Research Article
Robotic Sacrocolpopexy: Results, Complications and Evaluation of Impact on Quality of Life
Moreno Sierra J*, Ciappara Paniagua M, Ruiz León MA, Fernandez Montarroso L, Resel Folkersma L, Galante Romo MI, Fernandez Perez C and Redondo Gonzalez E
Department of Urology, Institute of Health Research, Hospital San Carlos Hospital, Complutense University of Madrid, Spain
*Corresponding author: Moreno-Sierra J, Department of Urology, Complutense University of Madrid, C/Martin Lagos s/n 28040 Madrid, Spain
Published: 05 Oct, 2018
Cite this article as: Moreno Sierra J, Ciappara Paniagua M,
Ruiz León MA, Fernandez Montarroso
L, Resel Folkersma L, Galante Romo
MI, et al. Robotic Sacrocolpopexy:
Results, Complications and Evaluation
of Impact on Quality of Life. Clin Surg.
2018; 3: 2143.
Abstract
Introduction: Robotic surgery for pelvic organ prolapse provides the advantages of laparoscopic
approach with a shorter learning curve and an improvement of the surgeon ergonomic. The main
objective is to describe our series providing an analysis of intra/postoperative complications and as
secondary objective to analyze the improvement in Quality of Life (QoL).
Materials and Methods: Prospective longitudinal study. Mean age, Body Mass Index (BMI),
POP-Q stage, length hospital stay, operative time, surgical blood loss, intraoperative/postoperative
complications according Clavien-Dindo classification, recurrence rate and EPIQ questionnaire
score before and 6 months after surgery. Qualitative variables were analyzed by Chi-square test or
Fisher Test and quantitative variables by T-Student test and ANOVA (SPSS 15.0).
Results: From 2006 to 2011 49 RASC were performed with a follow up of 25.5 months (SD 13.7), TOT
was performed in 35 patients due to stress urinary incontinence. Five patients had intraoperative
complications (10.1%). One presented a bleeding of the middle sacral artery, 3 bladder perforations
and one vaginal perforation. Most frequent Clavien-Dindo postoperative complications were
grade I and II (32.6% and 10.2%). Three grade IIIB complications (6.1%) were described. One
mesh exposure, a relapsing vasovagal syncope due to an excessive tension of the mesh and a trocar
hernia. The recurrence rate was 14.9% (7 patients) QoL scores improved in all categories except in
functional defecation disorders and anal incontinence.
Conclusion: RASC has a low rate of complications with good anatomical results providing a
significant improvement in QoL. High grade Clavien-Dindo complications and recurrence were
factors that influenced in QoL.
Keywords: Robotic Sacrocolpopexy; EPIQ; QoL; RASC
Introduction
Pelvic organ prolapse (POP) surgery has evolved over the last decades remaining the abdominal
approach the gold standard. Robotic surgery is a minimally invasive technique with the advantages
of laparoscopic approach (less bleeding, shorter length hospital stay, good anatomical and functional
results) with a shorter learning curve and an improvement of the surgeon ergonomic. The outcome
of POP surgery is to provide a good anatomical correction of symptomatic prolapse, with a low rate
of intra and postoperative complications, improving the quality of life (QoL) [2-6].
The use of validated QoL questionnaires allows an objective assessment of the clinical situation
before and after surgery being a highly recommended practice. Several questionnaires have been
performed to evaluate the clinical global in order to study, from a general point of view, the
repercussion of symptoms in patients with POP [6]. Some questionnaires used are Medical Outcomes
Study Short Form SF-36, King´s Health Questionnaire, Incontinence Impact Questionnaire (IIQ),
Pelvic Floor Distress Inventory (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7) or the
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) [6-10].
Robotic-assisted Laparoscopic Sacrocolpopexy (RASC) has been previously described by our
group [4,6] and nowadays it is a consolidated technique [13]. To perform our study we decided
to use EPIQ-questionnaire (Spanish validation) mainly because of its simplicity and applicability.
