Access the full text.
Sign up today, get DeepDyve free for 14 days.
L. Delbridge (2003)Total thyroidectomy: the evolution of surgical technique
ANZ Journal of Surgery, 73
W. Laycock, T. Trus, J. Hunter (2007)New technology for the division of short gastric vessels during laparoscopic Nissen fundoplication
Surgical Endoscopy, 10
C. Lombardi, M. Raffaelli, A. Cicchetti, M. Marchetti, C. Crea, R. Bidino, L. Oragano, R. Bellantone (2008)The use of “harmonic scalpel” versus “knot tying” for conventional “open” thyroidectomy: results of a prospective randomized study
Langenbeck's Archives of Surgery, 393
M. Frazzetta, G. Furgiuele, Dario Raimondo, A. Sammartano, E. Mannino, G. Simone, G. Vetri, S. Bonventre, G. Gesù (2005)Tiroidectomia totale con impiego del dissettore ad ultrasuoni: risultati di uno studio prospettico randomizzato
Il Giornale di chirurgia, 26
M. Rafaelli C. P. Lombardi (2008)The use of “harmonic scalpel
Langenbeck's Archives of Surgery, 393
O. Yıldırım, T. Umit, M. Ebru, Unal Bulent, K. Belma, Bozkurt Betul, Dolapci Mete, Cengiz Omer (2008)Ultrasonic harmonic scalpel in total thyroidectomies
Advances in Therapy, 25
N. Družijanić, Z. Perko, D. Kraljević, J. Juričić, M. Šimunić, K. Bilan, D. Krnic, Z. Pogorelić, S. Tomić, D. Sršen (2008)Harmonic scalpel in transanal microsurgery.
Hepato-gastroenterology, 55 82-83
克也 平山, 昌造 森 (1995)A prospective randomized trial
Nihon Gekakei Rengo Gakkaishi (journal of Japanese College of Surgeons), 20
(2006)Randomized controlled trial of harmonic scalpel use during thyroidectomy Archives of Otolaryngology—Head and Neck Surgery
C. Cummings (2010)Cummings otolaryngology--head & neck surgery
P. Miccoli, P. Berti, G. Dionigi, J. d’Agostino, C. Orlandini, G. Donatini (2006)Randomized controlled trial of harmonic scalpel use during thyroidectomy.
Archives of otolaryngology--head & neck surgery, 132 10
A. Salami, M. Bavazzano, R. Mora, M. Dellepiane (2008)Harmonic scalpel in pharyngolaryngectomy with radical neck dissection.
Journal of otolaryngology - head & neck surgery = Le Journal d'oto-rhino-laryngologie et de chirurgie cervico-faciale, 37 5
Roye Gd, J. Monchik, Amaral Jf (2000)Endoscopic adrenalectomy using ultrasonic cutting and coagulating.
Surgical technology international, 9
L. Shemen (2002)Thyroidectomy using the Harmonic Scalpel: Analysis of 105 Consecutive Cases
Otolaryngology–Head and Neck Surgery, 127
M. Frazzetta, G. Furgiuele, D. Raimondo, A. Sammartano, E. Mannino, G. Simone, G. Vetri, S. Bonventre, G. Gesù (2005)[Ultrasonic dissector for total thyroidectomy: results of prospective randomized study].
Il Giornale di chirurgia, 26 8-9
R. Dersimonian, R. Dersimonian, N. Laird, N. Laird (1986)Meta-analysis in clinical trials.
Controlled clinical trials, 7 3
C. Begg, Madhuchhanda Mazumdar (1994)Operating characteristics of a rank correlation test for publication bias.
Biometrics, 50 4
W. Marsden (2012)I and J
A. Siperstein, E. Berber, Ebru Morkoyun (2002)The use of the harmonic scalpel vs conventional knot tying for vessel ligation in thyroid surgery.
Archives of surgery, 137 2
M. Egger, G. Smith, Martin Schneider, C. Minder (1997)Bias in meta-analysis detected by a simple, graphical test
M. Marchesi, M. Biffoni, R. Cresti, M. Mulas, V. Turriziani, A. Berni, F. Campana (2003)[Ultrasonic scalpel in thyroid surgery].
Chirurgia italiana, 55 2
M. Kilic, M. Keşkek, T. Ertan, O. Yoldaş, Aydin Bilgin, M. Koç (2007)A prospective randomized trial comparing the harmonic scalpel with conventional knot tying in thyroidectomy
Advances in Therapy, 24
P. Voutilainen, C. Haglund (2000)Ultrasonically activated shears in thyroidectomies: a randomized trial.
Annals of surgery, 231 3
Palli Hallgrimsson, L. Lovén, J. Westerdahl, A. Bergenfelz (2008)Use of the harmonic scalpel versus conventional haemostatic techniques in patients with Grave disease undergoing total thyroidectomy: a prospective randomised controlled trial
Langenbeck's Archives of Surgery, 393
T. Defechereux, F. Rinken, S. Maweja, E. Hamoir, M. Meurisse (2003)Evaluation of the Ultrasonic Dissector in Thyroid Surgery. A Prospective Randomised Study
Acta Chirurgica Belgica, 103
J. Ortega, C. Sala, B. Flor, S. Lledó (2004)Efficacy and cost-effectiveness of the UltraCision harmonic scalpel in thyroid surgery: an analysis of 200 cases in a randomized trial.
