Debate

Laparoscopy vs Robotic
In Gynec Oncology
Dr.Reba
Dr.Niraj
Moderator:Dr.Rema, Dr. Akhil
Laparoscopy in gynecological
cancers
Lap in Ca Em
Evolution of surgical approach in Ca Em

● 1987 : GOG 33 Trial

● 1988 : FIGO changes from clinical to comprehensive surgical staging
● 1990s : use of MIS to replicate comprehensive surgical staging of
endometrial cancer. Adequacy and safety demonstrated in small
single-institution studies by Dargent, Querleu et al, Childers et al
● 2012 : LAP2 Trial
● 2017 : LACE Trial
● 2021 : EEE guidelines: ‘ MIS is the preferred sx approach in early
stage ca em including HR ca’
ESGO Guidelines 2021
Standard sx procedure in ca em:

● TH(Simple or Extrafascial hysterectomy)+ BSO without vaginal cuff excision

● Infracolic omentectomy- clinically stage I serous ca, carcinosarcoma &
undifferentiated
● LN staging: SLNB or systematic LND
ESGO Guidelines 2021
Apparent Stage I/II Ca Em

● MIS - preferred sx approach, including HR cases

● Intraperitoneal tr spillage, tr rupture, morcellation - AVOIDED
● Vaginal extraction risks rupture → minilap/ endobag
● Relative C/I - Mets outside uterus and cx excluding LN mets
Benefits of LAP over open
● Superior QOL
● Faster recovery
● Fewer complications
● Less pain
● Reduced hospital stay
● Decreased blood loss
● smaller incisions
● limited reduction of postoperative mobility
Evidence of Lap in Ca Em
● Aim: Laparoscopy versus laparotomy
○ 6-week morbidity and mortality,
○ hospital length of stay
○ conversion rates, RFS, site of recurrence, and QoL.
● Stage I to IIA uterine cancer: Laparoscopy (n = 1,696) or laparotomy
(n = 920)
Results

● Similar rates of intraop complications

● Post op adverse events decreased in lap (14% vs 21%)
● Hospitalisation > 2 days lower in lap (52%vs 94%)
● 3-year recurrence rate of 11.4% with laparoscopy and 10.2% with
laparotomy,
● 5-year overall survival was almost identical in both arms at 89.8%.
Conclusion

Lap: feasible and safe

● Improved short-term outcomes

● fewer complications
● shorter hospital stay.
● Aim: Whether TLH is equivalent to TAH in women with endometrial cancer.
● Multinational, randomized equivalence trial
● Randomly assigned to TAH (n = 353) or TLH (n = 407).
 Results

● Improvements in QoL up to 6 months after surgery in TLH arm

● Postoperative serious adverse events: lesser in TLH group -7.9% vs TAH
group -19.0% (p=0.002)
Results

No statistically significant between-group difference in

● DFS was 81.3% in the TAH group and 81.6% in the TLH group.
● recurrence rate of endometrial cancer : TAH group 7.9% vs TLH group 8.1%
● OS in TAH group 6.8% vs TLH group 7.4%
Conclusion:

● Equivalent DFS at 4.5 years and no difference in OS in both groups

● Improved QoL & adverse event profile in TLH group
● Supports use of lap hysterectomy for stage I endometrial cancer
Laparoscopy in Ca Cervix
Early carcinoma Cervix

Radical hysterectomy with pelvic lymphadenectomy :the

standard of care
NCCN guidelines
Extrafascial hysterectomy -

➤ IA1 with no LVSI,

➤ IA2 and IB1 with no LVSI and Tm size </=2 cm and meeting other conservative
surgery criteria

Modified radical hysterectomy -

➤ IA1,IA2 with LVSI

Radical hysterectomy -

➤ Stage IB1 not meeting conservative surgery criteria

➤ Stage IB2

➤ Stage IIA1
Evolution of sx approach
● 1898 : Dr. Ernst Wertheim performed the first radical abdominal
hysterectomy for cervical cancer
● 1987 : Laparoscopic LND + Radical VH by Dargent - introduced Lap in gyne
oncology
● 1992 : Lap RH first described by Nezhat et al, LRH introduced in many
centres
● 2002: Spirtos et al : adequate DFS & OS of LRH with acceptable morbidity
● 2018: LACC trial
● Phase 3, multicenter, randomized trial
● To evaluate whether MIS was non inferior to open RH in cervical cancer
● Primary outcome-disease-free interval at 4.5 years after surgery
● Secondary outcome -recurrence rates and OS

