounding factors.
In a 2009 retrospective study that compared robotic surgery to laparoscopy for hysterectomy,
the operative time was found to be like those reported in our casuistic. There were
no statistically significant differences in operative time, blood loss or length of
stay, and conversion to laparoscopy was not required.[15] Reynolds and Advincula[16] and Hanssens et al[17] have shown that the time required for robotic surgery exceeds that for laparoscopy,
though these results vary according to the surgeons' experience.
Fastrez et al,[18] in a multicenter study with a group of 37 robot-assisted pelvic lymphadenectomies,
reported that one patient had an aortic injury requiring conversion to laparotomy
and one patient had a ureteral lesion treated without conversion. In the nine lymphadenectomies
performed at HIAE, none of these complications were observed, a result which reflects
the safety of this kind of approach for this procedure.
At the hospital evaluated herein, 66 myomectomies were performed through minimally
invasive robot-assisted approach between 2008 and 2014 and no conversions were required.
This result is compatible with the data from Cheng et al,[19] in which 21 robotic myomectomies were performed between 2010 and 2012 with no conversions
were required either.
In 2015, Corrado et al[20] compared different surgical approaches for the treatment of endometrial cancer and
showed that the group who underwent robotic surgery had a 1.4% rate of conversion
to laparotomy and a 2.7% rate of conversion to laparoscopy, comparable to the rate
observed at HIAE for all robotic gynecological surgeries between 2008 and 2014 (1.1%).
The same authors reported a 1.4% blood transfusion rate, slightly lower than the 5.8%
observed in the current study.[20]
Although we had only one case of sacrocolpopexy, a systematic review conducted in
2016 by Pan et al,[21] showed that the robotic approach is as safe as laparoscopy for performing the procedure,
as there are no statistical differences between the two approaches in either complication
rates or operative time. One of the biggest challenges of minimally invasive gynecological
surgery is the difficulty in performing this type of approach on morbidly obese patients.[22] Being aware of this issue, minimally invasive surgeries must be introduced slowly
and safely to those patients. Our casuistic had three patients with BMI > 40 kg/m2, with no complications at all.
Conclusion
Robot-assisted laparoscopy in gynecological surgeries has been shown to be safe, with
the presence of a proctor being critical for a successful transition for less experienced
teams. This study demonstrates the safety of the model here presented for the introduction
of robotic gynecological surgery into the hospital practice, but the rapid development
in robot-assisted surgery calls for long-term prospective randomized controlled trials.
