Determining the Optimal Route of Hysterectomy for Benign...
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©2015 MFMER | slide-1
Determining the Optimal Route of Hysterectomy for Benign Indications: a Clinical Decision Tree Algorithm
John B. Gebhart, MD, MSMay 17, 2019
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Disclosures• UroCure – Advisory Board• UpToDate – Royalties• Elsevier - Royalties
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©2015 MFMER | slide-3
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Objectives• Background
• Retrospective Algorithm
• Design and Preparation of Prospective Algorithm• Deviations and exclusion criteria• Optimizing documentation• 3-D pelvic models
• Prospective Algorithm Results
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Background of Project• ACOG
• Vaginal route preferred • ≤12 week size• Nulliparity not a contraindication
• Surgical approach is non-standardized
• Surgical trends
• Dr. Kovac algorithms
Obstet Gynecol. 2009 Nov; 114(5)Morgan, et al. Am J Obstet Gynecol. 2018 Aplr;218(4)
Kovac, et al. Am J Obstet Gynecol. 2002 Dec;187(6):1521-7.Burkett, et al. Female Pelvic Med Reconstr Surg. 2011 Sep; 17(5)
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Phase I: Retrospective Algorithm
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Objectives• Primary Aims
• Create clinical algorithm to determine optimal route of hysterectomy
• Retrospectively apply the algorithm to a cohort who underwent hysterectomy
• Outcomes when algorithm was followed vs deviated
• Secondary Aims• Evaluate effect of robotic surgery on practice patterns• Identify cost implications
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Methods• Modified existing algorithm*
• Vaginal access to uterus• Uterine size
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Exclusion CriteriaAdnexal disease as primary indication
Mesh-related surgery or excision
Adnexal torsion Müllerian or uterine anomalies
Age < 18 years old Ovarian, fallopian tube, or peritoneal cancer
Cervical cancer > stage 1A1 Pelvic kidney
Cesarean hysterectomy Planned umbilical hernia repair affecting route
Concomitant anti-incontinence procedures
Planned appendectomy, cholecystectomy or bowel surgery
Did not consent for research Radical hysterectomy
Emergent hysterectomy Risk-reducing surgery (ie BRCA+)
Endometrial hyperplasia > complex Tubo-ovarian abscess
Multiple cone excisions, no available cervical tissue
Uterine cancer or suspicion for sarcoma
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Benign Disease
No
No
No
No
NoYes
Yes
Yes
Yes
Yes
Laparoscopic or robotic hysterectomy
Uterus accessible transvaginally
Uterine size <18 weeks
Abdominal Hysterectomy
Uterine size <12 weeks
Vaginal hysterectomy
Uterine size <18 weeks
Abdominal Hysterectomy
Laparoscopic or robotic hysterectomy
Algorithm not appropriate
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Benign Disease
No
No
No
No
NoYes
Yes
Yes
Yes
Yes
Laparoscopic or robotic hysterectomy
Uterus accessible transvaginally
Uterine size <18 weeks
Abdominal Hysterectomy
Uterine size <12 weeks
Vaginal hysterectomy
Uterine size <18 weeks
Abdominal Hysterectomy
Laparoscopic or robotic hysterectomy
Algorithm not appropriate
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Benign Disease
No
No
No
No
NoYes
Yes
Yes
Yes
Yes
Laparoscopic or robotic hysterectomy
Uterus accessible transvaginally
Uterine size <18 weeks
Abdominal Hysterectomy
Uterine size <12 weeks
Vaginal hysterectomy
Uterine size <18 weeks
Abdominal Hysterectomy
Laparoscopic or robotic hysterectomy
Algorithm not appropriate
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Benign Disease
No
No
No
No
NoYes
Yes
Yes
Yes
Yes
Laparoscopic or robotic hysterectomy
Uterus accessible transvaginally
Uterine size <18 weeks
Abdominal Hysterectomy
