da Vinci® Sacrocolpopexy for Vaginal Vault or Uterine Prolapse:

Lessons Learned Oz Harmanli, MD

Chief, Urogynecology and Pelvic Surgery

Baystate Medical CenterProfessor of OB/GYN

Tufts University School of Medicine

Massachusetts

Apical Prolapse

Any surgical correctionof the anterior and posterior walls will fail if the apex is not adequately supported

Vaginal apex is the keystone

Procedures for Apical Support

Sacral colpopexy

Sacrospinous ligament fixation

Utero-sacral ligament suspension

Ilio-coccygeus suspension

Vaginal mesh systems such as Prolift, Avaulta, Perigee/Apogee and etc.

Apical Prolapse SurgeryCochrane Database Analysis for abdominal sacral

colpopexy versus vaginal sacrospinous colpopexy3 trials (Benson 1996; Lo 1998; Maher 2004)Abdominal sacral colpopexy was better than vaginal

colpopexy in terms ofLower rate of apical recurrence (3/84 vs 13/85; RR 0.23,

95% CI 0.07 to 0.77)Higher success rate (The number of women failing to

improve to Stage 2 or better) (3/52 vs 13/66; RR 0.29, 95% CI 0.09 to 0.97)

Lower postoperative dyspareunia (7/45 vs 22/61; RR 0.39, 95% CI 0.18 to 0.86)

No significant difference in reoperation rate for prolapse (6/84 vs 14/85, RR 1.46, 95% CI 0.19 to 1.11)

Sacrospinous colpopexy was Quicker Cheaper Faster return to normal activities

The data were too few to assess other clinical outcomes and complications Maher et al. Neurourology and Urodynamics 2008

Sacral Colpopexy

Abdominal Sacral ColpopexyElevation of vaginal vault to Sacral 2

utilizing a mesh bridgeAbdominal, laparoscopic, or robotic

approachMay change the vaginal axis (if sacral

promontory is used)85-90% success rateMay be done with cervical preservation as

a cervicopexyMesh erosion around 3-5 %, higher with

concomitant hysterectomy

Nygaard, Obstet Gynecol 2004, Kohli , Obstet Gynecol 1998

All the benefits of standard laparoscopy

Tremor filtration Motion scaling 3D vision EndoWrist® instruments with 7

degrees of freedom 4th arm to perform traction and

retraction tasks Net result: Improved

technical capabilities

da Vinci Robotic Surgery Benefits

5 cm

1 cm

Patient BenefitsSame as Standard Laparoscopy

Less post-operative pain

Less blood loss Fewer transfusions Less risk of infection Less scarring Improved cosmesis Shorter hospital stay Faster recovery time Equivalent

urogynecologic outcomes

Surgeon Benefits Improved access to the

pelvis Easier, more precise

dissections Improved handling of

suture and mesh Easier, quicker and more

precise intracorporeal suturing

Control of camera and 3rd instrument arm adds precision, autonomy and efficiency

No short cuts just because it is minimally invasive surgery

Easier to learn, perform and teach

Surgeon Benefits

• Precise dissection• Intracorporeal suturing• Mesh handling• Graft attachment

When compared with open techniques, robotic abdominal sacrocolpopexy is associated with less blood loss, shorter lengths of stay, and longer operative times

Geller Obstet Gynecol 2008 McDermott Obstet Gynecol Clin North Am 2009

da Vinci Sacrocolpopexy: Proven Results

E.J. Geller et al. Short-Term Outcomes of Robotic Sacrocolpopexy Compared With

Abdominal Sacrocolpopexy. Obstetrics & Gynecology. 2008;112:1201–6

29.5%47.9%Concomitant Hysterectomy

+1+3Pre-op POP-Q Exam: C point*

Open (Abdominal)Sacrocolpopexy

N=105

RoboticSacrocolpopexy

N=73

0.02

0.002

P Value

2.71.3Length of Stay (days)

255103EBL (ml)

-8-9Post-op POP-Q Exam: C point*

<0.001

<0.001

0.008

225328Total Operative Time (min) <0.001

da Vinci Sacrocolpopexy: Proven Results

73 v 105 patients Higher POPQ values and more concomitant hysterectomies in the

robotic group Blood loss and length of stay in the robotic group C point suspension superior to open cohort results

Obstet Gynecol 2014Costs of robotic sacrocolpopexy are higher

than laparoscopicShort-term outcomes and complications are

similarPrimary cost differences resulted from robot

maintenance and purchase costs.

