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General Session II:Presentation of Award Winning Abstracts & Videos

Amy L. Garcia, MD Gerald J. Harkins, MDKeith B. Isaacson, MD S. Sony Singh, MD

M. Jonathon Solnik, MD

Julia K. Troncon, MD Christina I. Ramirez, MDMarie E. Shockley, MD Maria V. Vargas, MDBenjamin D. Beran, MD

DISCUSSANTS

PRESENTERS

General Session II: Presentation of Award-Winning Abstracts & Videos

Faculty: Benjamin D. Beran, Christina I. Ramirez, Marie E. Shockley,

Julia K. Troncon, Maria V. Vargas

Discussants: Amy L. Garcia, Gerald J. Harkins, Keith B. Isaacson, S. Sony Singh, M. Jonathon Solnik

Course Outline

7:45 Analysis of the Differential Genetic Expression Between Symptomatic and

Asymptomatic Endometrial Polyps J.K. Troncon, A.L. Garcia

7:55 Questions & Answers

8:00 Laparoscopic Management of Cesarean Scar Ectopic

Pregnancy C.I. Ramirez, M.J. Solnik


8:15 The Sterility of Selected Operative Sites During Total Laparoscopic

Hysterectomy M.E. Shockley, G.J. Harkins


8:30 Proficiency Based Robotics Training Curriculum for Suturing Tasks:

Transferability of Skills to a Live Porcine Model M.V. Vargas, S.S. Singh


8:45 Laser Angiography with Indocyanine Green (ICG) to Assess Vaginal Cuff Perfusion During Total

Laparoscopic Hysterectomy (TLH): A Pilot Study B.D. Beran, K.B. Isaacson


9:00 Adjourn

1

PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop (listed in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* R. Edward Betcher* Amber Bradshaw Speakers Bureau: Myriad Genetics Lab Other: Proctor: Intuitive Surgical Sarah L. Cohen Consultant: Olympus Erica Dun* Joseph (Jay) L. Hudgens Contracted Research: Gynesonics Frank D. Loffer, Medical Director, AAGL* Suketu Mansuria Speakers Bureau: Covidien Linda Michels, Executive Director, AAGL* Karen C. Wang* Johnny Yi* SCIENTIFIC PROGRAM COMMITTEE Sawsan As-Sanie Consultant: Myriad Genetics Lab Jubilee Brown* Aarathi Cholkeri-Singh Consultant: Smith & Nephew Endoscopy Speakers Bureau: Bayer Healthcare Corp., DySIS Medical, Hologic Other: Advisory Board: Bayer Healthcare Corp., Hologic Jon I. Einarsson* Suketu Mansuria Speakers Bureau: Covidien Andrew I. Sokol* Kevin J.E. Stepp Consultant: CONMED Corporation, Teleflex Stock Ownership: Titan Medical Karen C. Wang* FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Benjamin D. Beran* Amy L. Garcia Consultant: Gynesonics, Minerva Surgical, NVision Gerald J. Harkins* Keith B. Isaacson Consultant: Karl Storz Christina I. Ramirez Marie E. Shockley*

2

S. Sony Singh Speakers Bureau: AbbVie, Allergan, Bayer Healthcare Corp. M. Jonathon Solnik Consultant: Medtronic Other: Advisory Board: AbbVie Julia Kefalas Troncon* Maria V. Vargas* Content Reviewer has no relationships. Asterisk (*) denotes no financial relationships to disclose.

3

Analysis of the Differential Genetic Expression between Symptomatic and

Asymptomatic Endometrial Polyps

Júlia Kefalás Troncon, M.D.

MSc Student in Obstetrics and Gynecology,

Assistant Physician - Department of Obstetrics and Gynecology, Faculty of

Medicine of Ribeirão Preto, University of São Paulo - USP, Ribeirão Preto (SP), Brazil

I have no financial relationships to disclose.

