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 Table of Contents  
ORIGINAL ARTICLE
Year : 2020  |  Volume : 18  |  Issue : 1  |  Page : 98-103

A comparative study between sutureless total thyroidectomy by harmonic scalpel and traditional method (clamp and tie)


Department of General Surgery, Faculty of Medicine for Girls, Al-Azhar University, Cairo, Egypt

Date of Submission23-Sep-2019
Date of Decision08-Dec-2019
Date of Acceptance27-Jan-2020
Date of Web Publication26-Mar-2020

Correspondence Address:
Rasha Abd Elaziz Abd Elghany
5 Redan St. Alabbasiya, Cairo, 11517
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/AZMJ.AZMJ_131_19

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  Abstract 


Objective The objective of our study is to compare the outcome of sutureless total thyroidectomy performed by the focus harmonic scalpel (HS) versus operations that were performed with the traditional technique (clamp and tie).
Study design This is a prospective randomized clinical trial that has been carried out at the Department of General Surgery, Al-Zahraa University Hospital.
Patients and methods This clinical trial was carried out between April 2016 and April 2019. In all, 200 patients who underwent total thyroidectomy were randomly divided into two equal groups : group A (100 patients) underwent total thyroidectomy with HS and group B (100 patients) underwent total thyroidectomy with the traditional hemostatic method ligation with clamp and tie.
Results The intraoperative time was significantly shorter in the HS group (A) than in the traditional hemostasis group (B); intraoperative blood loss and total fluid drainage volume were lower in the HS group (A) than the traditional hemostasis group (B). Postoperative bleeding was observed in five (5%) patients in the traditional hemostatic group (B), versus two (2%) patients in the HS group (A). Postoperative seroma was observed in only four patients in the traditional thyroidectomy group.
Conclusion HS in total thyroidectomy significantly reduces intraoperative time, intraoperative blood loss, drainage volume, and postoperative complications.

Keywords: harmonic scalpel, total thyroidectomy, traditional methods (clamp and tie)


How to cite this article:
Abd Elghany RE, Zarad MS. A comparative study between sutureless total thyroidectomy by harmonic scalpel and traditional method (clamp and tie). Al-Azhar Assiut Med J 2020;18:98-103

How to cite this URL:
Abd Elghany RE, Zarad MS. A comparative study between sutureless total thyroidectomy by harmonic scalpel and traditional method (clamp and tie). Al-Azhar Assiut Med J [serial online] 2020 [cited 2020 Apr 3];18:98-103. Available from: http://www.azmj.eg.net/text.asp?2020/18/1/98/281348




  Introduction Top


Although goiter has been endemic in several parts of the world throughout history, it was in in AD 500 that Abdul Kasan Kelebis Abis in Baghdad carried out the first recorded goiter surgical removal. The patient survived despite massive postoperative bleeding [1].

The main problems that was found in the 19th century were bleeding and infection even as surgeon Theodor Billroth reported 36% intraoperative mortality for thyroid surgery. There were three factors that contributed to the development of thyroid surgery during the second half of the 19th century: inhalation anesthesia, antisepsis, and surgical hemostatic instrumentation [2].

At the end of the 19th century Kocher performed more than 5000 thyroidectomies over the course of his career. He was a meticulous surgeon who paid careful attention to hemostasis. He introduced initial ligation of the inferior thyroid arteries, which substantially reduced the risk of hemorrhage. The use of antisepsis and hemostasis was manifest in his mortality rates. He reported a reduction in mortality from 12.6% in the 1870s to 0.2% in 1898 [1].

As the thyroid gland has a widespread vascular supply, an effective hemostasis is a necessary phase of the procedure; a dry surgical field is required not only to avoid doubtlessly fatal hemorrhage but additionally to keep away from inadvertent damage to the adjoining essential structures like superior and recurrent laryngeal nerves or parathyroid glands [3].

