Keywords hysterectomy - laparoscopic surgery - education - suture training
Palavras-chave histerectomia - cirurgia laparoscópia - educação - treinamento de sutura
Introduction
Laparoscopy-assisted hysterectomy has evolved as an alternative to conventional open
surgery since the end of the twentieth century.[1 ] It uses cameras and specific instruments to remove the uterus, the fallopian tubes,
and/or the ovaries through a minimally-invasive trans-vaginal access.[2 ]
[3 ] The procedure is called total laparoscopic hysterectomy (TLH) when hemostatic clamping
of the uterine vessels, resection of the uterosacral and cardinal ligaments, and colporrhaphy
are all performed through a minimally-invasive video-assisted approach.[3 ] The benefits of TLH are diminished postoperative pain, lower use of opioid analgesics,
shorter hospital stay, early rehabilitation and return to work, minimal blood loss,
enhanced visualization of intra-abdominal structures, which minimizes the risk of
iatrogenic lesion to bladder and ureters, and lower rate of short- and long-term complications.[4 ]
[5 ]
[6 ] Additonally, the intrafascial dissection technique preserves the vaginal apex support
structures, maintaining vaginal length.[6 ]
[7 ]
[8 ]
[9 ]
However, TLH is not widespread in many countries.[5 ]
[7 ]
[10 ]
[11 ]
[12 ] Data from the Brazilian Unified Healthcare System reveals only 2,947 laparoscopic
procedures out of 932,382 hysterectomies performed from 2008 to 2017.[13 ] Developed countries like the United States and England estimate that 20% to 30%
of hysterectomies are laparoscopic-assisted.[10 ]
[14 ] The major struggle regarding laparoscopic surgery expansion has been to train new
surgeons. The long learning curve to achieve proficiency in two-dimension screen vision,
camera navigation, hand-eye coordination, and psychomotor skills to handle laparoscopic
tools with dexterity conflict with a limited number of procedures and professionals
in teaching hospitals with scarce resources.[7 ]
[12 ]
[15 ]
[16 ] On the other hand, increased demand for laparoscopic procedures in private health
systems pressure junior surgeons to take up complex cases they may not be proficient
to deal with, resulting in lower surgical performances and increased morbidity and
mortality.[15 ]
[17 ]
Laparoscopic psychomotor skills must be preliminarily acquired by practicing on specific
validated training models outside the operating room.[15 ]
[16 ]
[17 ] Similar to a video game, training platforms enable the repetitive practice of standard
laparoscopic tasks. They also evaluate performance objectively, and provide feedback
to the trainees.[18 ] Simulators were proven to shorten surgical time and improve perioperative morbidity
in TLH procedures,[19 ] and they potentially reduce the learning curve compared to traditional surgical
teaching methods.[20 ] Current surgical practice regulations demand a controlled, standardized and validated
training program for new laparoscopic surgeons, such as the “Winners” program in Europe
and the American College of Obstetricians and Gynecologists (ACOG) Fundamentals of
Laparoscopic Surgery (FLS) program, in the US.[15 ] In an effort to validate an implemented standardized laparoscopic training in Brazil,
the present study evaluated the impact of the systematic laparoscopic skill and suture
training (SLSST) on the outcomes of TLH performed in a teaching hospital (Santa Casa
de Misericórdia de São Paulo, in the city of São Paulo, Brazil) from 2008 to 2014.
We hypothesized that the SLSST would have a positive impact on the intra- and postoperative
outcomes of TLH.
Methods
The present research was approved by the Ethics in Human Research Committee and Institutional
Review Board of Santa Casa de Misericórdia de São Paulo (under number: 14945313.8.0000.5479)
We conducted a cross-sectional observational study in which 610 charts of patients
submitted to hysterectomy at Santa Casa de Misericórdia de Sãoo Paulo from 2008 to
2014 were reviewed. All TLHs were included in the study, corresponding to 40% (244)
of the procedures. The exclusion criteria were: subtotal or partial hysterectomy;
hysterectomies associated with open rectosigmoidectomy and/or partial cystectomy due
to endometriosis; and malignant diseases requiring total hysterectomy with open retroperitonial
exploration.
Patient-specific (age, parity, previous cesarean sections, abdominal surgeries and
endometriosis) and surgery-related (hospital stay, operative time, rate of conversion
to open procedure, uterine volume, intra- and postoperative complications) variables
were analyzed.
