Hysterectomy for Large Sized Uteri with Benign Pathology: Total Laparoscopic or Vaginal Hysterectomy Using Blood Vessel Sealing Systems? Analysis of 514 Patients

Abstract

Objective: The goal of this research was to compare surgical outcomes of vaginal hysterectomy (VH), using a bipolar vessel sealing system (BVSS; Ligasure,® Valleylab, Boulder, CO), with total laparoscopic hysterectomy (TLH) for patients with large uteri. Materials and Methods: Design: This was a dual-center, retrospective analysis (Canadian Task-force Classification II −3) that took place in two tertiary-care hospitals. Patients: Reviews were performed on hospital records of women with large uteri (uterine weight ≥500 g) who underwent VH or TLH for benign indications between the years 2003 and 2011. Evaluations were conducted on a total of 1988 VH cases, using BVSS, performed in the Minimally Invasive Gynecological Surgery Unit of Valdese Hospital, in Turin, Italy, and 1529 TLH cases, in the department of Obstetrics and Gynecology of the Sacred Heart Hospital, in Negrar, Italy. Data for patients' demographics, indications for surgery, patient histories with respect to previous surgeries, duration of surgeries, blood loss, perioperative complications, and length of in-patient stays were collected from the medical records. Exclusion criteria were: coexistence of uterine, cervical, or ovarian malignancy; uterine-vaginal prolapse; reconstructive pelvic surgery; and associated or other concurrent procedures. Intervention: The intervention analyzed was VH using a Ligasure BVSS and TLH. Results: The two groups were homogenous with respect to demographic data and indications for surgery. The groups were significantly different for mean operative time (VH: 74.7 ± 34 versus TLH: 139.4 ± 57 minutes; p < 0.005); mean hospital stay (VH: 1.5 ± 1.1 versus TLH: 2.8 ± 1.6 days; p < 0.05); mean blood loss (TLH: 184.6 ± 211.3 mL versus VH: 478 ± 627.4 mL; p < 0.005). The overall complication rates were 16.25% in the VH versus 10.61% in the TLH group (p = 0.003). Conclusions: In expert hands, both techniques seem to be feasible and relatively safe for enlarged uteri. VH using BVSS results in reduced operative time and hospital stay. Total laparoscopic hysterectomy results in lower blood loss and a lower incidence of perioperative complications, compared with VH, using BVSS. (J GYNECOL SURG 32:324)

Introduction

Hysterectomy remains the second most common gynecologic operation, after cesarean section. Three main approaches are available to perform hysterectomy: abdominal; vaginal; and laparoscopic routes. For large uteri with benign pathologies, the abdominal approach has been most commonly used, as large uterine dimensions were considered to be a limitation for laparoscopic and vaginal routes.¹ Laparoscopic hysterectomy (LH) for large uteri has been the focus of controversial comments.^2,3

Vaginal hysterectomy (VH) is becoming widely utilized for nonprolapsed uteri with benign uterine diseases. Some studies support the choice of VH as an alternative to abdominal hysterectomy for enlarged uteri.^4–7

During the last decade, there has been a quest for efficient and fast hemostatic techniques that can replace conventional suture ligatures safely for the VH approach.^8–10 The use of a variable bipolar vessel sealing system (BVSS) has been evaluated in gynecologic surgery, and there is a general consensus about the effectiveness and safety of using a variable BVSS in hysterectomy, with its variable approaches and degrees of difficulty.^11–16

The purpose of this study was to compare surgical and perioperative outcomes of women with large uteri estimated to weigh at least 500 g, undergoing either VH, using a BVSS (Ligasure,® Valleylab, Boulder, CO), or total laparoscopic hysterectomy (TLH).

To the best of the current authors' knowledge, this is the first study to compare these two minimally invasive approaches to hysterectomy for enlarged uteri in a large series of patients.

