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ORIGINAL ARTICLE
Year : 2018  |  Volume : 31  |  Issue : 1  |  Page : 175-180

Comparativestudy between Focus harmonic scalpel and conventional hemostasis in open total thyroidectomy


Department of General Surgery, Faculty of Medicine, Menoufia University, Menoufia, Egypt

Date of Submission10-Dec-2015
Date of Acceptance15-Feb-2016
Date of Web Publication14-Jun-2018

Correspondence Address:
Ahmed R Abd El Bary
Shibin Al-Kom, Menoufia
Egypt
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/mmj.mmj_520_15

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  Abstract 


Objective
The aim was to compare between Focus harmonic scalpel and conventional hemostasis in open total thyroidectomy regarding operative time, postoperative complications(hypocalcemia and recurrent laryngeal nerve injury), postoperative blood drainage volume, postoperative pain, and hospital stays.
Background
Thyroidectomy is one of the most common operations, and many studies have been done to improve the technique of thyroidectomy. Therefore, the author conducted this study to determine if Focus harmonic scalpel is effective in thyroidectomy or not.
Materials and methods
This study is a prospective, comparative, randomized, and descriptive study of 40patients having nontoxic multinodular goiter. The patients were divided into two groups: groupA was subjected to open total thyroidectomy with Focus harmonic scalpel(20patients), and groupB was subjected to open total thyroidectomy with conventional hemostasis(20patients). Both groups were compared for age, sex, operative time, postoperative complications(hypocalcemia and recurrent laryngeal nerve injury), postoperative blood drainage volume, postoperative pain, and hospital stays.
Results
Use of Focus harmonic scalpel in open total thyroidectomy leads to shorter operative time, asP value was highly significant; decrease of postoperative blood drainage volume, asP value was significant; decrease of postoperative pain, asP value was highly significant; and shorter postoperative hospital stays, asP value was significant; however, it does not decrease the rate of postoperative complications(hypocalcemia andtheRecurrent laryngeal nerve (RLN) injury), asP value was nonsignificant.
Conclusion
In open total thyroidectomy, the Focus harmonic scalpel is a reliable and safe tool. Its use is more effective than conventional hemostasis. The surgical operative time and the hospital stay are shorter. The postoperative blood drainage volume is reduced; furthermore, the postoperative pain is less. However, the rates of transient hypocalcemia and recurrent laryngeal nerve injury are statistically nonsignificant.

Keywords: conventional hemostasis, Focus harmonic scalpel, total thyroidectomy


How to cite this article:
Sultan HM, Ammar MS, Gaber A, Hagag MG, Abd El Bary AR. Comparativestudy between Focus harmonic scalpel and conventional hemostasis in open total thyroidectomy. Menoufia Med J 2018;31:175-80

How to cite this URL:
Sultan HM, Ammar MS, Gaber A, Hagag MG, Abd El Bary AR. Comparativestudy between Focus harmonic scalpel and conventional hemostasis in open total thyroidectomy. Menoufia Med J [serial online] 2018 [cited 2019 Apr 18];31:175-80. Available from: http://www.mmj.eg.net/text.asp?2018/31/1/175/234221




  Introduction Top


Over the past decades, the techniques of thyroid operations have undergone only minor changes; however, in the past 20years, dynamic development of new instruments has been seen, which has had a significant effect on the improvement of old and introduction of new surgical techniques [1].

Today thyroidectomy is among the most commonly performed procedures involving the endocrine glands, and the development of advanced surgical methods combined with the determination to perform the operation in a manner that is minimally invasive for the patient has considerably increased the need for instruments that limit surgical trauma [2].

Appropriate hemostasis and a traumatic tissue dissection in addition to protecting the tissues against excessive thermal injuries leading to their structural damage have provided foundations for developing an instrument that would combine precision and versatility with safety for the surrounding structures [2].

The ultrasonic knife introduced to operating rooms at the turn of the 20thand 21stcenturies has provided new opportunities for safe sealing of blood vessels combined with a minimal thermal effect exerted on the neighboring tissues [3].

Surgical treatment of thyroid diseases is associated with complications, of which bleeding is among the most severe. However, appropriate and cautious surgical techniques combined with exercising care to fully identify anatomical structures have significantly decreased the number of such complications [4].