The postoperative complications were divided according to the Clavien-Dindo (C-D)
classification ([Table 1 ]), which was created in 1992 (by Clavien PA, Dindo D and Demartines N at University
Hospital of Zurich, Zurich, Switzerland) is widely used, and is based on the type
of therapy needed to correct the complication.[21 ]
Table 1
Clavien-Dindo classification
Grades
Definition
Grade I
Any deviation from the normal postoperative course without the need for pharmacological
treatment or surgical, endoscopic and radiological interventions.
The allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics,
diuretics and electrolytes and physiotherapy. This grade also includes wound infections
opened at the bedside.
Grade II
Requiring pharmacological treatment with drugs other than those allowed for grade
I complications. Blood transfusions and total parenteral nutrition are also included.
Grade III
Requiring surgical, endoscopic or radiological interventions.
IIIa
Intervention not under general anesthesia..
IIIb
Intervention under general anesthesia
Grade IV
Life-threatening complications (including central nervous system complications)* requiring
management at intermediate care or intensive care unit.
IVa
Single-organ dysfunction (including dialysis).
IVb
Multiple-organ dysfunction.
Grade V
Death of a patient.
Note: *Brain hemorrhage, ischemic stroke, subarachnoid bleeding, but excluding transient
ischemic attacks.
In our institution, we receive every year 4 first-year residents (PGY-4 OB/GYN) of
the Gynecologic Endoscopy and Endometriosis Fellowship Program, and 2 second-year
residents (PGY-5 OB/GYN) of the Gynecologic Endoscopy and Endometriosis Fellowship
Program. The surgeries were divided into three different time-frame groups reflecting
distinct benchmarks of the SLSST curriculum implemented for the Gynecology Endoscopy
and Endometriosis Fellowship Program: 2008-09 (I-1) – TLH performed by senior attending
physicians with more than 5 years of experience in laparoscopic surgery; 2010-11 (I-2)
– TLH performed by the new first-year residents (PGY-4 OB/GYN) before the implementation
of the SLSST, supervised by senior physicians; and 2012-14 (I-3) –TLH performed by
the new first-year residents (PGY-4 OB/GYN) after the implementation of the SLSST.
The surgeries performed during the first 14 weeks of the SLSST (dominant hand training
period) were excluded from this group. The surgeries were assisted and supervised
by a second-year (PGY-5 OB/GYN) resident who was also submitted to the same training
program, but at the end of the previous year.
An average of 7 TLHs per PGY-4/year was observed in the I-2 group, and an average
of 14 TLHs per PGY-4/year was observed in the I-3 group.
Standard Total Laparoscopic Hysterectomy
The intrafascial technique has been standardized to all TLHs performed by the Gynecologic
Endoscopy and Endometriosis Group of Santa Casa de Misericórdia de São Paulo since
2008. The same standard steps are performed in the same order for every TLH.
Position on the gynecological table with the legs on the gaiters, the buttocks 5 cm
above the table, and arms on jambs along the body, asepsis/antisepsis, followed by
late bladder catheterization using a no. 14 Foley catheter, hysterometry and uterine
manipulator placement.
Intra-umbilical incision (longitudinal or arch-shaped), abdominal puncture using a
Veress needle followed by safety maneuvers (dual recoil test, saline infusion-suction
test, and pendant drop test), peritoneum distention with CO2 (6 mmHg to 20 mmHg), assessment of abdominal distension symmetry, and loss of liver
solidness to percussion sign.
Introduction of the intra-umbilical trocar and cavity inventory to assess puncture
accidents and adherences. Low pneumoperitoneum pressure to 14 mmHg, Trendelemburg
position, and establishment of accessory portals using 5-mm trocars ([Figure 1 ]).
Left round ligament styptic section, dissection of the anterior peritoneum from the
broad ligament to the bladder reflex, and establishment of an avascular plane left
uterus-ovarian ligament styptic section, followed by left salpingectomy. If left oophorectomy
is required, identify the left ureter and perform the styptic section of the infundibulum
([Figure 2 ]).
Dissect the posterior peritoneum from the broad ligament of the uterus to the sacrouterine
ligament and perform the styptic section of the left uterine vessels ([Figure 3A ]).
The same sequence (4 and 5) is then repeated on the right side.
Bladder retracted inferiorly ([Figure 3B ]), colpotomy using a monopolar cautery ([Figure 3C ]), and transvaginal removal of the uterus employing a vaginal liner.
