Research Article
Efficacy of LigaSure® Use during Total Thyroidectomy for Multinodular Goitre: A Prospective Randomized Study
Selahattin Vural, Metin Kement*, Kenan Cetin, Osman Civil, Mehmet Eser, Fikri Kundes, Levent Kaptanoglu and Nejdet Bildik
Department of General Surgery, Kartal Training and Research Hospital, Turkey
*Corresponding author: Metin Kement, Department of General Surgery, University of Medical Sciences, Kartal Training and Research Hospital, Istanbul, Turkey
Published: 13 Dec, 2016
Cite this article as: Vural S, Kement M, Cetin K, Civil
O, Eser M, Kundes F, et al. Efficacy
of Ligasure® Use during Total
Thyroidectomy for Multinodular Goitre:
A Prospective Randomized Study. Clin
Surg. 2016; 1: 1248.
Abstract
Background: Thyroid surgery commonly carried out by surgeons is generally achieved by threadtying technique which lengthens the operation period. Therefore, new technologies are needed
to decrease the operation time without increasing complications. LigaSure® PreciseTM is a new
vascular sealing system with an integrated active feedback control. The aims of the present study
are to assess the efficacy of LigaSure® in total thyroidectomy and compare the clinical outcomes with
traditional technique.
Methods: This prospective randomised study included a total number of 80 patients, underwent a
total thyroidectomy for multinodular goitre. The patients were operated either with LigaSure® (Group
L; n=40) or conventional technique (Group C; n=40). These were assessed and compared within
the groups: demographics, peroperative (length of incision, amount of bleeding, operative period,
necessity of drain use) and postoperative (calcium levels, pain, drainage volume, complications)
data.
Results: Length of incision (7.7±1.9 vs. 6.7±1.5 cm in Group C vs. Group L; p< 0.05) and operation
time (92.2±26.4 vs. 79.1±30.9 minutes in Group C vs. Group L; p < 0.05) were significantly shorter
in Group L. Other parameters were similar within the groups.
Conclusion: LigaSure® may shorten the operation time and the length of the incision during total
thyroidectomy for multinodular goitre.
Keywords: LigaSure®; Multinodular goitre; Total thyroidectomy
Introduction
Thyroidetomy may be sometimes troublesome operation due to the excessive vascularization
of the thyroid, and the control of the bleeding may be difficult or even harmful. Although a
“thread tying” technique combined with a bipolar electro-cauterization process has become a gold
standard, multiple knots may lengthen the duration of the procedure [1]. Thus, multiple devices
have been investigated in order to shorten the operation time without any increase in complications,
particularly in the safety of the operation by risking a secure bleeding control.
LigaSure® device has been presented as an alternative to the conventional knotting technique,
and has been effectively used for thyroid surgery [1-3]. The aim of this prospective randomized
study was to evaluate the outcomes of LigaSure® device use by comparing to conventional technique
in total thyroidectomy The LigaSure® PreciseTM (Valleylab, Tyco International Healthcare, Boulder,
CO, US) is a new vascular sealing system with an integrated active feedback control. It consists
of an electro-surgical generator and hand piece device. The tissue is grasped and compressed by
the instrument and the response generator senses the density of the tissue bundle. In turn, the
generator’ computer automatically adjusts the amount of energy to be delivered. When sealing
is completed, the microprocessor-controlled feedback automatically terminates the pulse. Then
the semi-transparent window can be safely divided [4-6]. This device has been approved by USA
Food and Drug Administration (FDA) to seal vessels up to 7 mm in diameter while experimental
histological studies of vessels sealed with a LigaSure® demonstrated 1,5 to 3,3 mm thermal spread,
beyond the tissue within the forceps’ jaw [7]. The effectiveness and safety of the device have been
proven especially for laparoscopic surgery [8] and may reduce the period of the operation [9]. Recent
studies have revealed that LigaSure® may be also safely used in thyroid surgery.
The aim of this prospective randomized study was to evaluate the outcome of using LigaSure® device by comparing to conventional technique in total thyroidectomy.
Table 1
Table 2
Table 3
Materials and Methods
A prospective, randomized study was conducted between July
2013 and September 2014, and 80 consecutive patients operated for
benign multinodular goitre at our institution were included. Prior
to study, hospital ethic committee had approved the design of the
study, and a written consent was obtained from all patients before
the operations. Patients with thyroid cancers, Graves’ disease and
those had history of previous thyroid surgery were excluded from the
study. However, patient with toxic multi nodular goitre included to
the study, and operated after the regulation of hormone levels. All
patients were preoperatively evaluated with ultrasonographic and fine
needle aspiration biopsy and if clinically necessitated, scintigraphic
examinations and indirect laryngoscope were performed in order to
rule out the malignancy and vocal cord immobility.
