The Clinical Utility of a Pulsed Bipolar System and Its Electrosurgical Device During Total Laparoscopic Hysterectomy

Abstract

Objective:

The aim of this research was to evaluate the efficacy and safety of the PlasmaKinetic™ (PK) PKS OMNI® (Gyrus ACMI, Maple Grove, MN) sealing device in laparoscopic hysterectomy.

Materials and Methods:

For this retrospective observational study, 60 patients who underwent multiport total laparoscopic hysterectomy between January 2014 and January 2015 in a tertiary-care university-based teaching hospital and an academically affiliated hospital were included in this study. The PKS OMNI is a bipolar electrosurgical device that takes energy from a PK generator workstation G400. This pulsed wave system has two different modes; cutting (High Cut 1,2,3) and coagulation (Vaporization 1,2,3).

Results:

Records of 60 patients were analyzed. The median age was 50 (range: ages 40–84), median body mass index was 26 kg/m² (range: 22–32 kg/m²), and median parity was 2 (range: 1–8). The median total operation time was 100 minutes (range: 70–240 minutes), estimated blood loss was 80 mL (range: 30–250 mL), and uterine weight was 207 g (range: 50–900 g). Degree of Surgical Difficulty and postoperative pain scores at rest were evaluated with a visual analogue scale system, from 0 to 10, and the medians of these scores were 5 (range: 3–7) and 4 (range: 2–6), respectively. The median recovery time of bowel movement was 16 hours (range: 8–26 hours), median spontaneous urination time was 7 hours (range: 4–29 hours), and median postoperative mobilization time was 8 hours (range: 6–10 hours). Conversion to laparotomy was needed in 1 patient due to severe pelvic adhesions. The median duration of hospital stay was 2 days (range: 2–4 days). Vaginal cuff dehiscence was detected in 1 (1.7%) patient who engaged in sexual intercourse on the 122nd day after surgery. Cuff cellulitis in 1 (1.7%) patient and unexplained fever in 1 (1.7%) patient were the other recorded complications. The median follow-up time was 12 months (range: 6–17 months).

Conclusions:

The PKS OMNI is a novel, underused energy modality that promotes quick recovery and acceptable operation time with minimal blood loss. (J GYNECOL SURG 33:253)

Introduction

Hysterectomy is one of the most common procedures in the surgical part of gynecologic practice.¹ Within the last 2 decades, technological developments in endoscopic surgery attracted surgeons to the laparoscopic approach. In several studies, the advantages of laparoscopic hysterectomy have been shown with respect to surgical-site infections, postoperative pain scores, length of hospital stays, postoperative intra-abdominal adhesion formations, and patients returning back to daily routines.^2–6

Standard electrosurgery, including monopolar and bipolar electrocautery, is associated with unpredictable and weak vessel sealing and increased lateral thermal spread. Advanced laparoscopic procedures technically depend on adequate hemostasis and tissue dissection to facilitate surgeries. Currently, various electrosurgical devices are commercially available, such as the advanced bipolar or ultrasonic devices used in gynecologic surgery. These devices include a combination of multifunctions such as grasp, dissection, cut, and seal. According to the literature, the efficacy and safety of energy-based surgical devices have been demonstrated in multicenters.^5,7–9

The PlasmaKinetic™ (PK) tissue management system (Gyrus ACMI, Maple Grove, MN) uses pulsed bipolar energy for coagulation. The PK Pulse Generator system delivers intermittent pulses of energy via instruments to the tissue as opposed to conventional continuous bipolar energy. Hence, this mechanism prevents tissue adhesion, as the instrument enables keeping the area between the jaws of the device and the tissue-surface cold. Therefore, lateral thermal injury and tissue sticking is limited. Presthus et al. reported that vessel sealing with a pulsed bipolar system was more useful than clips, sutures, or staples in a porcine model.¹⁰