Place a vaginal tampon to hold the pneumoperitoneum, followed by trans-peritoneal
colporrhaphy using no. 0 Vicryl (polyglactin 910 manufactured by Ethicon Inc., a subsidiary
of Johson and Johnson) with x-shaped stitches at the angles of the vagina and continuous
stitches in the center ([Figure 3D ]).
Review the hemostasis, remove the vaginal tampon, perform the suction of the pneumoperitoneum,
return to horizontal decubitus, and perform the intra-umbilical aponeurosis suture
and trocar incision closure.
Fig. 1 Locations of the portals.
Fig. 2 (A ) Hemostatic section of the left round ligament; (B ) dissection of the left broad ligament of the uterus; (C ) left avascular window; (D ) hemostatic section of the left uterus-ovarian ligament.
Fig. 3 (A ) Section of the left uterine vessels; (B ) lower retraction of the bladder; (C ) colpotomy; (D ) colporrhaphy.
Systematic laparoscopic skills and suture training (SLSST)
The training was implemented to the curriculum of the Gynecologic Endoscopy and Endometriosis
Fellowship Program in 2012. Based on the Romeo Gladiator Rule seven-week activities[22 ] ([Table 2 ]), the SLSST consisted of a 21-week (4 hours per week) hands-on training at the experimental
laboratory. Each week, the residents had to practice the scheduled exercise for a
minimum of 4 hours. The core exercises were performed with the dominant hand on the
lateral trocar for the initial 7 weeks of the program, followed by the dominant hand
on the central trocar from the 8th to the 14th weeks, and the non-dominant hand on
the lateral trocar from the 15th to the 21st weeks.
Table 2
Systematic laparoscopic skills and suture training core program
Week
Exercises
1st
Gladiator navigation
2nd
Gladiator with knot technique
3rd
Needle and guidelines
4th
Check-cross, deep and shallow stitches (staggering)
5th
Simple stitch with knot (number and resistance)
6th
Vaginal apex: x-shaped stitches, continuous suture right to left and left to right
7th
Myomectomy sutures and invaginating stitches
1st to 7th: Dominant hand on lateral trocar
8th to 14th: Dominant hand on central trocar*
15th to 21st: Non-dominant hand on lateral trocar*
Notes: Training based on the Romeo Gladiator Rule.[22 ] *Same exercise sequence as weeks 1 to 7.
Statistical Analysis
All data were recorded in Excel (Microsoft Corp., Redmond, WA, US), version 14.5.7,
spreadsheets, and the statistical analyses were performed using in the Statistical
Package for the Social Sciences (SPSS, IBM Corp., Armonk, NY, US) software, version
22. The calculation of the sample size was estimated based on a pilot group of 10
patients obtained from the first period of time (I-1). Using a standard deviation
of 50 minutes and an estimated difference of 30 minutes, a sample of 34 patients was
suggested to obtain a study power of 80% with a significance of 5%. The Kolmogorov-Smirnov
test was performed for each independent variable to determine normal distribution.
The Chi-squared test was used to compare parametric variables. The Student t -test was used to compare parametric continuous variables, and logistic regression
was performed to determine the association between the variables. Data are shown as
mean ± standard deviation (SD). Values of p < 0.05 were considered significant for the inferential analysis.
Results
We included 244 cases of TLH in the study: 24 operated in 2008-09 (I-1); 55 in 2010-11
(I-2); and 165 in 2012-14 (I-3). The increase in TLHs performed per year at our hospital
between periods I-1 and I-2 was of 129%, and between I-2 and I-3, it was of 100%.
The mean age of the patients was 45,93 ± 8,37 (SD) years. Patient-specific variables
are reported on [table 3 ]. The procedures performed together with TLH, like salpingectomy, oophoroplasty/oophorectomy,
and deep endometriosis are shown in [table 3 ].