The patients were randomized into 2 groups with the use of a
computer-generated randomization schedule. They were operated
either with LigaSure® (Group L; n=40) or conventional technique
(Group C; n=40). In the Group L, LigaSure® was used for sealing the
vessels including superior and inferior thyroid vessels and medial
vein. In Group C, all stages were completed with knotting and using
bipolar or unipolar cautery. The necessity of the drain use was decided
by the surgeon at the end of the procedure. All patients were operated
by a surgeon (S.V.) who dedicated primarily to thyroid surgery.
These were assessed and compared within the groups:
demographics (age and gender), peroperative (length of incision,
amount of bleeding, duration of operation, necessity of drain use)
postoperative (pain, drainage volume, complications, hospitalization)
data. All operations were begun with a 5 cm incision and if necessitated,
the incisions were lengthened. The duration of operation was defined
as the duration between the incision and dermal closure. The amount
of peroperative bleeding was estimated with the total blood in the
operative sponges at the end of the operation. The pain level was
postoperatively evaluated with a visual analog scale (VAS) ranging 1
to 5 at 3, 6 and 12 hours. The calcium level was assessed in all patients
6 and 24 hours after the operation. Patients were discharged from
the hospital the day after the operation unless any suspicion for
complication including hypocalcemia or laryngeal nerve palsy. If the
nerve palsy or hypoparathyroidism extent more than 6 months, it was
defined permanent.
A SPSS 15 for Windows software was used for statistical analysis.
Data were presented as means and standard deviations or percentages,
and the comparisons were made by using a student t or chi-square
test. A p value less than 0.05 were considered significant.
Results
A total of 80 patients (48 [60.0%] female, 48.9±13.1 years old)
were included to the study. Gender (25 [62.5%] vs. 23 [57.5%] females
in Group C and Group L, respectively; p=0.64) and age (46.9±13.2 vs.
50.9±12.9 years in Group C and Group L, respectively; p=0.17) were
similar within the groups. Elevated hormone levels were determined
and preoperative treatment were necessitated in 17 (42.5%) and 18
(45.0%) patients in Group C and Group L, respectively (p=0.82)
(Table 1).
Perioperative data were presented in Table 2. Length of incision
(7.7±1.9 vs. 6.7±1.5 cm in Group C vs. Group L; p< 0.01) and operation
time (92.2±26.4 vs. 79.1±30.9 minutes in Group C vs. Group L; p<
0.04) were significantly shorter in Group L. Other parameters were
similar within the groups.
The complication ratio was 15% (n=12) in our study (Table 3).
A hematoma observed in the Group L was treated conservatively,
and none of the complications was permanent. As these results no
difference between both groups was observed significantly.
Discussion
Multinodular goitre is the most frequently encountered thyroidal
pathology. Among therapeutically options, surgical intervention is
still the most important route of therapy [10-12]. Total thyroidectomy
may be the best choice for the treatment of multinodular goitre as
it is also an adequate surgical option for thyroid cancer which may
be incidentally noticed in the specimen. If total thyroidectomy
is adequately performed, no recurrence will be seen. A standard
thyroidectomy operation depends on a meticulous anatomical
dissection, and secure and effective hemostasis [13]. Conventional
knotting techniques with the use of cautery have been used and
accepted as a gold standard in thyroidal surgery. In fact, this method
may extend the duration of the operation and may necessitate a larger
incision in order to secure the knots especially located to the poles.
Therefore, new devices have been investigated.
Ligasure is a new vascular sealing system of which the effectiveness
and safety have been proven especially for laparoscopic surgery [9]
and reduces the period of the operation [14,15]. Recent studies have
revealed that LigaSure® may be also safely used in thyroid surgery,
however the effect of LigaSure® use on operation time is controversial
[14-16]. In the present study, we evaluated the outcomes in patients
underwent total thyroidectomy for multinodular goitre using either
conventional knotting techniques or LigaSure®. Demographics and
perioperative data were similar within the groups. Our data suggested
that the operation time significantly decreased when LigaSure® was
used. The shorter operation time is expected in LigaSure® group,
since multiple knots take more time in the conventional technique.
Furthermore as the thread is a foreign substance we will also recover
from the rest. Additionally, in conditions where the upper pole is
placed at the high position we are able to close vessels more safely by
the LigaSure®. In addition, present data has revealed that LigaSure® use
may decrease the length of incision, which has never been evaluated
in the previous studies. This advantage may be due to the requirement
of a larger space for knotting in conventional technique.