OBJECTIVES

• Discuss the association between endometrial polyps andendometrial cancer

• Evaluate if there is benefit in performing hysteroscopicpolypectomy in asymptomatic postmenopausal patients

BACKGROUND

• PATHOGENESIS OF ENDOMETRIAL POLYPS

-Differential hormonal receptor expression favouringhyperestrogenism

-Unbalance between cellular proliferation and apoptosisfavouring tissue growth

Association with type I endometrial cancer?

NOGUEIRA. 2005, RBGO.SANT’ANA DE ALMEIDA et al. 2004,MATURITAS.

MAIA et al. 2004, BJOG.

BACKGROUND

• RISK FACTORS FOR MALIGNANCY

-Age (> 60 years)

-Menopausal status

-Polyp size (> 15mm)

-Postmenopausal bleeding

Around 3,5% prevalence of endometrial hyperplasiaand cancer

ANTUNES et al. 2007, MATURITAS.BAIOCCHI et al. 2009, AJOG.BEN-ARIE et al. 2004, EUR J OBSTET GYNECOL REPROD BIOL.

METHODS

• Cross-sectional study

• Tertiary referral hospital

• Postmenopausal patients undergoing hysteroscopicpolypectomy

39 symptomatic

21 asymptomatic

• Exclusion: use of hormonal therapy or tamoxifen

• Signed informed consent

4

METHODS

• Sample of tissue from the extracted polyp

• DNA extraction and PCR (Polimerase Chain Reaction)

• Analysis of the differential genic expression: genesinvolved in endometrial carcinogenesis

GENES EVALUATED

• PTEN

Tumor-suppressor gene (favors apoptosis)

• MLH-1

Mismatch repair system (Microsatellite instability)

• CTNNB1

Beta-catenin protein (WNT pathway of cellulardifferentiation)

• BCL-2

Inhibits apoptosisABAL et al. 2006, HISTOL HISTOPATHOL.HECHT, MUTTER. 2006, J CLIN ONCOLKONOPKA et al. 2007, J CANCER RES CLIN ONCOL. MUTTER et al. 2000, J NATL CANCER I.SAKURAGI et al. 2002, GYNECOL ONCOL. SANSAL, SELLERS. 2004, J CLIN ONCOL. WANG et al. 2009, CLIN CANCER RES. YANG et al. 2015, CANCER CAUSES CONTROL

RESULTS

Variable Group N. Obs. Average Minimum Maximum P-value

AGE0 21 60,29 48 79

0,161 39 63,15 51 83

DURATION OF MENOPAUSE

0 21 11,48 2 240,13

1 38 14,79 2 37

BCL2__RQ_0 21 2,84 0,23 17,88

0,981 39 2,14 0,02 26,95

PTEN__RQ_0 21 2,93 0,1 31,28

0,741 39 4,37 0,06 71,68

MLH1__RQ_0 21 4,74 0,38 64,31

0,311 39 3,74 0,17 68,98

CTNNB1_RQ_0 21 2,01 0,52 18,7

0,741 39 1,65 0,18 11,17

POLYP SIZE0 21 2,55 1,5 4,8

0,881 39 2,51 0,8 6

DISCUSSION

• Lack of evidence estabilishing if endometrial polyps arein fact cancer precursors – DETECTION BIAS

• It can not be determined if the bleeding was trulyoriginated from the polyp – LESS THAN 1% OFCANCERS CONFINED TO THE POLYP

• EPIDEMIOLOGICAL ASSOCIATION?

SAVELLI et al. 2003, AJOG.

PERRI et al. 2010, AJOG.

CONCLUSIONS

• Evaluate the uterine cavity in its entirety

• Offer polypectomy in symptomatic patients wheneverpossible

• Individualize the conduct in asymptomatic polyps /Patient’s desire

• Further studies needed – are polyps only markers ofendometrial disease and not cancer precursors?

MITTAL, DA COSTA. 2008, INT J GYNECOLPATHOL.PERRI et al. 2010, AJOG.