Hemostasis was achieved with basic strategies such as tie and clamp, electrocautery, clips, or glue of fibrin is time consuming and loaded with hazards of knot slipping, unsettlement, and thermal trauma [4].

New methods to acquire a secure and faster hemostasis with much lesser thermal spread to limit each operative time and complications have been researched and developed. Harmonic scalpel (HS, previously named UltraCision; Ethicon Endo-Surgery), developed in the early 1990s, controls the bleeding vessels by way of sealing it with a protein coagulum at temperatures ranging from 50 to 100°C [3].

The harmonic focus device involves a variety of ultrasonic surgical gadgets that allow simultaneous dissection and coagulation of tissue. Ultrasonic waves are created via electromagnetic power from a generator. The blade of the HS vibrates at 55 kHz, producing mechanical power that breaks the hydrogen bonds. The harmonic focus is hand activated, with cutting and sealing of vessels finished by means of placing the curved blade in contact with the tissue and applying pressure [5].

The hemostatic effect is accomplished by means of protein denaturation as an alternative other than warmth used in electrosurgical hemostatic devices, which uses a high electric current to produce the temperature required for the hemostatic effect [6].

Our aim of this study is to compare between total thyroidectomy using the HS and traditional method using clamp and tie in terms of operative time, intraoperative blood loss, volume of the drained fluid, and postoperative complications such as seroma or wound infection.


  Patients and methods Top


This is a prospective randomized clinical study that has been carried out between April 2016 and April 2019 at the Department of General Surgery. Ethical approval from the Research ethics comittee of faculty of medicine for girls, Cairo, Al-Azhar University (FM-IRB) IRB NO: 201907115. A total of 200 patients between 20 and 70 years old with thyroid disease, either benign or malignant, scheduled for total thyroidectomy were enrolled in our study. Some patients were excluded according to the exclusion criteria including: patients who need neck dissection, previous neck irradiation or radioactive iodine, and patients undergoing only hemithyroidectomy or thyrotoxic patients. All included patients were informed about the surgical procedure and written informed consent was obtained from all patients.

Those patients were randomly allocated using the computerized random number generator into two equal groups: group A (100 patients) underwent total thyroidectomy with a HS and group B (100 patients) underwent total thyroidectomy hemostasis with traditional methods using absorbable sutures in arterial and venous pedicles and monopolar or bipolar electrocautery for smaller vessels and bleeding points.

All patients had routine investigation, preoperative serum calcium level, and indirect laryngoscopy. All surgeries were performed under general anesthesia; skin incision was made parallel to the normal skin crease at one finger breadth below the cricoid arch, elevation of skin flab deep into the platysma muscle, opening of superficial layer of deep cervical fascia and retraction of strap muscles; division of the strap muscle was done only in case of huge goiters, hemostasis was done in group A using a HS including major vessels ([Figure 1]) while in group B using the traditional method with ligation using Vicryl 3/0 (clamp and tie) ([Figure 2]). In both groups, identification of superior and recurrent laryngeal nerves and parathyroid glands was done. Insertion of a suction drain was maintained for 24 h for all patients. Postoperative serum calcium levels were measured after 24 h; patients with serum calcium levels of less than 8 mg/dl were considered as having hypocalcemia. All patients had been discharged after 48 h except complicated cases.
Figure 1 Harmonic scalpel used in total thyroidectomy in group A.

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Figure 2 Total thyroidectomy was done by the traditional method (tie ligation) in group B.

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Study endpoints

The primary endpoints were operative time in minutes, intraoperative blood loss and the amount of drained fluids and postoperative calcium level.

Secondary endpoints were postoperative bleeding, seroma formation, and recurrent laryngeal nerve injury.

Statistical analysis

Statistical analyses were carried out using the statistical software program, SPSS, for Windows, version 25.0 (SPSS Inc., Chicago, Illinois, USA).

Data are presented as mean±SD for continuous variables and as frequency and percentage for categorical variables.

For quantitative variables, parametric independent t test was used for comparison in the case of Gaussian distribution, while the Mann–Whitney U test was used for non-Gaussian distribution.