LACC Trial,NEJM,2018
● Patients with Stage 1A1 (LVSI+),1A2,1B1(Tumour size <4cm) & ECOG 0-1
● Type 2 or 3 RH
● Closed prematurely: Higher death rate
● 631 /740 patients
 LACC Trial
631 patients with Stage IA, IA2, IB, CA Cervix

TLH n=407 TAH n= 353

(Lap: 84.4% + Robotic 15.6%)

4.5 years
DFS(4.5 yrs) 86% diff-10.6 96.5% Diff -16.4 to -7
p0.87

3 Year DFS 91.2% 97.1%

Hazard ratio for 3.74

recurrence/death

3 year OS 93.8% 99%

● Results were consistent in robot assisted surgery group and lap surgery
group
● Potential reasons for inferior oncological outcome in MIS
group
○ Routine use of uterine manipulator ⇒ increase tumour spillage
○ Effect of insufflation gas on tumour cell growth/spread
Conclusion
● Minimally invasive RH,when compared to open in patients with Ca Cervix
was asso with
○ higher rate of recurrence
○ lower rate of DFS
○ Lower OS
● The results of this trial cannot be generalized to patients with “low-risk”
cervical cancer (tumor size <2 cm; no LVSI; depth of invasion, <10 mm; and
no lymph-node involvement)
Trends of RH - Post LACC Trial
● MIS(Lap/Robotic RH) Vs Abdominal RH in patients with Figo 2009 Stage 1B1
Ca Cervix
● Primary endpoint-DFS at 4.5years
● The secondary endpoints -
○ overall survival at 4.5 years
○ to explore the association between specific surgical maneuvers and the
risk of relapse.
● Inverse probability weighting-statistical tool used to avoid bias
● Patients with Stage 1B1 cervical cancer who underwent MIS/Open Type B/C
RH with bilateral pelvic lymphadenectomy

● Prior conisation → excluded from analysis→ missing pathological

information like size of tumour,stage
 SUCCOR STUDY
693 patients with Cervix Stage IB

291 underwent MIS 402 underwent Open Surgery

Relapses 20.6% 11.7%

Disease free survival 79% 89% P=0.003

Hazard ratio for recurrence 2.09 (0.79 - 3.4)

P=0.0001

Overall survival 89% 97% P=0.014

Hazard ratio for death 2.42 (1.34 - 4.9)

P=0.004

These differences were significant in patients with tumor > 2cm

 Impact of Uterine Manipulator in MIS for CA Cervix
652 patients with CA Cervix

Open MIS without MIS with Manipulator

n= 402 Manipulator n=106 n =144

Relapses 11.7% 16% 26.3%

Disease free survival 89% 83% 73%

Hazard ratio for recurrence 2.76 (1.75 - 4.3)

P<0.001

Hazard ratio for death 3 (1.6 - 5.6)

P=0.001
● The adverse effect of uterine manipulator significantly impacted patients
with tumour size>2cm
● Patients who underwent MIS without uterine manipulator had similar
relapse to those who underwent open surgery
 Protective Vaginal Closure in MIS

Open MIS without MIS with protective

Surgery protective vaginal closure
vaginal closure

Relapses 11.7% 25% 7%

Disease free survival 89% 74% 93% P<0.001

Hazard ratio for recurrence 2.58 (1.7 - 3.9)

P<0.001

Hazard ratio for death 2.85

Conclusions:

● MIS was associated with significantly worse oncologic

outcomes than open surgery.
● Avoiding the uterine manipulator and a meticulous
closure of the vagina over the tumor to prevent tumor
spillage may improve the outcomes of MIS
Robotics in Gyne oncology
Introduction

● Original intention of robotic surgery -- conduct a surgical procedure

from a remote distance without touching the patient
○ Arthrobot -- 1st surgical robot (ortho positioning)
○ Unimation Puma 200 -- brain bx
○ AESOP
○ Zeus
○ Da Vinci
INTRODUCTION

