Comparison of the Thunderbeat and Other Energy Devices in Laparoscopic Colorectal Resection: A Single-Center Experience

Abstract

Background:

The THUNDERBEAT (TB) is a relatively novel energy device that is used in laparoscopic colorectal resection (LCR), which integrates both ultrasonic and bipolar energy. There are limited data on its use in LCR, compared with bipolar diathermy (LigaSure^™ [LS]) or ultrasonically generated heat (Harmonic ACE [HA]). The aim of this study was to compare outcomes in patients undergoing LCR with TB versus LS or HA, for both benign and malignant colorectal diseases.

Methods:

This study is a prospective trial using retrospective controls in patients undergoing LCR. The study period was over 6 months from June 2015, during which all elective laparoscopic colonic resections were performed using TB only. The retrospective control population included all consecutive patients who underwent LCR during the preceding 6 months, using either LS or HA. The primary outcome measure was the total operative time. Secondary outcome measures evaluated were rates of postoperative surgical complications, mortality, and length of stay.

Results:

A total of 114 patients were included in the study. Median operative time was not significantly different between LS/HA and TB arms (246 versus 240 minutes, P = .779). Both arms showed no device failure. There was equivalent rate of intraoperative complications (P = .755) and conversion to open surgery (P = .075). There were no statistically significant differences in postoperative morbidity (P = .938) and mortality (P = .392) observed between the two arms. There was also no difference in the length of stay between LS/HA and TB arms (6 versus 7 days, P = .085).

Conclusions:

Our dataset has the largest number of cases comparing TB and other energy devices in laparoscopic colorectal cancer surgery. They all appear to be equally safe and effective. Operating the TB device does not require a steep learning curve and utilizes similar techniques transferable from the use of other conventional energy devices.

Introduction

There is increasing acceptance of the use of laparoscopic surgery for both benign and malignant colorectal disease. Laparoscopic colorectal resection (LCR) has shown better short-term outcomes and similar survival rates when compared to open surgery for the treatment of colorectal cancer.^1–4

LCR involves the dissection of soft tissue and division of large vessels that require specific instruments and techniques that differ from traditional open surgery. The need for safe and effective hemostasis in laparoscopic procedures spawned the development of new energy devices that employ either bipolar diathermy (LigaSure^™ [LS]; ValleyLab, Inc.) or ultrasonically generated heat (Harmonic ACE [HA]; Ethicon). Energy devices revolutionized laparoscopic surgery, allowing for rapid dissection and reliable hemostasis, leading to the ability to perform more complex procedures. Both LS and HA have been used for laparoscopic colorectal surgery with no significant difference in terms of intraoperative/postoperative morbidity and operative time.⁵ Thus, their efficiency can be compared interchangeably.

The THUNDERBEAT (TB; Olympus Medical Systems Corp.) is currently the only commercially available device integrating bipolar and ultrasonic energies in a single instrument, combining the advantages of both energy sources. Earlier studies demonstrated that TB is safe and efficient for tissue dissection and vessel ligation—potentially reducing operative time by allowing more effective and efficient dissection, while reducing the need for instrument changes.^6–8 Given its novelty, there is little in this literature pertaining to this device. To date, it is uncertain whether there is an advantage in using TB over other alternatives such as LS or HA.

The aim of this study was to compare outcomes in patients undergoing LCR with TB or other energy devices (LS or HA), for both benign and malignant colorectal diseases.

Methods

This study is a prospective trial using retrospective controls. Data were collected prospectively for 6 months for the study (TB arm) and compared to retrospective data (LS/HA arm) from the preceding 6 months. The study period was over 6 months from June 2015, during which all elective laparoscopic colonic resections were performed using TB only. All cases were performed using TB alone as the sole dissecting and sealing instrument. The retrospective control population included all consecutive patients who underwent LCR from October 2014 to March 2015. Emergency colorectal resections were excluded from the trial. The study was approved by the Monash Health Human Research Ethics Committee and all patients gave written informed consent.