The PKS OMNI® (Gyrus ACMI) is an electrosurgical instrument available on the market. This instrument delivers multiple tissue effects through its pulse generator system. The PKS OMNI takes energy from a PK generator workstation G400. This pulsed wave system has two different modes. The instrument performs coagulation in a vapor pulse mode and cutting tissue in a PK high-cutting mode.³ PK pulse wave technology provides both high- and low-current voltage together. This mechanism acts in the form of quick pulses, and it enables the instrument to achieve a chilling effect. For this reason, thermal lateral injury risks decrease. The vessels are occluded with coagulum by denaturating the protein on the vascular walls.¹¹

The PK system does not alert the surgeon with a feedback mechanism like other vessel-sealing systems, but a change of sound from the generator warns and helps the surgeon to establish optimal energy delivery.⁵ The PKS OMNI has dual-action jaws enabling adequate mechanical dissection in surgery. The jaws of the instrument affect the utility of the electrosurgical device significantly during an operation. The design of the PKS OMNI also facilitates its grasp capabilities, with advanced bipolar coagulation and sharp cutting functions in the same instrument.

To the current authors' knowledge, no study in the current literature has investigated the use of the PKS OMNI pulsed bipolar energy device in gynecologic endoscopic surgery.

The purpose of this study was to evaluate the safety and efficacy of the PKS OMNI sealing device in laparoscopic hysterectomy and to determine the instrument's functions and possible advantages in the current authors' clinical practice.

Materials and Methods

Study population

Between, March 2014 and January 2015, 60 consecutive patients were enrolled into this study. They had benign conditions and were undergoing multiport total laparoscopic hysterectomy (TLH) involving use of a PK pulse bipolar system. All surgeries were performed by 2 expert endoscopic surgeons using the same dissection techniques and energy modalities. All of the cases in this study had a PK energy system and a PKS OMNI used for the operations. Patients were operated in two affiliated institutions (the Koc University School of Medicine, Istanbul, Turkey and the Istanbul American Hospital, Istanbul, Turkey). Each patient underwent a standard preoperative workup, including pelvic examination, ultrasonography, biochemistry, and magnetic resonance imaging/endoscopy, when indicated. All patients underwent mechanical bowel cleansing, and were given 1 g of Cefamezin (cephalosporin) intravenously as antibiotic prophylaxis as well as low-molecular-weight heparin according to each patient's weight and age. Written informed consent was obtained from all of the participants due to operational risks and possible complications of the gynecologic endoscopic surgery. The trial was approved by the Koc University School of Medicine's institutional review board.

Data collection

Data were collected from the joint electronic medical database system shared by the two hospitals. The data included preoperative examination notes, operative reports, discharge summaries, pathology reports, and outpatient follow-up records. All surgical operations were video-recorded and watched again. An individual laparoscopic hysterectomy worksheet was prepared for each patient, and it was completed at the end of the process. These records were checked every month by a task force to avoid loss of data.

Study variables

The characteristics of each patient, including age, body mass index (BMI; in kg/m²), parity, previous history of vaginal/cesarean delivery or laparotomy, menopausal status, indication for hysterectomy, and comorbidities (hypertension, chronic obstructive pulmonary disease, immunosuppression, diabetes mellitus, etc.) were recorded. Surgical variables were total operation time, estimated blood loss (EBL), uterine weight, extent of surgery (TLH with/without salpingo-oophorectomy or salpingectomy), recovery time of bowel movements, spontaneous urination time, and length of hospital stay. Total operation time was defined as the interval between Veress needle insertion and skin closure.

The schedule was documented by the anesthesia staff. A Degree of Surgical Difficulty (DOSD) score was assessed subjectively by the 2 endoscopic surgeons using a visual analogue scale (VAS), which ranged from 1 (low difficulty) to 10 (high difficulty). This was checked again, according to the video record, for this article. The amount of blood loss was measured by substitution of irrigation and aspiration fluid. Recovery time of bowel movements was accepted as the time between the end of the operation and the beginning of patients' perception of first flatus. A Foley catheter was not used to drain the bladder routinely in all cases; spontaneous urination was anticipated and documented. Intraoperative and postoperative complications were recorded. Length of hospital stay was defined as days between the hospitalization and the discharge of each patient.