● Intuitive Surgicals combined 2 evolutionary trends in surgery-

Laparoscopy & Telepresence surgery

● FDA clearance for the da Vinci System - 2000 (for Gen Sx initially)
○ Gynec malignancies in 2005
Benefits of Robotic surgery
● 7-degree freedom in instrumental range of motion
● 3D stereoscopic immersion optics
● wristed refined instrumentation allowing for scaled (1:3) delicate
movements
● smooth movements with tremor reduction
● improved surgeon comfort and reduced fatigue
● natural hand - eye coordination
THE ENDOWRIST DESIGN

● Most instruments have

articulated wrist mechanism to
allow dexterous and intuitive
tissue interaction
● EndoWrist is the trade name for
these articulated instruments
HIGH DEFINITION 3-D VIDEO →

Allows surgeons to see tissue similar to an open operation, and also

magnifies the tissue

Ability to scale motion and filter physiologic tremor →

Enhances the surgeon’s precision during fine dissection or suturing

IS MIS GOOD IN GYNECOLOGICAL ONCOLOGY ?
ROBOTIC SURGERY IN ENDOMETRIAL CARCINOMA - WORKHORSE
FOR MIS
● 51 studies-- 10,800 pts -- early stage EC
● Conversion rates
○ Similar btw LH & RH, in BMI >30 kg/m2,
○ 7.0% vs 3.8% , LH Vs RH BMI >40 kg/m2.
● Intolerance of Trendelenburg position caused 31% of LH and 6% of RH
conversions(lesser)
RS vs LPS
Decrease the estimated blood loss, the incidence of intraoperative
complications, the length of hospital stay, and the rate of conversion, and
increased the rate of readmission.
● In with EC and obesity, LH and RH have similar rates of conversion
○ and periop complications
● In BMI>40 ,RH may offer benefit specifically by reducing conversions
because of positional intolerance
● RCTs required
● Less conversion
● Shorter OT
● Robotic surgery → significant lower blood loss and 24-h pain score vs Laparoscopy
and Laparotomy ;

● showed favorable short-term outcomes with comparable survival.


● n=101, Robotic-assisted lap
Vs traditional lap
● Primary outcome - operation
time
● Secondary outcome - total
time spent in the operating
room, and surgical outcome
(LN harvested, complications,
recovery)
●
● Robotic- assisted
laparoscopic surgery
● faster to perform
● Surgical outcome similar
● Effective and safe
alternative in the surgical
Rx of EC
ROBOTIC SURGERY IN CA CERVIX

● Radical hysterectomy → standard of care early Ca cervix

○ 5-year overall survival rates greater than 80%
● RH → a complex surgery to perform and teach
● The first robotic-assisted RH was reported in 2005
○ prompted the beginning of a trend toward increasing usage of
the robotic platform
● Faster learning curve

● Easy transition of open surgery experience to Robotic

● Easy anatomical dissection

● Easy development of pelvic spaces

● Easy to dissect vessels, nerves, and to tailor radicality

● Greater precision and improved visualization seen with robotics,

may help in improvement in margin status
CRITICISM OF LACC
● Inability to generalize the results to ’low risk’ Ca cx including tumors
<2 cm due to the trial being under-powered

● The key elements in robotic sx - improved visualization, depth

perception with 3D, efficiency in suturing, precise dissections were
not accounted for during the study period

● Only 16% of patients underwent RRH

○ therefore the extrapolation of data is difficult to interpret
10 (3.5%) conversion in LACC (All from Laparoscopy group).

Reasons :- MC - poor visualization (5 patients) and prolonged operative time (2

patients)
Population-based data on all Danish women with early-stage CC, who
underwent radical hysterectomy January 1st 2005 - June 30th 2017

n - 1125

530 pts undergone Sx before Robotic MIS introduction

595 pts Sx after Robotic MIS introduction

5-yr rate of recurrence - 8.2% vs 6.3% (p - 0.55)

5-yr DFS, hazard ratio (HR) 1.23

No difference in site of recurrence

The cumulative cancer-specific survival was 94.1% and 95.9%

864 women (236 open and 628 robotic)