All LCR were performed by the same surgical team who are experienced in advanced laparoscopic techniques. The use of TB was at the discretion of the surgeon. During the study period, LS and HA were also available for use. Participating surgeons were given a 2-week familiarization period to troubleshoot any potential technical problem. Dissection was performed using a combination of electrocautery and energy device. Vessel sealing with HA was operated at power level 3; LS was operated in the default mode, at two green bars, while TB was operated using the seal and cut mode.

The primary outcome measure was the total operative time. This was selected because it subsumed the different components of the laparoscopic operative process affected by the use of TB, including, but not limited to instrument exchanges, surgical entry port site placement and wound closure, vessel sealing time, and other haemostatic procedures. Secondary outcome measures evaluated were rates of postoperative surgical complications, mortality, and length of stay. Conversion to open surgery was defined as an unplanned incision or an incision made longer than planned. Intraoperative and postoperative complications were further assessed to determine whether they were device related or not. Complications suspected to be device-related were bleeding complications and thermal injuries. Postoperative complication rates were retrospectively compared to rates from the 12 months preceding the introduction of TB (May 2014 to May 2015) at our institution.

Statistical analysis

Statistical analysis was carried out with SPSS^® version 22 (IBM, New York, New York). Means and standard deviations were calculated for continuous variables, and categorical data were summarized using proportions. Univariate analysis was performed to verify any difference between the two arms (TB and LS/HA, respectively). Categorical variables were analyzed with Pearson's chi-squared test. Continuous variables were analyzed using the Mann–Whitney U test. A P value of <.05 was considered statistically significant.

Results

A total of 114 patients were included in the study: 66 patients who underwent LCR with LS or HA (LS/HA arm) were compared with 48 patients who had LCR with TB (TB arm). The median age was 65.5 years for patients in the LS/HA arm, and 71 years for patients in the TB arm (P = .332). There were similar patient characteristics between the two arms, in terms of gender distribution (P = .328), median body mass index (P = .569), and median American Society of Anesthesiologists (ASA; P = .655), without any significant difference. There was a difference in the caseload between the two arms, with a higher preponderance of cancer cases for the TB arm, compared to the LS/HA arm. There were also slightly higher right-sided resection cases in the LS/HA arm, compared to the TB arm. Table 1 summarizes the patients' characteristics.

Table 1.

Patient Characteristics

Patient characteristics	LS/HA (n = 66)	TB (n = 48)	P
Median age, years (range)	65.5 (19–90)	71 (29–85)	.332
Gender, female (%)	31 (47.0)	27 (56.2)	.328
Median BMI, kg/m² (range)	25 (17.7–40.4)	25 (21–38)	.569
Median ASA score (range)	II (I–III)	II (I–III)	.655
Indications, n (%)			.001
Cancer	35 (53.0)	42 (87.5)
Benign	31 (16.6)	6 (12.5)
Surgical procedure, n (%)			.015
Right hemicolectomy	23 (34.8)	8 (16.7)
Subtotal/extended right hemicolectomy	6 (9.09)	3 (6.25)
Left hemicolectomy/Hartmann's	5 (7.58)	1 (2.08)
High anterior resection	27 (40.9)	19 (39.6)
Ultra-low anterior resection	4 (6.06)	12 (25)
Abdominoperineal resection	1 (1.52)	4 (8.33)
Proctocolectomy	0 (0)	1 (2.08)

ASA, American Society of Anesthesiologists; BMI, body mass index; HA, Harmonic ACE; LS, LigaSure^™; TB, THUNDERBEAT.