The EPIQ questionnaire was developed by Lukacz et al. [10] in the United States and consists of 53
questions, some taken from other previously validated instruments and partly developed specifically
for this questionnaire.
The main objective of this article is to describe our series of robotic
sacrocolpopexy providing an analysis of intra and postoperative
complications according to Clavien-Dindo classification. A
secondary objective is to analyze the improvement in QoL through
EPIQ questionnaire (Spanish validation).
Table 1
Materials and Methods
A prospective cohort of patients undergoing robot assisted
sacrocolpopexy between November 2006 and May 2011 was
analyzed. The patients were diagnosed with anterior vaginal wall and/
or cervical prolapse with/without stress incontinence. RASC were
performed in all patients using Alyte® Y Mesh Graft, made by BARD®.
Tension free suburethral sling was performed in patients when stress
incontinence was associated. Two meshes were used when more than
one pelvic floor compartment were repaired. All the interventions
were performed by the same urologist.
The EPIQ-questionnaire was performed before surgery and at the
6th month in order to quantify the improvement in QoL.
Follow up was performed every 6 months in order to detect
recurrence or other complications.
The variables analyzed were mean age, Body Mass Index (BMI),
previous POP surgery, International Continence Society (ICS)
staging system based on Pelvic Organ Prolapsed Quantification
(POP-Q) stage, length hospital stay, operative time, surgical blood
loss, intraoperative complications, postoperative complications
according Clavien-Dindo classification [13] (Table 1) and recurrence
rate. Recurrence was defined like a non complete correction of the
prolapse (POP-Q stage ≥ 2). Qualitative variables were analyzed by
Chi square test or Fisher test depending on the number of patients
and quantitative variables by T-Student test and ANOVA using SPSS
15.0.
Results
We performed 49 RASCs from November 2006 to May 2011 in a
single institution with a follow up of 25.5 months (SD 13.7); tension
free sub urethral sling was performed in 35 patients due to urinary
stress incontinence. One of the patients could not complete the EPIQ
questionnaire because of reading and understanding difficulties.
In our series mean age was 66.1 (SD 8.7), the 57% of them were
over 65 years old. Mean body mass index was 25.9 kg/m2 (SD 3.3).
48.9 % were multipara, 49% were hysterectomized and 26.4% had a
previous POP surgery. Thirty nine patients (79.6%) presented 2 or
more pelvic compartment involved. 25 patients associated an apical
prolapse, 9 patient's rectoceles and 5 enteroceles.
The length hospital stay was 3 days (interquartile range Q3-Q1:3)
Two patients presented a longer stay, one for and acute urine retention
owing to an excessive tension of the suburethral sling that had to be
removed (14 days), and the other patients suffered an paralytic ileus
that was resolve with conservative measures (10 days).
The mean operative time was 192.6 minutes (SD 16.8) with a mean
estimated intraoperative blood loss of 50 ml (SD 30). One conversion
to open surgical approach was performed due to intolerance to
pneumoperitoneum (2.04%).
Five patients had intraoperative complications (10.1%). One
presented a bleeding of the middle sacral artery controlled with
cauterization, 3 patients suffered a bladder perforation during the
vaginal dissection resolved with absolvable suture and one patient
presented a vaginal perforation. Postoperative complications were
analyzed according to Clavien-Dindo classification [13]. The most
frequent complications were grade I and II (32.6% and 10.2%,
respectively) (Table 2).
Grade IIIB complications were the most severe complications
(3 patients, 6.1%) in our series. One patient had a mesh exposure
that was surgically corrected. Other patient presented a relapsing
vasovagal syncope due to an excessive tension of the mesh that
required surgical correction. The third patient developed a trocar
hernia that was corrected two months after the POP correction.
Complications grade IV and V were not described.
We analyzed the followings variables: elderly patients (>65
years old), overweight (BMI>25), and previous hysterectomy/pelvic
surgery with the risk of develop a postoperative complication and any
association was found (p>0.05).