Journal of laparoendoscopic & advanced surgical techniques. Part A, 14 1
S. Wiseman, Paul Tomljanovich, N. Rigual (2004)Thyroid lobectomy: Operative anatomy, technique, and morbidity
Operative Techniques in Otolaryngology-head and Neck Surgery, 15
S. Bessa, T. Al-Fayoumi, K. Katri, A. Awad (2008)Clipless laparoscopic cholecystectomy by ultrasonic dissection.
Journal of laparoendoscopic & advanced surgical techniques. Part A, 18 4
(2004)Thyroid lobectomy: operative anatomy
C. Cordón, R. Fajardo, J. Ramírez, M. Herrera (2005)A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy.
Surgery, 137 3
T. L. Trus W. S. Laycock (1996)New technology for the division of short gastric vessels during laparoscopic Nissen fundoplication. A prospective randomized trial,
Surgical Endoscopy, 10
Hindawi Publishing Corporation International Journal of Surgical Oncology Volume 2010, Article ID 396079, 8 pages doi:10.1155/2010/396079 Review Article Harmonic Scalpel Compared to Conventional Hemostasis in Thyroid Surgery: A Meta-Analysis of Randomized Clinical Trials Adrienne L. Melck and Sam M. Wiseman Department of Surgery, Saint Paul’s Hospital, University of British Columbia, C303-1081 Burrard Street, Vancouver, BC, Canada V6Z 1Y6 Correspondence should be addressed to Adrienne L. Melck, email@example.com Received 23 August 2009; Revised 9 November 2009; Accepted 6 December 2009 Academic Editor: Perry Shen Copyright © 2010 A. L. Melck and S. M. Wiseman. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Background. The study’s aim was to determine whether conventional hemostasis (CH) or the Harmonic Scalpel (HS) results in shorter operative times for thyroidectomy and to evaluate the incidence of postoperative complications with each approach. Methods. A literature search was conducted from study inception to September 30, 2008. Included studies randomized thyroidectomy patients to either CH or HS and reported the incidence of postoperative transient recurrent laryngeal nerve dysfunction (RLND) and hypocalcemia. Results. Nine RCTs were included. Use of the HS reduced operative time by 23.1 minutes (95% CI = 13.8, 32.33). There was no diﬀerence in the incidence of transient RLND (RR = 1.25, 95% CI = .56, 2.76), but a lower rate of transient hypocalcemia with the use of the HS (RR = .69, 95% CI = .51, .92). Conclusions. The use of HS in thyroidectomy signiﬁcantly reduces operative time and is associated with a reduction in postoperative hypocalcemia compared to CH. 1. Introduction tissue injury, a lack of neuromuscular stimulation, and the avoidance of electrical energy transmission either to There have been few developments in the technical aspects or through the patient . Since the adoption of the of thyroid surgery since the surgical approach described by Harmonic Scalpel (HS) into modern surgical practice, its Kocher greater than a century ago . Given the signiﬁcant utility for a wide variety of operations has been well vascularity of the thyroid gland  and the relatively small documented. For example, a randomized prospective clinical operative ﬁeld, meticulous hemostasis has and will always be trial demonstrated its ability to diminish blood loss as well as an important prerequisite for a successful outcome in thyroid operative time for laparoscopic Nissen fundoplication . surgery. The mainstay for achieving hemostasis in thyroid Over the last decade, many reports have evaluated the surgery has been tying and/or clipping of blood vessels, utility of the HS for thyroid surgery and the majority of both eﬀective but time-consuming techniques. In the current these studies have been carried out at European centers. The climate of healthcare constraints and long surgical waiting investigators have shown similar results regarding reduced lists, any methodology that can reduce operative times operative times with its utilization, but conﬂicting results while maintaining acceptable complication rates warrants regarding other postoperative outcomes such as transient investigation. postoperative hypocalcemia and recurrent laryngeal nerve The Harmonic Scalpel (Ethicon Endosurgery, Cincin- dysfunction (RLND). These complications are relatively nati, Ohio) was introduced into the surgeon’s armamentar- uncommon and the number of cases reported in individual ium almost two decades ago. Using mechanical vibrations studies is limited. Consolidating the data may allow for at 55.5 kHz, this device is able to cut and coagulate tissue elucidation of signiﬁcant associations between HS utilization simultaneously. The proposed advantages of using this device and postoperative complications. To date, no meta-analysis over traditional electrocautery include less lateral thermal evaluating the utilization of HS in thyroid surgery has 2 International Journal of Surgical Oncology been reported. The purpose of this study was to determine not describe how postoperative hypocalcemia was deﬁned. whether conventional hemostasis (CH) or the HS results in Although studies could report on a variety of secondary shorter operative times for thyroidectomy and to evaluate postoperative outcomes (e.g., amount and/or duration of the incidence of postoperative complications with each wound drainage, postoperative hematoma formation, pain, approach. analgesic requirements, time to hospital discharge, cost- eﬀectiveness), they were excluded if they did not report these two speciﬁc outcomes. 