Uterine size <12 weeks
Vaginal hysterectomy
Uterine size <18 weeks
Abdominal Hysterectomy
Laparoscopic or robotic hysterectomy
Algorithm not appropriate
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Methods• Cohorts
• 2009-2013 (Cohort A)• 2004-2005 (Cohort B)
• Expected surgical route determined by applying algorithm
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Methods• Statistical analysis
• Categorical: χ2 or Fisher exact test • Ordinal: Wilcoxon rank sum test• Continuous: 2-sample t test • Postoperative health: Logistic Regression models
• UTI• SSI• Accordion Classification grade ≥3
• Cost estimates
Strasberg, et al. Ann Surg. 2009;250(2):177-86Woelk, et al. Obstet Gynecol 2014 Feb;123:255-62
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Results – Practice Patterns • Expected Vaginal Route
• Cohort B (2004-2005), N = 305• 15.1% deviation
• Cohort A (2009-2013), N = 743• 25.8% deviation
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Expected Vaginal Route
Vaginal (N = 551)
Robotic (N = 154)
Abdominal (N = 38)
P value (VH vs RH)
Vaginal parity 500/550 (90.9) 65/153 (42.5) 20/38 (52.6) <0.001Cesarean Delivery 72/550 (13.1) 60/153 (39.2) 13 (34.2) <0.001OR time, median (IQR)
59 (43, 82) 141 (106, 168) 70 (60, 95) <0.001
UTI 22/531 (4.1) 12/149 (8.1) 3/36 (8.3) 0.05SSI 1/531 (0.2) 7/149 (4.7) 0/36 (0.0) <0.001Intraoperative route conversion
5 (0.9) 2 (1.3) --- ---
No significant difference in: postoperative blood transfusion, ASA score, overall postoperative complications, Accordion grade 3+ complications, hospital readmission
Actual Route Performed
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Multivariable Analysis: SSI
Adjusted OR (95% CI) P Value
Operative time 1.51 (1.02-2.24) 0.04
Route of Hysterectomy 0.006
Vaginal Reference
Abdominal 13.6 (2.77-66.74)
Robotic 7.50 (1.52-37.06)
UTI: No independent predictors identified
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Multivariable Analysis: Accordion Grade 3+ Complications
Adjusted OR (95% CI) P Value
Route of Hysterectomy 0.009
Vaginal Reference
Abdominal 4.58 (1.58-13.33)
Robotic 3.41 (1.39-8.36)
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Results – cost implications• Unadjusted mean cost*
• Vaginal: $10,318• Robotic: $14,402• Abdominal: $15,079
• Expected vaginal route, Cohort A (2009-2013)• 30 hysterectomies abdominal• 154 hysterectomies robotically
• Total cost savings if followed algorithm ~ $800,000
*Woelk, et al. Obstet Gynecol 2014 Feb;123:255-62
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Strengths and Limitations• Strengths
• Large cohort• 13 surgeons • Historical data from Cohort B (2004-2005)
• Limitations• Retrospective• Fellowship trained surgeons
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Conclusion• Robotic surgery initiation:
• 20% absolute reduction of laparotomy• 10% absolute reduction of VH
• Using algorithm, VH associated with lower infection rates, operative times and costs
• Utilize vaginal route when feasible
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Phase II: Design and Implementation of Prospective Algorithm
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Deviations • Pathology uterine size > estimated size• Endometriosis • Laparotomies • Nulliparity
• Adnexal cyst >4 cm• Gender confirming surgery
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Exclusion CriteriaPrimarily adnexal indication or benignadnexal mass >4 cm
Mesh-related surgery or excision
Adnexal torsion Müllerian or uterine anomalies
Age < 18 years old Ovarian, fallopian tube, or peritoneal cancer
Cervical cancer > stage 1A1 Pelvic kidney
Cesarean hysterectomy Planned umbilical hernia repair affecting route
Concomitant anti-incontinence procedures
Planned appendectomy, cholecystectomy or bowel surgery
Gender confirming surgery Radical hysterectomy