For categorical variables, Fisher’s exact and c2 tests were used as appropriate. For all tests, a P value of 5% or less at a two-sided test was considered statistically significant.


  Results Top


This study included 200 patients with multinodular goiter. The patients were classified into two equal groups: group A (100 patients) had total thyroidectomy with a HS and group B (100) patients had total thyroidectomy hemostasis with traditional methods.

Baseline characteristics were comparable between the study groups in terms of patients’ sex and preoperative calcium+2 ([Table 1]), while the age of the patients showed a significant difference. Patients’ age ranged between 21 and 69 years; the mean age in group A was 40±10 while in group B was 39±9 ([Figure 3]). Group A had 78 (78%) women and 22 (22%) men while group B had 84 (84%) women and 16 (16%) men ([Figure 4]).
Table 1 Demographic criteria of patients and preoperative calcium+2

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Figure 3 Mean age of the study groups.

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Figure 4 Sex distribution among the study groups.

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Surgical outcome

Primary outcome

The patients who underwent total thyroidectomy by a HS showed a significant lower operative time of 77±10 min than the traditional thyroidectomy group 102±11 min, P value less than 0.001. There were significantly lower amounts of blood loss in group A,71±15 ml than in group B, 138±12 ml, and drain in group A 64±20 ml than in group B 136±24 ml were found in the harmonic thyroidectomy group than the traditional thyroidectomy group with P value less than 0.001 ([Table 2]). Postoperative calcium+2 had no significant difference between both groups (8.7±0.5 for harmonic thyroidectomy and 8.6±0.5 for traditional thyroidectomy, P=0.06) ([Figure 5]).
Table 2 Intraoperative and postoperative evaluations

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Figure 5 Preoperative and postoperative calcium+2 levels in the two study groups.

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The incidence of hypocalcemia had no significant difference between the two groups (10% in harmonic thyroidectomy vs. 9% in traditional thyroidectomy, P=0.55) ([Table 3]). All patients developed transient hypocalcemia which was treated with oral calcium for few weeks except one patient in group B who required intravenous calcium and required oral calcium for more than 6 months.
Table 3 Postoperative complications

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Secondary outcomes

The incidence of postoperative bleeding was higher in traditional thyroidectomy than harmonic thyroidectomy (5 vs. 2%, respectively), while the incidence of recrrent laryngeal nerve (RLN) palsy was comparable in the two groups. Postoperative seroma was only observed in four patients in the traditional thyroidectomy group ([Table 3] and [Figure 6]).
Figure 6 Postoperative complication in the two groups.

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There was no need for intraoperative blood transfusion which was recorded in both groups.

There were no intraoperative complications or mortality which was recorded in both groups during the study.


  Discussion Top


The history of thyroid surgery documents the evolution of modern surgical techniques and the blending of these techniques with an expanded understanding of anatomy and endocrinology [1].

Benign multinodular goiter is the most frequent endocrine disease, particularly in endemic areas of iodine deficiency. Indications for surgical treatment are pressure symptoms such as: dysphagia or shortness of breath, suspected malignancy, massive retrosternal extension, drug-resistant hyperthyroidism, and cosmetic concerns [7].

Total thyroidectomy is the preferred choice for the treatment of benign multinodular goiter and the standard therapy for malignant goiter. Meticulous dissection and hemostasis is necessary to provide a clear surgical field, reduce the chance of structural damage, prevent postsurgical hemorrhage, and avoid the need for surgical drains; however, the safest, most efficient, and cost-efficient way to attain these goals is nevertheless under debate [8].

The main sources of bleeding during thyroidectomy are injured thyroid vessels and thyroid parenchymal hemorrhage. Hemorrhage either (intraoperative or postoperative) may cause some complications such as seromas and/or hematomas, and also responsible for potentially lethal asphyxia. Hemostasis is a critical factor for prolongation of operative time, the length of hospital stay, and costs [9].