Materials and Methods

Patients and methods

A review was conducted of medical records of consecutive patients who underwent hysterectomy for enlarged uteri (weight ≥500 g) in two tertiary-level referral centers from January 2003 to December 2011. The patients were divided into two groups: 1988 patients (VH group) who underwent VH with the Ligasure BVSS; and 1529 patients (TLH group) who underwent TLH. The surgeries for the VH cases, using BVSS, were performed in the Minimally Invasive Gynecological Surgery Unit of Valdese Hospital, in Turin, Italy, and the surgeries for the TLH cases, were performed in the department of Obstetrics and Gynecology of the Sacred Heart Hospital, in Negrar, Italy. All the procedures were performed by skilled surgeons from each center. In both centers, retrospective observational studies are exempt from institutional review board approval. The perioperative and postoperative outcomes were compared for both groups.

Exclusion criteria were: coexistence of uterine, cervical or ovarian malignancy; uterine-vaginal prolapse; reconstructive pelvic surgery; and associated or other concurrent procedures. There were 203 patients included in the (VH) group and 311 included in the (TLH) group. The following data were retrieved from the computer-based hospital records: patients' demographic data; medical and surgical history; indications for surgery; and surgical duration. In vaginal surgery, operating time was considered from the first incision to the end of vaginal suture, whereas in laparoscopic approach from the induction of pneumoperitoneum to the end of suture of laparoscopic access.

Some patients underwent cystoscopy at the end of the hysterectomy (especially in the TLH group), and these patients are also included in the data reported herein, because this procedure also takes only a few minutes and does not contribute to patients' morbidity.¹⁷ Estimated blood loss, in mL, was measured at the end of surgery, using standard operating room routines, from a collimated collection canister. Uterine weight was measured in grams after surgery, without any adnexa. Perioperative complications (intraoperative and early postoperative) were defined as registered unfavorable events related to the operation, from the day of surgery until 2 weeks postoperatively. Data were retrieved with respect to types of complications, their durations, actions taken, and outcomes. Major complications were considered to be conversion to laparotomy, hemorrhage requiring blood transfusion, blood loss ≥1000 cc, or a second surgical procedure to establish adequate hemostasis, and repair of urinary tract injury or bowel perforation. Hospital stay was defined from the hour of admittance and lasted until the hour of discharge.

Surgical techniques

Vaginal hysterectomy using BVSS

This operation was performed under general or spinal anesthesia. Each patient was draped and placed in a lithotomy position, with her thighs at an angle of 90°. A urinary catheter was left in place during the operation. Four retractors were positioned into the vagina to expose the cervix, which was firmly grasped. A circumferential vaginal incision was made around the cervix. The anterior vaginal fornix was opened, the bladder was mobilized, the uterovesical fold was exposed and incised, and the pouch of Douglas was exposed and incised. The order of peritoneal opening was inverted in cases in which the opening of the uterovesical pouch was not feasible at the beginning of the operation. The uterosacral ligaments—the cardinal ligaments containing the uterine vessels—were coagulated and transected, using a Ligasure clamp to achieve hemostasis. The anterior and posterior leaflets of the broad ligament were coagulated together and cut in proximity to the uterine wall. The adnexa and round ligaments were divided and separated from the uterus after achieving hemostasis with the Ligasure.

Depending on whether or not the adnexae were to be removed, either the infundibulopelvic or the ovarian ligaments were grasped, coagulated, and cut. In case of failure of systematically completing the whole process, because of the uterine size, vaginal hysterectomies were performed using volume-reduction techniques—intramyometrial coring, corporal bisection, and morcellation—before or after complete uterine devascularization. After removal of the uterus, a McCall culdoplasty was performed and the vaginal cuff was closed using a continuous suture, without peritonization.

