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

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

In gynecologic oncology patients, the Da Vinci robot has most commonly been used for the treatment of endometrial cancer.¹ Hysterectomy and lymphadenectomy are both performed with this technology. One of the main advantages of the daVinci hysterectomy (DH) over the laparoscopic 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 laparoscopically assisted vaginal hysterectomy (LAVH). Advantages 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 hysterectomy vaginally. Potential advantages of this approach include 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 inconvenience 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 contamination 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 robotic hysterectomy (RH).

Materials and Methods

The gynecologic oncology practice at TGH began a robotics program in February, 2009. Because of concerns regarding 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 developed (including a posterior v-shaped “Torpin”² incision) and closed over the cervical os followed by irrigation with Betadine solution. Anterior and posterior colpotomy, division of remaining attachments, and cuff closure were then performed. Laparoscopic inspection and closure followed.

Data collection

As part of a gynecologic oncology fellowship quality assurance program, a prospective data bank was kept, which included operative time and blood loss by component, assessment of vaginal surgical access at the time of examination under anesthesia (favorable, intermediate, or unfavorable), the number of prior vaginal hysterectomies the resident or fellow had performed, and the transition time from completing robotic surgery to staring vaginal surgery. The transition time was not included in the vaginal operative time, as this was essentially the number of minutes that was required to undock the robot. From March 2009 to March 15, 2010, 29 robotic hysterectomies were performed at TGH. Eight of these were performed as RH because of poor vaginal access, and were excluded from further analysis. The remaining 21 were performed as RAVH and formed the study group. Radical hysterectomies and morcellated uteri were not included. During the same time period, 14 abdominal hysterectomies and 10 vaginal hysterectomies were performed for endometrial cancer. The USF institutional review board (IRB) reviewed this study and approved exempt status, as the data was derived from an existing, de-identified database.

Comparison group

For a comparison group, we used the data (also collected prospectively) from a gynecologic oncologist in private practice (RC) who was an experienced robotic surgeon exclusively performing RH for the robotic cases. The rationale for 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 included hysterectomy. Three were excluded because of uterine morcellation² and conversion to laparotomy for a complication.¹ The remaining 62 were performed as RH and formed the cohort. Specifically, the time, blood loss, and complications for the part of each operation that extended from starting uterine artery coagulation to completion of cuff closure was prospectively recorded for each case. This was done so that a comparison could be made with the comparable portion of the operation being performed in the study group, and will be referred to as the “component.”

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

Because a specific component of the robotic hysterectomy was being compared, operative times and complications related to other parts of the operation were not included in the analysis. One patient in the RH group underwent a high uterosacral vaginal vault suspension during cuff closure and 2 patients in the RAVH group underwent anterior and posterior colporrhaphy (1 with transvaginal high uterosacral colpopexy). The operative times for these ancillary procedures were included as part of the “component.”

Statistical analysis

Data were entered into an Excel format and imported into PASW (SPSS) 18.0 software for statistical analysis. Normality of variables was evaluated using the Kolmogorov–Smirnov test. Descriptive statistics are reported as means and standard deviations for normally distributed variables and as medians and ranges for non-normally distributed variables. Outcome comparisons were conducted using the t test or Mann–Whitney U test for continuous variables and Fisher's exact test for categorical variables. A p-value<0.05 was considered statistically significant.

Results

The breakdown of diagnoses and some descriptive information regarding the RAVH group are given in Table 1. The most common diagnosis other than endometrial neoplasia was an ovarian tumor. Differences in diagnosis distribution between the two groups reflects practice patterns rather than patient selection.

Table 1.

Descriptive Data

	RH	RAVH
Diagnosis
Endometrial cancer	27 (45%)	18 (85.7%)
Endometrial hyperplasia	9 (15%)	1 (4.8%)
Other	24 (40%)	2 (9.5%)
Anatomy
Favorable		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 vaginal hysterectomy; SD, standard deviation.