Emergent hysterectomy Risk-reducing surgery (ie BRCA+)
Endometrial hyperplasia > complex Tubo-ovarian abscess
Endometriosis Uterine cancer or suspicion for sarcoma
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Hysterectomy indicated for Benign Disease
Uterine size ≤12 w (280 g)And
≤1 C-section/laparotomyAnd
Adequate vaginal caliber, mobility and descent in
office
Uterine size 13-16 w Or
≥2 C-section/laparotomyOr
Inadequate vaginal caliber, mobility and
descent in office
Uterine size ≥17 w
Vaginal Hysterectomy
Laparoscopic or Robotic Hysterectomy
Laparoscopic, Robotic, or Abdominal
HysterectomyExam Under Anesthesia
Uterus descends to halfway down vagina and adequate vaginal caliberYes
No
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Hysterectomy indicated for Benign Disease
Uterine size ≤12 w (280 g)And
≤1 C-section/laparotomyAnd
Adequate vaginal caliber, mobility and descent in
office
Uterine size 13-16 w Or
≥2 C-section/laparotomyOr
Inadequate vaginal caliber, mobility and
descent in office
Uterine size ≥17 w
Vaginal Hysterectomy
Laparoscopic or Robotic Hysterectomy
Laparoscopic, Robotic, or Abdominal
HysterectomyExam Under Anesthesia
Uterus descends to halfway down vagina and adequate vaginal caliberYes
No
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Hysterectomy indicated for Benign Disease
Uterine size ≤12 w (280 g)And
≤1 C-section/laparotomyAnd
Adequate vaginal caliber, mobility and descent in
office
Uterine size 13-16 w Or
≥2 C-section/laparotomyOr
Inadequate vaginal caliber, mobility and
descent in office
Uterine size ≥17 w
Vaginal Hysterectomy
Laparoscopic or Robotic Hysterectomy
Laparoscopic, Robotic, or Abdominal
HysterectomyExam Under Anesthesia
Uterus descends to halfway down vagina and adequate vaginal caliberYes
No
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Hysterectomy indicated for Benign Disease
Uterine size ≤12 w (280 g)And
≤1 C-section/laparotomyAnd
Adequate vaginal caliber, mobility and descent in
office
Uterine size 13-16 w Or
≥2 C-section/laparotomyOr
Inadequate vaginal caliber, mobility and
descent in office
Uterine size ≥17 w
Vaginal Hysterectomy
Laparoscopic or Robotic Hysterectomy
Laparoscopic, Robotic, or Abdominal
HysterectomyExam Under Anesthesia
Uterus descends to halfway down vagina and adequate vaginal caliberYes
No
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Hysterectomy indicated for Benign Disease
Uterine size ≤12 w (280 g)And
≤1 C-section/laparotomyAnd
Adequate vaginal caliber, mobility and descent in
office
Uterine size 13-16 w Or
≥2 C-section/laparotomyOr
Inadequate vaginal caliber, mobility and
descent in office
Uterine size ≥17 w
Vaginal Hysterectomy
Laparoscopic or Robotic Hysterectomy
Laparoscopic, Robotic, or Abdominal
HysterectomyExam Under Anesthesia
Uterus descends to halfway down vagina and adequate vaginal caliberYes
No
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Hysterectomy indicated for Benign Disease
Uterine size ≤12 w (280 g)And
≤1 C-section/laparotomyAnd
Adequate vaginal caliber, mobility and descent in
office
Uterine size 13-16 w Or
≥2 C-section/laparotomyOr
Inadequate vaginal caliber, mobility and
descent in office
Uterine size ≥17 w
Vaginal Hysterectomy
Laparoscopic or Robotic Hysterectomy
Laparoscopic, Robotic, or Abdominal
HysterectomyExam Under Anesthesia
Uterus descends to halfway down vagina and adequate vaginal caliberYes
No
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Standardizing Exam Documentation• 2004-2005
• 497 total patients (248.5/year)• 24 documentation issues (4.8%)
• 2009-2013• 1335 total patients (267/year)
• 121 documentation issues (9.1%)
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Prospective Algorithm ***Consultant performs examOffice dictation standardization
• Uterine size: weeks of gestation (<8 or normal, 10, 12, 14, 16, 18, 20, 22 weeks…)