2. Methods To be included, studies had to be prospective, ran- domized clinical trials and observational studies were not 2.1. Identiﬁcation of Trials. We sought to identify prospec- included in the analysis. Clearly blinding is not feasible in tive, randomized clinical trials comparing HS to CH methods studies evaluating two diﬀerent surgical techniques, though (i.e., ties, clips, and/or electrocautery) for thyroidectomy it was noted if assessors of the postoperative outcomes were utilizing a computerized literature search. We searched the blinded to the intervention. Cochrane Central Register of Controlled Trials, MEDLINE Regarding data collection and analysis, the two authors and EMBASE (January 1, 1995 to September 30, 2008), using (AM and SMW) independently assessed the titles and the following index terms: thyroidectomy, thyroid surgery, abstracts of studies retrieved from the literature search harmonic scalpel, harmonic shears, ultrasonic shears, ultra- and obtained full articles for all those that appeared to sonic scalpel, ultrasonic coagulator, ultrasonic dissector, satisfy inclusion criteria, ultimately including those that ultrasonic dissection, ultrasonically activated scalpel, ultra- met inclusion criteria after in depth review. The data sonic scissors, and coagulating shears. In addition, we from those studies were extracted independently by the reviewed the reference lists of retrieved articles, contacted authors, and any diﬀerences were resolved by discussion. experts in the ﬁeld, and contacted the major manufacturer The following information was abstracted for each study: of the HS (Ethicon Endosurgery) to determine if they year of publication, language of publication, country of were funding or aware of any trials being conducted using origin, study design (including details on randomization, their product. We also searched the proceedings of major blinding, allocation concealment, intention-to-treat analysis, endocrine surgery conferences for any reported trials that and losses to follow-up), provision of industrial support for may not have been published. All studies were considered the study, reason for ineligibility if the study was ultimately relevant irrespective of publication status or the language of excluded, number of patients enrolled in each study arm, publication. indication for thyroidectomy, type of thyroidectomy car- ried out (e.g., partial versus total versus subtotal), details 2.2. Study Eligibility. We restricted our study to adults older regarding type of HS and CH utilized (ties versus clips than 18 years of age. Only studies comparing traditional open versus electrocautery), mean operative time for total and thyroidectomy utilizing CH techniques to thyroidectomy subtotal thyroidectomies in each group, number of cases using the HS were considered. Any studies evaluating video- of transient and permanent postoperative hypocalcemia assisted or endoscopic thyroidectomy were excluded. Studies (either symptomatic or biochemical), number of cases of postoperative transient or permanent RLND, and number of where additional procedures were carried out at the time of thyroidectomy (e.g., lateral neck lymph node dissection) cases of postoperative hematoma formation. Study validity is were also excluded, unless these additional procedures presented qualitatively though no formal validity score was assigned. were accounted for by subtracting the time for the added procedurefromthe overalloperative time.Thyroid surgery for either benign or malignant histology was included. The principal outcome evaluated was the mean operative 2.3. Statistical Analysis. For the primary outcome, the meta- time, measured in minutes, for total or subtotal thyroidec- analysis evaluated the weighted mean diﬀerence in operative tomies carried out utilizing the two surgical techniques. times between thyroidectomy groups (HS versus CH) and Although studies could include a combination of total and the standard deviation of the diﬀerence from individual stud- subtotal thyroidectomies and thyroid lobectomies, they were ies using the METAN command in STATA 9.2 (StataCorp, excluded if they did not report a mean operative time College Station, Texas). In one study, the data regarding speciﬁcally for the total and subtotal thyroidectomies. The operative times was not reported as a mean with standard secondary outcomes we evaluated were the incidence of deviation, but