Total laparoscopic hysterectomy

This operation was performed under general anesthesia with the patient in a modified lithotomy position after insertion of a uterine manipulator. A Veress needle was inserted at the umbilicus or at the Palmer's point (a point 3 cm below the left costal margin in the midclavicular line). After insufflations with carbon dioxide, a 10-mm trocar was inserted at the umbilical site or higher depending on the size of the uterus. Three other 5-mm accessory ports were inserted under vision: one in the left lateral upper quadrant, the second in the right lateral upper quadrant, and the third port subumbilically. If necessary, in the case of a very large uterus, the subumbilical trocar was not inserted and lateral lower quadrants were bilaterally placed.

The pelvis and the abdomen were inspected and adhesions, if present, were lysed first. The course of the ureters was traced at the start of the procedure. The round ligaments were then coagulated, using bipolar coagulation, and cut. The peritoneum of the uterovesical fold was identified and opened from the round ligaments on either side. The bladder was dissected down completely. A window was created in the posterior leaflet of the broad ligament close to the uterine vessels. If the ovaries needed to be removed, the infundibulopelvic ligaments were dissected, coagulated, and cut. When adnexectomy was not required, the cornual pedicles were secured and cut. The uterine vessels were identified and, after confirming the position of the ureters, they were desiccated with bipolar coagulation and cut. Afterward, the uterosacrals and cardinal ligaments were dessicated and cut. A vaginal incision was made with a unipolar hook, using the ceramic cup of the uterine manipulator as a guide. The completely freed uterus was laparoscopically morcellated with a cold knife, if necessary, and then pulled into the vagina. The vaginal vault was sutured laparoscopically, using delayed absorbable running sutures with intracorporeal knots, anchoring the uterosacral ligaments to the vaginal vault.

Statistical analysis

All statistical analysis was performed using Statistical Package for Social Sciences (SPSS, Version 18 for Windows; SPSS, Inc., Chicago, IL). All tests were conducted using a p-value of 0.05 for statistical significance. The data were expressed as mean ± standard deviation (SD) and median (range) for continuous variables, and categorical variables as number of cases (n) and percentage of occurrence (%). Between-group differences were analyzed with a χ² test. Fisher's exact test was used for categorical data. Kruskal–Wallis test and analysis of variance (ANOVA) were used for continuous variables. When ANOVA revealed a difference within the three treatment groups, a posthoc comparison using a Bonferroni correction was performed to determine which means or medians were significantly different from each other.

Results

Demographic data and indications for hysterectomy are summarized in Table 1. Pathologic reports were mainly myoma growth and dysfunctional uterine bleeding.

Table 1.

Demographic Data and Main Indications for Hysterectomy ^a by Approach

Demographics	TLH group (n = 311)		VH group (n = 203)
Age (mean ± SD)	48.2 ± 3.4		49.1 ± 2.9
BMI (mean ± SD)	24.2 ± 1.8		25.1 ± 3.6

Indications for surgery ^a	n	%	n	%
Myomas	247	79.4	164	80.7
Adenomyosis	3	0.96	3	1,48
Dysfunctional uterine bleeding	147	47,26	73	35.96
Dysmenorrhea or pelvic pain	60	19.29	14	6.89

Mono or bilateral ovariectomy was an associated procedure in 32% and 54% of cases for vaginal and laparoscopic hysterectomy, respectively. Incidental occurrence of endometriosis was found in 56/311 cases of laparoscopic hysterectomy.

Some patients had more than one indication reported.

SD, standard deviation; BMI, body mass index; TLH, total laparoscopic hysterectomy; VH, vaginal hysterectomy.

Table 2 shows operative parameters, surgical outcomes, and postoperative hospital stays in the two groups. The postoperative hospital stays in the VH group were significantly shorter than those of the TLH group (1.50 ± 1.10 days versus 2.82 ± 1.61 days; p = 0.000). The mean estimated blood loss in the TLH group was significantly lower, compared with that of the VH group (184.62 ± 211.34 mL versus 478.08 ± 627.39 mL; p = 0.000).

Table 2.