REFERENCES1. Abal M, Planaguma J, Gil-Moreno A, Monge M, Gonzalez M, Baro T, et al. Molecular pathology of endometrial carcinoma: transcriptional

signature in endometrioid tumors. Histol Histopathol. 2006;21(2):197-204.2. Antunes A, Jr., Costa-Paiva L, Arthuso M, Costa JV, Pinto-Neto AM. Endometrial polyps in pre- and postmenopausal women: factors

associated with malignancy. Maturitas. 2007;57(4):415-21.3. Baiocchi G, Manci N, Pazzaglia M, Giannone L, Burnelli L, Giannone E, et al. Malignancy in endometrial polyps: a 12-year experience.

AJOG. 2009;201(5):462 e1-4.4. Ben-Arie A GC, Laviv Y, Levy R, Caspi B, Huszar M, et al. The malignant potential of endometrial polyps. Eur J Obstet Gynecol Reprod

Biol. 2004;115(2):206-10.5. Hecht JL, Mutter GL. Molecular and pathologic aspects of endometrial carcinogenesis. J Clin Oncol. 2006;24(29):4783-91.6. Konopka B, Janiec-Jankowska A, Czapczak D, Paszko Z, Bidzinski M, Olszewski W, et al. Molecular genetic defects in endometrial

carcinomas: microsatellite instability, PTEN and beta-catenin (CTNNB1) genes mutations. J Cancer Res Clin Oncol. 2007;133(6):361-71.7. Maia H, Jr., Maltez A, Studart E, Athayde C, Coutinho EM. Ki-67, Bcl-2 and p53 expression in endometrial polyps and in the normal

endometrium during the menstrual cycle. BJOG . 2004;111(11):1242-1247.8. Mittal K, Da Costa D. Endometrial hyperplasia and carcinoma in endometrial polyps: clinicopathologic and follow-up findings. Int J

Gynecol Pathol. 2008;27(1):45-8.9. Mutter GL, Lin MC, Fitzgerald JT, Kum JB, Baak JPA, Lees JA, et al. Altered PTEN expression as a diagnostic marker for the earliest

endometrial precancers. J Natl Cancer I. 2000;92(11):924-31.10. Nogueira AA. Pólipos endometriais. RBGO. 2005;27(5):289-92.11. Perri T, Rahimi K, Ramanakumar AV, Wou K, Pilavdzic D, Franco EL, et al. Are endometrial polyps true cancer precursors? AJOG.

2010;203(3):232 e1-6.12. Sakuragi N, Salah-eldin AE, Watari H, Itoh T, Inoue S, Moriuchi T, et al. Bax, Bcl-2, and p53 expression in endometrial cancer. Gynecol

Oncol. 2002;86(3):288-96.13. Sansal I, Sellers WR. The biology and clinical relevance of the PTEN tumor suppressor pathway. J Clin Oncol. 2004;22(14):2954-63.14. Sant'Ana de Almeida EC, Nogueira AA, Candido dos Reis FJ, Zambelli Ramalho LN, Zucoloto S. Immunohistochemical expression of

estrogen and progesterone receptors in endometrial polyps and adjacent endometrium in postmenopausal women. Maturitas.2004;49(3):229-233.

15. Savelli L, De Iaco P, Santini D, Rosati F, Ghi T, Pignotti E, et al. Histopathologic features and risk factors for benignity, hyperplasia, andcancer in endometrial polyps. AJOG. 2003;188(4):927-31.

16. Wang Y, Hanifi-Moghaddam P, Hanekamp EE, Kloosterboer HJ, Franken P, Veldscholte J, et al. Progesterone inhibition of Wnt/beta-catenin signaling in normal endometrium and endometrial cancer. Clin Cancer Res. 2009;15(18):5784-93.

17. Yang HP, Meeker A, Guido R, Gunter MJ, Huang GS, Luhn P, et al. PTEN expression in benign human endometrial tissue and cancer in relation to endometrial cancer risk factors. Cancer Causes Control. 2015;26(12):1729-36.