after correspondence with the authors, the transient postoperative RLND and hypocalcemia. Transient data was provided in such a format as to allow inclusion RLND was not well deﬁned in most studies. One study in the analysis . In 2 cases, attempts to contact the deﬁned RLND as transient if vocal cord function recovered authors were unsuccessful and thus these papers could not within twelve months of the operation . Some studies be included in the analysis, though they had otherwise met did not provide an explanation for how transient RLND inclusion criteria [14, 15]. Signiﬁcant heterogeneity across was diagnosed [6–8]. In the majority of the papers, post- studies was noted; thus a pooled estimate of the diﬀerence in operative laryngoscopy was performed on every patient to operative time was generated using a random eﬀects model assess vocal cord function [5, 9–13]. Transient postoperative . A sensitivity analysis excluding the two studies that hypocalcemia was deﬁned either by biochemical parame- disclosed ﬁnancial support from the HS manufacturers was ters or by clinical symptoms or both. Some studies did also carried out. International Journal of Surgical Oncology 3 34 potentially relevant studies screened for retrieval 15 retrieved for more 19 excluded detailed evaluation 1evaluated 18 retrospective 6 excluded 9 included additional or non- procedures randomized 3 duplicate reports on same patient cohort 3 relevant data not provided Figure 1: Flow diagram showing the number of studies initially identiﬁed and the reasons for study exclusion. For the secondary outcomes of postoperative RLND and overall number of cases of this was small and this was not hypocalcemia, results are presented as risk ratios (RRs). a statistically signiﬁcant ﬁnding (see Figure 4). Two studies The ﬁxed eﬀects model was utilized to obtain the summary reported no cases of transient RLND [10. 12] and were estimates of the logRR from the group of studies. We did excluded from this analysis. The χ test for heterogeneity was not proceed to a random eﬀects model once the ﬁxed not signiﬁcant (P-value = .51); thus we did not proceed to a eﬀects analysis did not reveal any signiﬁcant heterogeneity random eﬀects analysis. (Q statistic). The pooled estimate and 95% conﬁdence interval of the Publication bias was assessed with Begg’s and Egger tests relative risk of postoperative transient hypocalcemia from a and Begg’s funnel plot [17, 18]. A P-value of <.05 was ﬁxed eﬀects model was 0.69 (P = .01; 95% CI = 0.51, 0.92). considered statistically signiﬁcant. Thus, there was a statistically signiﬁcant reduced risk of transient postoperative hypocalcemia with the use of HS (see Figure 5). The χ test for heterogeneity was not signiﬁcant 3. Results (P-value = .53); so a random eﬀects analysis was not carried out. Thirty-four studies that potentially met inclusion criteria A sensitivity analysis excluding studies with industry were identiﬁed from the literature search. After abstract supportrevealedanevengreater reductioninoperative time screening, 19 were excluded for variety of reasons. Of the with use of the HS (25 minutes; 95% CI = 16.3, 33.62). 15 that were reviewed in depth, 6 were excluded, leaving Interestingly, there were a total of 3 cases of postoperative 9 studies that were incorporated into the meta-analysis. hematoma in the CH group and 1 in the HS group Figure 1 depicts a ﬂow diagram of the study selection process (Table 1) suggesting a trend toward a lower incidence of this and Table 1 summarizes the characteristics of the studies serious postoperative complication with the HS. However, included in the meta-analysis. There were no incidents of the overall numbers are too small to draw any meaningful author disagreement in either the study selection or data conclusions. extraction phase The quality of the studies was assessed based on the Regarding the primary outcome of mean operative time, following criteria: appropriateness of randomization, alloca- the pooled estimate of the weighted mean diﬀerence (WMD) tion concealment, blinding of patients, blinding of outcome in operative time obtained from a random eﬀects model was assessors, utilization of intention-to-treat analysis, and a 23.1 minutes (95% CI = 13.8, 32.33). This was statistically 2 description of any patients that were lost to follow-up. In signiﬁcant, with a P-value of <.001 (Figure 2). The χ test most cases, these parameters were not speciﬁed and thus the for heterogeneity was signiﬁcant with a P-value of <.001. methodological quality of the included studies could only be Tests for publication bias were not statistically signiﬁcant deemed as fair. These results are presented in Table 2. (P = .97). See Figure 3 for Begg’s funnel plot. Regarding secondary outcomes, the pooled estimate and 95% conﬁdence interval of the relative risk of postoperative 4. Discussion transient RLND from a ﬁxed eﬀects model was 