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Table of Contents
ORIGINAL ARTICLE
Year : 2011  |  Volume : 13  |  Issue : 2  |  Page : 125-129

The evidence of safely using tisseel in drain-free thyroidectomies prospective cohort study


Department of Otolaryngology-Head & Neck Surgery King Abdulaziz University Hospital College of Medicine, King Saud University Riydah, Saudi Arabia

Date of Web Publication6-Jan-2020

Correspondence Address:
MD. MSc. FRCSC K AL-Qahtani
Department of Otolaryngology-Head & Neck Surgery King Abdulaziz University Hospital College of Medicine, King Saud University Riydah
Saudi Arabia
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/1319-8491.274757

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  Abstract 


Objectives: To evaluate the safely and effectively using of Hemostatic Fibrin Glue in drain-free thyroidectomies.
Study Design: Prospective cohort study of 25 patients undergoing thyroidectomies. Surgery was done using tessel without the use of surgical drains. The complication and duration of the hospital stay were obtained.
Methods: Thyroidectomies were undertaken by one surgeon. Prior to wound closure, the skin flap and wound bed were approximated using Tisseel tissue sealant, and no drains were used. Data regarding incidence of any complication and the duration of the hospital stay were obtained. Patients were followed to assess surgical outcome and document any complications.
Results: There were no cases of seroma, hematoma, recurrent laryngeal nerve paresis or paralysis. However, there were six patient who had hypocalcaemia post operatively. Three of those six patient had hypocalcaemia for one month, two patients had it for three months, and one patient had it for more than six months.
Conclusions: Thyroidectomies can be undertaken safely and effectively without the need for surgical drains. Hemostatic actions of fibrin glue precluded the necessity of usage of drains.

Keywords: Tisseel, Drain Free,Recurrent Laryngeal Nerve (RLN),Papillary Thyroid Carcinoma(PTC), Seroma, Hematoma


How to cite this article:
AL-Qahtani K. The evidence of safely using tisseel in drain-free thyroidectomies prospective cohort study. Saudi J Otorhinolaryngol Head Neck Surg 2011;13:125-9

How to cite this URL:
AL-Qahtani K. The evidence of safely using tisseel in drain-free thyroidectomies prospective cohort study. Saudi J Otorhinolaryngol Head Neck Surg [serial online] 2011 [cited 2021 Apr 21];13:125-9. Available from: https://www.sjohns.org/text.asp?2011/13/2/125/274757




  Introduction: Top


Thyroid nodules are a common clinical finding in the general population, with a prevalence estimated to be from 4 to 7%; of these, 5% are malignant. However, in the Kingdom of Saudi Arabia the prevalence of thyroid cancer in Saudi females is 9%,which makes it the fastest rising incidence of all cancers. Thyroid surgery was first reported in the 1800s.1 The initial experience with this procedure was poor, with a reported 40% mortality rate [1]. By the early 1900s, improved technique had decreased the mortality to 3% [1],[2]. It has become routine surgery for many otolaryngologists.

Operations on the thyroid are the most common surgical procedures performed in the neck. In the past most surgeons employed wound drains routinely with the hope of decreasing the risk of acute airway obstruction by hematoma as well as postoperative hematoma or seroma [3]. Several authors, however, have suggested that use of drains could increase the risk of infection, the length of hospital stay, treatment costs, and discomfort for the patient. Moreover, the routine use of drains is not a substitute for meticulous surgical technique with careful hemostasis [4]. Therefore, the use of routine drainage in thyroid surgery has become controversial. The four major complications include recurrent laryngeal nerve injury, hypocalcemia, thyroid storm, and neck hematoma [5] The overall complication rate is low at approximately 4% [6]. The motivation for using a neck drain is to try to avoid, or identify early, the potentially life-threatening complication of a neck hematoma and to prevent seroma formation. Overall, the incidence of neck hematoma is < 1% [2],[5],[6].

Initial testing of tissue sealant consisting of fibrinogen and thrombin was undertaken by Young and Medawar in 1940(7). During the past two decades, the idea of using fibrin glue as a biological adhesive has gained popularity in various surgical procedures including microneural repairs, otolaryngologic surgery, craniofacial surgery,and aesthetic surgery [8].

Fibrin glue aids hemostasis by mirroring the final common pathway of the coagulation cascade and facilitates close apposition of surfaces for healing. These biological effects allow a rapid healing with decreased rate of postoperative complications and improve the final cosmetic results. With new techniques comes the opportunity to consider alternative postoperative management approaches with specific surgical procedures.

