The use of “harmonic scalpel” versus “knot tying” for conventional “open” thyroidectomy: results of a prospective randomized study

Lombardi, Celestino Pio; Raffaelli, Marco; Cicchetti, Americo; Marchetti, M; Crea, Carmela De; Bidino, Rossella Di; Oragano, Luigi; Bellantone, Rocco Domenico Alfonso

doi:10.1007/s00423-008-0380-9

Cited by 77 publications

(104 citation statements)

References 21 publications

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“…In some studies11, 20, 21, 25, 31, transient hypocalcaemia was less common when US were used but, more often, rates were similar to those in the control arm7, 8, 9, 18, 22, 23, 27, 29, 30. Postoperative pain has rarely been evaluated, and only in a few studies12, 21, 27 did US reduce pain.…”

Section: Discussionmentioning

confidence: 99%

“…Some found the US device to be cost‐effective in terms of surgical procedure and/or hospital admission24, 28, whereas others8, 9 reported that, owing to the higher cost of disposable materials, the overall cost of hospitalization was not significantly different between US and CH groups. Economic analyses are difficult to extrapolate to different countries because of differences in hospital costs and organization.…”

Section: Discussionmentioning

confidence: 99%

“…The single‐use device, HARMONIC FOCUS ® (Ethicon Endo‐Surgery, Johnson & Johnson, Cincinnati, Ohio, USA), has been evaluated in a number of clinical studies with discordant results. Although it is generally acknowledged that use of US reduces operating time7, 8, 9, 10, the impact on postoperative complications is unclear. Some studies have reported lower rates of complications, whereas others failed to demonstrate benefits over conventional haemostasis (CH)8, 9, 10, 11, 12, 13, 14.…”

Section: Introductionmentioning

confidence: 99%

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Randomized clinical trial of ultrasonic scissorsversusconventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr)

et al. 2017

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BackgroundThe benefits of single‐use ultrasonic scissors in thyroid surgery are still debated. Although this device has been shown to reduce operating time compared with conventional haemostasis, its cost‐effectiveness has never been demonstrated. The aim of this study was to evaluate the efficacy, cost‐effectiveness and safety of ultrasonic scissors for total thyroidectomy.MethodsThis was a prospective, randomized, multicentre trial conducted at 13 hospital sites. The primary endpoint was the percentage of patients with hypocalcaemia (serum calcium level below 2 mmol/l) on day 2. Secondary endpoints included postoperative complications and costs, with calculation of incremental cost differences and cost‐effectiveness ratios.ResultsIn total, 1329 patients who underwent total thyroidectomy were included in the analysis: 670 were randomized to treatment with ultrasonic scissors and 659 to conventional haemostasis. There was no difference between groups in the rate of complications, including hypocalcaemia on day 2 (19.7 per cent in ultrasonic scissors group versus 20.3 per cent in conventional haemostasis group; P = 0·743). Median operating times were significantly shorter with ultrasonic scissors (90 versus 100 min with conventional haemostasis; P < 0·001). Total mean(s.d.) direct costs at 6 months were €4311(1547) and €4011(1596) respectively (P < 0·001).ConclusionUltrasonic scissors were no more clinically effective than conventional haemostasis, but use of these devices was more costly. Registration number: NCT01551914 (http://www.clinicaltrials.gov).

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Randomized clinical trial of ultrasonic scissorsversusconventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr)

et al. 2017

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“…These devices rely heavily on high-energy sources, including radio waves and ultrasound, with specialized instruments now available specifically for thyroid surgery. [2][3][4][5] Recent studies have suggested that the Harmonic Focus method is associated with higher complication rates, whereas the LigaSure Precise method prolongs the operating time. 6 New scissors have also been introduced to increase efficacy and intraoperative safety.…”

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confidence: 99%

Differences in Thyroidectomy Outcomes Based on Surgical Method: A Comparison of LigaSure Precise, Harmonic Focus, and Traditional Methods

Çiftçi

2016

International Surgery

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New surgical devices have been developed to improve haemostatic control and vascular closure in thyroid surgery. Here, we compare the efficacy and clinical outcomes of 3 surgical methods, Harmonic Focus, LigaSure Precise, and the traditional suture-ligation method, in patients undergoing total thyroidectomies. This retrospective study compared total thyroidectomies performed between July 2008 and August 2012. Thyroidectomies were performed in 243 patients using Harmonic Focus (n ¼ 81), LigaSure Precise (n ¼ 81), and traditional suture-ligation (n ¼ 81). No significant differences were observed among groups in terms of patient demographics, thyroid weight, pathological diagnoses, pre-and postoperative calcium levels, postoperative complications, length of hospitalization, and clinical outcomes. The Harmonic Focus approach showed an~15% shortening in operating time relative to the suture-ligation group; no statistically significant differences were detected between the LigaSure and traditional suture-ligation groups. All 3 methods were found to be both safe and effective. Operating time was significantly shorter in the Harmonic Focus group; no differences in terms of postoperative complications were observed among groups.