1.25 (P = .59; 95% CI = 0.56, 2.76). Thus, there is a trend toward an Utilization of the HS for total and subtotal thyroidec- increased risk of transient RLND with the use of HS, but the tomy signiﬁcantly reduced operative time compared to CH 4 International Journal of Surgical Oncology Mean OR Author Year Country Industry CH # Time (min) for Transient Permanent Transient Permanent Postoperative funding techniques patients TT/ST (SD) RLND RLND hypocalcemia hypocalcemia hematoma Electrocautery CH = 24 CH = 168.8 (4.8) CH =1CH =0CH =7CH =1CH = 0 Hallgrimsson  2008 Sweden No ligatures clips HS = 27 HS = 134.7 (5.6) HS =4HS =0HS =5HS =0HS = 0 Electrocautery CH = 100 CH = 75.2 (23.5) CH =1CH =0CH = 29 CH =0CH = 1 Lombardi  2008 Italy No ligatures HS = 100 HS = 53.1 (20.7) HS =2HS =0HS = 28 HS =0HS = 1 Electrocautery CH = 54 CH = 105 (16) CH =5CH =1CH =7CH =1CH = 0 Yildirim  2008 Turkey No ligatures HS = 50 HS = 77.9 (12.5) HS =1HS =0HS =6HS =1HS = 0 Electrocautery CH = 40 CH = 57.8 (12) CH =0CH =0CH =5CH =0CH = 0 Kilic  2007 Turkey No ligatures HS = 40 HS = 47.1 (8.2) HS =1HS =0HS =2HS =0HS = 0 Electrocautery CH = 50 CH = 46.7 (10.8) CH =0CH =0CH = 16 CH =0CH = 0 Miccoli  2006 Italy Yes ligatures HS = 50 HS = 40 (6.8) HS =0HS =0HS =5HS =0HS = 0 Electrocautery CH = 60 CH = 96 (17) CH =2CH =0CH =6CH =0CH = 0 Frazzetta  2005 Italy No ligatures HS = 60 HS = 56 (18) HS =1HS =0HS =4HS =0HS = 0 Electrocautery CH = 12 CH = 136 (37) CH =0CH=0CH=9CH=0CH = 0 Cordon  2005 Mexico Yes ligatures clips HS =7HS = 104 (29) HS =1HS =0HS =3HS =0HS = 0 CH = 57 CH = 101 (16) CH =1CH =0CH =6CH =0CH = 2 Ortega  2004 Spain No Ligatures HS = 57 HS = 86 (20) HS =2HS =0HS =5HS =0HS = 0 Electrocautery CH = 17 CH = 96.5 (28.9) CH =0CH =0CH =4CH =0CH = 0 Defechereux  2003 Belgium No Ligatures clips HS=17 HS = 70.7 (18.3) HS=0HS=0HS=1HS=0HS=0 CH = 414 CH = 10 CH =1CH = 89 CH =2CH = 3 TOTAL HS = 408 HS = 12 HS =0HS = 59 HS =1HS = 1 CH: conventional hemostasis; OR: operative; HS: harmonic scalpel; TT: total thyroidectomy; ST: subtotal thyroidectomy; SD: standard deviation; RLND: recurrent laryngeal nerve dysfunction. International Journal of Surgical Oncology 5 Conventional Harmonic hemostasis scalpel WMD (95% CI) Weight (%) Hallgrimsson 34.1 (31.25,36.95) 12.5 Lombardi 22.1 (15.96,28.24) 12 Yildirim 27.1 (21.60,32.60) 12.2 Kilic 10.7 (6.20,15.20) 12.3 Miccoli 6.7 (3.16,10.24) 12.5 Frazzetta 40 (33.74,46.26) 12 Cordon 32 (2.00,62.00) 5.4 Ortega 1 15 (8.35,21.65) 1.9 Defechereux 25.8 (9.54,42.06) 9.1 Overall (95% CI) 23.07 (13.8,32.33) −62 0 23.1 62 WMD (mins) Figure 2: Forest plot depicting individual and pooled weighted mean diﬀerence (WMD) in operative times with 95% conﬁdence intervals. Table 2: Study validity. Author Randomization Concealed Patients Outcome assessors Intention- to-treat Patients LTFU? Done Adequate allocation blinded blinded Analysis Hallgrimsson Yes UC UC UC UC Yes UC Lombardi Yes UC UC Yes UC UC UC Yildirim Yes UC UC UC UC UC UC Kilic Yes UC UC UC UC UC UC Miccoli Yes UC UC Yes UC UC UC Frazzetta Yes UC UC UC UC UC UC Cordon Yes Yes UC UC Yes UC UC Ortega Yes UC UC UC UC UC UC Defechereux Yes Yes UC UC UC UC UC UC: unclear; LTFU: loss to follow-up. 60 there was also no statistically signiﬁcant diﬀerence in the risk of transient postoperative RLND between the two groups (pooled RR = 1.25, P-value = .59). We conclude that not only is HS utilization for total thyroidectomy signiﬁcantly faster than the conventional approach, with acceptable 20 postoperative complication rates, but also it may even protect against the development of transient postoperative hypocalcemia. All of the studies uniformly report decreased operating time with the use of an HS. This is not a surprising observa- −20 tion, given that the same outcome has been reported repeat- 0 5 10 15 edly foravarietyofothersurgicalprocedures[19–21]. With Standard error of WMD the exception of a single Mexican study, all of the reports were from European centers. There is no reason to believe that the Figure 3: Begg’s funnel plot with pseudo 95% conﬁdence limits. patients requiring thyroid surgery are any diﬀerent in Europe than in North America and thus we believe that our results are generalizable to other patient populations. From the techniques by greater than 23 minutes (P-value <.001). literature search, two reports from U.S. centers evaluating HS Furthermore, there was a 31% decreased risk of transient use for thyroidectomy were identiﬁed but excluded because postoperative hypocalcemia with HS utilization compared of their retrospective study design. Both of these studies also to CH techniques (pooled RR = 0.69, P-value = .01) and found the HS to be safe and time-saving [22, 23]. 