Robotic-assisted Hysterectomy: Single- vs. Multi-port Laparoscopic Access
Phase: NA
Conditions: Activity, Motor, Pain, Wound
Sponsor: Herning Hospital

 
1 
Robotic-assisted benign hysterectomy – learning curve 
for surgeons and a randomized comparison of robotic 
single-site hysterectomy vs. multi-port laparoscopic 
hysterectomy 
 
Background: 
Robotic-assisted surgery in gynecology is one of the fastest growing fields of robotic 
surgery. In Denmark yearly 4000 hysterectomies are performed on benign indications (1) 
and minimal invasive technique used in hysterectomies has increased from 35 % to 80 %. 
These include vaginal, laparoscopic assisted and lately robotic-assisted hysterectomy 
The robotic surgical system Da Vinci was introduced in 2000. By 2016, 3803 units were 
established worldwide and 644 of them in Europe. Hysterectomy and prostatectomy is by 
far the most common operations performed with the Da Vinci robot Robotic-assisted 
surgery is an alternative to conventional laparoscopy allowing better ergonomy for the 
surgeon  and precise movements due to endo-wristed  instruments.   
Robotic surgery in benign gynecology is still a matter of debate, due to expensive costs 
and lack of evidence of superiority to conventional laparoscopy regarding perisurgical 
outcome. 
 
A new approach in hysterectomy is the robotic single-site technique (R-SS), 
which is based on one single incision compared to standard four incisions in multiport 
robotic- as well as conventional laparoscopy.  This wound-sparring technique may reduce 
postoperative pain, allowing shorter hospitalization, shorter sick leave and better 
cosmesis. Since fast-track regimes are gaining ground in gynecology there is a need for 
detailed information about the new surgical technique, especially whether it can replace 
conventional multiport laparoscopy.  
 
Determination of learning curves for a novel surgical technique like the robot 
provides valuable information regarding safety as well as applicability. For these reasons 
proper knowledge is important to which extent e.g. BMI, uterine size, and docking time at 
the robotic console influence the procedure. Secondly, the proper patient selection could 
be established for the various surgical options. To date, there are no detailed reports on 
robotic single-site hysterectomy using the newest robotic technology, the da Vinci, Xi 
system. 
 
Multi-port versus Single-site in laparoscopic surgery  
The advantage of laparoscopic hysterectomy compared to abdominal hysterectomy is 
associated to the lack of large abdominal wound, resulting in shortened hospitalization, 
faster postoperative recovery, and less postoperative pain(1) (Aarts, Nieboer et al. 2015) 
However, multiport laparoscopy is not without risks. A laparoscopic hysterectomy requires 
4 trocar incisions, including muscles-splitting incisions. Reports suggest a 5% risk of 
neuropathic pain, as well as increased risk of infection and hernia at the trocar site (2) 
(Shin and Howard 2012). 
 
In an attempt to improve the benefits of laparoscopic surgery, such as 
minimizing wound lesions as well as optimizing cosmetic results, the laparoscopic single-
site technique was developed. This technique is based on one single multichannel device 

 
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placed through a 2 cm, relatively hidden, peri-umbilical skin incision. The device allows 
optics and multiple instruments access to the abdomen (Fig.1). A recent randomized study 
showed less bleeding (median 20 vs 50 ml) in robotic single port compared to laparoscopic 
multiport hysterectomy (3)(Paek et al 2016). In the largest randomized study to date Kim et 
al found transfusions rates were the most frequent complication required in 4.0% of single-
port cases and 7.9% of multiport cases (3a) (Kim et al 2015). A review and metaanalysis 
comparing laparoscopic single-site with conventional multiport laparoscopic hysterectomy 
found that laparoscopic single-site was feasible and safe (4) (Sandberg, la Chapelle et al. 
2017). There was no significant difference between the two techniques regarding 
complication rate, conversion risk and postoperative pain. However, the quality of 
evidence in the studies was low and various other observations like cosmesis was not 
consistently established.  
Women’s expectations; surgical safety and cosmesis 
Surgical safety and cosmesis are important considerations for patients undergoing 
laparoscopy. A study by Golkar et al. (5)showed that preoperatively patients were mostly 
concerned about the surgical safety but, postoperatively, the patients mainly focused on 
the cosmetic result Another prospective comparative study showed that the laparoscopic 
single-site incision was the preferred abdominal incision judged by questionnaire 
(6)(Yeung et al. 2013). Thus, there is a need for constantly improving and developing the 
end-points of care in our minimal invasive techniques.  
 
