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Original Articles Robotically Assisted Vaginal Hysterectomy is a Viable Alternative to Robotic Hysterectomy for Selected Patients Mitchel S. Hoffman, MD, 1 Richard Cardosi, MD, 2 and Katheryne Downes, MPH 1 Abstract Objective: The purpose of this study was to evaluate the operative outcomes associated with robotically assisted vaginal hysterectomy (RAVH). Methods: This study was designed as a cohort study using databases from two separate institutions: one where RAVH is used and the other where robotic hysterectomy (RH) is used. In the RAVH group, the surgery was converted to the vaginal approach just prior to uterine vessel coagulation. The main outcome variables were time to complete hysterectomy, blood loss, and complications. Results: RAVH (n = 21) and RH (n = 62) groups were comparable in terms of age, parity, body mass index (BMI), and uterine weight. There were no statistically significant differences between the vaginally completed operation and robotic performance of the same steps for operative time, blood loss, and operative complications. Conclusions: RAVH and RH have similar intraoperative characteristics. ( J GYNECOL SURG 28:1) Introduction I n gynecologic oncology patients, the Da Vinci robot has most commonly been used for the treatment of endo- metrial cancer. 1 Hysterectomy and lymphadenectomy are both performed with this technology. One of the main ad- vantages of the daVinci hysterectomy (DH) over the laparo- scopic approach is facilitation of cuff closure resulting from the greater ease of suturing and tying with the endowrist. This advantage is more applicable to women who are candidates for a total laparoscopic hysterectomy (TLH) but not a lapar- oscopically assisted vaginal hysterectomy (LAVH). Ad- vantages of a DH over an LAVH are less clear. The University of South Florida–Tampa General Hospital (USF-TGH) practice for endometrial cancer patients has been to electively ‘‘undock’’ the robot and complete the hysterec- tomy vaginally. Potential advantages of this approach in- clude a more oncologically appropriate operation, facilitated removal of larger uteri, relief from Trendelenburg position and pneumoperitoneum, resident education, and better separation of the bladder from the vagina with more secure closure of the vaginal cuff. Other than anatomic factors, the potential disadvantages of this approach include the incon- venience and time involved in changing operative fields – especially when staging based on frozen section is part of the operative plan, shifting to a less ergonomically favorable operative approach, increased transvaginal bacterial con- tamination of the operative field, the need for additional equipment, and an extended robotic learning curve for the portions done vaginally. The objective of this study was to evaluate the operative outcomes associated with robotically assisted vaginal hysterectomy (RAVH) compared with ro- botic hysterectomy (RH). Materials and Methods The gynecologic oncology practice at TGH began a ro- botics program in February, 2009. Because of concerns re- garding oncologic (exposure of peritoneal cavity to tumor, squeezing uterus through small colpotomy, inconsistency regarding extrafascial technique) and surgical issues, after 7 cases a change in approach to RAVH was made for the majority of endometrial cancer patients undergoing robotic surgery. Procedure Lymphadenectomy was performed first. After dividing the broad ligament and mobilizing the bladder, the robot was undocked and the hysterectomy was completed vaginally. The vaginal portion was performed by a senior resident or fellow. As a preliminary step, the vaginal cuff was devel- oped (including a posterior v-shaped ‘‘Torpin’’ 2 incision) and closed over the cervical os followed by irrigation with 1 Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of South Florida, Tampa, FL. 2 The Watson Clinic, Lakeland, FL. JOURNAL OF GYNECOLOGIC SURGERY Volume 28, Number 1, 2012 ª Mary Ann Liebert, Inc. DOI: 10.1089/gyn.2011.0070 1

Robotically Assisted Vaginal Hysterectomy is a Viable Alternative to Robotic Hysterectomy for Selected Patients

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Page 1: Robotically Assisted Vaginal Hysterectomy is a Viable Alternative to Robotic Hysterectomy for Selected Patients

Original Articles

Robotically Assisted Vaginal Hysterectomyis a Viable Alternative to Robotic Hysterectomy

for Selected Patients

Mitchel S. Hoffman, MD,1 Richard Cardosi, MD,2 and Katheryne Downes, MPH1

Abstract

Objective: The purpose of this study was to evaluate the operative outcomes associated with robotically assistedvaginal hysterectomy (RAVH). Methods: This study was designed as a cohort study using databases from twoseparate institutions: one where RAVH is used and the other where robotic hysterectomy (RH) is used. In theRAVH group, the surgery was converted to the vaginal approach just prior to uterine vessel coagulation. Themain outcome variables were time to complete hysterectomy, blood loss, and complications. Results: RAVH(n = 21) and RH (n = 62) groups were comparable in terms of age, parity, body mass index (BMI), and uterineweight. There were no statistically significant differences between the vaginally completed operation and roboticperformance of the same steps for operative time, blood loss, and operative complications. Conclusions: RAVHand RH have similar intraoperative characteristics. ( J GYNECOL SURG 28:1)