6 International Journal of Surgical Oncology Conventional Harmonic hemostasis scalpel RR (95% CI) Weight (%) Hallgrimsson 3.56 (0.43,29.66) 10 Lombardi 2 (0.18,21.71) 9.5 Kilic 3 (0.13,71.51) 4.7 Frazzetta 0.5 (0.05,5.37) 18.9 Cordon 4.88 (0.22,105.76) 3.6 Ortega 2 (0.19,21.44) 9.5 Yildirim 0.23 (0.03,1.92) 43.8 Overall (95% CI) 1.25 (0.56,2.76) −1 1 1.25 10 RR Figure 4: Forest plot depicting individual and pooled risk ratios (RRs) with 95% conﬁdence intervals (CIs) for transient postoperative recurrent laryngeal nerve dysfunction. Harmonic Conventional scalpel hemostasis RR (95% CI) Weight (%) Hallgrimsson 0.63 (0.23,1.74) 8.5 Lombardi 0.97 (0.62,1.50) 33.4 Kilic 0.4 (0.08,1.94) 5.8 Frazzetta 0.67 (0.20,2.24) 6.9 Cordon 0.57 (0.23,1.43) 7.6 Ortega 0.83 (0.27,2.58) 6.9 Yildirim 0.93 (0.33,2.57) 7.8 Miccoli 0.31 (0.12,0.79) 18.4 Defechereux 0.25 (0.03,2.01) 4.6 Overall (95% CI) 0.69 (0.51,0.92) −1 −69 1 10 RR Figure 5: Forest plot depicting individual and pooled risk ratios (RRs) with 95% conﬁdence intervals (CIs) for transient postoperative hypocalcemia. All studies reported an increased risk of postopera- directly or indirectly, with either mechanical forces or tive hypocalcemia with conventional hemostasis techniques, electrical currents. Thus, this ﬁnding of reduced transient though only one report had a large enough cohort for the postoperative hypocalcemia with HS utilization does seem association to be statistically signiﬁcant . Though the biologically plausible and highlights an important rationale mechanism is not fully understood, transient hypocalcemia for conducting the meta-analysis. When an outcome is observed after total thyroidectomy is believed to be related relatively uncommon, individual studies may all trend to traumatization of the parathyroid glands, which are toward that same outcome though none may have the anatomically intimately related to the thyroid gland and power to support statistical signiﬁcance, but calculating share its blood supply. We speculate that use of the HS a pooled estimate may allow for the determination of a may facilitate dissection of the parathyroid glands in a statistically signiﬁcant association. It is diﬃcult to draw plane farther away from the parathyroid gland capsule, any conclusions regarding permanent hypoparathyroidism thus reducing the chance of damaging their blood supply, and HS utilization. Permanent hypoparathyroidism is a rare International Journal of Surgical Oncology 7 complication of thyroidectomy, and there were only three majority of thyroidectomies in the study reporting the fastest reported cases of this among the nine studies, two of which mean operative time excluded patients with Graves’ disease occurred in the CH group and one in the HS group (Table 1). or extensive goiters . The complication of RLND after thyroidectomy is also One must consider whether or not benign versus an extremely uncommon occurrence. Included studies had malignant thyroid pathology aﬀected our results. All of the conﬂicting results in terms of the risks of RLND with HS studies incorporated in the meta-analysis excluded patients utilization compared to CH, and all reported either very requiring either a central or lateral compartment lymph node few or no cases of this complication. In the current meta- dissection; thus this could not have played a role in operative analysis, there were only twenty-two incidents of transient time or incidence of postoperative hypocalcemia. Of the 9 RLND out of 822 total thyroidectomies (.03%) or 1,644 studies, 4 excluded malignant disease (7, 10, 11, 13), 3 had nerves at risk (.01%). Given that HS has been shown no signiﬁcant diﬀerence in the proportion of malignant cases to cause less collateral thermal injury than conventional between the HS and CH groups (5, 6, 9), 1 only included low- electrocautery, we would expect to see less RLND in the HS risk T1N0M0 papillary thyroid cancers (12), and 1 did not group. Unfortunately, the numbers in this analysis are too clearly outline the pathologies. Given this, we do not feel that small to generate any meaningful conclusions. Only one case thyroid pathology is confounding our results for the primary of permanent RLND occurred in a patient who underwent or secondary outcomes. the CH technique. The time cutoﬀ to diﬀerentiate between Another consideration when interpreting the results of transient and permanent RLND was not well deﬁned in the current meta-analysis is that surgeons who conduct these the studies, but most investigators did use postoperative trials may have signiﬁcantly more experience with the HS laryngoscopy in all patients to document vocal cord paralysis. than the average thyroid surgeon, and the timesaving eﬀect Regarding the internal validity of included studies, one of the HS might be exaggerated compared to what a less- must accept that for studies evaluating surgical techniques, familiar surgeon would experience when ﬁrst adopting its use blinding of the surgeon is not possible. However, patients into their practice. can be blinded to the procedure they have undergone Future prospective, randomized trials of larger patient