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ORIGINAL RESEARCH

Randomized Trial of Suture Versus Electrosurgical Bipolar Vessel Sealing in Vaginal Hysterectomy

Levy, Barbara MD; Emery, Laura

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Hysterectomy is the most common non–pregnancy-related gynecologic surgical procedure performed in the United States. It has been estimated that one in three women will have a hysterectomy by the age of 60.1 A large proportion of hysterectomies are performed abdominally or laparoscopically, with fewer than 30% performed vaginally in most series.1 However, when hysterectomy is performed for benign conditions, the vaginal approach should be considered. The literature is replete with examples showing vaginal hysterectomy to be associated with decreased hospital costs, decreased length of stay, fewer complications, and a shorter period of convalescence relative to abdominal and laparoscopically assisted vaginal hysterectomy.1–5 Vaginal hysterectomy can safely be done in the outpatient setting and has been shown to be a viable alternative to an inpatient procedure, further decreasing costs without compromising patient satisfaction.2 Of particular concern for the vaginal surgeon is the ability to access, visualize, and ligate structures while maintaining adequate hemostasis. Just as new technologies have permitted the growth of laparoscopic surgery, a new method for achieving hemostasis may permit vaginal surgery in all but the most complicated of cases.

Technological advances in hemostatic methodology have provided the surgeon with a number of alternative methods for achieving hemostasis. Surgical clips, staples, and sutures are among some of the mechanical means of vessel ligation, whereas high frequency electrosurgery, ultrasonics, and lasers represent the bulk of energy-based technologies at the surgeon's disposal. Each modality has its strengths and weaknesses. All of the mechanical methods introduce foreign bodies into the patient and, perhaps with the exception of sutures, carry an increased cost. In addition, these mechanical methods may be cumbersome for the vaginal surgeon faced with limited visibility and access and risk patient injury from “blind” suturing.

Lasers carry such a high associated capital investment that they are rarely used in general gynecologic surgery. Ultrasonic technology has the ability to achieve hemostasis with limited collateral thermal damage; however, it is only labeled for vessels up to 2 mm in diameter, thereby restricting its application in many procedures. High-frequency electrosurgery has traditionally been the workhorse in the operating room, and recent development of an electrosurgical bipolar vessel sealer (The LigaSure System; Valleylab, Boulder, CO) offers the vaginal surgeon a safe and effective alternative hemostatic method.

The electrosurgical bipolar vessel sealer consists of a specialized electrosurgical generator and handset and can effectively seal vessels and vascular bundles up to 7 mm in diameter. This new energy-based technology uses an alternate form of electrosurgery to denature collagen and elastin in vessel walls and subsequently reform these proteins into a hemostatic seal. The performance of this technology, reflected in the seal burst strength, depends on the application of mechanical energy or pressure in conjunction with the delivery of electrical energy. The simultaneous delivery of mechanical and electrical energy remodels the vessel tissue to form a desiccated absorbable collagen seal out of native vessel protein.

During activation the specialized electrosurgical generator measures both voltage and current to monitor tissue response. As tissue impedance changes because of resistive heating, voltage and current will vary accordingly. When tissue response indicates a successful seal, a cool cycle is entered, during which time the device position is maintained and no power is delivered. After the cooling period, the generator emits an audible tone to indicate cycle completion. On average, the entire sealing and cooling cycle takes approximately 5 seconds.

The current study is the first to examine use of the electrosurgical bipolar vessel sealer during vaginal hysterectomy in a randomized, controlled fashion. The objective of this trial was to compare procedure time and blood loss with the use of the electrosurgical bipolar vessel sealer versus sutures.

MATERIALS AND METHODS

Between December 1999 and April 2001, 60 women, 18 years or older and scheduled to undergo vaginal hysterectomy for benign disease, voluntarily consented to participate in this study. The study protocol and patient informed consent were reviewed and approved by the Franciscan Health System Medical Research Evaluation Committee. The study was performed by a single surgeon at St. Francis Hospital in Federal Way, Washington, a 110-bed suburban hospital south of Seattle.

A priori calculations indicated that a sample size of 30 subjects in each treatment arm would have 80% power with 95% confidence to detect a 20% difference between procedure times with electrosurgical bipolar vessel sealer versus suture.

Patients were randomly assigned to one of two hemostatic methods: 1) electrosurgical bipolar vessel sealer or 2) suture. Randomization was completed via the SAS statistical package (SAS Institute Inc., Durham, NC). Sealed envelopes containing the assignment for each patient were opened just before the surgical procedure (Figure 1).

