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COLPASSIST VS EEAS: COMPARING TIME POINTS DURING ROBOTIC - - PowerPoint PPT Presentation

Jun 18, 2023 270 likes •493 views

COLPASSIST VS EEAS: COMPARING TIME POINTS DURING ROBOTIC SACROCOLPOPEXY, A RANDOMIZED CONTROLLED TRIAL T. Brueseke, C. Matthews, M. Willis-Grey, M. Nieto, J. Cruz, S. Knight, E. Geller Division of Female Pelvic Medicine and Reconstructive

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SLIDE 1
  • T. Brueseke, C. Matthews, M. Willis-Grey,
  • M. Nieto, J. Cruz, S. Knight, E. Geller

Division of Female Pelvic Medicine and Reconstructive Surgery

COLPASSIST VS EEAS: COMPARING TIME POINTS DURING ROBOTIC SACROCOLPOPEXY, A RANDOMIZED CONTROLLED TRIAL

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SLIDE 2
  • The Colpassist devices used in this study were provided by

Boston Scientific as part of an unrestricted investigator- initiated grant

  • Catherine Matthews:

– Boston Scientific: grant support and consultant – Johnson & Johnson: expert legal defense – Pelvalon: consultant

Disclosures

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SLIDE 3
  • Sacrocolpopexy is the gold standard surgical procedure

for correction of vaginal vault prolapse1

  • Robotic assisted sacrocolpopexy (RSC) provides a

minimally invasive approach but has been criticized for longer operative times2

  • Operative efficiency is key to minimize OR times and

maintain patient safety3

Background

1Maher Cochrane Database Syst Rev.2013;4(4) 2Paraiso Obstet Gynecol. 2011;118(5):1005-1013 3Geller J Minim Invasive Gynecol. 2013 20(1):43–8.

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SLIDE 4

Background

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SLIDE 5

Background

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SLIDE 6

Background

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SLIDE 7
  • Primary objective:

Compare operative time for RSC with Colpassist vs EEAS

  • Secondary objectives:

Compare VAS satisfaction scores between Colpassist vs EEAS

Objectives

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SLIDE 8

Study Design

  • Single center, RCT, Jan 2015 to Nov 2017
  • Consecutive patients scheduled for RSC
  • Inclusion criteria
  • >18 yo, planned RSC, prior hysterectomy, English speaking
  • Exclusion criteria
  • Prior sacrocolpopexy, pregnancy
  • Allocation stratified by surgeon
  • Randomized 1:1 (Colpassist : EEAS)
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SLIDE 9
  • Published mean operative time: 44 ±10 min1
  • 20% difference in operating time deemed significant
  • 80% power, α = 0.05, ß = 0.2
  • 25 women per group needed to detect a 9 minute

difference in operating time

Sample Size Estimate

1Geller, J Minim Invasive Gynecol. 2012, 20(1):43-48.

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SLIDE 10

Assessed for eligibility (n=61)

Excluded (n=9)

¨ Not meeting inclusion criteria (n=2) ¨ Declined to participate (n=4) ¨ Other reasons (n=3)

Analysed

  • Intention to Treat (n=25)
  • Actual Use (n=9)

Allocated to Colpassist (n=25) Additional positioning device used (n=16) Analysed

  • Intention to Treat (n=27)
  • Actual Use (n=43)

Allocated to EEAS (n=27) Additional positioning device used (n=0) Allocation Analysis Randomized (n=52)

Enrollment

CONSORT Diagram

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SLIDE 11

Demographics

Colpassist™ (n=25) EEAS (n=27) Mean Age (years) ± SD 64±7 61±9 Race (white) 21 (84%) 20 (82%) Median CCI Score (IQR) 0 (0-1) 0 (0-1) Prior Hysterectomy Total 24 (96.0%) 25 (92.6%) Supracervical 1 (4.0%) 2 (7.4%) Prior Abdominal Surgery Other than Hysterectomy 17 (68%) 12 (44.4%) Prior Prolapse or Incontinence Surgery 12 (48%) 5 (22%) Mean BMI (kg/m2) ± SD 27±5 29±5 Greatest Pelvic Organ Prolapse Stage Stage 2 8 (32%) 12 (44%) Stage 3 15 (60%) 15 (56%) Stage 4 2 (8%) Data are n (%) unless specified