A single-layer unidirectional barbed suture closure was used in all subjects. Uterine weight data were obtained from the pathology reports. Vaginal vault dehiscence was described as complete separation of the anterior and posterior leaves of the vaginal epithelium with or without protrusion of intra-abdominal organs. Postoperative vaginal bleeding was divided into two groups, severe and minimal (vaginal spotting). Vaginal spotting was not quantifiable. However, it was evaluated qualitatively according to the patients' reports and findings during follow-up visits. Severe bleeding was defined as continuous heavy bleeding that required blood transfusion to achieve hemodynamic stabilization in the follow-up period.

All patients were hospitalized during the postoperative period. After discharge, in the first months, the patients were called via telephone every week by a special dedicated team that included doctors and nurses. During this contact, each patient was informed again about postoperative complications and warned again about avoiding sexual intercourse until obtaining permission from the surgeon. A postoperative examination was scheduled 45 days after the surgery. Pelvic ultrasonography and digital-vaginal/speculum examination were performed to assess the integrity of the vaginal vault during these visits. Patients were reexamined every 6 months until the end of the first year after surgery. All participants were followed for at least 6 months.

Surgical technique

All procedures were performed under general anesthesia in a dorsal–lithotomy position. After Veress needle insertion, the abdominal cavity was insufflated with CO₂ and pneumoperitoneum was achieved. A 10-mm trocar was placed at the level of the umbilicus (a supraumbilical approach was adopted when the uterus was large), and a 0° or 30° laparoscopic optical device was used. The initial intra-abdominal pressure was set at 20 mm Hg and was maintained at 10–12 mm Hg during the operation. Two lateral ancillary 5-mm trocars—either on the left or the right side—were introduced, depending on the principal surgeon performing the operation. Figure 1 shows the configuration of trocars and the schematic presentation of the operating room (OR).

FIG. 1.

(A) Configuration of trocars. (B) Schematic representation of the operating room.

Adhesiolysis was performed with a PKS OMNI when necessary. In the first step, the sigmoid colon was liberated from the left pelvic sidewall. Next, the round ligaments were coagulated and dissected from the anterior and posterior leaves of the broad ligament. The ureters were exposed and identified by a gentle dissection alongside the posterior leaf of the broad ligament. The vesicouterine plica was dissected from the anterior cervix and pushed downward to expose the colpotomy area. Infundibulopelvic or ovarian ligaments (depending on whether or not the adnexa was removed) were grasped, coagulated, and transected bilaterally. The uterine arteries were then perceived, coagulated three times on different edges, and cut bilaterally with the PKS OMNI. Figure 2 shows the PKS OMNI device during TLH.

FIG. 2.

PKS OMNI® (Gyrus ACMI, Maple Grove, MN) device during total laparoscopic hysterectomy. (A) Cutting of round ligament. (B) Dissection of bladder peritoneum. (C) Ligation of uterine artery.

A sharp malleable curette was initially placed into the uterine cavity to manipulate the uterus. Before colpotomy, the curette was replaced with a Clermont-Ferrand uterine manipulator (Karl Storz, GmbH, and Co., Tuttlingen, Germany). The ceramic cup of the uterine manipulator was pushed upward firmly to delineate the colpotomy incision site. The incision was initiated at the uppermost part of the anterior vagina, and colpotomy was performed over the cup of the uterine manipulator to preserve the essential parts of the uterosacral and cardinal ligaments. L-hook monopolar electrocautery at a 40-W cutting mode was used to transect the vagina circumferentially. Colpotomy was performed from the upper limit of the cervicovaginal junction, thereby preserving the cardinal and the uterosacral ligaments. A specimen was removed vaginally either in toto or by morcellation in cases with large uteri.

Vaginal cuff closure was performed with a single-layer technique using a unidirectional 3/0 V-Loc™ 180 (Covidien Healthcare, Mansfield, MA) unidirectional barbed suture. The first bite of the suture was locked by a loop at one side of the vaginal vault. Suturing was continued to the other end and completed without tying a knot at the other end. Each bite was taken with 1-cm margins, incorporating the pubocervical facial ring and the vaginal mucosa. The unidirectional barbed suture was not stitched backward, and the rest of the suture was cut flush over the vaginal cuff. Visceral peritoneum of the bladder was left open. Figure 2 demonstrates each step of vaginal cuff suturing.