Table 3
Patient-specific variables and procedures performed
Features
n
%
Parity
0
22
9.0%
1
29
11.9%
≥2
193
79.1%
Previous cesarean section
117
48.0%
Endometriosis
44
18.0%
Previous abdominal surgeries
(including cesarean section)
184
75.4%
Total laparoscopic hysterectomy only
102
41.8%
plus salpingectomy
76
31.1%
plus ovarian surgery
35
14.3%
plus endometriosis
24
9.8%
plus others procedures
07
2.9%
The clinical indications for TLH were mainly uterine myoma (66.4%) and endometriosis
(16.4%). Only two cases were diagnosed with malignant disease, and they were referred
to the gynecologic oncology service after surgery. Comparing the three groups studied,
we observed a significant difference in the number of previous cesarean sections,
previous abdominal surgeries, rate of conversion to open surgery, and hospital stay
longer than 2 days ([Table 4 ]). Out of 244 TLHs, 3 were converted to open laparotomy due to high uterine volume,
and 1 required an open vaginal route. The overall complication rate was of 5.7%: 2.0%
intraoperative and 3.7% postoperative complications.
Table 4
Clinical indications and associated variables stratified by time period
2008-09
(I-1)
2010-11
(I-2)
2012-14
(I-3)
p -value
Myomatosis
70.8%
56.4%
73.5%
0.52
Endometriosis
12.5%
20.0%
18.0%
0.72
Previous cesarean section
37.5%
32.7%
54.5%
0.02
Comorbidities
50.0%
56.3%
55.1%
0.86
Previous abdominal surgeries
45.8%
60.0%
69.7%
0.03
Conversion
4.1%
1.8%
1.2%
0.04
Hospital stay > 2 days
29.1%
49%
18.1%
0.01
Intraoperative complications
0.0%
3.6%
2.4%
0.52
Postoperative complications
8.3%
3.6%
4.2%
0.21
Clavien-Dindo[21 ]–I
0.0%
0.0%
0.0%
Clavien-Dindo – II
0.0%
0.0%
2,4%
Clavien-Dindo – IIIa
0.0%
0.0%
0,6%
Clavien-Dindo – IIIb
8,3%
1,8%
1,2%
Clavien-Dindo – IVa
0.0%
1,8%
0.0%
Clavien-Dindo – IVb
0.0%
0.0%
0.0%
Clavien-Dindo – V
0.0%
0.0%
0.0%
Note: Chi-squared statistical significance (p < 0.05).
We observed 6 intraoperative complications (1 internal iliac artery lesion, 1 acute
respiratory failure, 2 sutured bladder lesions and 2 vaginal wall lacerations) and
11 postoperative complications (1 left iliac fossa seroma – C-D II; 1 umbilical hernia
– C-D IIIb; 1 wall endometrioma – C-D IIIb; 2 vaginal dome granulomas – C-D IIIb;
1 buckling in the distal left ureter with loss renal function – C-D Iva; 1 intraperitoneal
vesical fistula – C-D IIIa; 1 vaginal dome bleeding – C-D IIIb; 1 urinary retention
– C-D II; 1 paralytic ileus – C-D II; and 1 postlumbar-puncture headache – C-D II).
We observed a decrease in uterine volume in group I-2 compared to group I-1: 217.8 cm3 and 154.2 cm3 respectively (p = 0.03). There was no difference in the uterine volume between groups I-2/I-3 and
I-1/I-3. The operative time was longer in group I-2 when compared to group I-3 (p = 0.01);
there was no difference between groups I-1/I-2 and I-1/I-3 ([Table 5 ]). The logistic regression showed an association between uterine volume and baseline
uterus disease (p = 0.02), comorbidities (p = 0.03), and type of surgery performed (p < 0.001). The operative time showed association with baseline uterus disease (p = 0.001), hospital stay > 2 days (p = 0.002), endometriosis (p = 0.002), and intraoperative complications (p = 0.013). No significant association was found between uterine volume and operative
time (p = 0.10) ([Table 6 ]).
Table 5
Uterine volume and operative time by group
2008-09
(I-1)
2010-11
I-2
2012-14
I-3
Uterine volume (cm3 ; mean ± standard deviation)
217,8 ± 159,5
154,2 ± 95,9*
180,8 ± 91,4
Operative time (min; mean ± standard deviation)
219,8 ± 50,0
228,8 ± 89,1
204,5 ± 51,9**
Notes: t -test statistical significance (p < 0.05); *I-1 versus I-2: p = 0.03; **I-2 versus I-3: p = 0.01.
Table 6
Logistic regression results
Associations
p -value
Uterine volume (cm3 ) x baseline uterus disease
p = 0.02
Comorbidities
p = 0.03
Type of surgery performed
p < 0.001
Operative time (min) x baseline uterus disease
p = 0.001
Hospital stay > 2days
p = 0.002
Endometriosis
p = 0.002
Intraoperative complications
p = 0.013
Uterine volume (cm3 ) x operative time (min)
p = 0.10
Note: Statistical significance (p < 0.05).