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SLIDE 12

Primary Outcome

Colpassist™ (n=25) EEAS (n=27) P value Total Time Using Vaginal Positioning Device 51 (41-77) 46 (29-60) 0.15 Anterior Vaginal Dissection Time 15 (10-18) 10 (8-15) 0.24 Posterior Vaginal Dissection Time 8 (5-12) 5 (4-8) 0.11 Anterior Vaginal Mesh Attachment Time 12 (10-16) 11 (7-15) 0.35 Posterior Vaginal Mesh Attachment Time 16 (11-20) 12 (8-18) 0.15

Data are formatted as: median minutes (interquartile range)

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SLIDE 13

Colpassist

¨ Intention to treat (n=25) ¨ Actual Use (n=9)

EEAS

¨ Intention to treat (n=27) ¨ Actual Use (n=43)

Actual Use Analysis

Colpassist™ (n=9) EEAS (n=43) P value Total Time Using Vaginal Positioning Device

53 (42-85) 46 (27-56) 0.56

Data are formatted as: median minutes (interquartile range)

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SLIDE 14

Colpassist

¨ Intention to treat (n=25) ¨ Actual Use (n=9)

EEAS

¨ Intention to treat (n=27) ¨ Actual Use (n=43)

Actual Use Analysis

Colpassist™ (n=9) EEAS (n=43) P value Total Time Using Vaginal Positioning Device

53 (42-85) 46 (27-56) 0.56

Data are formatted as: median minutes (interquartile range)

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SLIDE 15

Surgeon and Fellow Satisfaction Scores

Data are median VAS scores range 0-68 (interquartile range) Colpassist™ (Surgeons n=22) (Fellows n=20) EEAS (Surgeons n=27) (Fellows n=22) P value* How satisfied are you overall with the vaginal manipulator? Surgeon 19 (11-33) 63 (61-65) <0.01 Fellow 33 (24-45) 62 (53-65) <0.01 Colpassist™ (n=24) EEAS (n=27) P value* How satisfied are you overall with the vaginal manipulator? 49 (31-58) 60 (50-65) 0.07

Vaginal Surgical Assistant Satisfaction Scores

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SLIDE 16

Surgeon and Fellow Satisfaction Scores

Data are median VAS scores range 0-68 (interquartile range) Colpassist™ (Surgeons n=22) (Fellows n=20) EEAS (Surgeons n=27) (Fellows n=22) P value* How satisfied are you overall with the vaginal manipulator? Surgeon 19 (11-33) 63 (61-65) <0.01 Fellow 33 (24-45) 62 (53-65) <0.01 Colpassist™ (n=24) EEAS (n=27) P value* How satisfied are you overall with the vaginal manipulator? 49 (31-58) 60 (50-65) 0.07

Vaginal Surgical Assistant Satisfaction Scores

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SLIDE 17

Additional Secondary Outcomes

Colpassist™ (n=25) EEAS (n=27) P value Mean Estimated blood loss (mL) ± SD 52±37 50±29 0.95 Incidental Cystotomy 3 (12%) 1 (3.7%) 0.34 Incidental Vaginotomy 6 (24%) 5 (18.5%) 0.63

Data are n (%) unless specified

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SLIDE 18

Strengths

  • Randomized controlled trial
  • Objective outcomes
  • Intent to treat design
  • Variation in surgical technique and suture type

between surgeons

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SLIDE 19

Limitations

  • Single academic center
  • No pre-study training on Colpassist
  • Cross-over rate to EEAS
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SLIDE 20

Conclusions

  • No significant difference in operating time between

Colpassist and EEAS, however, multiple Colpassist cases did use an additional positioning device

  • Surgeons and fellows overall more satisfied with

EEAS

  • Vaginal surgical assistants were equally satisfied with

Colpassist and EEAS

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SLIDE 21

Implications

  • Surgical efficiency may not be strongly influenced by

choice of positioning device

  • Surgeons should be aware of various options of

positioning devices available and select one with the most desired characteristics (may vary based on patient anatomy)

  • Future research to optimize efficiency in RSC may

include examination of additional intraoperative variables

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SLIDE 22
  • T. Brueseke, C. Matthews, M. Willis-Grey,
  • M. Nieto, J. Cruz, S. Knight, E. Geller

Division of Female Pelvic Medicine and Reconstructive Surgery

COLPASSIST VS EEAS: COMPARING TIME POINTS DURING ROBOTIC SACROCOLPOPEXY, A RANDOMIZED CONTROLLED TRIAL