Statistical analysis

Continuous and categorical variables were measured as median and mean with a standard deviation. Statistical analyses were performed using SPSS software (Statistical Package for the Social Sciences, Version 20; SPSS Inc., Chicago, IL).

Results

Records of 60 patients were analyzed. Their median age was 50 (mean: 52 years; range: 40–84 years), median BMI was 26 kg/m² (mean: 25.74 kg/m²; range: 22–32 kg/m²), and median parity was 2 (mean: 1.74; range: 1–8). Of these patients, 26 (43.3%) had histories of vaginal delivery, 38 (69.4%) had previous cesarean sections, and 46 (76.6%) had previous abdominal surgeries (myomectomy in 5 [10.8%], benign adnexal surgery in 3 [6.5%], and cesarean section in 38 [97%]). Sixteen patients (29.9%) were premenopausal, 18 (32.9%) were perimenopausal, and 26 (38.8%) were postmenopausal. The presence of fibroids was the most common indication for hysterectomy (30 patients; 50%). Other indications included: cervical dysplasia (10; 16.7%), benign adnexal mass (9; 15%), early stage endometrial cancer (4; 6.7%), endometrial hyperplasia (3; 5%), breast cancer history with abnormal uterine bleeding (2; 3.3%), and adenomyosis (2; 3.3%). Of the 37 patients with comorbidities, 27 (45%) had only hypertension, 4 (6.7%) had both hypertension and diabetes mellitus, 4 (6.7%) had diabetes mellitus, and 2 (3.3%) had chronic obstructive pulmonary disease. Table 1 summarizes the characteristics of the patients.

Table 1.

Demographic and Clinical Characteristics of the Patients ^a

Characteristics	Laparoscopic hysterectomy with PKS OMNI^b (N = 60)
	Median (range)
Age (years)	50 (40–84)
Body mass index (kg/m²)	26 (22–32)
Parity (n)	2 (1–8)
Previous vaginal delivery	26 (43.3)
Previous cesarean section	38 (69.4)
Previous laparotomy history	46 (65)
Myomectomy	5 (10.8)
Benign adnexal surgery	3 (6.52)
Cesarean section	38 (82.6)
Menopausal status
Premenopausal	16 (26.7)
Perimenopausal	18 (30.0)
Postmenopausal	26 (43.3)
Indications
Uterine fibroids	30 (50)
Cervical dysplasia	10 (16.7)
Benign adnexal mass	9 (15)
Endometrial cancer	4 (6.7)
Endometrial hyperplasia	3 (5)
Adenomyosis	2 (3.3)
Breast cancer history + AUB	2 (1.7)
Comorbidity^c
HT	27 (45)
DM	4 (6.7)
HT + DM	4 (6.7)
COPD	2 (3.3)
None	23 (38.3)

Data are given as median (range) or as # (%), as appropriate.

Gyrus ACMI, Maple Grove, MN.

AUB, abnormal uterine bleeding

COPD, chronic obstructive pulmonary disease; HT, hypertension; DM, diabetes mellitus.

The median total operation time was 100 minutes (mean: 102.45 minutes; range: 70–240 minutes), EBL was 80 mL (mean: 85.16; range: 30–250 mL), and uterine weight was 207 g (mean: 301.86; range: 50–900 g). Bilateral salpingo-oophorectomy (BSO) was performed in 30 (50%) patients, unilateral salpingo-oophorectomy in 3 (5%), and bilateral salpingectomy in 24 (40%).

DOSD and postoperative pain scores at rest were evaluated with a VAS system from 0 to 10, and the medians of these scores were 5 (range: 3–7) and 4 (range: 2–6), respectively. Of 60 patients, 46 (76.7%) had no adhesions, 11 (18.3%) had mild adhesions, and 3 (5%) had severe adhesions. The median recovery time of bowel movement was 16 hours (mean: 16.42 hours; range: 8–26 hours), spontaneous urination time was 7 hours (mean: 7.96 hours; range: 4–29 hours), and postoperative mobilization time was 8 hours (mean: 7.64 hours; range: 6–10 hours). Conversion to laparotomy was needed in 1 patient due to severe pelvic adhesions. This patient was excluded from the final analysis of the results. The median duration of hospital stay was 2 days (mean: 2.11 days; range: 2–4 days). Table 2 summarizes the surgical variables.