5-yr OS - 92% and 94% and

DFS was 84% and 88%

The recurrence pattern → similar in both groups

No difference in recurrence rate and survival

 Robotic Open P value
RH=109 RH=202

Complications 9% 23% 0.002

Blood 0 4% <0.001
transfusion

3 year PFS 89.9% 89.1% 0.14 ● Robotic RH - Lesser complications

○ Lesser transfusions
3 year OS 97.2% 95% 0.96
○ Similar recurrences
○ Similar 3 year PFS & OS
● Results were consistent in robotic and lap group

● Potential reasons for inferior oncological outcome in MIS group

○ Routine use of uterine manipulator
○ Effect of insufflation gas on tumour cell growth/spread
● Conclusion: MIS RH in Ca Cervix was asso with
○ higher recurrence
○ lower DFS & OS

● Cannot be generalized to pts with “low-risk” Ca Cx(size <2 cm; no

LVSI ; depth of invasion <10 mm; and no LN involvement)
Retrospective study
To assess 5-yr survival outcomes patients who underwent an,ORH, RRH
or LRH for ca cervix
Conclusion → irrespective of operative approach, patients who
underwent a RH for early stage cervical cancer attained similar 5-year
DFS and OS.
The use of uterine manipulator is not allowed, and the closure of the vagina before
colpotomy is recommended but not mandatory
Given the potential benefit of MIS, the ROCC trial seeks to address the
limitations of the LACC trial
Multicentric, Prospective, RCT, non-inferiority trial.
Primary objective - 3 year DFS
Secondary objective - OS, patterns of recurrence, peri- and
postoperative complications, long-term morbidity, development of
lower extremity lymphedema
FIGO 2018 stage IA2-IB2.
Use of transcervical uterine manipulators is not allowed
Proper tumor containment is required.
Photographic evidence of specimen with tumor contained is mandated.
●
●
●
● RCT
● 203 pts with EC or OC, randomized to extraperitoneal or
transperitoneal PALND using a minimally invasive approach (either
lap or robot)
● extraperitoneal robot-assisted PALND a/w lesser complications
DIFFICULTY IN SHOWING SUPERIORITY WITH ROBOTICS
For Laproscopy: Rebuttal
2D vs 3D Imaging

● 3D superior to 2D only in some aspects ( adhesions, RP neural structures)

● Did not apply to blood vessels, ureters, uterus and ovaries
2D vs 3D Imaging

● Why is it still not widespread?

● Principle of stereoscopy: creates an illusion of
depth to an otherwise flat image by mimicking
the real world.
● Geometric knowledge & depth perception-
better but not perfect
Ergonomic position
Restricted movement
● Restricted positioning and movement of OR personal

● Restricted access to patient due to bulk of equipment being set over patient
Ability to access confined anatomic spaces in lap
● Inguinal space, sacral roots, vesicouterine and vesicovaginal ligaments,
inferior hypogastric plexus - difficult to access areas
● All accessible for an experienced lap surgeon
Clinical limitations of Robotic surgery
● No clinical evidence of superiority to std laparoscopy
● Increased operative time: preparing the device, docking, exchange
instruments
● Require large operating room space
● Require good patient side assistant
● Not cost effective
Advantages of Lap over robotic

● Direct connection to intra abdominal situs - crucial in case of complications

● Haptic feeling- tactile sensation of structures
● No wasted operative time by preparing the device, docking, exchange
instruments
● Doesn't require special trained or personal
2,464 women: 1,027 (41.7%) underwent lap hysterectomy and 1,437 (58.3%) robotic
hysterectomy
no significant differences in the rates of
● intraoperative complications
● surgical site complications
● medical complications
● prolonged hospitalization.

The mean cost for robotic hysterectomy was $10,618 versus $8,996 for
laparoscopic hysterectomy (P < .001)
Surgeons equally proficient in both approaches
Conclusion

RL had No difference in terms of

● severe morbidity <6m

● Conversion rates
● Transfusion rate
● Overall survival rates

RL Longer operating time (190mins Vs 145mins)

Surgeon’s perspective
2020 paper: no patient advantage

2023 paper : objective ergonomic advantage

● 1087 morbidly obese (BMI ≥40kg/m(2)) endometrial cancer patients

● In morbidly obese Em ca patients, MI robotic or lap surgeries associated

with fewer complications and less days of hospitalization c/w open surgery.