Figure 1
Figure 1:
Participant flow diagram. Levy. Vessel Sealing in Vaginal Hysterectomy. Obstet Gynecol 2003.

Vaginal hysterectomy was performed in a standard fashion for both study groups. In patients with difficult vaginal access, a Deavor retractor was used posteriorly in lieu of the standard weighted speculum. The procedure began with a paracervical block using a combination of 6 U of vasopressin diluted in 30 mL of 0.75% bupivicaine with 1:200,000 epinephrine. A posterior culpotomy incision was made using monopolar electrosurgery and scissors, and the uterosacral ligaments bilaterally were clamped, cut, and suture ligated in traditional fashion. The uterosacral pedicles were held for use in closing the vault at the conclusion of the procedure. The electrosurgical bipolar vessel sealer device consists of a standard-size Heany-type clamp modified to accept a disposable bipolar electrode on the inner surface of its jaws. The clamp is used in exactly the same fashion as standard hysterectomy clamps. Pedicles are clamped, sealed, and then cut on the uterine side before the clamp is released and advanced to the next pedicle. Back bleeding is virtually eliminated by traction on the cervix after the vasopressin injection. For those patients randomized to electrosurgical bipolar vessel sealer, the device was used on all pedicles beginning with the cardinal ligament, the broad ligament including the uterine arteries, and the round and uteroovarian ligaments. The suture arm consisted of suture ligation employing a polyglycolic suture. Closure of the vaginal cuff was identical in both study arms. The posterior cuff was closed with a running whipstitch of polyglycolic acid suture incorporating the uterosacral–cardinal complex at each angle. The round ligament pedicles were attached to the anterior vaginal mucosa, and the mucosa was closed side to side and attached to the uterosacral–cardinal complex, thereby closing the pubocervical ring. Procedure time for the vaginal hysterectomy portion of all cases was measured from initial mucosal injection to complete closure of the vaginal cuff with satisfactory hemostasis. Blood loss was estimated by the anesthesia service to guard against potential surgeon bias. Additional data collected include length of stay, uterine mass, and postoperative morbidity. Postoperative complications were assessed via patient diaries maintained for 30 days after the procedure and by two follow-up clinic visits that occurred at 3 and 6 weeks after the procedure.

Data were analyzed with the Student t test if data were determined to be normally distributed or with the Wilcoxon rank-sum test for nonparametric data. All comparisons were two tailed, with a P value less than .05 considered significant. All analyses were completed using SAS statistical software (SAS Institute).

RESULTS

Thirty patients were randomized into each hemostasis modality. All women who signed consent forms ultimately took part in the study. The two groups were similar in age, body mass index (BMI), uterine mass, and parity (Table 1). Although the electrosurgical bipolar vessel sealer group did have a statistically shorter mean length of stay (P = .03), this is not clinically significant because the majority of patients (78%) were treated on an outpatient basis. Thirteen women were kept overnight because they were elderly, had medical complications, or lived on an island with limited access to emergency health services. Inpatient subjects did not differ significantly from outpatient subjects in age, BMI, uterine mass, or parity (Table 2).

Table 1
Table 1:
Patient Characteristics by Hemostasis Modality (Mean ± Standard Deviation, Median, Range)
Table 2
Table 2:
Patient Characteristics by Inpatient Versus Out-patient Status (Mean ± Standard Deviation, Median, Range)

The majority of subjects underwent multiple procedures in addition to vaginal hysterectomy, including salpingo-oophorectomy and vaginal repair. Total time and vaginal hysterectomy procedure time were assessed. Use of electrosurgical bipolar vessel sealer resulted in statistically shorter total and vaginal hysterectomy procedure times: The mean vaginal hysterectomy procedure time for the electrosurgical bipolar vessel sealer arm was 39.1 ± 17.7 minutes, versus 53.6 ± 26.7 minutes for the suture arm (P = .003). Mean estimated blood loss was also statistically less in the electrosurgical bipolar vessel sealer arm: 68.9 ± 51.6 mL versus 126.7 ± 113.3 mL for the suture arm (P = .005) (Table 3).