Table 2.

Surgical Variables ^a

Variables	Laparoscopic hysterectomy with PKS OMNI® (n = 60) Mean (SD)	Median (range)
Total operation time (min)	102.4 (25)	–
Estimated blood loss (mL)	85.1 (39.2)	–
Uterine weight (g)	301.8 (211.5)	–
Surgical procedure		–
TLH only	3 (5)
TLH + BSO	30 (50)
TLH + USO	3 (5)
TLH + BS	24 (40)
DOSD score	–	5 (3–7)
Post-operative pain score		4 (2–6)
Conversion to laparotomy	1/60 (1.7)
Adhesions
None	46 (76.7)
Mild	11 (18.3)
Severe	3 (5.0)
Recovery time of bowel movement (h)	–	16 (8–26)
Spontaneously urination time (h)	–	7 (4–29)
Postoperative mobilization time (h)	–	8 (6–10)
Duration of hospital stay (d)	–	2 (2–4)

Data are given as mean (standard deviation; SD), median (range), or as # (%), as appropriate.

min, minutes; TLH, total laparoscopic hysterectomy; BSO, bilateral salpingo-oophorectomy; USO, unilateral salpingo-oophorectomy; BS, bilateral salpingectomy; DOSD, Degree of Surgical Difficulty; h, hours; d, days.

Vaginal cuff dehiscence was detected in 1 (1.7%) patient; this followed sexual intercourse on the 122nd day after surgery. The patient was admitted with pain, bleeding, and vaginal evisceration of the bowel. She underwent transvaginal repair of the defect under general anesthesia using 0-coated Vicryl™ (polyglactin 910; Ethicon, Somerville, NJ). She was discharged 3 days later.

Cuff cellulitis (1; 1.7%) and unexplained fever (1; 1.7%) were the other recorded complications. Pelvic or vaginal abscesses and hematoma formations were not observed. Blood transfusions were not required. Table 3 summarizes the incidence of overall complications.

Table 3.

Postoperative Complications

Complications	N = 60	%
Vaginal cuff dehiscence	1/60	1.7
Blood transfusion requirement	None	0
Hematoma formation	None	0
Pelvic or vaginal abscess	None	0
Vaginal cuff cellulitis	1/60	1.7
Unexplained fever	1/60	1.7

The median follow-up time was 12 months (mean: 11.3 months; range: 6–17 months).

Discussion

In the last decade, innovations in laparoscopic instruments, especially those in electrosurgical devices, provided better options for cutting and coagulation while decreasing complication rates significantly.¹² Many studies have shown the benefits of various energy modalities in laparoscopic hysterectomy.^4,5,11,13 In addition, several articles reported the efficacy and safety of a pulsed energy system with PK cutting forceps as an electrosurgical device in laparoscopic hysterectomy.^2,3,14–17 Table 4 shows results in some of this literature.^{2,3,5,15,17,18}

Table 4.

Literature for PKS OMNI Cutting Forceps in Gynecology Practice

First author, year & reference	# of patients	Procedure	Operation time (min)	EBL (mL)	Complications
Ou et al., 2004²	27	TLH or TLH + BSO	64.8	111.8	–
Wang et al., 2005¹⁷	31	LAVH	87.6	196.8	–
Lee et al., 2007¹⁵	38	Laparoscopic radical hysterectomy	171.8	397.4	Rectum perforation (n = 1)
Fanning et al., 2010¹⁸	11	Laparoscopic supracervical hysterectomy +BSO +omentectomy	150	275	Conversion to laparotomy (n = 2)ATN (n = 1)Pneumonia (n = 1)
Cho et al., 2012³	40	TLH	157.3	467.9	–
Aytan et al., 2014⁵	15	TLH or TLH + BSO	51,9	118	Not reported

min, minutes; EBL, estimated blood loss; TLH, total laparoscopic hysterectomy; BSO, bilateral salpingo-oophorectomy; LAVH, laparoscopically assisted vaginal hysterectomy; ATN, acute tubular necrosis.