Introduction

In gynecologic oncology patients, the Da Vinci robot

has most commonly been used for the treatment of endo-metrial cancer.1 Hysterectomy and lymphadenectomy areboth performed with this technology. One of the main ad-vantages of the daVinci hysterectomy (DH) over the laparo-scopic approach is facilitation of cuff closure resulting fromthe greater ease of suturing and tying with the endowrist. Thisadvantage is more applicable to women who are candidatesfor a total laparoscopic hysterectomy (TLH) but not a lapar-oscopically assisted vaginal hysterectomy (LAVH). Ad-vantages of a DH over an LAVH are less clear.

The University of South Florida–Tampa General Hospital(USF-TGH) practice for endometrial cancer patients has beento electively ‘‘undock’’ the robot and complete the hysterec-tomy vaginally. Potential advantages of this approach in-clude a more oncologically appropriate operation, facilitatedremoval of larger uteri, relief from Trendelenburg positionand pneumoperitoneum, resident education, and betterseparation of the bladder from the vagina with more secureclosure of the vaginal cuff. Other than anatomic factors, thepotential disadvantages of this approach include the incon-venience and time involved in changing operative fields –especially when staging based on frozen section is part of theoperative plan, shifting to a less ergonomically favorableoperative approach, increased transvaginal bacterial con-

tamination of the operative field, the need for additionalequipment, and an extended robotic learning curve for theportions done vaginally. The objective of this study was toevaluate the operative outcomes associated with roboticallyassisted vaginal hysterectomy (RAVH) compared with ro-botic hysterectomy (RH).

Materials and Methods

The gynecologic oncology practice at TGH began a ro-botics program in February, 2009. Because of concerns re-garding oncologic (exposure of peritoneal cavity to tumor,squeezing uterus through small colpotomy, inconsistencyregarding extrafascial technique) and surgical issues, after 7cases a change in approach to RAVH was made for themajority of endometrial cancer patients undergoing roboticsurgery.

Procedure

Lymphadenectomy was performed first. After dividing thebroad ligament and mobilizing the bladder, the robot wasundocked and the hysterectomy was completed vaginally.The vaginal portion was performed by a senior residentor fellow. As a preliminary step, the vaginal cuff was devel-oped (including a posterior v-shaped ‘‘Torpin’’2 incision) andclosed over the cervical os followed by irrigation with

1Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of South Florida, Tampa, FL.2The Watson Clinic, Lakeland, FL.

JOURNAL OF GYNECOLOGIC SURGERYVolume 28, Number 1, 2012ª Mary Ann Liebert, Inc.DOI: 10.1089/gyn.2011.0070

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Betadine solution. Anterior and posterior colpotomy, divisionof remaining attachments, and cuff closure were then per-formed. Laparoscopic inspection and closure followed.

Data collection

As part of a gynecologic oncology fellowship quality as-surance program, a prospective data bank was kept, whichincluded operative time and blood loss by component, as-sessment of vaginal surgical access at the time of examinationunder anesthesia (favorable, intermediate, or unfavorable),the number of prior vaginal hysterectomies the resident orfellow had performed, and the transition time from com-pleting robotic surgery to staring vaginal surgery. The tran-sition time was not included in the vaginal operative time, asthis was essentially the number of minutes that was requiredto undock the robot. From March 2009 to March 15, 2010, 29robotic hysterectomies were performed at TGH. Eight of thesewere performed as RH because of poor vaginal access, andwere excluded from further analysis. The remaining 21 wereperformed as RAVH and formed the study group. Radicalhysterectomies and morcellated uteri were not included.During the same time period, 14 abdominal hysterectomiesand 10 vaginal hysterectomies were performed for endome-trial cancer. The USF institutional review board (IRB) re-viewed this study and approved exempt status, as the datawas derived from an existing, de-identified database.

Comparison group

For a comparison group, we used the data (also collectedprospectively) from a gynecologic oncologist in privatepractice (RC) who was an experienced robotic surgeon ex-clusively performing RH for the robotic cases. The rationalefor this was the desire to compare the nonstandard approach(RAVH) to a robust standard. From June 1, 2009 to March 15,2010, R.C. performed 65 robotic operations, which includedhysterectomy. Three were excluded because of uterine mor-cellation2 and conversion to laparotomy for a complication.1

The remaining 62 were performed as RH and formed thecohort. Specifically, the time, blood loss, and complicationsfor the part of each operation that extended from startinguterine artery coagulation to completion of cuff closure wasprospectively recorded for each case. This was done so that acomparison could be made with the comparable portion ofthe operation being performed in the study group, and willbe referred to as the ‘‘component.’’

During the same time period, RC performed 10 abdominalhysterectomies for endometrial cancers.