Hemostasis during thyroidectomy can be performed by classic suture ligation with clamp-and-tie maneuvers and/or by electrocoagulation. Although suture ligation is a time-consuming procedure and carries the risk of knot slipping, electrocautery is an unattractive alternative because it implies the potential risk of injuring surrounding tissues from dispersion of heat [5].

The aim of this study was to compare between the Focus harmonic scalpel and the conventional hemostasis in open total thyroidectomy regarding the operative time, postoperative complications(hypocalcemia and recurrent laryngeal nerve injury), hospital stay, postoperative pain, and postoperative blood drainage.


  Materials and Methods Top


This was a prospective, comparative, randomized, and descriptive study conducted on 40patients having nontoxic multinodular goiter. They were admitted to the Department of General Surgery, Menoufia University. All patients underwent total thyroidectomy. The patients were divided into two groups: groupA included 20patients who underwent total thyroidectomy using Focus harmonic scalpel, and groupB included 20patients who underwent total thyroidectomy using conventional hemostasis, for example, diathermy and ligature.

Both groups were compared for age, sex, operative time, postoperative complications(hypocalcemia and the RLN injury), postoperative pain, postoperative blood drainage volume, and hospital stay.

Inclusion criteria

The study included patients who were diagnosed as having nontoxic multinodular goiter.

Exclusion criteria

The following were the exclusion criteria: patients who had undergone previous thyroid or parathyroid surgery, who had toxic goiter, who had fine needle aspiration biopsy report suspicious of thyroid cancer, who had history of previous neck irradiation, who were preoperatively diagnosed as having recurrent laryngeal nerve palsy, and who were preoperatively diagnosed as having hypocalcemia.

Informed consents were obtained from all patients included in the study. The study was approved by the local ethics committee of General Surgery Department of Faculty of Medicine, Menoufia University.

All the patients included in this study were subjected to the following.

Preoperative assessment

This included meticulous history taking with special emphasis on personal data, history of the present illness, medical history, previous operations, and family history.

Clinical examination

It included both general(pulse, blood pressure, and eye signs of thyroid toxicity) and local(inspection and palpation of the neck) examination.

Laboratory investigations

Thyroid profile(T3, T4, thyroid-stimulating hormone), complete blood count, liver profile(e.g.,aspartate transaminase, alanine transaminase, prothrombin time), renal function tests(serum urea and creatinine), serum calcium level, fine needle aspiration biopsy from thyroid nodule, ECG if the patient above 50years old, neck ultrasonography(neck US), and indirect laryngoscope by an otorhinolaryngologist to assess vocal cords mobility were examined.

Intraoperative assessment

Open total thyroidectomy was done for groupA using Focus harmonic scalpel(Ethicon Endo-Surgery Inc., Cincinnati, Ohio, USA) and for groupB using conventional hemostasis(diathermy and ligature). The operative time(from skin incision to skin closure) was calculated for each patient.

Postoperative assessment

Assessment of recurrent laryngeal nerve was done clinically (voice or breathing abnormality) and by indirect laryngoscope by an otorhinolaryngologist. Serum calcium level was measured for each patient 24h postoperatively. Postoperative pain was assessed. Follow-up of postoperative blood drainage volume and hospital stays was done. Follow-up of the patients was done in the outpatient clinic after a week and 2months.

The results were collected, evaluated, calculated, tabulated, and statistically analyzed using statistical package for the social sciences(SPSS), version20 (IBM Corp., Armonk, NY).

The following are the types of tests used:

  1. Descriptive statistics included number and percentage for qualitative data and mean, SD, and range for quantitative data
  2. Analytic statistics included the following:


Student's t-test is a test used for comparison between groups having quantitative variables.

Mann–Whitney test(nonparametric test) is a test of significance used for comparison between two groups not normally distributed having quantitative variables.

X2-test was used to study association between two qualitative variables.

Fisher's exact test was used for 2×2 tables when expected cell count of more than 25% of cases was less than 5.

Z test is a significance test for testing proportions.

Pvalue greater than 0.05 was considered statistically insignificant.

Pvalue less than or equal to 0.05 was considered statistically significant.

Pvalue less than or equal to 0.001 was considered statistically highly significant.