● Robotic → comparable rates of complications but higher charges c/w lap

Skilled laparoscopy in obese em ca patients
● Adapted placement of trocar
● Additional trocar
● Pelvic LND→ Suspension of sigmoid
colon
● Para aortic LND → Extra peritoneal
approach
● Trainees with laparoscopic training performed better on a robotic simulator
than trainees without laparoscopic training
● Suggest transference of skills from laparoscopic to robotic surgery
SLN: role in reducing conversions
● Reduces need for comprehensive
pelvic LND - in em & cx ca

● Reduced need for aortic LND

RA-MIS associated poorer RFS, OS &
DSS
Coming back to LACC Trial..
Would the results have changed with the use of only robot in MIS Arm?

In the MIS arm, 4.5yr survival was 86% in robotic group & 96% in laparoscopic
group.
To conclude..
● Only demonstrated benefit of robotic assistance is not for patients but for
surgeons.
● This demands a reassessment of the cost–benefit balance of robotic
assistance.
● Comfort does not automatically improve performance
● Use of SLN and decreasing radicality of hysterectomy make lap more feasible
● Suspicion of adverse oncological events for robotic in ca em
● Use of robot in morbidly obese makes sense but should be documented by
level 1 Evidence
To conclude..
● Training in both lap n robotic mandatory
● In the Robotic Era it's still impossible to skip lap training
● Lap Training should not be sacrificed in gyne oncology divisions
Rs 50/–
For robotic : Rebuttal
 ROBO GYN 1004 TRIAL LIMITATIONS
1) Robotic surgery experience was insufficient.

2) Robot-assisted surgery → new approach → surgeons → more careful in reporting

morbidities in this treatment group

3) Non Superiority of robotics → poorly cited, most probably because its results are
not in line with the current trend.
RCT BY Minna M. Mäenpää
Operative time and conversion rate as primary outcome.

Rest were secondary endpoints; study was not powered to investigate these.
Lack of information on surgeon subspecialty and years of experience

Lack of data on tumor stage and details of preoperative comorbid conditions,

which may influence the surgeon's choice of procedure type.

Do not have information regarding re-hospitalizations or long-term complications

resulting from surgery
Posture during Lap → challenging for all body parts except the back.

Increase in discomfort over time (up to 4 h) for the hands and arms, neck, and
legs in Lap .

Perceived physical activity, effort and abilities were rated higher in Lap.

Better results of robotics, even in average BMI pts

used novice medical students, which may have been the reason for significant
results.

Voluntary nature of this study could introduce a selection bias as it likely only
enrolled medical students interested in surgery
Single institution design may affect the generalizability of the results

only 10 sessions were performed in each modality, it is difficult to infer

much from their learning curves
WOULD WE SEE THIS IF ROBOTICS WAS INFERIOR TO LAP ????
COST vs BENEFITS (ROBOTICS)
LIMITATIONS OF LAPAROSCOPY
● Fixed fulcrum of the trocar combined with straight instruments

● Long learning curve

● Video predominantly 2D and flat view make lap approaches and

visualization different from traditional open surgery

● Lap surgery particularly difficult in confined spaces, where the

restricted angulation of the instruments was problematic
BENEFITS OF ROBOTICS OVER LAPAROSCOPY

● Ergonomically superior

● Intuitive nature

● Camera stabilization

● Wristed instrumentation with improved dexterity (precision with

dissection/ease of suturing
● Motion dampening sensors (tremor filtration)

● Depth perception by 3D camera (less blood loss, less complications)

● Avoidance of prolonged Trendelenburg position.

● May facilitate MIS for morbid obese

● Lower conversion rate to open

CONCLUSION FOR ROBOTICS IN CA ENDOMETRIUM

● MIS - Standard treatment of early EC

● Robotics and Lap should work together considering
cost-effectiveness
● Obesity, esp Morbid Obesity- best indication for Robotic approach
● Increase Robotic Sx in EC considering the implementation of Robotic
technology (Firefly& Xi)
CONCLUSION FOR ROBOTICS IN CA CERVIX

● RH - feasible but safe? → LACC trial

● Improved operative outcome and post-op complications

● Counselling of patients - very important step

● Every effort is made to avoid spillage of tumour if MIS being done.

FIGHT CONTINUES…….