Statistical analysis
Statistical heterogeneity between the studies was evaluated with the use
of the I2 statistic, as formally suggested in the Cochrane Handbook for
systematic reviews (8 ). A I2
< 50% and a p value over 0.05 were considered non-significant
heterogeneity. Meta-analysis was conducted with the results being either
pooled percentages or standardized mean difference (SDM) of the
meta-analysed outcomes during comparisons. As per the most widely
accepted definitions, difference amongst the assessed parameters was
evaluated as small for SMD = 0.2; medium for SMD = 0.5; and large for
SMD = 0.8, with p<0.05 being considered statistically
significant for all comparisons
(13 ,14 ). Where possible and most
relevant, forest plots were constructed to facilitate visualization of
the assessed corelations, otherwise data was provided in text, tables or
supplementary material. Calculations and graphs were carried out using
the Stata Statistical Software: Release 14.2 by StataCorp LP.
Results
The initial pool of 955 studies, which resulted from the preliminary
search of the medical databases was refined via manual screening of the
title and abstract, leading to 107 reports being moved to full-text
assessment. Through constant evaluation and strict application of the
pre-established inclusion criteria, 53 studies were ultimately included
in this review (15-67 ). This
systematic process of selection is summarized on Figure 1 . Most
of the eligible studies originated from the USA, the Republic of Korea
and Taiwan and the vast majority were based on data collected
retrospectively from institutional medical records, with only 8 studies
being conducted prospectively. 25 of the studies utilized an eligible
comparator; CLM, AM or both, thus were utilized in comparative analysis.
Ultimately, this systematic review included data from 7109 women. This
information is summarized on Table 2 .
The mean age of the included participants ranged from 34 to 48.2 and
mean BMI from 20.2 to 31. The main indications for myomectomy were
clinical symptoms such as feeling of pelvic mass, pelvic pain, uterine
bleeding, infertility, gastrointestinal symptoms, urinary symptoms etc
and a sizeable percentage of participants had a history of prior
abdominal surgery and/or caesarean section (Table 3) . With regard to RALM technical characteristics, the majority of
available studies used older Da Vinci Surgical System, with only 9
studies using the 4th generation Da Vinci X and Xi
systems. With regard to the procedure, the basic steps were consistent
amongst all studies. Most studies used a 12mm robotic port for the
camera, placed either above or below the umbilicus, with at least 2
additional, most commonly 8mm robotic ports bilaterally. A few studies
used a third 8mm robotic port and most researchers used an accessory 12,
10 or 5mm port as well. The mean number of robotically excised myomas
per study ranged from 1.5 to 7, as did the mean myoma diameter (3-8.3
cm), the mean diameter of the largest myoma (5-11cm) and mean myoma
weight (30-450 g) (Table 4) .
With regard to risk of bias, the included studies were assessed using
the tools for case series, case-control and non-randomized trials,
recommended by the NIH (12 ). Based
on the results of this analysis, 38 (72%) of the included studies were
of “Good” quality with regard to risk of bias, 8 studies (15%) were
of “Fair” quality and the remaining 7 studies (13%) were of “Poor”
quality with regard to risk of bias assessment.
Heterogeneity among the studies was assessed using the
I2 index. Regarding the RALM and AM comparison of
primary surgical outcomes, there was statistically significant
heterogeneity, namely I2=81.5% (p<0.001)
for the EBL comparison, I2=83.2% (p<0.001)
for the MOD comparison and I2=95.3%
(p<0.001) for the LOS comparison. Heterogeneity was
non-significant for the complication rate comparison
(I2=0%, p=0.716) and for the transfusion rate
comparison (I2=0%, p=0.418). With regard to actual
outcomes, RALM had significantly lower EBL compared to AM, with
SMD=0.312, p=0.004 (Figure 2a) , AM was superior with regard to
MOD, requiring significantly less operation time, with SMD=1.251,
p<0.001 (Figure 2b) and RALM necessitated
significantly less hospitalization duration than AM, with the LOS
SMD=1.368, p<0.001 (Figure 2c) . RALM had a
significantly lower complication rate compared to AM, being nearly 70%
safer, with OR=0.669, p=0.016 (Figure 3a) , in addition to a
40% less frequent requirement of transfusion compared to AM, with a
pooled OR=0.402, p<0.001 (Figure 3b) .