The recurrence rate was 14.9% (7 patients), the previous variables
were analyzed in order to detect some association with the possibility
of recurrence and we did not found any association in our series. To
analyze the quality of life EPIQ questionnaire (Spanish validation)
was used. 48 of the 49 patients completed all the study. EPIQ
questionnaire is divided in 7 categories (quality of life, overactive
bladder, anal incontinence, micturition difficulty/pain, functional
defecation disorders, stress urinary incontinence, pelvic organ
prolapse) [11].
The results of pre and post surgery scores shows and improvement
in all categories except in functional defecation disorders and anal
incontinence. Anal incontinence questions were not properly
answered. The greatest improvement was related to pelvic prolapse
perception 84.7 vs. 22 CI 95% (48.5-76.8) (Table 3).
We performed an analysis on patients who developed
intraoperative/postoperative complications and recurrence.
Patients with intraoperative complications (5 patients) showed an
improvement in the same categories as when the whole complete
series was studied (Table 4). Patients with significant postoperative
complications classified as Clavien-Dindo IIIb (3 patients) shown
improvement only in the overall quality of life category (Table 5).
We did not find statistical significance in the improvement in the 7
patients who developed recurrence (Table 6).
Table 2
Table 3
Table 4
Table 5
Table 6
Discussion
RASC is a minimally invasive surgery that combines the
knowledge of the open and laparoscopic surgery [14]. Since Di Marco
et al. [15] published his first paper in 2004; we found few references
about complications and quality of life in this technique. We should
take into account that pelvic floor correction could produce a pelvic
dysfunction so routine use of questionnaire of quality of life must be
used, especially when the final outcome of this kind of surgery is to
provide an anatomical correction that associates an improvement in
the QoL. Serati et al. [16] published a systematic review where 1488
patients were analyzed, being the study where more patients were
studied.
Operative time in this review was 194 min (75-537). Others
authors as Germain [17] or Bradley [18] described an operative time
of 190 (75-340) and 301 min (205-440) respectively. In our institution
the operative time was 192min. Operative time could be increased
when other surgical intervention are associated such as a tension free
suburethral sling or hysterectomy.
Main advantages of RASC regarding open approach are a
decrease in the intraoperative blood loss and length hospital stay. In
the Serrati´s review blood loss was 50 ml (10-1000), similar results are
reported by Bradley et al. (66.2 ml) or our group (50 ml). When Geller
et al. compared open and robotic approach a significant decrease was
reported (103 +/- 96 mL compared with 255 +/- 155 mL, P<0.001)
and shorter length of stay (1.3 +/- 0.8 days compared with 2.7 +/-
1.4 days, P<0.001). A length hospital stay of 2 days was reported by
Serrati et al. [16].
In spite of in the published literature the incidence of
intraoperative complications is low, it is mandatory to detect and
resolve them during the intervention, since unnoticed lesions could
develop important complications. Bradley and Serati [16] described
similar intraoperative complications that in our series but we did not
notice any intestinal or ureteral injury [18].
Clavien-Dindo classification is a useful tool that allows
comparing and describing surgical complication. In our series grade
I complications were the most frequent (16 patients, 32%). The
incidence of grade II and IIIb were 10.2% and 6.1% respectively.
Serrati et al. [16] describes an incidence of 3% (27 patients) for Grade
I complications, 4% (39 patients) for grade II, <1% for grade IIIa (1
patient) and 2% (19 patients) for grade IIIb. Complications grade IV
and V were not described.
The incidence of serious complications such as grade IIIb or
higher is infrequent. Germain et al. [17] described one case of
peritonitis due to a bowel perforation of a consecutive series of 52
patients. Bradley et al. [18] describes 2 patients (3.8%) who present
intestinal obstruction that required surgical intervention.
Mesh erosion is described in several articles [16,20] with an
estimated risk between 0% to 8%. Hudson et al. [20] published a
meta-analysis describing a risk of 4.1% (CI 95% 1.4-6.9) for mesh
erosion/exposure. In our series one patient presented mesh erosion
(2%) of the suburethral sling.