to minimize reporting bias when evaluating postoperative cohorts with more detailed and uniform deﬁnitions of outcomes such as symptomatic hypocalcemia or pain. Fur- postoperative complications, randomization procedures, thermore, those individuals evaluating outcomes (operative intention-to-treat analyses, and blinding of outcome asses- time, RLND, hypocalcemia) can also be blinded to the sors are needed to draw more meaningful conclusions with intervention to reduce observation bias, and this was only regard to the inﬂuence of HS utilization on complications explicitly carried out in a single study . Ideally, authors after total or subtotal thyroidectomy. In addition, cost- should also give a detailed description of their randomization eﬀectiveness analyses to determine whether the costs saved procedures, allocation concealment, and use of intention- from the reduced time spent in the operating theater to-treat analysis, which was not consistently reported in the outweigh the added cost of the HS scalpel would also be studies included in this meta-analysis. To assure internal important. Several of the studies did report reduced overall validity, future randomized studies evaluating this question cost associated with the HS [7, 8, 10] while another reported should include details addressing these issues. The quality of no diﬀerence in overall costs when comparing the two a meta-analysis is only as good as the reports from which techniques . Other beneﬁts seen with HS demonstrated in it is derived, and so our study is inherently limited by the these studies included less operative bleeding [6, 8–12], fewer methodological limitations of the included reports. cases of postoperative hematoma formation , fewer ties No tests of publication bias were statistically signiﬁcant. used [6, 8, 9, 13], less drain utilization , less postoperative Begg’s funnel plot for the pooled estimate of the WMD in pain or analgesic requirements [10, 12], and smaller incisions operative time did exhibit some asymmetry, but this was not . The impact of a recently introduced, smaller handheld statistically signiﬁcant. The asymmetry was likely a result HS on thyroid surgery outcomes also warrants further study. of between-study heterogeneity (tau-squared = 175.88). Reports of the use of another vessel sealing technology, the When between-study heterogeneity is large and when the Ligasure (Covidien, Boulder, Colorado), for thyroid surgery number of included studies is small, none of these tests have emerged in the recent literature, and comparisons to detect publication bias work well. Though all studies between this device and the HS would also be of interest. found that thyroidectomy was faster with the HS, they were From the current study, we are able to deﬁnitively conclude quite heterogeneous in terms of the baseline length of time that not only does the use of the HS signiﬁcantly decrease required to carry out a conventional thyroidectomy (range operative time compared to CH techniques with ties, clips, from 46.7 to 168.8 minutes). This observed diﬀerence in and/or electrocautery but it is also safer in terms of reducing time required to carry out the same operation is quite the incidence of transient postoperative hypocalcemia. striking. The heterogeneity may have been due to the size of the gland that was being resected, which was not clearly deﬁned in all studies. In addition, all of the thyoidectomies Acknowledgments in the Hallgrimsson study, which reported the longest mean operative time for conventional thyroidectomy, were carried The authors would like to thank Dr. Andrea Petrucci and Mr. out for Graves’ thyrotoxicosis, wherein the vascularization Antonio Canino for their help with translation of the French of the thyroid gland can be very extensive. In contrast, the and Italian articles. In addition, they would like to thank 8 International Journal of Surgical Oncology Dr. Rob van Dam and Ms. Christie Jeon of the Harvard  P. E. Voutilainen and C. H. Haglund, “Ultrasonically activated shears in thyroidectomies: a randomized trial,” Annals of School of Public Health for their invaluable input. Dr. Surgery, vol. 231, no. 3, pp. 322–328, 2000. Wiseman is a Michael Smith Foundation for Health Research  R. DerSimonian and N. Laird, “Meta-analysis in clinical trials,” Scholar. Controlled Clinical Trials, vol. 7, no. 3, pp. 177–188, 1986.  C. B. Begg and M. Mazumdar, “Operating characteristics of a References rank correlation test for publication bias,” Biometrics, vol. 50, no. 4, pp. 1088–1101, 1994.  L. Delbridge, “Total thyroidectomy: the evolution of surgical  M. Egger, G. Davey Smith, M. Schneider, et al., “Bias in meta- technique,” ANZ Journal of Surgery, vol. 73, no. 9, pp. 761–768, analysis detected by a simple, graphical test,” British Medical Journal, vol. 315, no. 7109, pp. 629–634, 1997.  