The Tisseel components are sterilized through a dry heat and vapour heat protocol, and all donors are screened for communicable diseases. To date, there have been no reported or suspected cases of Tisseel-mediated transmission of any communicable diseases, including hepatitis B, hepatitis C, human immunodeficiency virus (HIV), or  Creutzfeldt-Jakob disease More Details [9].

Tisseel is a commercially available fibrin glue product that has been used previously to reduce or eliminate the need for a percutaneous drain in facial cosmetic surgery(8).It is composed of human-derived thrombin and fibrinogen, as well as bovine-derived aprotinin, which function to form a fibrin mesh in vivo independently from the proximal coagulation cascade of either the intrinsic or the extrinsic pathway. This mesh binds host platelets to form a thrombus, which is stable for approximately 10 to 14 days in humans.

This prospective study evaluates the use of tissue glue in drainless thyroid surgery, which evaluates the duration of hospital stay, and postoperative complication rate in thyoidectomy patients with the use of Tisseel.


  Materials and Methods Top


A prospective and consecutive cohort of 25 patients underwent thyroidectomies with recurrent laryngeal nerve preservation (without neck dissection) between May 2009 and January 2010 at King Abdulaziz University Hospital, Riydah. In this cohort, 3 patients underwent Right hemithyroidectomy, 3 had a Left hemithyroidectomy and 19 had a total thyroidectomies. The cohort consisted of 25 females with a median age of 40.8 years (range 19-65 years). Fifteen of these patients had a presumed benign disease process based on clinical findings and investigations, including fine-needle aspiration cytology and imaging. The surgery was planned to use tessel and without the use of surgical drains.

Surgical Protocol:

All patients underwent thyroidectomy thought 6 cm skin incision, about 1 cm above the suprasternal notch, then dividing the strap muscle in the midline till reaching the thyroid gland, then using a capsular dissection technique; very few hemoclips and no suture ligatures were used during the surgery. Hemostasis was achieved using bipolar cautery on the small vessels entering the thyroid tissue; the main trunks of the superior and inferior thyroid arteries were preserved. All recurrent laryngeal nerves were identified visually, and at the end of the procedure, they were tested using a nerve stimulator and arytenoid palpation to confirm that they were intact. When the parathyroids were identified during the dissection, all efforts were made to preserve them and their blood supply. If we were concerned that they were devascularized, a small piece was sent for frozen section and the gland was reimplanted in the sternocleidomastoid muscle if positive. A slow-setting mixture of fibrin tissue glue was prepared according to the manufacturer’s instructions. The preparation used contains 500 IU/mL of human thrombin. Two milliliters of the fibrin glue was applied to the wound bed. The glue was delivered to the area by a spray device.

The skin flap was reapproximated to the wound bed, and sustained pressure was applied for 5 minutes. The superficial skin was then closed using a running absorbable suture. No drain was used. Patients were followed to assess surgical outcome and document any complications. Patients were initially reviewed 10 days after their surgery. Any complications were documented, as well as their experiences regarding the surgery. The mean follow-up period was 6 months (range 2-12 months).

Postoperative Period

Calcium levels were regularly evaluated in the early period 6 , 12, 20 hours postoperative, then twice a day if needed. 131 I total-body scans were done in cancer patients 6 to 12 weeks postoperatively; these scans were done when the patients’ thyroid-stimulating hormone was maximal. Maximal thyroid-stimulating hormone was achieved by withdrawing thyroxine 6 weeks pre- scan (or liothyronine sodium 2 weeks pre-scan), and the patients were on iodine-free diets for 2 weeks pre- scan.

Data Collection

The incidence of postoperative complications such as hematoma, seroma, wound dehiscence, hypocalcaemia and recurrent laryngeal nerve paresis or paralysis were noted for all patients. The length of hospital stay was noted for all the patients.

Statistical Analysis

Statistical analysis was performed using SPSS, version 15.0 for Windows.