5

Laparoscopic Management of Cesarean Scar Ectopic Pregnancy

Presenter: Christina I. Ramirez, MD Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania

Objective: To show how a cesarean scar ectopic pregnancy can be safely managed with laparoscopic resection. Design: Stepwise demonstration of the technique with narrated video footage. Setting: Cesarean scar pregnancies are a rare form of ectopic pregnancy with an estimated incidence of 1 in 2000 pregnancies. In these ectopic pregnancies, the overlying myometrial wall is weakened due to fibrous scar tissue which increases the risk of uterine rupture and hemorrhage. In this patient, medical management with 7 doses of systemic Methotrexate followed by intragestational injection of potassium chloride was unsuccessful. Using advanced laparoscopic techniques, the cesarean scar pregnancy was safely excised laparoscopically at 14 weeks while preserving the patient’s fertility. Interventions: Laparoscopic approach to a cesarean scar ectopic pregnancy with several key strategies to minimize blood loss, lyse dense bladder adhesions and reconstruct the anterior uterine wall:

1. Development of the retroperitoneal space with temporary uterine artery ligation. 2. Temporary ligation of bilateral infundibulopelvic ligaments. 3. Injection of Vasopressin at the junction between the uterus and gestational sac. 4. Back-filling the bladder for identification of the vesicouterine reflection. 5. Inflation of a Foley catheter within the uterus during anterior uterine wall reconstruction for

orientation and to prevent incorporation of the posterior uterine wall. Conclusion: Although cesarean scar ectopic pregnancies can be managed medically or surgically, the optimal treatment strategy is still unknown due to the rarity of the condition. In patients who desire fertility conservation, laparoscopic resection can be performed safely and effectively in the hands of a skilled laparoscopic surgeon. Here we demonstrated several techniques to successfully excise a cesarean scar ectopic pregnancy while minimizing intraoperative blood loss.

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1

The Sterility of Selected Operative Sites During Total Laparoscopic Hysterectomy

Marie E. Shockley, M.D.Fellow in Minimally Invasive Gynecologic Surgery

Cleveland Clinic Florida

Disclosure

• I have no financial relationships to disclose

Objectives

• Discuss the incidence of surgical site infection (SSI) in gynecologic laparoscopy

• Describe the types of bacteria found on various surfaces encountered during total laparoscopic hysterectomy (TLH)

• Prioritize when to perform intraoperative sterile attire changes

Subject: Sterile field requirements for laparoscopic hysterectomy (NEW QUESTION)

I am having discussions with my OR team regarding best practices for laparoscopic hysterectomy.

I have read several articles in the past on whether or not it is necessary to change gloves, drapes, and reprep the patient when going from below to above. I would appreciate some references to cite for any randomized controlled trials to look at this, what the best evidence is and recommendations others have in their institutions.

- Richard P. Marvel MD

Background• No RCTs

• Safety of TLH requires freedom of movement between the abdominal and perineovaginal fields

• Incidence of SSI following TLH is 1.0 – 2.7%1-3

• Cultures from infected hysterectomy patients demonstrate polymicrobialgrowth of the patient’s own vaginal flora4

• No established guidelines for preparation of concomitant abdominal and perineovaginal surgical fields5

• Tradition has dictated that the perineum and vagina are contaminated, and the abdomen is clean5-6

Methods• IRB approval

• 31 women undergoing TLH for benign indications

• Exclusions

- Bacterial vaginosis

- Pre-existing cellulitis

- Uterine size precluding vaginal extraction

• 100% received perioperative antibiotic prophylaxis

• Separate perineovaginal preparation and abdominal preparation with 4% chlorhexidine gluconate

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2

Collection of swab from:

6. Tips of laparoscopic devices used exclusively in cuff closure

Laparoscopic closure of the vaginal cuff

Collection of swabs from:

4. Surgeon’s gloves after extraction of specimen(s)

5. Uterine serosa

Total laparoscopic hysterectomy with transvaginal extraction of specimen(s)

Collection of swab from:

3. Surgeon’s gloves after placement of uterine manipulator device

Placement of uterine manipulator and Foley catheter

Draping of patient

Collection of swabs from:

1. Vaginal fornices

2. Abdomen

Preparation of abdominal and perineovaginal surgical fields

Met

ho

ds

Anaerobic AgarsBrucella blood

Phenylethyl alcoholKanamycin vancomycinBacteroides bile esculin

Aerobic Agars5% Sheep blood

Chocolate

Negative Cultures: No bacterial growth

Contamination: ≥ 5,000 Colony Forming Units (CFU)/ml 4,7

ABDOMEN Bacterial growth in positive swabs by species

Anaerobic pathogens 0

Aerobic pathogens

λ- Hemolytic streptococci 2/31 (6%)

α- Hemolytic streptococci 2/31 (6%)

Gram positive Diptheroid-like bacilli 2/31 (6%)

VAGINAL FORNICES Bacterial growth in positive swabs by species


Aerobic pathogens 0

Number of samples with positive growth: 3Number of samples with growth ≥ 5000 CFU/mL: 0

Number of samples with positive growth: 0

ResultsSURGEON’S GLOVES FOLLOWING UTERINE

MANIPULATOR PLACEMENT

Bacterial growth in positive swabs by species

Anaerobic pathogens

Peptostreptococcus 2/31 (6%)

Aerobic pathogens



Klebsiella pneumoniae 1/31 (3%)


Results

SURGEON’S GLOVES FOLLOWING TRANSVAGINAL EXTRACTION OF SPECIMEN


Anaerobic pathogens

Peptostreptococcus 5/31(16%)

Bacteroides 1/31(3%)

Propionibacterium 6/31(19%)

Prevotella 2/31(6%)

Aerobic pathogens

E. coli 1/31 (3%)


Coagulase-negative Staphylococcus 2/31 (6%)

Group B streptococci 1/31 (3%)


Highest absolute growth from any single sample: 8900 CFU/mL

ResultsUTERINE FUNDUS AFTER

HYSTERECTOMYBacterial growth in positive

swabs by species

Anaerobic pathogens

Peptostreptococcus 4/31(13%)

Bacteroides 1/31(3%)

Propionibacterium 6/31(19%)

Clostridium (not perfringens) 1/31(3%)

Aerobic pathogens

E. coli 1/31 (3%)






Results

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3

TIPS OF INSTRUMENTS USED TO CLOSE THE VAGINAL CUFF



Aerobic pathogens





Number of samples with positive growth: 4Number of samples with growth ≥ 5000 CFU: 0

Bacterial growth in 98.9% of samples was below the infection threshold

No surgical site infections were diagnosed over a follow up period of 6 weeks

Results

0, 0

3, 2230

3, 330

4, 100

10, 1570

12, 1350

0

500

1000

1500

2000

2500

0 1 2 3 4 5 6 7 8 9 10 11 12 13

Me

an

(±

SD

) C

FU

/mL

• Vaginal Fornices

• Tips of surgical instruments used to close the vaginal cuff

• Surgeon’s gloves following uterine manipulator placement

• Uterine fundus

• Surgeon’s gloves following transvaginal extraction of specimen

• Abdomen

Mean CFU of Total Bacteria & Number of Positive Samples by Site

Number of positive samples

Discussion • Multiple species of aerobic and anaerobic bacteria can be cultured from selected

sites encountered when performing TLH

• Intraoperative bacterial counts during TLH are below the threshold which causes surgical site infection

• Prioritize changing gloves following transvaginal extraction of specimen(s)

Conclusions • 4% Chlorhexidine is an adequate preparation of the vaginal and abdominal fields

prior to performance of TLH

• Further studies are needed before approaching the perineal and abdominal fields as one

References1. Harris WJ, Daniell JF. Early complications of laparoscopic hysterectomy. Obstetrical & Gynecological

Survey. 1996;51(9):559-567.

2. Lake AG, McPencow AM, Dick-Biascoechea MA, Martin DK, Erekson EA. Surgical site infection after hysterectomy. American Journal of Obstetrics and Gynecology. 2013;209(5):490.e1-490.e9.

3. Chang W, Lee M, Yeh L, Hung Y, Lin C, Lin L. Quality-initiated prophylactic antibiotic use in laparoscopic-assisted vaginal hysterectomy. Australian and New Zealand Journal of Obstetrics and Gynaecology. 2008;48(6):592-595.