S. Wiseman, P. Tomljanovich, and N. Rigual, “Thyroid lobec-  A. Salami, M. Bavazzano, R. Mora, et al., “Harmonic scalpel in tomy: operative anatomy, technique, and morbidity,” Oper- pharyngolaryngectomy with radical neck dissection,” Journal ative Techniques in Otolaryngology—Head and Neck Surgery, of Otolaryngology—Head and Neck Surgery,vol. 37, no.5,pp. vol. 15, no. 3, pp. 210–219, 2004. 633–637, 2008.  G. D. Roye, J. Monchik, and J. F. Amaral, “Endoscopic  S. S. Bessa, T. A. Al-Fayoumi, K. M. Katri, et al., “Clipless adrenalectomy using ultrasonic cutting and coagulating,” laparoscopic cholecystectomy by ultrasonic dissection,” Jour- Surgical Technology International, vol. 9, pp. 129–138, 2000. nal of Laparoendoscopic and Advanced Surgical Techniques A,  W.S.Laycock,T.L.Trus, andJ.G.Hunter,“Newtechnology vol. 18, no. 4, pp. 593–598, 2008. for the division of short gastric vessels during laparoscopic  N. Druzijanic, Z. Perko, D. Kraljevic, et al., “Harmonic scalpel Nissen fundoplication. A prospective randomized trial,” Sur- in transanal microsurgery,” Hepatogastroenterology, vol. 55, gical Endoscopy, vol. 10, no. 1, pp. 71–73, 1996. no. 82-83, pp. 356–358, 2008.  C. P. Lombardi, M. Rafaelli, A. Cicchetti, et al., “The use  L. Shemen, “Thyroidectomy using the harmonic scalpel: of “harmonic scalpel” versus “knot tying” for conventional analysis of 105 consecutive cases,” Otolaryngology—Head and “open” thyroidectomy: results of a prospective randomized Neck Surgery, vol. 127, no. 4, pp. 284–288, 2002. study,” Langenbeck’s Archives of Surgery, vol. 393, no. 5, pp.  A. E. Siperstein, E. Berber, and E. Morkoyun, “The use of the 627–631, 2008. harmonic scalpel vs conventional knot tying for vessel ligation  M. Kilic, M. Keskek, T. Ertan, et al., “A prospective randomized in thyroid surgery,” Archives of Surgery, vol. 137, no. 2, pp. 137– trial comparing the harmonic scalpel with conventional knot 142, 2002. tying in thyroidectomy,” Advances in Therapy, vol. 24, no. 3, pp. 632–638, 2007.  J. Ortega, C. Sala, B. Flor, et al., “Eﬃcacy and cost-eﬀectiveness of the UltraCision harmonic scalpel in thyroid surgery: an analysis of 200 cases in a randomized trial,” Journal of Laparoendoscopic and Advanced Surgical Techniques A, vol. 14, no. 1, pp. 9–12, 2004.  M. Frazzetta, G. Furgiuele, D. Raimondo, et al., “Ultrasonic dissector for total thyroidectomy: results of prospective ran- domized study,” Giornale di Chirurgia,vol. 26, no.8-9,pp. 295–301, 2005.  C. Cordon, R. Fajardo, J. Ramirez, et al., “A randomized, prospective, parallel group study comparing the harmonic scalpel to electrocautery in thyroidectomy,” Surgery, vol. 137, no. 3, pp. 337–341, 2005.  T. Defechereux, F. Rinken, S. Maweja, et al., “Evaluation of the ultrasonic dissector in thyroid surgery. A prospective randomised study,” Acta Chirurgica Belgica, vol. 103, no. 3, pp. 274–277, 2003.  P. Hallgrimsson, L. Loven, J. Westerdahl, et al., “Use of the harmonic scalpel versus conventional haemostatic techniques in patients with Grave disease undergoing total thyroidec- tomy: a prospective randomised controlled trial,” Langenbeck’s Archives of Surgery, vol. 393, no. 5, pp. 675–680, 2008.  P. Miccoli, P. Berti, G. Dionigi, et al., “Randomized controlled trial of harmonic scalpel use during thyroidectomy,” Archives of Otolaryngology—Head and Neck Surgery, vol. 132, no. 10, pp. 1069–1073, 2006.  O. Yildirim, T. Umit, M. Ebru, et al., “Ultrasonic harmonic scalpel in total thyroidectomies,” Advances in Therapy, vol. 25, no. 3, pp. 260–265, 2008.  M. Marchesi, M. Biﬀoni, R. Cresti, et al., “Ultrasonic scalpel in thyroid surgery,” Chiropractic in Italy, vol. 55, no. 2, pp. 299– 308, 2003. MEDIATORS of INFLAMMATION The Scientific Gastroenterology Journal of World Journal Research and Practice Diabetes Research Disease Markers Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 International Journal of Journal of Immunology Research Endocrinology Hindawi Publishing Corporation Hindawi Publishing Corporation http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 Submit your manuscripts at http://www.hindawi.com BioMed PPAR Research Research International Hindawi Publishing Corporation Hindawi Publishing Corporation http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 Journal of Obesity Evidence-Based Journal of Journal of Stem Cells Complementary and Ophthalmology International Alternative Medicine Oncology Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 Parkinson’s Disease Computational and Behavioural Mathematical Methods AIDS Oxidative Medicine and in Medicine Research and Treatment Cellular Longevity Neurology Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation Hindawi Publishing Corporation http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014 http://www.hindawi.com Volume 2014
International Journal of Surgical Oncology – Hindawi Publishing Corporation
Published: Feb 16, 2010
Access the full text.
Sign up today, get DeepDyve free for 14 days.