Economic issues 
Cost-analysis on R-SS compared to laparoscopic multiport hysterectomy in benign 
gynecology has a knowledge gap. A retrospective study suggests increased cost per case 
using R-SS compared to laparoscopic multiport hysterectomy (7)(El Hachem et al. 2016). 
A variety of circumstances influences the analyses such as already established 
infrastructure for robotic surgery at the hospital, high volume versus low volume robotic 
centers and experienced robotic teams. Cost-effectiveness analyses are essential in order 
to provide a responsible utilization of health care resources and includes determination on 
sick-leave, consultation to healthcare (ex kontakt I amb ell e.l. pga kir.relaterede 
problemstilling). If out-of-hospital costs are included these may vary between countries; 
however, the phase between hospital stay and return to work may imply extra cost for the 
patient, need for reimbursement from health insurances, visits to medical professionals 
due to related morbidity a.s.o. If rehabilitation with RSS is shorter and includes less extra 
medical cost and visits the total cost may be less. 
 
Summary: 
R-SS hysterectomy is a novel technique, which may be superior to conventional 
laparoscopic multiport hysterectomy in select patients regarding sick-leave, cosmesis and 
and postoperative pain. We, therefore, aimed at evaluating the learning curve using 
different robotic equipment (DaVinci Si Multiport  surgical system and Davinci Xi  multiport 
and single site surgical system) in our cohort since 2014 to determine its applicability in 
our hospital setting. Secondly, we perform a randomized trial to compare R-SS 
hysterectomy with conventional laparoscopic multiport hysterectomy with regard to 
outcome postoperative rehabilitation, cosmesis,  and the operational cost 
 
 
 

 
3 
Aim of study 
Our study aims to evaluate R-SS with respect to:  
 
Primary outcome: 
 Length of hospital stay and time to return to daily activities /work 
 Cosmesis; pre-and postoperative evaluation 
 Postoperative pain (VAS) 
 
Secondary outcome 
 Learning curve for robotic-assisted hysterectomy including R-SS hysterectomy 
 Patient satisfaction with the cosmesis   
 Duration of operation incl. detailed information of time consumption of defined steps 
at hysterectomy, operation- and console time, blood loss, conversion rates, 
additional ports, port-site hernias, time at hospital, re-admission  
 Cost-effectiveness analysis for the R-SS hysterectomy 
  
 
 
 

 
4 
Materials and Methods 
 
Study 1: 
Detailed learning curves for robotic surgery- single site and multiport hysterectomy – a 
prospective, controlled study. A retrospective study of all robotic hysterectomy since 2014 
 
The prospective controlled study compares R-SSH with robotic multiport hysterectomy (the 
controls) and will be performed at the Department of Gynecology, Herning Hospital, 
between September 2016 to end of December 2017. Sample size is estimated based on 
recommendations from the literature (8)(Cala V. et al. 2012). The study consists of two 
sub-studies (A and B). Each of the two sub-studies includes 40 procedures performed by 
two experienced laparoscopists with 20 procedures each. 
A: Determination of learning curve for two similar experienced surgeons, for 40 robotic 
multiport hysterectomies – 20 hysterectomies per surgeon. 
Inclusion criteria for the learning curve studies are hysterectomy on benign indication, ASA 
group 1 or 2, BMI (body mass in kg/heights in metres2) less than 35 kg/m2 (for R-SS 
hysterectomy less than 30), uterine size less than 300 g estimated by ultrasound, using 
Ferraris formula. 
Exclusion criteria are risk of adhesions, prior extensive abdominal surgery and prior 
midline incision, cutis laxa of abdomen surgery, endometriosis, and more than 1 cesarean 
section.  
The procedure is video recorded and peri-and postoperative data are collected 
prospectively. Various steps during the procedure are determined such as various split 
time measurements like docking time, console time, vaginal cuff suturing, incision start, 
skin-to-skin and closure time.  Uterine size and blood loss, as well as patient demographic 
data are registered. 
 
B. The on-going study estimates the learning curve for R-SS hysterectomy. In- and 
exclusion criteria as for Study 1 except for inclusion criteria of BMI less than 30 kg/m2 
 
C. Further, a retrospective cohort from the first robotic hysterectomies in 2014 until 
recently will be evaluated. The surgeries in the prospective studies are performed using 
the Da Vinci Xi surgical system and in the retrospective study using the Da Vinci Si 
Multiport system. Due to its design only crude incidences on perioperative variables will be 
evaluated. 
 
Study 2 
Robotic single-site hysterectomy compared to laparoscopic multiport hysterectomy – a 
prospective randomized controlled study; cosmetic satisfaction and surgical outcome. 
 