• Vaginal Caliber: • narrow or adequate
• Uterine/cervix location: • high or normal/prolapsed
• Uterine mobility: • mobile or not mobile
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Prospective Algorithm ***Consultant performs exam if EUAOffice dictation standardization
• Uterine size: weeks of gestation (<8 or normal, 10, 12, 14, 16, 18, 20, 22 weeks…)
• Vaginal Caliber: • narrow or adequate
• Uterine/cervix location: • high or normal/prolapsed
• Uterine mobility: • mobile or not mobile
EUA dictation standardization
• Under anesthesia• Bimanual assess caliber and
descensus• Stirrups
• If unsure:• Weighted speculum • 2 tenaculums + traction
• Dictate in operative note• Uterine size (weeks gestation)• Vaginal caliber• Uterine descensus/mobility
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3-D Models for Uterine Size Estimates• Collaboration with Radiology department at St. Mary’s 3-D
printer lab
• Mayo 12 and Eisenberg 4A
• Pelvic girdle with bladder, vagina and abdominal layers• Interchangeable uteri: 100 g, 280 g, 500+ g
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Phase III: Prospective Algorithm
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Introduction and Implementation• Gynecologic Surgery Division Meetings
• Reviewed Retrospective Results• Introduce Prospective Algorithm
• Pelvic models• Review Prospective Algorithm
• November 23, 2015 – December 31, 2018
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Hysterectomy indicated for Benign Disease
Uterine size ≤12 w (280 g)And≤1 C-section/laparotomyAndAdequate vaginal caliber, mobility and descent in office
Uterine size 13-16 w Or≥2 C-section/laparotomyOrInadequate vaginal caliber, mobility and descent in office
Uterine size ≥17 weeks
Vaginal Hysterectomy
Laparoscopic or Robotic Hysterectomy
Laparoscopic, Robotic, or Abdominal
HysterectomyExam Under Anesthesia
Uterus descends to halfway down vagina and adequate vaginal caliberYes
No
55.3% 29.9% 14.8%
15.9%
71.2% 14.0%
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Gray: expected route = actual route Red: Actual route more invasive than expected (deviation)
Green: Actual route less invasive than expected (no deviation)Blue: EUA performed and TVH could not be performed
Adherence to algorithm when TVH was expected = 170/202 (84.2%)
Expected Routeper Algorithm
Actual Route performed
Vaginal Abdominal Robotic Total (%)
Vaginal 170 2 30 202 (55.3)
Abd/Robotic/Lap 1 38 15 54 (14.8)
EUA then vaginal 41 2 15 58 (15.9)
EUA then robotic 6 2 43 51 (14.0)
Total (%) 218 (59.7) 44 (12.0) 103 (28.2) 365 (100)
Adherence when TVH+ EUA-TVH expected = 211/260 (81.2%)
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Vaginal Hysterectomy• Outcomes
• 0 route conversion • 3 intraop complications (cystotomy, 1.8%)• 5 transfusions (2.9%)• 10 UTIs (5.9%) • 2 Accordion grade 3+ (1.2%)
• Return to OR • Bleeding from gonadal vessels then pelvic
abscess requiring IR drain• Acute blood loss anemia – found a
contained retroperitoneal hematoma• Nearly 95% discharged by 24 hours
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Deviations when VH Expected• N = 49 (13.4%)
• 16 nulliparous (32.7%)• 13/48 (27%) 1+ cesarean delivery• No route conversions, intraop complications,
or transfusions• 2 UTI (4.4%), 1 port site cellulitis (2.2%)• 1 Accordion grade 3+
• Return to OR for ureteral injury• 86% discharged within 24 hours
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Conclusion• Algorithm increased VH rate from 74 to 84%• 100% of TVH group were successfully
completed vaginally• 95% of EUA-TVH group were successfully
completed vaginally• Algorithm can be used to identify straight
forward vs complex cases• Algorithm may increase the rate of VH and
lower health care costs
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Questions & Discussion