Discussion
The data confirmed our hypothesis that the SLSST would have a significant impact on
TLH outcomes. The procedures performed by the SLSST-trained residents (group I-3)
presented a reduction in operative time, length of hospital stay and conversion, reinforcing
that a systematic training program can shorten the long learning curve, improve performance,
and promote safe laparoscopic surgical practice in a teaching hospital.[23 ] Technique standardization for TLH contributed to make the surgical outcomes comparable
regardless of the surgeon who performed the procedure, and made the training process
easier for the residents, who were no longer exposed to multiple technique variations.
We observed an increasing number of TLHs during the time-frames analyzed in the present
study. The mean annual number of procedures more than tripled after the implementation
of the training program. The complexity of the surgeries also increased, with bilateral
salpingectomy becoming routine in 2013, but it did not increase the surgical time,
hospital stay, or the complication rates. The bilateral salpingectomy became routine
for all TLHs in order to decrease the risk of ovarian cancer.[24 ] These findings may be related to an increased confidence and proficiency in performing
more complex laparoscopic procedures after the training program. When analyzing the
hospital stay for patients submitted to TLH, one should consider quantitative data
or a qualitative approach. Considering that the majority of the patients were discharged
between the first and second postoperative days, we preferred to use qualitative data
and a cutoff of two days of hospitalization. The length of our hospital stay was consistent
with the current literature, and the rate of complications was half of those reported
in the literature.[25 ] We found higher prevalence rates of previous cesarean sections (48%) and endometriosis
(18%) than those reported in the literature,[23 ]
[26 ] which may be related to the extraordinary number of cesarean sections performed
in Brazil,[25 ] and to the fact that our hospital is a center of excellence for endometriosis care.
The present study did not find an association between uterine volume and operative
time, neither between uterine volume and rate of complications. Our trained residents
were able to significantly reduce TLH operative time in about 25 minutes, despite
the fact that they resected a higher volume of uteri than the non-trained residents,
suggesting that adequate training provided time-efficient abilities to young surgeons.
The traditional apprentice-tutor model is no longer valid to develop all skills necessary
in gynecological surgery; the complexity of modern surgery has increased the demands
and challenges to surgical education and the quality control.[27 ] Simulators motivate residents through the journey of proficiency in laparoscopy.[28 ] The positive impact that simulator-acquired skills have on real surgeries was published
in a recent systematic review.[19 ] A positive relationship between systematic training in simulators and reduced operative
time and complications were also reported in cases of bariatric and urologic laparoscopic
surgery.[29 ]
[30 ] In a Turkish study, Asoglu et al[31 ] concluded that a simulator lab improves the outcomes of hysterectomy performed at
a teaching institution, and may play an adjunct role in developing the resident's
surgical skills; the results found by them are in line with the findings of our study.
In the present study, repetitive practice in simulators enabled the fellows to improve
their psychomotor skills without the fear of making mistakes that could had been fatal
in an actual surgery. The mistakes were analyzed by tutors who provided feedback and
guided the residents to overcome obstacles. Tutorship in a stress-free environment
translated into faster, safer and efficient surgical performance even for more experienced
attending physicians.[32 ] Many countries have established systematic training on simulators as requirements
for laparoscopic surgeons.[33 ] The present study was the initial step to validate a laparoscopic training program
in Brazil. Our model may stimulate other academic hospitals to expand their proficiency
laparoscopic skills, serving a bridge to a safe and effective full practice of in vivo laparoscopy.
Our study had several limitations. The cross-sectional design did not enable us to
establish a temporal relationship between the training and surgical outcomes, or to
determine if the experience of the surgeon measured by the number of TLHs previously
performed had any influence over the surgical outcomes. Moreover, the substantial
difference in the number of TLHs among the groups, and the variable skill levels of
the senior attending physicians whose surgeries were included in group I-1 may be
possible biases. Further prospective studies may define the number of previous TLHs
necessary to reduce complications. On the other hand, the present study was, to our
knowledge, this first clinical study to apply and evaluate the interference of the
Romeo Gladiator training method on the outcomes of a surgical procedure.
Conclusion
The operative time for TLH was significantly shorter in the group of patients operated
after the SLSST was introduced in our hospital.