Surgery-Related Outcomes by Groups

	Mean ± SD
Outcome	TLH group (n = 311)	VH group (n = 203)	p-Value
Operative time (minutes)	139.42 ± 57.01	74.71 ± 34.04	0.0000
Uterus weight (g)	773.22 ± 332.32	695.60 ± 250.64	NS
Blood loss (mL)	184.62 ± 211.34	478.08 ± 627.39	0.0000
Hospital stay (days)	2.82 ± 1.61	1.50 ± 1.10	<0.05

SD, standard deviation; TLH, total laparoscopic hysterectomy; VH, vaginal hysterectomy; NS, not significant.

Mono or bilateral ovariectomy was an associated procedure in 45% and 51% of cases, respectively, for the VH and TLH groups (p > 0.05).

The mean operating time was significantly shorter with VH than with TLH (139.42 ± 57.01 versus 74.71 ± 34.04 minutes; p = 0.00)

With respect to intraoperative complications, the TLH and VH groups required blood transfusions in 3 and 4 cases, respectively. Postoperative complications in the TLH group included 5 cases of febrile morbidity, 1 case of vaginal suture dehiscence, 1 pelvic hematoma and 1 case of temporary urinary retention. A ureterovaginal fistula was found in 1 case each for both the TLH and VH groups. Bladder injury, rectum perforation, and ureteral stenosis were found in 3 cases in the VH group; there were no cases of these conditions in the TLH group. Data are summarized in Table 3. Conversion to the abdominal route was required in 3 cases in the VH group and in 10 cases in the TLH group. The overall complication rate in the TLH group was 10.61%; in the VH group, the overall complication rate was 16.25% (p = 0.003).

Table 3.

Perioperative Complications ^a

	TLH group (n = 311)		VH group (n = 203)
Complications	n	%	n	%	p-Value
Minor complications
Bladder lesion	0	0	1	0.49
Fever (> 38°C)	5	1.60	0	0
Urinary retention	1	0.32	0	0
Major complications
Hemorrhage	13	4.18	26	12.80
Blood loss ≥1000 mL	10	3.21	22	10.83
Blood transfusion	3	0.96	4	1.97
Ureterovaginal fistula	1	0.32	1	0.49
Vaginal suture dehiscence	1	0.32	0	0
Intra-abdominal bleeding requiring reintervention	1 (late onset)	0.32	1 (perioperative)	0.49
Ureteral stenosis	0	0	1	0.49
Rectal perforation	0	0	1	0.49
conversion to laparotomy	10	3.21	3	1.47
All	33	10.61	33	16.25	<0.05

Some patients might have had more than one complication reported.

Discussion

In the literature, there is a general consensus that vaginal and laparoscopic routes should be considered more beneficial, if compared with laparotomic hysterectomy in cases of benign uterine diseases.¹ Such superiority of minimally invasive approaches for hysterectomy, however, is controversial, in cases of patients with enlarged uteri.^18–20

Distortion of normal anatomy (especially the ureters and the uterine vessels), poor exposure, and difficulty with establishing secure hemostasis of the uterine vessels can increase the potential risk of vascular, bladder, ureteric, and bowel complications associated with the minimally invasive approach for removing large uteri. These factors are usually compounded by the technical difficulty involved in extracting such uteri. Therefore, in many centers, it is usually suggested that enlarged uteri are a contraindication for laparoscopic or vaginal hysterectomy.

The recent advances in laparoscopic and vaginal surgery, allowed better exposure of the surgical fields and permitted the development of efficient and fast hemostatic techniques that can replace conventional suture ligature safely.¹¹ The use of variable BVSS has been evaluated in vaginal hysterectomy with variable degrees of difficulty.^8–16

There is a paucity of studies that compare VH and TLH for removal of large uteri. Two studies compared the outcomes of conventional VH with those of laparoscopically assisted vaginal hysterectomy (LAVH) in women with enlarged uteri. The researchers did not find any significance in the overall complication rates between the two approaches and concluded that performing LAVH had no advantages compared to with standard VH.^21,22