4. Culligan P, Heit M, Blackwell L, Murphy M, Graham CA, Snyder J. Bacterial colony counts during vaginal surgery. Infectious Diseases in Obstetrics & Gynecology. 2003;11(3):161-165.

5. Burlingame B. Clinical issues - July 2011. AORN Journal. 2011;94(1):97-106.

6. O'hanlan K, A., McCUTCHEON S, Paris, McCUTCHEON J, G., Charvonia B, E. Quality improvement: Single-field sterile scrub, prep, and dwell for laparoscopic hysterectomy. AORN Journal. 2013;97(5):539-546.

7. Faro C, Faro S. Postoperative pelvic infections. Infectious Disease Clinics of North America. 2008(22):653-663.

Acknowledgements

• Benjamin Beran, M.D.

• Katrin Arnolds, M.D.

• Heather Nutting, M(ASCP)

• Michael L. Sprague, M.D.

• Stephen Zimberg, M.D.

9

Laparoscopic Management of Cesarean Scar Ectopic Pregnancy

Christina I. Ramirez, MD Magee-Womens Hospital of UPMC, Pittsburgh, Pennsylvania

Objective: To show how a cesarean scar ectopic pregnancy can be safely managed with laparoscopic resection. Design: Stepwise demonstration of the technique with narrated video footage. Setting: Cesarean scar pregnancies are a rare form of ectopic pregnancy with an estimated incidence of 1 in 2000 pregnancies. In these ectopic pregnancies, the overlying myometrial wall is weakened due to fibrous scar tissue which increases the risk of uterine rupture and hemorrhage. In this patient, medical management with 7 doses of systemic Methotrexate followed by intragestational injection of potassium chloride was unsuccessful. Using advanced laparoscopic techniques, the cesarean scar pregnancy was safely excised laparoscopically at 14 weeks while preserving the patient’s fertility. Interventions: Laparoscopic approach to a cesarean scar ectopic pregnancy with several key strategies to minimize blood loss, lyse dense bladder adhesions and reconstruct the anterior uterine wall:

1. Development of the retroperitoneal space with temporary uterine artery ligation. 2. Temporary ligation of bilateral infundibulopelvic ligaments. 3. Injection of Vasopressin at the junction between the uterus and gestational sac. 4. Back-filling the bladder for identification of the vesicouterine reflection. 5. Inflation of a Foley catheter within the uterus during anterior uterine wall reconstruction for

orientation and to prevent incorporation of the posterior uterine wall. Conclusion: Although cesarean scar ectopic pregnancies can be managed medically or surgically, the

optimal treatment strategy is still unknown due to the rarity of the condition. In patients who desire

fertility conservation, laparoscopic resection can be performed safely and effectively in the hands of a

skilled laparoscopic surgeon. Here we demonstrated several techniques to successfully excise a cesarean

scar ectopic pregnancy while minimizing intraoperative blood loss.

10

Proficiency Based Robotics Training Curriculum for Suturing Tasks: Transferability of Skills to a Live

Porcine Model

Presenter: Maria V. Vargas, MD

Division of Gynecology, George Washington University Medical Faculty Associates, Washington, DC, 20037

Disclosures

I have no financial relationships to disclose.

:

Objectives

– Define proficiency based training

– Explain the impact of proficiency based training on the performance of live suturing tasks

– Identify gaps in available literature on the transfer of skills from virtual reality simulation to operative performance

Background

• Virtual reality simulation is a cost-effective approach for developing basic robotic surgical skills

• The daVinci Skills Simulator has been studied and validated

• Proficiency based curriculums are the standard

• Limited data about the transfer of skills from virtual reality simulation to the operating room environment

Objective

• To assess whether a proficiency-based simulation program improved the performance of novice surgeons on a suturing task using a live porcine model

Methods

• Design: Single-blind randomized controlled trial

• Participants: Medical students naïve to robotic surgery

• Intervention: Proficiency-based curriculum– Camara clutching 1– Suture sponge 1– Suture sponge 2– Tubes