The ability of a PK pulsed bipolar system for sealing vessels up to 7 mm in diameter was shown by Presthus et al. in porcine models, and it was found to be more effective than with clips, suture, or staples.¹⁰ Table 5 summarizes the comparision of advanced bipolar and ultrasonic devices in laparoscopic surgery.^4,11,13

Table 5.

Comparison of Advanced Bipolar and Ultrasonic Devices in Laparoscopic Surgery

Device	Energy	Desiccation, coaptation	Lateral thermal spread	Tissue transection	Mean burst pressure (mm Hg)	Seal time, (sec)
LigaSure™^a	Advanced bipolar	+	1.8 mm	+	385 ± 76	10.0 ± 0.9
ENSEAL®^b	Advanced bipolar	+	0.98 mm	+	255 ± 80	19.2 ± 1.1
PlasmaKinetic™ PKS OMNI®^c	Advanced bipolar	+	1.5–3.2 mm	Bipolar cutting mode	290 ± 110	11.1 ± 1.0
HARMONIC®^b	Ultrasonic	+	0–3 mm	+	204 ± 59	14.3 ± 1.0

Valleylab, Boulder, CO.

Ethicon, Somerville, NJ.

Gyrus ACMI, Maple Grove, MN.

sec, seconds.

The purpose of the current study was to evaluate the clinical utility of the PKS OMNI electrosurgical device used with a pulsed generator for laparoscopic hysterectomy. Previous studies reported that a PK cutting forceps with a pulsed bipolar system might be safe and efficient for TLH.¹⁶ To the best of the current authors' knowledge, the present study is the first to demonstrate the clinical utility of the PKS OMNI electrosurgical device for gynecologic procedures, especially for TLH.

Ou et al.² evaluated 27 patients who underwent TLH, using PK cutting forceps. Of these patients, 17 had ovary-sparing (OS) and 10 had BSO. The researchers measured the operation time and blood loss for each group. In the OS group, mean operation time was 64.6 minutes and mean EBL was 111.8 mL. In the BSO group, mean operation time was 69.2 minutes and mean EBL was 140 mL. Conversions to laparotomy and intraoperative or postoperative complications were not reported for any of the cases. The duration of hospital stay was not evaluated in this study.²

A study by Cho et al.³ used a pulsed bipolar system in 40 patients who underwent TLH. The mean operation time was 157.3 minutes and the mean EBL was 467.9 mL. In that study, there were no intraoperative and postoperative complications observed. No conversions to laparotomy occurred.³

Wang et al.¹⁷ examined the efficacy of the pulsed bipolar system in laparoscopically assisted vaginal hysterectomy (LAVH) in 31 patients. The mean operative time was 93.4 minutes and the mean EBL was 253.2 mL. No major complications were observed but, in 2 cases, blood transfusion was required due to heavy bleeding (> 500 mL). All procedures were performed without any conversions to laparotomy, and the mean postoperative hospital stay was 3 days.¹⁷

Lee at al.¹⁵ analyzed the efficacy, results, and complications of using a pulsed bipolar system in 38 patients who underwent laparoscopic radical hysterectomy. The mean operation time and EBL were 172 minutes and 397 mL, respectively. In 1 case, rectal perforation occurred during right uterosacral ligament dissection. Postoperative complications were not observed within 60 days of surgery. None of the laparoscopic procedures required conversion to laparotomy.¹⁵

Fanning et al.¹⁸ evaluated the feasibility of laparoscopic cytoreduction with PK cutting forceps for primary advanced ovarian cancer (stage III–IV) in 11 cases. Nine of the 11 cases were debulked successfully without conversion to laparotomy. The researchers reported that there was no residual disease in 45% of patients and that there was a complication rate of 18%.¹⁸