Because a specific component of the robotic hysterectomywas being compared, operative times and complications re-lated to other parts of the operation were not included in theanalysis. One patient in the RH group underwent a highuterosacral vaginal vault suspension during cuff closure and2 patients in the RAVH group underwent anterior andposterior colporrhaphy (1 with transvaginal high uterosacralcolpopexy). The operative times for these ancillary proce-dures were included as part of the ‘‘component.’’

Statistical analysis

Data were entered into an Excel format and imported intoPASW (SPSS) 18.0 software for statistical analysis. Normalityof variables was evaluated using the Kolmogorov–Smirnovtest. Descriptive statistics are reported as means and stan-dard deviations for normally distributed variables and asmedians and ranges for non-normally distributed variables.Outcome comparisons were conducted using the t test orMann–Whitney U test for continuous variables and Fisher’sexact test for categorical variables. A p-value < 0.05 wasconsidered statistically significant.

Results

The breakdown of diagnoses and some descriptive infor-mation regarding the RAVH group are given in Table 1. Themost common diagnosis other than endometrial neoplasiawas an ovarian tumor. Differences in diagnosis distributionbetween the two groups reflects practice patterns rather thanpatient selection.

Table 1. Descriptive Data

RH RAVH

DiagnosisEndometrial cancer 27 (45%) 18 (85.7%)Endometrial hyperplasia 9 (15%) 1 (4.8%)Other 24 (40%) 2 (9.5%)

AnatomyFavorable 9 (42.9%)Intermediate 9 (42.9%)Unfavorable 3 (14.3%)

No. of prior TVH by trainee(mean, SD, range)

21.5 (16.7), 5–40

Transition time(mean, SD, range)

5.8 (1.3), 5–10

RH, robotic hysterectomy; RAVH, robotically assisted vaginalhysterectomy; SD, standard deviation.

Table 2. Comparability of Groups

RH (n = 62) RAVH (n = 21) Test p-Value 95% CI of difference

Age (mean, SD) 61.6 (12.3) 59.7 (12.9) t test 0.561 –4.4 to 8.1BMI (mean, SD) 33.6 (8.0) 33.4 (7.5) t test 0.930 –3.8 to 4.1No. vaginal deliveries (median, range) 1, 0–7 2, 0–5 Mann-Whitney U 0.281No. cesarean sections (median, range) 0, 0–2 0, 0–1 Mann-Whitney U 0.269Uterine weight (mean, SD) 113.9 (53.9) 139.4 (66.9) t-test 0.083 –54.4 to 3.4

RH, robotic hysterectomy; RAVH, robotically assisted vaginal hysterectomy; CI, confidence interval; SD, standard deviation; BMI, bodymass index.

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The RAVH and RH groups were comparable in terms ofage, body mass index (BMI), and obstetric history, anduterine weight was heavier in the RAVH group (Table 2).

There was no difference in component operative time,blood loss, or operative complications between the RAVHand RH groups (Table 3). Six operative complications oc-curred in the RH group that were related to the componentof the operation being studied. Four of the six were vaginallacerations that occurred during vaginal extraction of theuterus, and these were repaired transvaginally without se-quelae. For three of the four, the repairs were included in thestudy operative time. The 4th patient had severe endome-triosis and underwent supracervical hysterectomy followedby robotic trachelectomy and cuff closure. A vaginal lacera-tion occurred during removal of the specimens and only theinjury was included for purposes of analysis. In a 5th patientwith leiomyomata and a thinned-out lower uterine segment,the cervix was avulsed during transvaginal traction. The fourlacerations and the one avulsion were thought possibly to berelated to the size of the uterus relative to the colpotomytypically made immediately around the cervix during RH.The mean uterine weight in these 5 cases was 180 g (range:142–266), compared to 100 g (range: 18–264) for the other 57RH patients ( p = 0.001). During transection of the vagina, a6th patient had a rectal injury. This operation was convertedto laparoscopy and only the injury was included for pur-poses of analysis. The RAVH group was associated withsignificantly longer overall operative times, postoperativecomplications, and length of stay (Table 3). Five of the sevenpostoperative complications in the RAVH group were anileus and contributed significantly to the difference in lengthof stay. A significantly greater number of lymphadenec-tomies were performed in the RAVH group.

Discussion

During RH, a colpotomy is generally made over a ma-nipulator.3,4 When malignancy is present, this maneuverpotentially exposes the peritoneal cavity and dissected pelvictissues to malignant cells. RAVH as performed in the presentstudy precludes potential spillage. The current study was notdesigned to evaluate oncologic outcome and, to date, thereare no data to suggest an increased risk of recurrence forendometrial cancer patients managed with RH.