The study is scheduled to start May 2018 and compares R-SS hysterectomy to 
laparoscopic multiport hysterectomy.  Procedures are performed by an experienced three-
surgeon team. Patients are randomized to either laparoscopic multiport hysterectomy 
(N=62) or R-SS hysterectomy (N=62) by random numbers in sealed envelopes prepared 
by a third party. Eligibility criteria are the same as for study 2B (i.e. BMI < 30 kg/m2). 
Patient's satisfaction with body image and cosmesis is assessed at different time points 
pre- and postoperatively by means of multidimensional body-self relations questionnaire – 
appearance evaluation sub-scale and POSAS. Postoperative pain and analgesia use will 

 
5 
be registered as well as secondary outcome parameters as described above. A follow-up 
at one, three, and six month include self evaluation of the scar and registration of port-site 
hernias, vaginal dehiscence or other complications (Vercellia et al).  Interviews and diaries 
will include time of return to home and work, daily activities including sexuality 
The R-SS hysterectomy is performed using da Vinci, Xi robotic system. One single port, 
diameter 2 cm is applied at the umbilicus. Applying an additional assistant port is defined 
as conversion of procedure 
The laparoscopic multiport hysterectomy is performed using our standard equipment and 4 
trocars, 5 mm each. 
 
Study 3 
Socio-economical consequences of R-SS hysterectomy versus conventional laparoscopic 
hysterectomy 
 
Study details in preparation 
Instrumental cost 
Hospital stay 
Post-hopsitalization cost. sick days, extra visits to the out-aptient clinic, genereal 
practioner, medical expenses 
 
 
 
Sample size calculation was based a PhD- study on fast track hysterectomy, which 
showed a difference in return to work of 4 days and SD ±8. 62 women in each group are 
needed for a power of 80% (beta=0.2) to replicate this study. To include those not working, 
we calculated that with an expected VAS of 0.86 ±0.2 and 62 in each group the sample 
was sufficient to detect of difference of 0.1 in VAS; still, with a power of 80%. All 
calculations are based on two-sided testing with alpha = 0.05. 
The retrospective study was approved by the Data Authority (no. 1-16-02-913-17). The 
randomized trial is registered at clinicaltrials.gov (NHS). 
 
 
Statistics 
 
For statistical calculations of proportions the 2-test with Yates’ correction for discontinuity 
or the Fisher’s Exact-test was used. For continuous variables Student’s t-test, Mann-
Whitney’s U –test, and Wilcoxon’s Signed Rank test was used when appropriate. 
Questionnaires with partial answers were included in the calculations, if possible. ANOVA 
and Kruskal Wallis' test was performed between group variables. Post-hoc test with 
Newman-Keul’s test was performed between group pairs, if ANOVA was significant. 
Repeated measurements were evaluated with 2-way ANOVA and surgical procedure as 
group variable with potential confounding variables like age, BMI, surgeon, and additional 
surgery added. The distribution of BMI, age, blood loss, split times during operation, 
hospital stay and time of return to daily activities and work were evaluated by means of 
Kaplan-Meyer analysis. The level of significance was a two-sided p < 0.05. Logistics 
regression analysis was performed with surgical procedure as dependent variable and the 
various split times, surgeon, age, BMI, parity, as independent variables. Learning curves 
were established for each individual surgeon, surgical procedures, and combined 

 
6 
monitored over time of the studies. Data are given as mean ±SD if following Gaussian 
distribution and median (minimum, maximum) if non-Gaussian distributed. IBM SPSS 
Statistics 20 was used as the statistical software 
 
 
.. 
Research plan 
 
Study 1; jan 2017-june  2018 
Study 2; may. 2018-jan. 2020 
Study 3; 2020-2021 
 
 

 
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Responsibility: 
 
Finn Friis Lauszus, MD, Assistant Professor, Ph.D. Department of Gynecology and 
Obstetrics, Herning Hospital, Principal data supervisor and investigator for clinicaltrials.gov 
Helene Nortvig, MD, Ph.D. Department of Gynecology and Obstetrics, Herning Hospital 
 
References 
 
El Hachem, L., et al. (2016). "Robotic Single-Site and Conventional Laparoscopic Surgery 
in Gynecology: Clinical Outcomes and Cost Analysis of a Matched Case-Control Study." J 
Minim Invasive Gynecol 23(5): 760-768. 
 
 
Golkar, F. C., et al. (2012). "Patients' perceptions of laparoendoscopic single-site surgery: 
the cosmetic effect." Am J Surg 204(5): 751-761. 
 
 
Sandberg, E. M., et al. (2017). "Laparoendoscopic single-site surgery versus conventional 
laparoscopy for hysterectomy: a systematic review and meta-analysis." Arch Gynecol 
Obstet 295(5): 1089-1103. 
 