All of these studies evaluated use of a PK cutting forceps. To date, the current study is the first to use the PKS OMNI electrosurgical device in TLH. Operation time and EBL were similar or shorter, compared with studies that used the same bipolar pulsed generator systems with PK cutting forceps. Articles about different energy modalities, such as LigaSure,™ (Valleylab, Boulder, CO), ENSEAL,® (Ethicon, Somerville, NJ), and standard bipolar systems reported similar operation times and blood loss as occurred in the present study.^4,16 Moreover, in spite of the learning curve for the new device, these parameters were better than in previously reported studies that used PK bipolar energy.^2,3 In the current study, mean uterus weight was more than in the previous studies,^2,3 except for the study by Wang et al.¹⁷ LAVH was performed by Wang et al., and they reported that this approach was more feasible and made it easier to remove large uteri.¹⁷

Enhanced design of the PKS OMNI device provides better performance in cutting and coagulation in complex hysterectomies, especially those involving large uterine fibroids. No major complications were observed, except for the case of a 54-year-old patient who was admitted with vaginal cuff dehiscence due to sexual intercourse on the 122nd day after surgery. Unexplained fever and cuff cellulitis were the other postoperative complications observed in 2 cases. Blood transfusion was not required during or after any of the operations. Patients were followed for at least 10 months after surgery. These results were comparable with similar studies in the literature.^3,5,7,17,19

All of these energy instruments produce smoke or a vapor plume during laparoscopic surgery. This situation not only restricts the surgeon's vision but also is a potential health hazard for the OR staff due to its genotoxic and mutagenic properties.²⁰ In the literature, just 1 study examined the smoke plume of the Gyrus PK systems, and the researchers reported that the device had the worst subjective visibility, compared to the HARMONIC® (Ethicon, Somerville, NJ) scalpel, and LigaSure, and ENSEAL devices.²¹ Contrary to this study, the 2 expert surgeons in the present study stated that the PKS OMNI instrument produced less smoke. However, it should be remembered that there are no quantitative data to support this opinion.

In the present study, postoperative pain evaluation revealed a significant decrease in the need for analgesics. This finding may be a result of shorter operation time or reduced thermal injury in the tissue. Several studies evaluated postoperative pain with use of various energy modalities and all of these studies reported substantial decreases in analgesic needs.^18,22,23

The PK pulsed bipolar system has enhanced dissection capability for difficult cases along with effective hemostasis performance. Despite the lack of any quantifiable measurements, the 2 expert surgeons concluded that the device would provide better dissection and was faster when used in cutting mode in cases of obliterated cul-de-sac, dense uterovesical adhesions, and deep pelvic endometriosis. Due to technical problems, the electrosurgical device was not used to ligate the uterine artery branches in 3 cases, and bleeding was controlled by clipping the uterine arteries. These cases comprise a reminder that vessel-sealing instruments, such as uterine clips, should be ready in the OR. However, the PKS OMNI fulfills the need for an extra tool for this procedure and eases the workload of the surgeon and OR staff as reported in previous studies.³

The major limitations of the present study were its retrospective design and absence of a comparison group. In addition, all of the procedures were performed by 2 expert surgeons who used the same instruments and surgical technique; therefore, these results might not apply to general practice.

To the best of the current authors' knowledge, the present study is the first report about the usage of PKS OMNI electrosurgical device during TLH. The findings include all of the parameters that have been mentioned before for various energy modalities in previous articles. This study also provides comparative data for evaluating instruments in the daily practice of surgeons. Another remarkable point is the excellent postoperative recovery of all participants without any early and late complications. This analysis suggests the safety and feasibility of the PKS OMNI as good among the advanced bipolar and ultrasonic vessel sealing systems. Especially fast vessel sealing time, optimal vessel burst pressure, minimal lateral thermal spread, and enhanced dissection ability makes the PKS OMNI the proper choice for challenging cases, such as those with severe dense adhesions. Incorporation of multiple functions in a single device can minimize instrument complexity for surgeons and decrease costs.

Conclusions

The PKS OMNI is a safe and practical device that can be used in TLH. It should not be forgotten the selection of instrument is often driven by the surgeon's preference, training, and estimated cost. An important validation of the present results is needed for assessing the clinical utility of this instrument to learn about its extensive potentials for usage. The lack of data about this device in the literature should be resolved with well-designed, prospective, randomized large-scale studies to obtain high-quality evidence.

Footnotes

Author Disclosure Statement

The authors declare that there are no conflicts of interest associated with this article.

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