11

Methods

• Final assessment: Blinded video review of cystotomy closure on a live porcine model

• Primary outcomes: – Global Evaluative Assessment of Robotic Skills

score– Time to complete the task

• Sample size: 20 per group– 90% power to detect

• 3 point difference • 3 min difference

Results

Results

• No baseline differences in participants

• Intervention group:– Median total training time on the dvSS was

116 min (range 53-209 min)

– Ten out of the 19 participants achieved proficiency in all of the four exercises

Results

Comparison of final GEARS Scores

Comparison of final task time in minutes

Conclusions

• In this study, a proficiency-based simulation curriculum on the dvSS did not improve performance of a cystotomyclosure task on a live porcine model when compared to standard orientation to the robotic console.

Conclusions

• Weaknesses: – Non-standardized selection of exercises– Proficiency not defined for virtual reality

simulation

• Strengths- Randomized controlled design with the use of

blinded assessments and a validated assessment tool

- First RCT to evaluate the effect of training with the dvSS on live performance

12

References

• Moglia A, Ferrari V, Morelli L, Ferrari M, Mosca F, Cuschieri A. A systematic review of virtual reality simulators for robot-assisted surgery. Eur Urol. 2016;69(6):1065-1080.

• Liss MA, McDougall EM. Robotic surgical simulation. Cancer J. 2013;19(2):124-129.

• Sheth SS, Fader AN, Tergas AI, Kushnir CL, Green IC. Virtual reality robotic surgical simulation: An analysis of gynecology trainees. J Surg Educ. 2014;71(1):125-132.

• Schulz KFK. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. International journal of surgery (London, England). 2011;9(8):672; 672-677; 677.

• Kelly DC, Margules AC, Kundavaram CR, et al. Face, content, and construct validation of the da vinci skills simulator. Urology. 2012;79(5):1068-1072.

• Kiely DJ, Gotlieb WH, Lau S, et al. Virtual reality robotic surgery simulation curriculum to teach robotic suturing: A randomized controlled trial. J Robot Surg. 2015;9(3):179-186.

• Goh AC, Goldfarb DW, Sander JC, Miles BJ, Dunkin BJ. Global evaluative assessment of robotic skills: Validation of a clinical assessment tool to measure robotic surgical skills. J Urol. 2012;187(1):247-252.

• Lerner MAM. Does training on a virtual reality robotic simulator improve performance on the da vinci surgical system? Journal of endourology. 03;24(3):467; 467-472; 472.

References continued

• Korets R, Mues AC, Graversen JA, et al. Validating the use of the mimic dV-trainer for robotic surgery skill acquisition among urology residents. Urology. 2011;78(6):1326-1330.

• Cho JS, Hahn KY, Kwak JM, et al. Virtual reality training improves da vinci performance: A prospective trial. J Laparoendosc Adv Surg Tech A. 2013;23(12):992-998.

• Whitehurst SV, Lockrow EG, Lendvay TS, et al. Comparison of two simulation systems to support robotic-assisted surgical training: A pilot study (swine model). J Minim Invasive Gynecol. 2015;22(3):483-488.

• Vaccaro CM, Crisp CC, Fellner AN, Jackson C, Kleeman SD, Pavelka J. Robotic virtual reality simulation plus standard robotic orientation versus standard robotic orientation alone: A randomized controlled trial. Female Pelvic Med Reconstr Surg. 2013;19(5):266-270.

• Culligan P, Gurshumov E, Lewis C, Priestley J, Komar J, Salamon C. Predictive validity of a training protocol using a robotic surgery simulator. Female Pelvic Med Reconstr Surg. 2014;20(1):48-51.

• Stegemann AP, Ahmed K, Syed JR, et al. Fundamental skills of robotic surgery: A multi-institutional randomized controlled trial for validation of a simulation-based curriculum. Urology. 2013;81(4):767-774.