Intraoperative outcomes

Median operative time was not significantly different between the two arms, that is, 246 and 240 minutes, for LS/HA and TB arms, respectively. Both arms showed equivalent reliability in function of the device, with a similar rate of device failure and intraoperative complications. The intraoperative bleeding in the LS/HA arm was related to bleeding on the lateral pelvic wall during total mesorectal dissection, and bleeding during ligation of a thick and edematous mesocolon due to inadequate vessel sealing. Both cases required conversion to open procedure, whereas the single intraoperative bleeding in the TB arm was related to injury to the external iliac artery, requiring conversion to open surgery. There was a trend toward a higher rate of conversion to open surgery in the TB arm (22.9%) compared to the LS/HA arm (10.6%), although it is not statistically significant. Summary of intraoperative outcomes is reported in Table 2.

Table 2.

Intraoperative Outcomes

Intraoperative outcomes	LS/HA (n = 66)	TB (n = 48)	P
Median operative time, minutes (IQR)	246 (202–291)	240 (210–270)	.779
Device failure, n (%)	0	0	1
Intraoperative complications, n (%)	2 (3.03)	1 (2.08)	.755
Bleeding	2	1
Injury to organs	0	0
Conversion to open surgery, n (%)	7 (10.6)	11 (22.9)	.075
Adhesions	1	5
Bleeding	2	1
Body habitus	3	3
Locally advanced cancer	1	2

HA, Harmonic ACE; IQR, interquartile range; LS, LigaSure^™; TB, THUNDERBEAT.

Postoperative outcomes

There were no statistically significant differences in postoperative complications observed between the two arms. Subgroup analysis looking at the postoperative morbidity showed similar pulmonary complications, ileus, and anastomotic leak. The single mortality in the study was for a patient in the LS/HA arm—an elderly male patient, for whom surgery was a palliative procedure. He had a laparoscopic right hemicolectomy, which had to be converted to a laparotomy due to the size of cancer. On postoperative day 1, he had a cardiac arrest, and in accordance with his wishes, was not resuscitated. The median length of stay was not significantly different between the two arms, slightly lower in the LS/HA arm with 6 days, compared to 7 days in the TB arm (P = .085). Table 3 summarizes the postoperative outcomes.

Table 3.

Postoperative Outcomes

Postoperative outcomes	LS/HA (n = 66)	TB (n = 48)	P
Morbidity, n (%)	11 (16.7)	7 (14.6)	.938
Pulmonary complications	3	2
Prolonged ileus	6	3
Anastomotic leak	2	2
Mortality, n (%)	1 (1.52)	0 (0)	.392
Median length of hospital stay, days (IQR)	6 (5–11)	7 (5–10)	.085

HA, Harmonic ACE; IQR, interquartile range; LS, LigaSure^™; TB, THUNDERBEAT.

Right- and left-sided colectomies between the two arms

Subgroup analysis comparing the outcome of right-sided and left-sided colectomies between the two arms is summarized in Table 4. Right-sided colectomies constituted right hemicolectomy and subtotal/extended right hemicolectomies, while left-sided colectomies included left hemicolectomy, anterior resection, and abdominoperineal resections. Preponderance of right-sided colectomies in the LS/HA arm compared to the TB arm limit the comparative value between this subgroup of patients. Within that limitation, there was no significant difference in intraoperative and postoperative outcomes. Subgroup analysis looking at patients who underwent left-sided colectomies, did not show any significant difference in intraoperative outcomes with patients who underwent right-sided colectomies, but showed a trend toward a higher rate of conversion to open in the TB arm. Left-sided colectomies subgroup also has similar postoperative outcomes between the two arms, but showing a trend toward longer length of stay in the TB arm at a median of 8 days compared to 6.5 days in the LS/HA arm, but not statistically significant.

Table 4.