  Results Top


Twenty five patients were enrolled in this study. The demographics of study patients are outlined in [Table 1]. The cohort consisted of 25 females with a median age of 40.8 years (range 19-65 years). The mean follow-up period was 6 months (range 2-12 months).
Table 1: Patient Demographic Information

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In this cohort, 3 patients underwent Right hemithyroidectomy, 3 had a Left hemithyroidectomy and 19 had a total thyroidectomies. [Table 2].
Table 2: Type of Surgery

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Fifteen of these patients had a presumed benign disease process based on clinical findings and investigations, including fine-needle aspiration cytology and imaging. However, three of those fifteen had PTC in the final pathology. Five patient had follicular lesion in the FNA and it showed benign lesion in the final pathology. In the other hand five patient had PTC in the FNA and it showed the same in the final pathology. [Table 3],[Table 4].
Table 3: Histopathology type Based on FNA

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Table 4: Histopathology type Based on final Pathology

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There were no cases of seroma, hematoma, recurrent laryngeal nerve paresis or paralysis. However, there were six patient who had hypocalcaemia post operatively. Three of those six patient had hypocalcaemia for one month, two patients had it for three months, and one patient had it for more than six months.

In this cohort, The mean hospital stay was 3 days (range 2-6 days). All patients expressed satisfaction with their surgery. No patients felt that discharge had been premature.


  Discussion Top


Fibrin glues, such as Tisseel, can potentially reduce drainage from postoperative wounds. Using Tisseel’s ability to form a coagulum and enhance hemostasis, the surgeon has another therapeutic adjunct to potentially eliminate serious complications, such as hematomas, seromas, and infection. This investigation determined the effectiveness of Tisseel to reduce post-thyroidectomy wound drainage. This finding is critical in the use of human blood products because such products must be free of pathogens, with a limited side-effect profile to attain wide clinical application.

Within the specialty of otolaryngology-head and neck surgery, tissue glue has been used in several situations, including facial plastic surgery,[10] thyroidectomy, nasal septal surgery, tonsillectomy, and more complex head and neck surgery [11].

There are different concentrations of thrombin available for use in Tisseel. The one used in this study is the fast-setting thrombin 500 IU/mL concentration, which functions more as a hemostatic agent and a glue. The thrombin 4 IU/mL concentration takes 1 to 2 minutes to set and functions more as a sealant. Although the thrombin 4 IU/mL concentration has been used successfully in facial cosmetic surgery in the past, the thrombin 500 IU/mL concentration used in this study because the instant hemostatic and glue properties were more likely to be effective in the parotidectomy wound bed. In addition, the duploject syringe application method was used because it provides a more controlled and directed application of the Tisseel than the available spray attachment.

According to the literature, females are more commonly affected by thyroid cancer than males. The ratio is about 2:1(12).However, in this series, females constituted 100% of the cohort. Although some investigators, [13] have reported younger age groups, the mean age of our patients was 40.8(range 19-65 years), similar to other studies [14].

We have been able to consistently diagnose the patients with malignant disease based on FNA. There were only three cases who had different result between the FNA and the final pathology. This is shown very clearly by the high sensitivity of the test in the hands of expert pathologists. Similar results have been shown by Boyd et al.[15] showed the sensitivity of the FNA was 86% with a positive predictive value of 96%. In the study by Hamming et al., the sensitivity was much less (67%), but, again, they have a higher specificity (99%) [16]. In these two studies, follicular neoplasia was considered as negative and suspicious as positive.

Frozen section was not done intraoperatively because of its inaccuracy and inability to improve the sensitivity of FNAB. Hamburger and Hamburger’s study [17] demonstrated that only 1% of the patients who had frozen section intraoperatively had their surgical plan altered.

Recurrent laryngeal nerve injury has been reported as the second most common complication of thyroid surgery after hypoparathyroidism. The estimated incidence of permanent paralysis varies from 0.3 to 4%.(18). When temporary paralysis is included, it was reported as high as 13% in patients with malignant disease(19). Many studies reported the incidence of nerve injury in relation to the patients at risk, which may not be the best correlation.(19). The nerve injury has been found to be significantly associated with surgery done for malignant disease rather than the extent of surgery.(19). We believe that we were able to keep a low incidence of nerve injury in our patients (0%) by clear identification of the recurrent laryngeal nerves at their distal end before they enter the larynx. In agreement with other studies, [15] other techniques, such as capsular dissection, avoidance of suture ligature, hemoclips, and ligation of the main trunk of the thyroid arteries, also helped to keep the incidence of paralysis in our patients low.

The incidence of hypoparathyroidism was reported with variable percentages in the literature. Mazzaferri et al. reported a high incidence of permanent hypoparathyroidism (13%) in 1981, [13] and in 1994, he reported an incidence of 5% [12]. Tsang et al. also reported an incidence of 5%., 14An incidence as low as 1.6% has been reported too.(15). Temporary hypoparathyroidism is much more common. Incidences as high as 20% have been reported [14]. Many authors report that a calcium + vitamin D requirement of 1 year or more is needed to classify someone as permanently hypoparathyroid. We were able to keep out incidence of permanent hypocalcemia low (4%) by careful capsular dissection and preservation of the inferior thyroid arteries.