The recurrence rate is variable. In 2 published meta-analysis
Hudson et al. reported in all 13 of the selected studies an overall apical
anatomic cure rate of 98.6% (95% CI 97.0% to 100%) and Serati et al.
[16] and objective and subjective cures ranged from 84% to 100% and
from 92% to 95%, respectively. In our series we observed a recurrence
rate of 14.3%; this result may be due to the POP stage of the patients
(91.8% stage ≥ III).
Multiple questionnaires have been used like the Pelvic Floor
Distress Inventory- Short Form (PFDI-20), Pelvic Floor Impact
Questionnaire Short Form 7 (PFDI-7) and the Pelvic Organ Prolapse/
Urinary Incontinence Sexual Function Questionnaire (PISQ-12). All
these questionnaires have an important applicability problem, since
they are long and hard to understand for patients, making it difficult
to carry out. Due to this there is a great heterogeneity in the literature.
We choose the EPIQ questionnaire (Spanish validated version), in
our environment it was the most simple and useful questionnaire that
we have nowadays, being useful for diagnosis and follow up.
In our series we observed an improvement in all categories except
those related to anal incontinence and defecatory dysfunction with
no modification of the EPIQ questionnaire score or a modification
without statistical significance. These results may be due to a large
number of patients presented anterior or middle compartment
prolapse, and second, a great number of patients did not answer
questions referred to anal incontinence. This point is another
weakness of the study and their results must be regarded with caution.
Other limitation in our series that should be corrected in the future is
the analysis of sexual quality of life.
Geller et al. [19,21] reported mean scores for the Pelvic Floor
Distress Inventory (PFDI), Pelvic Floor Impact Questionnaire
(PFIQ), and Pelvic Floor Prolapse/Urinary Incontinence Sexual
Questionnaire (PISQ) preoperatively and at 12-month follow up with
the following respective values: 117 vs. 38, 60 vs. 10, and 34 vs. 36.
Mourik et al. [22] used a Dutch variation of the Urinary Distress
Inventory and Incontinence Impact Questionnaire. In their study,
they reported an 88.1% satisfaction rate and 78.6% rate of sexual
activity at 6 weeks to 8 weeks postoperatively.
Paraiso et al. [23] reported average PFDI, PFIQ, and PISQ
scores preoperatively and at one year (128 vs. 44, 63 vs. 0, 20 vs. 16
respectively).
RASC is a safety and reproducible technique that has gained
popularity in the pelvic floor surgery. But it remains uncertain if it
provides any advantages comparing to laparoscopic approach. Geertje
et al. [24] performed a systematic review of 2 randomized controlled
trials comparing robotic and laparoscopic sacrocolpopexy reporting
that there were no differences in anatomical outcomes, pelvic floor
function, and quality of life. Costs for using the robot were
significantly higher in both studies (US$11,573 ± 3191 vs. RASC
US$19,616 ± 3135; p<0.001 and LSC US$ 14,342 ± 2941 vs. RASC
16,278 ± 3326; p=0.008 respectively). Though RASC may have other
benefits, such as reduction of the learning curve and increased
ergonomics or dexterity, these remain to be demonstrated. In
our opinion [25] and Jonk et al. [26] RASC provides an increased
ergonomics and dexterity with a shorter learning curve that allows
the possibility of performing highly complex surgery, so that patients
can benefit from this minimally invasive technique.
Conclusion
RASC is a safety technique with a low rate of complications and good anatomical results providing a significant improvement in QoL. High grade of Dindo-Clavien complications or recurrence were factors that influenced in QoL. Improvement in QoL must be a main objective and the use of validated questionnaires should be used as a routine in order of providing a good knowledge of our results. There is not a perfect validated questionnaire but in our centre, EPIQ questionnaire (Spanish validation) is a simple and easy to use questionnaire that provides useful information about the patients QoL situation.
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