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“…The Harmonic Scalpel FOCUS has an active blade that oscillates at 55 kHz, simultaneously sealing and cutting tissue. This vibration denatures hydrogen bonds, leading to formation of a protein coagulum [5,6]. Thermal spread from either instrument is reported to be 0.5-2 mm and is related to vessel size and hence he corresponding energy required for proper vessel sealing.…”

Section: Introductionmentioning

confidence: 99%

Suturless Thyroidectomy

Karaca¹

2015

Ann Clin Anal Med

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ÖzetAmaç: Bu klinik çalışmanın amacı, Harmonik Scalpel (HS) ile yapılan sütürsüz tiroidektomileri konvansiyonel tiroidektomilerle evrensel parametreler açısın-dan karşılaştırmaktır. Gereç ve Yöntem: Bu prospektif randomize çalışma total tiroidektomi uygulanan 929 hasta üzerinde yapıldı. Hastalar randomize olarak 2 gruba ayrıldı. Grup I 461 hasta içeriyordu ve bu hastalara harmonic scalpel ile total tiroidektomi uygulandı. Grup II ise 468 hastadan oluşuyordu ve onlarada konvansiyonel tiroidektomi uygulandı. Bulgular: Operasyon süresi Grup I'e göre Grup II (49 ± 11min) (32 ± 8 dk) anlamlı olarak daha uzundu.Ortalama kan kaybı hastalarda her iki grupta da anlamlı değildi. Tiroid boyutunda istatistiksel olarak anlamlı bir fark yoktu. Geçici / kalıcı hipokalsemi oranları karşılaştırıldığında, iki grup benzerdi. Kalıcı RLN felci açısından istatistiksel olarak anlamlı fark yoktu Grup I'de beş hastada görüldü. Ameliyat sonrası kanama, enfeksiyon oranları, hastanede kalış süresi iki grup arasında farklı değildi. Tartışma: Sonuç olarak, tiroid cerrahisinde HS kullanımı, geleneksel yöntemlere göre ameliyat süresini kısaltmaktadır. Ameliyat sonrası komplikasyonlar arasında hiçbir fark yoktur. HS tiroid cerrahisinde etkili, uygun ve güvenilir bir yöntemdir. Anahtar KelimelerTiroid Cerrahisi; Harmonik Scalpel; Total Tiroidektomi Abstract Aim: Our purpose, Harmonic Scalpel (HS) and Conventional thyroidectomy in this clinical study was to compare in terms of universal parameters. Material and Method: This prospective randomized trial study was performed on these 929 consecutive patients given total thyroidectomy. Patients were randomly assigned to either the Focus group (in which the operation was performed entirely using the Harmonic Focus and no other hemostatic tool; 468 patients) or the classic group (in which the operation was performed using conventional clamp-and-tie technique and mono-polar electric scalpel; 461 patients). Results: The operation time was significantly longer in Group II (49±11min.) than Group I (32±8 min). The mean blood loss was not significantly in patients both groups. There was no statistically significant difference in specimen size. The two groups were similar when transient/permanent hypocalcaemia rates were compared. Permanent RLN palsy was seen in five patient in Group I. There was no statistically significant difference in drain usege. Postoperative bleeding, seroma, infection rates, hospitalisation time were not different between the two groups. Discussion: In conclusion, usage of the UHS in thyroid surgery decreases operation time when it is compared to conventional methods. On the other hand there is no difference in postoperative complications. The UHS is an effective, reliable and feasible technique in thyroid surgery.

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The use of “harmonic scalpel” versus “knot tying” for conventional “open” thyroidectomy: results of a prospective randomized study

Abstract: HS is a safe alternative to KT, allowing for a significant reduction of operative time without increasing complications rate and overall costs and probably better utilization of health resources.

Cited by 77 publications

References 21 publications

Randomized clinical trial of ultrasonic scissorsversusconventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr)

Randomized clinical trial of ultrasonic scissorsversusconventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr)

Differences in Thyroidectomy Outcomes Based on Surgical Method: A Comparison of LigaSure Precise, Harmonic Focus, and Traditional Methods

Suturless Thyroidectomy

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