Hemostasis obtained with traditional techniques such as clamp and tie, use of clips or electrocautery, and fibrin glue is time consuming and carry the risk of knot slipping, dislodgement, and thermal damage [10].

Ligation and division of the thyroid vessels is the most time-consuming part of the operation. There are several ways to reduce the operative time by using new strategies of vessel ligation and division without increasing the risk of postoperative complications [9].

Technological innovation allowed us to use ultrasonic mechanical power to enhance the methods of dissection and coagulation, thus facilitating the surgical act in terms of hemostasis and reducing the operative times [11].

The ability of the HS to reduce the operative time by many minutes compared with the standard technique has been long demonstrated. In the published literature [12], it ranges from 15% up to 30%, and is more apparent when surgical procedures are long and complex [3]. It has been observed that there has been a relative reduction of 27% in surgical time, which was significantly shorter in the harmonic group than in the traditional group (105±27 vs. 143±32 min, respectively).

Sultan et al. [13] have reported that the operative time for the HF group ranged from 30 to 100 min, with a mean of 60.25±22.68 and the operative time for the conventional hemostasis group ranged from 70 to 130 min, with a mean of 102.50±18.46.

In this study, a reduction in operative time was also significantly shorter in the HS group (77±10 vs. 102±11 min) than the traditional thyroidectomy group.

Sartori et al. [14] reported no significant difference in intraoperative blood loss between patients in the conventional thyroidectomy group who had a mean blood loss of 107±25 ml and in the HS group the estimated blood loss amounted to 97±19 ml.

Zanghì et al. [3] reported that significant difference in the intraoperative amount of blood loss was more in the traditional group than in the HS group (36±23 vs. 24±18 ml) and the mean amount of postoperative fluid drainage has no significant difference between the two groups (10±3 vs. 11±4 ml HS and traditional group). In our study, we reported a significant lower amount of blood loss in the harmonic group 71±15 than the traditional thyroidectomy group 138±12 and significant lower amounts of drain were observed in the harmonic thyroidectomy 64±20 group than the traditional thyroidectomy group 136±24.Zanghì et al. [3] and Papavramidis et al. [15] found that postoperative serum calcium levels has no significant differences between two groups while Al-Dhahiry and Hameed [4] reported a statistically significant difference between conventional suture ligation group versus HS as regards postoperative hypocalcemia. In our study, postoperative calcium+2 has no significant differences between the two groups (8.7±0.5 for harmonic thyroidectomy and 8.6±0.5 for traditional thyroidectomy, P=0.06).

Dhahiry and Hameed [4] found a significant difference between conventional suture ligation group versus HS regarding postoperative bleeding. All patients with postoperative bleeding in our study had smooth recovery; only one case required reoperation in the traditional group.

Lewis and Weber [1] and Zanghì et al. [3] reported no significant difference as the temporary recurrent laryngeal nerve palsy rate was found between two groups with no case of permanent RLN paralysis. In our study, it was comparable between both groups with no permanent paralysis.


  Conclusion Top


At the end of the study, the use of the HS during total thyroidectomy is a reliable and safe tool. It significantly reduces intraoperative time, intraoperative blood loss, and postoperative drainage. HS is more effective than traditional technique.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
  References Top

1.
Lewis CM, Weber RS. Surgery of the thyroid and parathyroid glands. 2nd ed. Philadelphia, PA: Elsevier; 2012. 389–398.  Back to cited text no. 1
    
2.
Röher, Klaus-Martin Schulte and Hans-Dietrich. Surgery of the thyroid and parathyroid glands. Oertli D, Udelsman R, editors. Berlin, Heidelberg: ESpringer Berlin Heidelberg; 2012. http://link.springer.com/10.1007/978-3-642-23459-0.  Back to cited text no. 2
    