  
Shin, J. H. and F. M. Howard (2012). "Abdominal wall nerve injury during laparoscopic 
gynecologic surgery: incidence, risk factors, and treatment outcomes." J Minim Invasive 
Gynecol 19(4): 448-453. 
 
e. 
Yeung, P. P., Jr., et al. (2013). "Patient preferences of cosmesis for abdominal incisions in 
gynecologic surgery." J Minim Invasive Gynecol 20(1): 79-84. 
 
 
Aarts, J. W., et al. (2015). "Surgical approach to hysterectomy for benign gynaecological 
disease." Cochrane Database Syst Rev(8): Cd003677. 
 
 
Paek J, Lee JD, Kong TW, Chang SJ, Ryu HS. Robotic single-site versus 
laparoendoscopic single-site hysterectomy: a propensity score matching study. Surg 
Endosc. 2016 Mar;30(3):1043-50. doi: 10.1007/s00464-015-4292-9. 
 
3a Kim TJ, Shin SJ, Kim TH, et al. Multi-institution, Prospective, Randomized Trial to 
Compare the Success Rates of Single-port Versus Multiport Laparoscopic Hysterectomy 
for the Treatment of Uterine Myoma or Adenomyosis. J Minim Invasive 
Gynecol. 2015;22(5):785–91. 10.1016/j.jmig.2015.02.022 
 
Cela V, Freschi L, Simi G, Ruggiero M, Tana R, Pluchino N. Robotic single-site 
hysterectomy: feasibility, learning curve and surgical outcome.Surg Endosc. 2013 
Jul;27(7):2638-43. doi: 10.1007/s00464-012-2780-8. 
 
Vercellia S, Ferrieroa G, Sartorioa F, Cisarib C, Bravini E. Clinimetric properties and 
clinical utility in rehabilitation of postsurgical scar rating scales: a systematic review  
 
 
 
 
 

 
8 
Figure 1 
 
 Single-site device                                      Da Vinci Si system 
 
 

 
9 
References 
 
1. 
Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, et al. Surgical 
approach to hysterectomy for benign gynaecological disease. The Cochrane database of 
systematic reviews. 2015(8):Cd003677. 
2. 
Shin JH, Howard FM. Abdominal wall nerve injury during laparoscopic 
gynecologic surgery: incidence, risk factors, and treatment outcomes. Journal of minimally 
invasive gynecology. 2012;19(4):448-53. 
3. 
Paek J, Lee JD, Kong TW, Chang SJ, Ryu HS. Robotic single-site versus 
laparoendoscopic single-site hysterectomy: a propensity score matching study. Surgical 
endoscopy. 2016;30(3):1043-50.  
3a  
Kim TJ, Shin SJ, Kim TH, et al. Multi-institution, Prospective, Randomized Trial to 
Compare the Success Rates of Single-port Versus Multiport Laparoscopic Hysterectomy for 
the Treatment of Uterine Myoma or Adenomyosis. J Minim Invasive Gynecol. 2015;22(5):785–
91. 10.1016/j.jmig.2015.02.022 
4. 
Sandberg EM, la Chapelle CF, van den Tweel MM, Schoones JW, Jansen FW. 
Laparoendoscopic single-site surgery versus conventional laparoscopy for hysterectomy: a 
systematic review and meta-analysis. Archives of gynecology and obstetrics. 
2017;295(5):1089-103. 
5. 
Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, et al. Patients' 
perceptions of laparoendoscopic single-site surgery: the cosmetic effect. American journal of 
surgery. 2012;204(5):751-61. 
6. 
Yeung PP, Jr., Bolden CR, Westreich D, Sobolewski C. Patient preferences of 
cosmesis for abdominal incisions in gynecologic surgery. Journal of minimally invasive 
gynecology. 2013;20(1):79-84. 
7. 
El Hachem L, Andikyan V, Mathews S, Friedman K, Poeran J, Shieh K, et al. Robotic 
Single-Site and Conventional Laparoscopic Surgery in Gynecology: Clinical Outcomes and Cost 
Analysis of a Matched Case-Control Study. Journal of minimally invasive gynecology. 
2016;23(5):760-8. 
8. 
Cela V, Freschi L, Simi G, Ruggiero M, Tana R, Pluchino N. Robotic single-site 
hysterectomy: feasibility, learning curve and surgical outcome. Surgical endoscopy. 
2013;27(7):2638-43. 
9.  
Vercellia S, Ferrieroa G, Sartorioa F, Cisarib C, Bravini E. Clinimetric properties 
and clinical utility in rehabilitation of postsurgical scar rating scales: a systematic review 
  
Formateret: Dansk