  Results Top


The age of the patients of HF group ranged from 23 to 60years, with a mean of 38±8.17years. The age of the patients of CH group ranged from 25 to 50years, with a mean of 35.15±6.81years. P value was 0.23. The sex distribution was 28female and 12male patients. The P value was 0.49[Table1].
Table 1: Demographic characteristics of the studied patients for both surgical techniques of open total thyroidectomy

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The operative time for HF group ranged from 30 to 100min, with a mean of 60.25±22.68. The operative time for conventional hemostasis group ranged from 70 to 130min, with a mean of 102.50±18.46. The P value was less than 0.001[Table2].
Table 2: Intraoperative assessment of operative time, postoperative assessment of pain, postoperative assessment of drains, and postoperative assessment of hospital stay among the studied patients for both surgical techniques of open total thyroidectomy

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The difference in pain between HF group and CH group is highly significant according to visual analog scale, as mean for HF group was 3.97±1.31 and for CH group was 5.91±1.69. P value was less than 0.001 [Table2].

The drains at the first day for HF group ranged from 50 to 130ml, with a mean of 75.75±28.15. The drains at the first day for CH group ranged from 70 to 190ml, with a mean of 147.50±46.13. The P value was 0.03. The number of drains that contained less than 20ml and removed at the second day for HF group was 14(70%). The number of drains that contained less than 20ml and removed at the second day for CH group was five(25%). The P value is 0.02. The number of drains that were removed at the third day for HF group was six(30%). The number of drains that were removed at the third day for HF group was 15(75%). The P value was 0.04[Table2].

The number of patients staying for only 24h in the hospital in the HF group was 14(70%), with mean of 31.20±11.18. The number of patients staying for only 24h in the CH group was five(25%), with mean of 42.00±10.66. The P value was 0.005[Table2].

The number of patients having hoarseness of voice in HF group was one(5%), whereas in CH group was three (15%)(P=0.29). The number of patients diagnosed as having immobile vocal cord by indirect laryngoscope (done by an otorhinolaryngology specialist), which showed immobile right vocal cord, in HF group was one(5%). The number of patients diagnosed as having immobile vocal cord by indirect laryngoscope, which showed immobile right vocal cord in one patient and immobile left vocal cord in two patients, in CH group was three(15%). P value is 0.29[Table3].
Table 3: Postoperative RLN assessment (clinical and indirect laryngoscope) among the studied patients for both surgical techniques of open total thyroidectomy

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The number of patients having postoperative transient hypocalcemia in HF group was two(10%). The number of patients having postoperative transient hypocalcemia in CH group was three(15%). P value was 0.65[Table4].
Table 4: Postoperative assessment of serum calcium level (24 h postoperatively) and follow-up in outpatient clinic (after a week and 2 months), among the studied patients for both surgical techniques of open total thyroidectomy

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There were three(15%) patients who had hoarseness of voice during follow-up in outpatient clinic 1week from hospital discharge in HF group, and none of the patients had hypocalcemia. In CH group, five(30%) patients had hoarseness of voice during follow-up in outpatient clinic 1week from hospital discharge, and one(5%) patient had hypocalcemia. P value was 0.28(nonsignificant). Follow-up in outpatient clinic 2months after hospital discharge showed improvement of all patients who had hoarseness of voice, but only one patient still had hypocalcemia in CH group. P value was 0.31[Table4].


  Discussion Top


Our study included 40patients, with 28females and 12males. This indicates that thyroid diseases are more common in female than male individuals, which is in agreement with Parker etal. [6].

Our study revealed that the Focus harmonic scalpel takes less operative time than the conventional hemostasis. This is because ligation and then division of blood vessels in the CH group take more time, but the HF can coagulate, seal, and divide blood vessels at the same time.

Similarly, Askar etal. [7] revealed that the operative time for the HF group is shorter than the CH group, where mean±SD for the HF group was 50.27±8.03, but for the CH group was 102.38±14.63.

Moreover, Miccoli etal. [8] revealed that the HF reduces the operative time than the CH, where mean±SD for the HF group was 33.04±14.25 and for the CH group was 47.2±7.66.

In our study, postoperative assessment of blood drainage showed that the drains were removed after 24h for 14patients who underwent total thyroidectomy using the HF, but the drains were removed after 24h for only five patients who underwent total thyroidectomy using the CH. The explanation is that the HF achieves efficient hemostasis and minimal tissue manipulation during surgery than the CH.

Similarly, Ferri etal. [9] revealed that the HF reduces the postoperative blood drainage volume, where mean±SD for the HF group was 37.4±2.4 and for the CH group was 56.1±4.2.