3.
Zanghì A, Cavallaro A, Di Vita M, Cardì F, Di Mattia P, Piccolo G et al. The safety of the Harmonic® FOCUS in open thyroidectomy: a prospective, randomized study comparing the Harmonic® FOCUS and traditional suture ligation (knot and tie) technique. Int J Surg 2014; 12 (Suppl 1):132–135.  Back to cited text no. 3
    
4.
Al-Dhahiry JKS, Hameed HM. Total thyroidectomy: conventional suture ligation technique versus sutureless techniques using harmonic scalpel or maxium. Ann Med Surg (Lond) 2016; 5:29–34.  Back to cited text no. 4
    
5.
Van Slycke S, Gillardin JP, Van Den Heede K, Minguet J, Vermeersch H, Brusselaers N. Comparison of the harmonic focus and the thunderbeat for open thyroidectomy. Langenbecks Arch Surg 2016; 401:851–859.  Back to cited text no. 5
    
6.
Docimo G, Tolone S, Ruggiero R, del Genio G, Brusciano L, Pezzolla A et al. Total thyroidectomy with harmonic scalpel combined to gelatinthrombin matrix hemostatic agent: is it safe and effective? A single-center prospective study. Int J Surg [Internet] 2014; 12:209–212.  Back to cited text no. 6
    
7.
Mauriello C, Marte G, Canfora A, Napolitano S, Pezzolla A, Gambardella C et al. Bilateral benign multinodular goiter: what is the adequate surgical therapy? A review of literature. Int J Surg [Internet] 2016; 28:S7–S12.  Back to cited text no. 7
    
8.
Ruggiero R, Docimo L, Tolone S, De Palma M, Musella M, Pezzolla A et al. Effectiveness of an advanced hemostatic pad combined with harmonic scalpel in thyroid surgery. A prospective study. Int J Surg [Internet] 2016; 28:S17–S21.  Back to cited text no. 8
    
9.
Revelli L, Damiani G, Bianchi CBNA, Vanella S, Ricciardi W, Raffaelli M et al. Complications in thyroid surgery. harmonic scalpel, harmonic focus versus conventional hemostasis: a meta-analysis. Int J Surg 2016; 1:S22–32.  Back to cited text no. 9
    
10.
Ruggiero R. Update on sutureless thyroidectomy. Giornale di Chirurgia. J Surg 2018; 39:45. https://www.giornalechirurgia.it/common/php/portiere.php?ID=d17d5526970560332c6cc8ab90078066.  Back to cited text no. 10
    
11.
Ruggiero R, Gubitosi A, Conzo G, Gili S, Bosco A, Pirozzi R et al. Sutureless thyroidectomy. Int J Surg 2014; 12:S189–193.  Back to cited text no. 11
    
12.
Hallgrimsson P, Lovén L, Westerdahl J, Bergenfelz A. Use of the harmonic scalpel versus conventional haemostatic techniques in patients with Grave disease undergoing total thyroidectomy: a prospective randomised controlled trial. Langenbeck’s Arch Surg 2008; 393:675–680.  Back to cited text no. 12
    
13.
Sultan HM, Ammar MS, Gaber A, Hagag MG, Abd El Bary AR. Comparative study between focus harmonic scalpel and conventional hemostasis in open total thyroidectomy. Menoufia Med J 2018; 31:175–180.  Back to cited text no. 13
    
14.
Sartori PV, De Fina S, Colombo G, Pugliese F, Romano F, Cesana G et al. Ligasure versus Ultracision® in thyroid surgery: a prospective randomized study. Langenbeck’s Arch Surg 2008; 393:655–658.  Back to cited text no. 14
    
15.
Papavramidis TS, Sapalidis K, Michalopoulos N, Triantafillopoulou K, Gkoutzamanis G, Kesisoglou I et al. UltraCision harmonic scalpel versus clamp-and-tie total thyroidectomy: a clinical trial. Head Neck 2009; 36:723–727.  Back to cited text no. 15
    


    Figures

  [Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6]
 
 
    Tables

  [Table 1], [Table 2], [Table 3]



 

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