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

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 8.1
BMI (mean, SD)	33.6 (8.0)	33.4 (7.5)	t test	0.930	–3.8 to 4.1
No. vaginal deliveries (median, range)	1, 0–7	2, 0–5	Mann-Whitney U	0.281
No. cesarean sections (median, range)	0, 0–2	0, 0–1	Mann-Whitney U	0.269
Uterine 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, body mass index.

There was no difference in component operative time, blood loss, or operative complications between the RAVH and RH groups (Table 3). Six operative complications occurred in the RH group that were related to the component of the operation being studied. Four of the six were vaginal lacerations that occurred during vaginal extraction of the uterus, and these were repaired transvaginally without sequelae. For three of the four, the repairs were included in the study operative time. The 4th patient had severe endometriosis and underwent supracervical hysterectomy followed by robotic trachelectomy and cuff closure. A vaginal laceration occurred during removal of the specimens and only the injury was included for purposes of analysis. In a 5th patient with leiomyomata and a thinned-out lower uterine segment, the cervix was avulsed during transvaginal traction. The four lacerations and the one avulsion were thought possibly to be related to the size of the uterus relative to the colpotomy typically 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 57 RH patients (p=0.001). During transection of the vagina, a 6th patient had a rectal injury. This operation was converted to laparoscopy and only the injury was included for purposes of analysis. The RAVH group was associated with significantly longer overall operative times, postoperative complications, and length of stay (Table 3). Five of the seven postoperative complications in the RAVH group were an ileus and contributed significantly to the difference in length of stay. A significantly greater number of lymphadenectomies were performed in the RAVH group.

Table 3.

Results Comparison

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

Two 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.

Discussion

During RH, a colpotomy is generally made over a manipulator.^3,4 When malignancy is present, this maneuver potentially exposes the peritoneal cavity and dissected pelvic tissues to malignant cells. RAVH as performed in the present study precludes potential spillage. The current study was not designed to evaluate oncologic outcome and, to date, there are no data to suggest an increased risk of recurrence for endometrial cancer patients managed with RH.

Surgical staging of endometrial cancer patients includes pelvic and para-aortic lymphadenectomy. Some women have endometrial tumors that are unlikely to have metastasized and some surgeons use frozen section to guide surgical management. RAVH would make this approach cumbersome because of the potential need for re-docking. Side docking would be an alternative but this technique was not familiar to the surgeons performing the operation.

Although not measured, the colpotomy typically performed during RAVH is larger than that done during RH. As suggested by the results of the present study, this facilitates removal of larger uteri – a factor that is of greater importance in endometrial cancer patients whose uteri should be removed intact and not squeezed through a small colpotomy. In addition, by directly developing the vaginal cuff, the integrity of this portion of the extrafascial technique is maintained with more certainty. The larger colpotomy would also be advantageous for patients with benign large uteri undergoing robotic hysterectomy.

An advantage of RAVH over RH is resident education in vaginal surgery, which is a deficiency in many programs.⁵ This approach also facilitates a more robust vaginal cuff closure. Although no cuff dehiscences were seen in either group, there are data to suggest a higher incidence of this complication with RH.⁶ For some obese women, it has been anecdotally noted that there is difficulty with exposure during the distal steps of RH and cuff closure, which has not been an issue with RAVH. Obviously there are other anatomic differences among patients that preclude the transvaginal approach for some women. From an educational standpoint, RAVH must certainly lengthen the learning curve for RH and robotically assisted vaginal cuff closure.⁷

Some obvious operative disadvantages of RAVH include changing operative fields, loss of favorable ergonomics, the need for additional equipment, and a greater degree of vaginal contamination of the operative site.

The significantly greater operative time, postoperative complications, and length of stay for the RAVH group are most likely a reflection of the performance of a lymphadenectomy and less experienced surgeons.

Conclusions

Based on the results of this study, RAVH and RH have similar intraoperative characteristics. RAVH is an alternative to RH for selected patients that may offer some theoretic advantages for women with endometrial carcinoma, especially in a training program.

Footnotes

Disclosure Statement

No competing financial conflicts exist.

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