Surgical staging of endometrial cancer patients includespelvic and para-aortic lymphadenectomy. Some women

have endometrial tumors that are unlikely to have metasta-sized and some surgeons use frozen section to guide surgicalmanagement. RAVH would make this approach cumber-some because of the potential need for re-docking. Sidedocking would be an alternative but this technique was notfamiliar to the surgeons performing the operation.

Although not measured, the colpotomy typically per-formed during RAVH is larger than that done during RH. Assuggested by the results of the present study, this facilitatesremoval of larger uteri – a factor that is of greater importancein endometrial cancer patients whose uteri should be re-moved intact and not squeezed through a small colpotomy.In addition, by directly developing the vaginal cuff, the in-tegrity of this portion of the extrafascial technique is main-tained with more certainty. The larger colpotomy would alsobe advantageous for patients with benign large uteri un-dergoing robotic hysterectomy.

An advantage of RAVH over RH is resident education invaginal surgery, which is a deficiency in many programs.5

This approach also facilitates a more robust vaginal cuffclosure. Although no cuff dehiscences were seen in eithergroup, there are data to suggest a higher incidence of thiscomplication with RH.6 For some obese women, it has beenanecdotally noted that there is difficulty with exposureduring the distal steps of RH and cuff closure, which has notbeen an issue with RAVH. Obviously there are other ana-tomic differences among patients that preclude the transva-ginal approach for some women. From an educationalstandpoint, RAVH must certainly lengthen the learningcurve for RH and robotically assisted vaginal cuff closure.7

Some obvious operative disadvantages of RAVH includechanging operative fields, loss of favorable ergonomics, theneed for additional equipment, and a greater degree ofvaginal contamination of the operative site.

The significantly greater operative time, postoperativecomplications, and length of stay for the RAVH group aremost likely a reflection of the performance of a lymphade-nectomy and less experienced surgeons.

Conclusions

Based on the results of this study, RAVH and RH havesimilar intraoperative characteristics. RAVH is an alternativeto RH for selected patients that may offer some theoreticadvantages for women with endometrial carcinoma, espe-cially in a training program.

Table 3. Results Comparison

RH (n = 60a) RAVH (n = 21) Test p-Value

Component operative time (median, range) 22, 10–48 25, 15–45 Mann-Whitney U 0.058Overall operative time (median, range) 82, 48–153 200, 120–480 Mann-Whitney U < 0.001EBL (median, range) 37.5, 23–200 25, 25–150 Mann-Whitney U 0.597Operative complications 6/62a (9.6%) 0/21 (0%) Fisher’s exact 0.330Postoperative complications 0/60 (0%) 7/21 (33.3%) Fisher’s exact < 0.001Postoperative days (median, range) 1, 0–5 2, 1–6 Man-Whitney U < 0.001Pelvic lymphadenectomy 20/60 (33.3%) 17/21 (81%) Fisher’s exact < 0.001Para-aortic lymphadenectomy 2/60 (3.3%) 6/21 (28.6%) Fisher’s exact 0.003

aTwo patients with operative complications were only included in that analysis, because other aspects of the surgery deviated from RH.Bolding indicates statistically significant p-value.RH, robotic hysterectomy; RAVH, robotically assisted vaginal hysterectomy; EBL, estimated blood loss.

RV VERSUS RAVH 3

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Disclosure Statement

No competing financial conflicts exist.

References

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2. Torpin R. Excision of the cul-de-sac of Douglas, for thesurgical care of hernias through the female caudal wall,including prolapse of the uterus. J Int Coll Surg 1955;24:322.

3. Shafer A, Boggess JF. Robotic-assisted endometrial cancerstaging and radical hysterectomy with the da Vinci surgicalsystem. Gynecol Oncol 2008;111(suppl):S18–S23.

4. Holloway RW, Ahmad S, DeNardis SA, Peterson LB, et al.Robot-assisted laparoscopic hysterectomy and lymphade-nectomy for endometrial cancer: Analysis of surgical perfor-mance. Gynecol Oncol 2009;115:447.

5. Brenot K, Govert GL. Impact of robotic surgery on obstetric–gynecologic resident training. J Reprod Med 2009;54:675.

6. Kho RM, Akl MN, Cornella JL, Magitbay PM, Wechter ME,Magrina JF. Incidence and characteristics of patients withvaginal cuff dehiscence after robotic procedures. Obstet Gy-necol 2009;114:231.

7. Seamon LG, Fowler JM, Richardson DL. A detailed analysisof the learning curve: Robotic hysterectomy and pelvic-aorticlymphadenectomy for endometrial cancer. Gynecol Oncol2009;114:162.

Address correspondence to:Mitchel S. Hoffman, MD

Department of Obstetrics and GynecologyDivision of Gynecologic Oncology

University of South Florida2 Tampa General Circle, 6th Floor

Tampa, FL 33606

E-mail: [email protected]

4 HOFFMAN ET AL.