In addition, Miccoli etal. [8] revealed that the HF reduces the postoperative blood drainage volume, where mean±SD for the HF group was 5.41±6.5 and for the CH group was 12.8±9.94.

In our study, postoperative assessment of pain after total thyroidectomy shows that using HF reduces postoperative pain compared with CH. Apossible explanation is that the HF causes reduced tissue injury, with no neuromuscular stimulation, as would be induced by diathermy.

Similarly, Defechereux etal. [10] revealed that the use of HF reduces the postoperative pain compared with CH, where mean±SD for the HF was 3.89±1.07 and for the CH was 5.06±2.11.

However, Cordon etal. [11] showed no significant difference in postoperative pain after total thyroidectomy between HF and CH.

Our study showed that the use of HF leads to reduction in the postoperative hospital stays in comparison with the CH, as in HF group, 14patients were discharged from the hospital after 24h in comparison with only five patients in CH groups. This is because using HF enables meticulous hemostasis with minimal tissue manipulation leading to early removal of drains than CH.

Similarly, Hallgrimsson etal. [12] revealed that use of the HF leads to significant reduction of postoperative hospital stays than CH.

Our study shows that postoperative transient hypocalcemia after 24h occurred in two patients of HF group and in three patients of CH groups. Our results seem to support the hypothesis that the reduced tissue injury resulting from less heat generated by the HF might lead to a reduced risk of impaired vascularity in the parathyroids glands. Many studies agree with our result, such as Miccoli etal.[8].

Although the result of postoperative transient hypocalcemia is statistically insignificant, randomized studies in the prospective future with a larger numbers of patients are required to show if there is significant reduction in number of patients undergoing total thyroidectomy with HF and experiencing postoperative transient hypocalcemia or no significant reduction. Many studies agree with us in this suggestion, such as Ferri etal.[13].

In our study, postoperative RLN assessment showed that one patient had hoarseness of voice in HF group and three patients in CH group. When indirect laryngoscope was done for all patients, in HF group, only one patient showed immobile vocal cord, and in CH group, three patients show immobile vocal cord.

Difference between HF and CH in relation to RLN injury is related to heat transmission, where in HF group, the heat transmission is up to 2mm all around, but in CH group, the heat transmission with diathermy may reach to 10mm all around. Many studies agree with our study, such as Miccoli etal.[8].

As in postoperative transient hypocalcemia, although the result of postoperative RLN injury is statistically insignificant, randomized studies in the prospective future with a larger number of patients are required to show if there is significant reduction in number of patients undergone total thyroidectomy with HF and experiencing postoperative RLN injury or no significant reduction. Many studies agree with us in this suggestion such as Ferri etal. [13].

Although at hospital discharge, only one patient had hoarseness of voice in HF group and three patients in CH group, follow-up of patient in the outpatient clinic after a week from hospital discharge shows that three patients of HF groups had hoarseness of voice, and five patients of CH group had hoarseness of voice. These patients who exhibited hoarseness of voice were referred to an ENT specialist for stereoscopy, which showed immobile vocal cord. These patients received medical treatment in the form of corticosteroids and neurotonics(vitamin B complex). The possible explanation for increasing number of patients who had hoarseness of voice is the possibility of development of edema around the RLN that led to neuropraxia and hoarseness of voice.

Later on, follow-up in the outpatient clinic after 2months from hospital discharge showed improvement of hoarseness of voice in all patients except one patient, who had permanent hoarseness of voice in CH group. Stereoscopy showed mobile vocal cords for all patients except the patient who had permanent hoarseness of voice, where the vocal cord remained immobile. This indicates permanent injury of the RLN with the diathermy.

The improvement of hoarseness of voice may be related to the subsiding of edema, which developed around the RLN postoperatively, with medical treatment.

Summary and conclusion

This study was conducted to compare between the Focus harmonic scalpel and the conventional hemostasis in open total thyroidectomy, and the study showed that the Focus harmonic scalpel is a reliable and safe tool. Its use is more effective than the conventional hemostasis. The surgical operative time and the hospital stay are shorter. The postoperative blood drainage volume is reduced, and also the postoperative pain is less; however, the rates of transient hypocalcemia and recurrent laryngeal nerve injury are statistically nonsignificant.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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    Tables

  [Table1], [Table2], [Table3], [Table4]



 

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