Kim et al. compared total vaginal hysterectomy (TVH) and TLH for large uteri weighing >300 g. These researchers found a shorter operating time and a longer hospital stay in their TVH group. However, the overall perioperative complication rate was similar in both groups.²³

To the best of the current authors' knowledge, no previous studies have compared VH using BVSS to TLH for removal of large uteri. According to the current study's results, there was a significant reduction of intraoperative blood loss with TLH, compared to the VH, despite the use of BVSS for performing that procedure. In this current series, the difference in blood loss was considerably high, being almost three times greater with the vaginal approach. This finding can be explained by the technical differences in performing the two operations. During TLH, complete devascularization preceded volume reduction. The uterus was completely freed first, using bipolar coagulation, and cutting all the vessels and ligaments, and then morcellating the uterus and removing it from the pelvis. In VH, however, volume reduction techniques (intramyometrial coring, corporal bisection, and morcellation) usually were performed after coagulation of uterine vessels but before coagulation of the utero-ovarian, infundibulopelvic, and round ligaments. In other words, volume reduction could start before complete devascularization. Many factors influenced the time requested to reduce the uterine volume enough to reach those vascular structures (the presence of multiple fibroids, the dimension, number and position of fibroids, the presence of pelvic adhesion and the compliance of vagina).

This technical difference in the sequence of these two steps (devascularization and volume reduction) can also be used to explain the longer operating time in the TLH group, compared to VH group. In TLH, laparoscopic reduction of uterine volume and its removal from the pelvis is a second separated step that is usually long. This procedure requires a consistent amount of time because of the technical difficulty caused by the limited space in which volume reduction is performed very close to important intra-abdominal structures. However, in VH, the two steps are performed contemporarily. In this case, after safe coagulation of the uterine vessels by BVSS, progressive reduction of uterine volume made by suitable reduction techniques, allows the surgeon to reach all the structures that connect the uterus with the pelvis. Volume reduction is then followed by safe completion of devascularization and freeing the uterus from its attachments, with its subsequent removal. Oophorectomy in both procedures did not prolong the duration of surgery significantly and did not raise the incidences of complications in both groups.

Although it was not statistically different, laparotomic conversions were more frequent in the TLH group. Difficult uterine mobility and poor exposure of the uterine vessels during laparoscopy were the main impetus for conversion to laparotomy, because of the impossibility of completing the procedure safely. In VH, however, poor mobility and difficult descent of uterus, during uterine-volume reduction did not impede completion of this minimally invasive approach.

In the current series, hospital stay was significantly less in the VH group. However, in the present study, hospital stay could be considered only partially connected to the surgical procedure performed. Given that there were two different groups operated on in two different centers, discharge of patients depended also on the postoperative protocols adopted in each center.

To the current authors' knowledge, this study evaluated the largest number of patients undergoing hysterectomy for enlarged uteri, with TLH or with VH using a BVSS technique, to date. A possible limitation of the present study was its retrospective nature, with the potential inaccuracy of calculation of the surgical data (e.g., operative time and blood loss). This study attempted to present everyday experience with these procedures, operating on patients with different indications and in variable situations in tertiary-care centers. The large number of evaluated patients may add to the significance of the obtained results. However, another limitation to the generalization of the conclusions of the present study is the nonvariability in the levels of surgeons' training. The presented data originated from two homogenous teams with consistent backgrounds and high levels of surgical training in each team with respect to performing each technique.

This study was not sufficient to generalize the indication or demonstrate safety or feasibility of either of the techniques in difficult hysterectomies with enlarged uteri. Further statistically powered, randomized controlled trials are needed to determine which approach is better for hysterectomy in patients enlarged uteri, with benign pathologies.

Conclusions

In expert hands, both techniques seem to be feasible and relatively safe for enlarged uteri. VH using BVSS results in reduced operative time and hospital stay. TLH results in lower blood loss and a lower incidence of perioperative complications, compared with VH, using BVSS

Footnotes

Disclosure Statement

No competing financial conflicts exist.

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