The most important complications in thyroidal surgery are
recurrent laryngeal nerve (RLN) injury and hypoparathyroidism.
Many current studies have indicated that there are no any difference
in complications between conventional knotting and LigaSure®
sealing. In literature, complications stated above have been observed
lesser in patients in the LigaSure® groups [17]. In our series permanent
RLN palsy and hypoparathyroidism were not noticed, and the
hypocalcemia ratios at postoperative 6th and 72nd hours were found
lower in the LigaSure® group, even though the differences were not
statistically significant. The peroperative bleeding amount does not
have a statistically significant importance between groups. Number
of patients needed drainage and postoperative amount of blood loss
of these patients was similar between groups. According to Visual
Analog Pain Scale (VAS), no significant difference was observed. The
duration of hospitalization is also similar within the groups. Most
importantly, the similar complication rates within the groups suggest
the safety of LigaSure® use.
Conclusion
LigaSure® does not jeopardize the safety of the procedure during total thyroidectomy for multinodular goitre. The use of the device may statistically shorten the operation time and the length of the incision.
References
- Lachanas VA, Prokopakis EP, Mpenakis AA, Karatzanis AD, Velegrakis GA. The use of Ligature Vessel Sealing System in thyroid surgery. Otolaryngol Head Neck Surg. 2005; 132: 487-489.
- Prokopakis EP, Lachanas VA, Helidonis ES, Velegrakis GA. The use of the Ligature Vessel Sealing System in parotid gland surgery. Otolaryngol Head Neck Surg. 2005; 133: 725- 728.
- Prokopakis EP, Lachanas VA, Karatzanis AD, BenakisAA, Velegrakis GA. How we do it: Application of Ligature Vessel Sealing System in patients undergoing total laryngectomy and radical neck dissection. Clin Otolaryngol. 2005; 30: 198-201.
- Dubuc-Lissois J. Use of a new energy-based vessel ligation device during laparascopic gynecologic surgery. Surg Endosc. 2003; 17: 466-468.
- Ligature vessel sealing system user’s manuel. Valley, Coviden, Boulder.
- Harold KL, Pollinger H, Matthews BD, Kercher KW, Sing RF, Heniford BT. Comparison of ultrasonic energy, bipolar thermal energy, and vascular clips for the hemostasis of small-, medium-, and large-sized arteries. Surg Endosc. 2003; 17: 1228–1230.
- Heniford BT, Matthews BD, Sing RF, Backus C, Pratt B, Greene FL. Initial results with an electrothermal bipolar vessel sealer. Surg Endosc. 2001; 15: 799–801.
- Horgan PG. A novel technique for parenchymal division during hepatectomy. Am J Surg. 2001; 181: 236-237.
- Schulze S, Krisitlansen VB, Hansen BF, Rosenberg J. Sealing of cystic duct with bipolar electrocoagulation. Surg Endoscopy. 2002; 16: 342-344.
- Mishra A, Agarval A, Agarval G, Mishra SK. Total thyroidectomy for benign thyroid disorders in an endemic region. World J Surgery. 2001; 25: 307-310.
- Franklyn JA. The management of hyperthyroidism. N Engl J Med. 1994; 330: 1731-1738.
- Hermus AR, Huysmans DA. Treatment of benign nodular thyroid disease. N Engl J Med. 1998; 338: 1438-1447.
- Bliss RD, Gauger PG, Delbridge LW. Surgeon’s approach to thyroid gland: Surgical anatomy and the importance of technique. World J Surgery. 2000; 24: 891-897.
- Saint Marc O, Cogliandolo A, Piquard A, Famà F, Pidoto RR. Ligature vs. Clamp-and-Tie Technique to Achieve Hemostasis in Total Thyroidectomy for Benign Multinodular Goiter: a prospective randomized study. Arch Surg. 2007; 142: 150-156.
- Cipolla C, Graceffa G, Sandonato L, Fricano S, Vieni S, Latteri MA. Ligature in Total Thyroidectomy. Surg Today. 2008; 38: 495-498.
- Kilic I, Sunamak I, Aydogan F, Sen B, Altintas B, Duren M, et al. Ligature Precise use in thyroid operations: a comparison with the conventional method. Eur Surg. 2007; 39: 54–56.
- Petrakis IE, Kogerakis NE, Lasithiotakis KG, Vrachassotakis N, Chalkidakis GE. Ligasure versus clamp and-tie thyroidectomy for benign nodular disease. Head Neck. 2004; 26: 903.