For the comparison of RALM to CLM, data was stratified in groups based
on overall myoma weight, so as to more thoroughly elucidate any possible
applications of each methodology based on myoma burden. Statistical
heterogeneity was assessed for each comparison and was significant, with
I2=87.6%, p<0.001 for the EBL comparison,
I2=96.6%, p<0.001 for the MOD comparison
and I2=72.2%, p<0.001. Heterogeneity was
non-significant for the complication rate comparison
(I2=0%, p=0.596), the transfusion rate comparison
(I2=18.2%, p=0.266) and the conversion to laparotomy
rate comparison (I2=0%, p=0.781). With regard to
outcomes, there was no statistically significant difference with regard
to EBL between RALM and CLM (SMD=0.079, p=0.544), however, when data was
stratified according to myoma weight, RALM caused significantly less
blood loss in cases with lower myoma weight (SMD=0.272, p=0.025), while
CLM was superior for the rest of the myoma cases, SMD=0.49, p=0.007(Figure 4a) . Similar to the RALM-AM comparison, RALM was
inferior to CLM with regard to MOD, SMD=0.97, p<0.001(Figure 4b) , while there were no statistically significant
differences between the two methods with regard to LOS, SMD=0.172,
p=0.094 (Figure 4c) . Complication and transfusion rates were
similar in both methods, with no statistically significant differences,
SMD=0.842, p=0.596 and SMD=0.984, p=0.951 respectively (Figure
5a and 5b) . Conversion to laparotomy rate also technically showed no
statistically significant difference between the two methods, however
the difference was only marginally non-significant, with OR=0.533 and
p=0.058 (Figure 5c) .
With regard to fertility outcomes, pregnancy rates ranged from 50-80%
post-operatively, with the majority originating from spontaneous
conception. Studies with sufficient follow-up, at the time of
publication, demonstrated a live birth rate of 25-100%. Detailed
fertility and obstetric outcomes are summarized on Table 1 .
Discussion
In this systematic review, we examined the application of RALM, one of
the newest minimally invasive available techniques for the treatment of
uterine fibroids and compared it to the other two established
methodologies, namely AM and CLM. All available studies with data on
RALM was collected and the information extracted on tables. RALM was
compared to AM favourably in almost all aspects apart from operation
duration. Operation duration was also more favourable in CLM than RALM,
with the rest of the assessed outcomes not being significantly different
between the two methods. The exceptions to that were EBL for lesser
myoma burden patients, which was significantly more favourable in RALM
and conversion to AM rate, which only marginally lacked statistical
significance.
The findings of the present systematic review are indicative of the
wider trend of minimally invasive surgery expansion and proliferation in
more and more fields of Gynaecologic Surgery. Our findings with regard
to AM and RALM comparison are in complete agreement with Wang et al
(68 ), who conducted a similar
meta-analysis in 2018. However, there are differences when the
comparison of RALM and CLM is concerned. In their analysis, as was the
case in ours as well, Wang et al showed that there were no statistically
significant differences in transfusion rates or LOS between RALM and CLM
(68 ). Additionally, they showed
that there was a statistically significant difference in conversion to
laparotomy rate (68 ) between the
two methods. In our analysis, while conversion rate difference was
non-significant, this was only by a very small margin, thus findings on
conversion rate are in actuality quite similar. Wang et al also showed
statistically significant differences in complication rates, although
when complications were analyzed in subgroups, the differences were
non-significant, similar to our general observations with regard to
complications. Another difference between the two analyses was with
regard to EBL, as Wang et al. showed there was a statistically
significant difference between RALM and CLM, regardless of other
conditions. This held true in our analysis only for lower overall myoma
burden patients, with the overall differences not being statistically
significant. Finally, with regard to operative time, Wang et al. showed
that there were no statistically significant differences, while in our
analysis CLM was significantly faster. However, regarding this
particular comparison, in the meta-analysis by Wang et al, the
difference was only marginally statistically significant
(68 ).