Robotic vs Standard Laparoscopic Sacrocolpopexy

Anger et al.

Systematic Review of Robotic Sacrocolpopexy

Hudson et al FPMRS 2014

13 studies were selected for the systematic review.

Meta-analysis yielded a combined estimated success rate of 98.6% (95%CI 97.0–100%)

The combined estimated rate of mesh exposure/erosion was 4.1% (95%CI 1.4–6.9%)

The rate of reoperation for mesh revision was 1.7%

The rates of reoperation for recurrent apical and non-apical prolapse were 0.8% and 2.5%

The most common surgical complication (excluding mesh erosion) was cystotomy

(2.8%), followed by wound infection (2.4%).

Systematic Review of Robotic Sacrocolpopexy

Hudson et al FPMRS 2014

Baystate Medical CenterTufts University School of MedicineMassachusettsOz Harmanli, MDKeisha Jones, MDBeril Yuksel, MDFaisal ElJehani, MD

Optimizing Operating Room Efficiency in Robotic Surgery

University of MassachusettsIsenberg School of ManagementMassachusettsSenay Solak, PhDArmagan Bayram, PhD

• This research was funded by an unrestricted educational grant

from Intuitive Surgical Inc.

To assess the critical threshold to optimize operating room time for each surgical team member in robotic sacrocolpopexy.

1. Evaluate the peak and plateau of the performances for each surgical team member

2. Determine the most optimal team configurations

Optimizing Operating Room Efficiency in Robotic Surgery

Objectives

Doctor 44 First Assistant 13 Anesthesia Provider 46 Scrub Technician 66 Circulating Nurse 56

Optimizing Operating Room Efficiency in Robotic Surgery

Optimal Experience Level

Descriptives

Davinci

N Mean Std.

Deviation

Std. Error 95% Confidence Interval for

Mean

Minimum Maximum

Lower Bound Upper Bound

1.00 62 176.8226 51.09442 6.48900 163.8470 189.7981 59.00 325.00

2.00 48 141.0833 44.75077 6.45922 128.0891 154.0776 18.00 259.00

3.00 210 109.4190 35.98811 2.48342 104.5233 114.3148 41.00 227.00

Total 320 127.2281 48.56474 2.71485 121.8868 132.5694 18.00 325.00

The Console Time of an inexperienced surgeon can be up to 1 hour longer

Console Time for Surgeon by Experience

Descriptives

Davinci

N Mean Std.

Deviation

Std. Error 95% Confidence Interval for

Mean

Minimum Maximum

Lower Bound Upper Bound

1.00 13 149.6923 74.59936 20.69014 104.6124 194.7722 66.00 325.00

2.00 14 133.2857 59.49975 15.90198 98.9316 167.6398 59.00 240.00

3.00 293 125.9420 46.52330 2.71792 120.5928 131.2912 18.00 295.00

Total 320 127.2281 48.56474 2.71485 121.8868 132.5694 18.00 325.00

While some difference (up to around 25 minutes) in average Console Times exists for FA with different experience levels, these time differences are not sufficient to claim a statistically significant distinction

First Assistant’s Experience Level and Console Time

Specifically, the impact of the shift change in the afternoon

Cases which start before 11am were significantly shorter than those that start after 11am

The average difference was 12 minutes

Does the Time of the Robotic Procedure Matter?

Effect of a highly experienced Anesthesia Provider on OR time and specifically surgery prep time was studied

No significant difference in total OR times (which may be due to the effects of other factors)

However, prep times was significantly different

The Role of a Dedicated Anesthesia Provider

The optimization tool can be used at a hospital to determine the `best’ surgical team assignments for any set of available team members with known experience levels

The Most Optimal Team Configurations Based on the

Stochastic Model

If a Surgeon has low experience, it is better to match him with more experienced First Assistant

If a Surgeon has high experience, it is fine to match him with less experienced First Assistant and Scrub Technician

If both the Surgeon and First Assistant are not as experienced it is better to match them with an experienced Scrub Technician

Practical Implications of the Stochastic Model

A low-experienced Scrub Tech should be matched with either a more-experienced Surgeon or First Assistant

We do not recommend to team up a low-experienced Surgeon, First Assistant, and Scrub Tech

If the anesthesia provider has more experience, it is fine to have a less experienced Circulating Nurse, however if anesthesia provider has less experience, it is best to match with a more experienced Circulating Nurse

Low-experienced Circulating Nurse should be teamed with an experienced Surgeon or vice versa

Practical Implications of the Stochastic Model