Selective use of drains after thyroidectomy is not surprising because it has been suggested in the literature not to routinely drain the thyroid bed [20]. In general, the incidence of postoperative hematoma reported in the literature ranges from 0% to 30% [21]. Hematomas can result from inadequate hemostasis at the time of closure or increased venous pressure at extubation because of coughing or straining. Neither the use of drains nor bulky pressure dressings prevents hematoma formation. Pressure dressings do not halt the development of a hematoma and may actually obscure early identification of hematoma in the postoperative period. Early intervention is key to the management of postoperative hematoma. Most hematomas are clinically apparent within 2 to 4 hours after surgery [22]. It must be considered that complications caused by postoperative bleeding after thyroidectomy, which might produce respiratory failure, cannot be prevented by using a drain without meticulous hemostasis. Many authors have demonstrated that drainage after uncomplicated thyroid surgery, including total thyroidectomy, lobectomy, and subtotal thyroidectomy, does not decrease the rate of complications related to postoperative bleeding [20]. Some authors have been selective in the use of drains after thyroidectomy, with the specific indications being a large dead space, resection of a substernal goiter, and a raw thyroid bed at the conclusion of subtotal thyroidectomy [5],[22]. Some authors recommend the use of drains in cases of hypervascularity, such as in Graves’ disease or extensive dissection of some cancers [23].

Since the thyroid surgery pioneers first attempted operative intervention approximately 200 years ago, it has evolved into a fairly routine and safe procedure for the competent surgeon. Postoperative hematoma is the potentially fatal complication that all thyroid surgeons fear. Common sense suggests that the routine use of surgical drains could help reduce the risk. However, in the last 20 years, several arguments against their routine use have arisen in the literature. Arguments against routine drain use include increasing risk of postoperative infection, increasing cosmetic deficit with increased scarring,and prolonged hospital admission. [23].

It is important to note that the complication rate is very surgeon and site specific. Two of the biggest factors in performing a complication-free thyroid operation are surgeon expertise and his or her diligence at ensuring perioperative hemostasis [23].Routine drain use is never a substitute for these factors. Sosa and colleagues found that surgeon experience was one of the most important factors in determining the length of stay and complication rate [5]. In our study, there were no cases of seroma, hematoma, recurrent laryngeal nerve paresis or paralysis.


  Conclusions Top


1- The addition of Tisseel decreases wound drainage. Current data suggest that Tisseel would be a safe and effective adjunct in drainfree thyroidectomies.

2- Thyroidectomy can be undertaken safely and effectively without the need for surgical drains.

3- This study demonstrates no advantage with regard to prevention of hematoma or seroma by the routine placement of postoperative closed wound suction drains beneath the skin flaps after thyroid surgery.



 
  References Top

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Boyd LA, Earnhadt RC, Dunn JT, et al. Preoperative evaluation and predictive value of fine-needle aspiration and frozen section of thyroid nodules. J Am Coll Surg. 1988;187:494-503.  Back to cited text no. 15
    
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Hamming JF, Vriens MR, Goslings BM, et al. Role of fine-needle aspiration biopsy and frozen section examination in determining the extent of thyroidectomy. World J Surg. 1998;22:575-580.  Back to cited text no. 16
    
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Hamburger JL, Hamburger SW. Declining role of frozen section in surgical planning for thyroid nodules. Surgery. 1985;98:307-312.  Back to cited text no. 17
    
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Lee SW, Choi EC, Lee YM, Lee JY, Kim SC, Koh YW. Is Lack of Placement of Drains After Thyroidectomy With Central Neck Dissection Safe? A Prospective,Randomized Study. Laryngoscope. 2006;116(9):16632-5.  Back to cited text no. 20
    
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Singh B, Lucente FE, Shaha AR. Substernal goiter: a clinical review. Am J Otolaryngol. 1994;15:409-416.  Back to cited text no. 21
    
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Shaha AR, Jaffe BM. Selective use of drains in thyroid surgery. J Surg Oncol. 1993;52:241-243.  Back to cited text no. 22
    
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    Tables

  [Table 1], [Table 2], [Table 3], [Table 4]



 

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