Subgroup Analysis Comparing Right-Sided and Left-Sided Colectomies Between the Two Arms

	LS/HA (n = 29)	TB (n = 11)	P
Right-sided colectomies (right hemicolectomy+subtotal/extended right hemicolectomy)
Intraoperative outcomes
Median operative time, minutes (IQR)	201 (161–246)	240 (204–241)	.285
Intraoperative complications, n (%)	0	0	1
Conversion to open surgery, n (%)	2	2	.288
Postoperative outcomes
Morbidity, n (%)			.522
Pulmonary complications	1	0
Prolonged ileus	3	0
Anastomotic leak	1	0
Mortality, n (%)	1	0	.533
Median length of hospital stay, days (IQR)	6 (5–7)	5 (5–6)	.294

	LS/HA (n = 37)	TB (n = 37)
Left-sided colectomies (left hemicolectomy+anterior resections)
Intraoperative outcomes
Median operative time, minutes (IQR)	263 (242–305)	270 (240–283)	.276
Intraoperative complications, n (%)	2	1	.556
Conversion to open surgery, n (%)	5	9	.235
Postoperative outcomes
Morbidity, n (%)			.950
Pulmonary complications	2	2
Prolonged ileus	3	3
Anastomotic leak	1	2
Mortality, n (%)	0	0	1
Median length of hospital stay, days (IQR)	6.5 (4–11)	8 (6–12)	.072

HA, Harmonic ACE; IQR, interquartile range; LS, LigaSure^™; TB, THUNDERBEAT.

Discussion

The gradual acceptance of laparoscopy as the default approach to colorectal resection has sparked a rise in technological advances to provide a safe, efficient, and cost-effective operation. The technical limitation of conventional electrosurgery in LCR has sparked the development of coagulating devices such as LS and HA.^5,9 The use of pre-existing devices such as LS and HA has since become routine practice for LCR at our hospital, both as dissecting instrument and vascular sealing device. The obvious difference between LS and HA has promoted the development of the multifunctional TB device, which utilizes both ultrasonic and electrically generated bipolar energy.

This literature pertaining to TB is scarce, given its novelty. Some studies compared the performance of TB versus other energy devices (LS and HA) in an ex vivo model.^10,11 Two studies were performed using porcine arteries of various types and diameters, while the third used human pulmonary arteries after anatomical lung resection. All studies showed significantly higher burst pressure in arteries up to 7 mm in diameter using TB compared to the other energy devices, as well as faster cutting speed in the porcine model.^10,11 This is significantly higher than HA, while slightly higher than the LS. The maximum generated temperature was higher with TB and HA compared to LS, while thermal spread was similar between TB and HA, although higher than LS.¹²

Two studies evaluate TB in vivo. A prospective pilot study in laparoscopic colonic surgery showed that TB was safe and efficient at tissue dissection and vessel ligation in left and right colectomies, but no comparison was made with other energy devices.⁸ The other study compared TB with standard electrosurgery in laparoscopic radical hysterectomy and pelvic lymphadenectomy for gynecologic cancer and found that TB was associated with shorter operative time and less postoperative pain.⁶

Our study has shown that the use of TB in LCR is equally safe and effective compared to existing energy devices that is, LS and HA. Conversion to laparotomy is not related to the type of energy device used. The absence of any device failure reflected more on the underpowered nature of the study. There were similar intraoperative and postoperative outcomes between the TB arm and the existing energy devices. There were no statistically significant differences found with regard to operating time, conversion to laparotomy, inpatient hospital stays, and postoperative complications between TB and LS/HA group. Subgroup analysis comparing right-sided and left-sided colectomies between the two arms did not find any statistically significant difference intraoperative and postoperative outcomes.

In conclusion, our study failed to demonstrate any significant inferiority in the use of TB, when compared with the more established energy devices that is, LS and HA. The use of TB did not require a steep learning curve, allowing the 2-week familiarization period provided to the surgeons involved in this study. The techniques required for effective use of TB appeared to be transferable from other energy devices. The choice of energy device should be according to the surgeon's preference and experience.

Footnotes

Disclosure Statement

No competing financial interests exist. The authors declare that they have no conflict of interests and have no affiliations with the producer of THUNDERBEAT^™ Olympus KK.

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