Table 3
Table 3:
Procedure Parameters (Mean ± Standard Deviation, Median, Range)

There were no cases of postoperative hemorrhage or return to the operating room in either arm of the trial. Two patients in the electrosurgical bipolar vessel sealer arm experienced complications: One reported right leg weakness that resolved within days without treatment, and the second patient experienced cystitis treated with oral antibiotics. One suture patient experienced femoral neuropathy that cleared without treatment 2 days after surgery. This patient had a spinal anesthetic and a long procedure (160 minutes). Another patient in the suture arm was readmitted 9 days after surgery with a pelvic abscess. This was treated with antibiotics and percutaneous drainage and resolved without sequelae. Indigo carmine dye was given intravenously in all cases. Cystoscopy was not performed. If thermal injury had taken place, it would have created delayed tissue injury and obstruction or perforation of the ureter undiscoverable during intraoperative cystoscopy. There was no evidence of collateral tissue injury or injuries to the urinary or intestinal tract in either arm. Because of the small sample size, statistical significance of the difference in complications rates (two of 30 [6.7%] for electrosurgical bipolar vessel sealer and three of 30 [10%] for the suture arm) cannot reliably be determined.

DISCUSSION

Hysterectomy is one of the most commonly performed gynecologic procedures. Over the past several years, approximately 600,000 hysterectomies have been performed annually in the United States.1 Though there exist multiple surgical approaches for hysterectomy for benign causes, vaginal hysterectomy is the ideal minimally invasive technique. Vaginal hysterectomy has been associated with decreased costs, shorter lengths of stay, and lower complication rates relative to abdominal hysterectomy and laparoscopically assisted vaginal hysterectomy.3,6,7 The rapid recovery time associated with vaginal hysterectomy allows the procedure to be safely performed in the outpatient setting, further decreasing the costs, both financial and emotional, associated with inpatient hospital stays.2 Despite these positive reports, the abdominal approach continues to be performed in the vast majority of patients. Kovac devised a system of guidelines in 1995 to encourage vaginal hysterectomy in an increasing number of patients. He and several others have demonstrated that vaginal hysterectomy may be performed in as many as 95% of patients presenting for surgery with benign conditions.3,7–15 In the author's private practice over 90% of all hysterectomies have been completed vaginally in the last decade.

Surgeons must be provided adequate training in the performance of vaginal hysterectomy so that the difficulty associated with adequate access to crucial structures does not result in overuse of the abdominal or laparoscopic approach for benign conditions. In addition, patients should be educated as to the expected outcomes of vaginal hysterectomy in terms of convalescence and postoperative pain such that the vaginal approach becomes routine for hysterectomy for benign indications. Along with appropriate training and education for both the surgeon and the patient comes the need for appropriate surgical tools to facilitate successful conversion to the vaginal route.

Patients with morbid obesity, significantly enlarged uteri, narrow vaginal canals, and contracted pelvises continue to pose a surgical challenge. Placing sutures high in the pelvis, under and around a narrow pubic arch, is difficult and often quite frustrating. Not only is it difficult to see in these regions, but also accurately placing a stitch and retrieving the needle is problematic. These difficulties may lead to increased blood loss, necessitating conversion to laparoscopic or abdominal approaches. Electrosurgical bipolar vessel-sealing technology seems uniquely suited for vaginal surgery. The surgical steps other than placement of suture are identical to those used during standard vaginal hysterectomy. Pedicles can be controlled rapidly and effectively with this device, virtually eliminating the need for suture except for reconstruction of the vaginal vault. Although in skilled hands vaginal hysterectomy may be performed using standard techniques even in difficult patients, the electrosurgical bipolar vessel sealer technology should permit the less experienced vaginal surgeon an opportunity to expand the indications for vaginal hysterectomy.8 Mastering coring and morcellation techniques is certainly more tolerable in a clean, dry operative field. The electrosurgical bipolar vessel sealer is a tool that facilitates access, minimizes procedural time, and decreases blood loss relative to sutures in the complicated vaginal hysterectomy case. When the competent surgeon is equipped with such devices, conversion of an abdominal hysterectomy to the vaginal route is both attainable and preferred.

In this series of randomized patients, all candidates for hysterectomy with benign disease were treated vaginally. Operative times compare favorably to those reported in other series of vaginal hysterectomies for non-prolapsed or enlarged uteri, and blood loss was insignificant.10–13,16 In the current study, use of electrosurgical bipolar vessel sealer resulted in a 27% reduction in operative time and a 47% reduction in blood loss. More importantly, however, this technology may permit more gynecologists the ability to perform vaginal surgery in difficult patients with minimal complications. Increasing the number of hysterectomies performed vaginally should translate into reduced morbidity and increased productivity for women while decreasing hospital length of stay and overall costs.

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© 2003 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.