These differences between the two studies may be attributed to
differences in baseline characteristics of the patients, as in multiple
studies the two groups had statistically significant difference with
regard to myoma number, size, weight etc. Additionally, since the more
modern studies also included patients operated on using the latest Da
Vinci surgical system platforms, the observed discrepancies may be
attributed to inexperience of the surgeon or the ancillary staff for
these first reported cases. Furthermore, in both analyses, there was
statistically significant heterogeneity amongst the included primary
comparisons, thus the results of the meta-analysis might be affected in
both cases.
With regard to the findings of the present study, the apparent
disadvantage of RALM versus CLM, namely the unfavourable comparison to
the other two methods with regard to operation duration, while indeed
constituting a notable drawback, may be acceptable if patient risk of
morbidity and mortality is significantly reduced in return.
Additionally, based on the data collected during the present study, RALM
operation duration is following a downward trend already (Figure
6) , and is likely to continue to do so in the future given the
continuous growth of robotic technology
(69 ) and improvement of training
standards. When the inevitable comparison to CLM is made, RALM proved to
be superior with regard to EBL in patients with smaller overall myoma
weights. These cases usually include patients with smaller myomas, a
situation where the absolute control and precision that the robotic
surgical system offers is best utilized, minimizing injuries and thus
resulting in reduced blood loss. Additionally, the fact that RALM
offered up to 50% reduced risk of conversion to laparotomy, a
complication associated with further, severe complications and an
overall more adverse outcome (70 );
reinforces the safety and risk minimization aspect emphasized by robotic
technology.
Robotic surgery has been a rapidly developing field in recent years,
particularly as far as Gynaecological Surgery is concerned. The robotic
equipment was designed to surpass the limitation of conventional
laparoscopy, providing superior, three-dimensional visualization of the
surgical site, increased magnification of areas of interest, enhanced
dexterity via highly articulating surgical instruments and absent tremor
(71 ,72 ). Additionally, the ergonomic
working configuration of the console ensures reduced strain, be it
physical or mental, to the surgeon, with significant improvement to
surgery ergonomics (73 ,74 ), a vital feature especially
for high-volume surgeons and/or multi-hour procedures. Given the
prevalence of uterine fibroids and the effect that they may have on
quality of life and fertility, a safe, effective, reliable and ergonomic
approach such as RALM is a necessary and beneficial addition to the
modern Gynaecologic Surgeon’s arsenal
(75 ).
Research on the applicability of robotic systems in Gynaecologic
Surgery, and in fibroid management in particular, is still lacking.
Future research projects should aim to design a randomized trial for
RALM and CLM comparison, as such a study has not been conducted yet and
would provide valuable insight. Additionally, further specialized
applications and indications for robotic surgery should be sought, as
such data may be utilized in updating management algorithms and promote
robotic surgery to patients who truly stand to gain the most from this
advanced method.
The present study does come with certain limitations, which should be
acknowledged. Firstly, there was statistically significant heterogeneity
in the pooled available data, which may have introduced bias, affecting
the results of the analysis. Additionally, there were not enough studies
utilizing the latest advances in robotic technology, i.e.
4th generation Da Vinci surgical systems, which may be
more representative of the capabilities of modern systems, since
robotics is such a rapidly evolving field. Finally, not enough primary
data was available to further stratify patients and thus to test the
performance of the three therapeutic approaches in more specific cases.
Conclusion
RALM is a safe and effective therapeutic option for uterine fibroids,
which is superior to AM in almost every regard and offers significant
risk reduction and safety over CLM. Robotic technology, as well as
surgical skill is likely to further improve in the future, thus
enhancing the benefits already offered by this technology. Further
primary research should focus on establishing patient subgroups which
would most benefit from this advanced methodology.
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