AcknowledgementsGaby N. Moawad, MD1 - Co-investigator

Kathryn Denny, BS2 – Co-investigator

Lyndsey Powers-Happ, PhD3

Samantha Marguelies, MD2 – Co-investigator

Elias Abi Khalil, MD1

Cherie Q. Marfori, MD1 – Principle Investigator

Jessica Opoku-Anane,MD - Co-investigator

Naya Misa – Co-investigator

Xiyan Li – Director of the Washington Institute of Surgical Education

Jenna Ebert – Research Coordinator

Participants

1 Division of Gynecology, George Washington University Medical Faculty Associates, Washington, DC, 200372 School of Medicine and Health Sciences, George Washington University, Washington, DC, 20037 3Milken Institute of Public Health, George Washington University, Washington, DC, 20052

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Laser Angiography with Indocyanine Green to Assess Vaginal Cuff Perfusion During Total Laparoscopic Hysterectomy: A Pilot Study

Benjamin D. Beran, M.D.Fellow in Minimally Invasive Gynecologic SurgeryCleveland Clinic Florida

Disclosures

• I have no financial relationships to disclose.

Objectives

• Describe role of laser angiography in evaluting vaginal cuff perfusion following total laparoscopic hysterectomy

• Develop novel applications of existing advanced technologies for gynecologic surgery

Vaginal Cuff Dehiscence

• Risk factors1

- Increased age

- Vaginal atrophy

- Poor wound healing

- Valsalva

- Post-operative cuff infection or hematoma

Photo courtesy of Marie Shockley, M.D.

Vaginal Cuff Dehiscence

• Incidence varies by approach 3

- Robotic: 1.64%

- Laparoscopic: 0.61%

- Vaginal: 0.18%

• Possible association with laparoscopic approach for vaginal cuff closure?

2

Laser Angiography

• Intravenous indocyanine green (ICG)

- Binds plasma protein

- Detection represents perfusion

- Peak spectral absorption at 800nm

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2

Study Design

• Feasibility trial with IRB approval

• To assess vaginal cuff perfusion

- After colpotomy (pre-closure)

- After cuff closure

• Women (20) undergoing TLH

- Benign indications

- No documented iodine allergy

TLH

(n=20)

Ultrasonic (n=10)

Barbed suture (n=5)

Non-barbed suture (n=5)

Monopolar (50 watts cut)

(n=10)

Barbed suture (n=5)

Non-barbed suture (n=5)

Randomization

Methods Methods

Results

• No complications related to ICG

• ICG fluorescence present at vaginal cuff in all participants

• Mean time to ICG appearance

- 22.8 seconds

• Initial dose

- 2.5 mg: 25% needed additional dose

- 5 mg: 0% needed additional dose

Marked and scored by 3 reviewers

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Results

• No difference in perfusion detected

• Ultrasonic: 67.5%

• Monopolar: 59.1%

• Barbed: 71.5%

• Non-barbed: 68.9%

En

erg

yS

utu

re

Conclusions

• ICG fluorescence is reliably present at vaginal cuff

• ICG 2.5 mg dose sufficient for most patients

• Colpotomy method and suture material had no measurable difference on cuff perfusion

• Future studies

- Develop quantifiable fluorescence technique

- Further analysis of instrument activation time effect on tissue

References

1. Cronin, B., et al. (2012). "Vaginal cuff dehiscence: risk factors and management." Am J Obstet Gynecol 206(4): 284-288.

2. Arnolds, K., et al. (2016). "Vaginal Cuff Dehiscence After Total Laparoscopic Hysterectomy." J Minim Invasive Gynecol 23(1): 5.

3. Uccella, S., et al. (2011). "Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature." Am J Obstet Gynecol 205(2): 119 e111-112.

Acknowledgements

• Marie Shockley, M.D.

• Katrin Arnolds, M.D.

• Pedro Escobar, M.D.

• Stephen Zimberg, M.D.

• Michael L. Sprague, M.D.

• Novadaq: Equipment grant

16

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsian

Indo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

17

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

general session ii: presentation of award winning ... · safely excised laparoscopically at 14...

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