Systematic review and meta-analysis of the use of high-energy devices for thyroid surgery.
GRADE assessment
High energy device
Meta-analysis
Systematic review
Thyroidectomy
Journal
Langenbeck's archives of surgery
ISSN: 1435-2451
Titre abrégé: Langenbecks Arch Surg
Pays: Germany
ID NLM: 9808285
Informations de publication
Date de publication:
17 Jul 2024
17 Jul 2024
Historique:
received:
11
12
2023
accepted:
26
06
2024
medline:
17
7
2024
pubmed:
17
7
2024
entrez:
17
7
2024
Statut:
epublish
Résumé
We conducted a systematic review and meta-analysis to evaluate the role of High Energy Devices (HEDs) versus conventional clamp and tie technique in thyroidectomy. This work is endorsed by the Italian Society of Surgical Endoscopy (Italian Society of Endoscopic Surgery and new technologies-SICE) in the broader project on the evaluation of the role of HEDs in different surgical settings with the full health technology assessment report. Inclusion criteria were adult patients (≥ 18 years old) undergoing Thyroidectomy/Parathyroidectomy conducted with High Energy Devices (as ultrasonic (US), radiofrequency (RF), and hybrid energy (H-US/RF)) in the setting of thyroid surgery (both partial and total) for benign and malign diseases. However, some variability was found in included studies and described in the text. This systematic review and meta-analysis were performed according to the Cochrane handbook for systematic reviews, and the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines were pursuit. Selection of abstracts was performed in Ryyan system by 2 independent reviewers, and doubts were solved by another independent reviewer. At the end of literature research, Randomized controlled trials and observational studies were included. Risk of Bias was assessed with ROB2 for RCTs, and New Castle Ottawa Scale for Observational studies. The literature search yielded 47 studies, including 29 RCTs and 18 observational studies. Meta-analysis was performed for 29 randomized clinical trials. Outcomes included in the comparison between High Energy Devise and conventional technique groups were operative time, operative blood loss, overall post-operative drainage volume, length of stay, complications, and costs. HED significantly reduced operative time (28 studies, 3097patients; MD -128.8; 95% CI -34.4 to -23.20; I2 = 96%, p < 0.00001, Random-effect), intra-operative blood loss (13 studies, 642 vs 519 patients; SMD -0.82; 95% CI -1.33 to -0.32; I2 = 93%, p < 0.00001, Random-effect), LOS (22 studies, 2808 vs 2789 patients; MD -0.38, 95% CI -0.59 to -0.17; I2 = 98%, p < 0.00001 Random-effect), and healthcare costs (8 studies, 1138 vs 1129 patients, SMD 1.05; 95% CI -0.06 to 2.16; I2 = 99%, p < 0.00001 Random-effect). The rate of overall intraoperative complications was significantly different between both groups (25 studies, 2804 vs 2775 patients; RR 0.88, 95% CI 0.80 to 0.97; I2 = 38%, p = 0.03 Random-effect), but the sensitivity analysis did not find a statistically significant difference (6 studies, 605 vs 594 patients, RR; 95% CI to; I2 = 0%, p = 0.50, Random-effect). There was no difference in the subgroup analysis for the occurrence of transient and permanent RLN palsy, nor hematoma formation and hypocalcaemia. Though findings of our systematic review and metanalysis are limited by heterogeneous data, surgeons, hospital managers, and policymakers should note that the use of High Energy Devices compared to conventional clamp and tie technique have reduced operative times, intra-operative blood loss, length of stay, and hospital costs in patients underwent to tyroid surgery. Future work must explore issues of equity to mitigate barriers to patient access to safe thyroid surgical care and define better this initial results.
Sections du résumé
BACKGROUND
BACKGROUND
We conducted a systematic review and meta-analysis to evaluate the role of High Energy Devices (HEDs) versus conventional clamp and tie technique in thyroidectomy. This work is endorsed by the Italian Society of Surgical Endoscopy (Italian Society of Endoscopic Surgery and new technologies-SICE) in the broader project on the evaluation of the role of HEDs in different surgical settings with the full health technology assessment report.
MEHODS
METHODS
Inclusion criteria were adult patients (≥ 18 years old) undergoing Thyroidectomy/Parathyroidectomy conducted with High Energy Devices (as ultrasonic (US), radiofrequency (RF), and hybrid energy (H-US/RF)) in the setting of thyroid surgery (both partial and total) for benign and malign diseases. However, some variability was found in included studies and described in the text. This systematic review and meta-analysis were performed according to the Cochrane handbook for systematic reviews, and the recommendations of the 2020 updated Preferred Reporting Items for Systematic reviews and Meta-analyses (PRISMA) guidelines were pursuit. Selection of abstracts was performed in Ryyan system by 2 independent reviewers, and doubts were solved by another independent reviewer. At the end of literature research, Randomized controlled trials and observational studies were included. Risk of Bias was assessed with ROB2 for RCTs, and New Castle Ottawa Scale for Observational studies.
RESULTS
RESULTS
The literature search yielded 47 studies, including 29 RCTs and 18 observational studies. Meta-analysis was performed for 29 randomized clinical trials. Outcomes included in the comparison between High Energy Devise and conventional technique groups were operative time, operative blood loss, overall post-operative drainage volume, length of stay, complications, and costs. HED significantly reduced operative time (28 studies, 3097patients; MD -128.8; 95% CI -34.4 to -23.20; I2 = 96%, p < 0.00001, Random-effect), intra-operative blood loss (13 studies, 642 vs 519 patients; SMD -0.82; 95% CI -1.33 to -0.32; I2 = 93%, p < 0.00001, Random-effect), LOS (22 studies, 2808 vs 2789 patients; MD -0.38, 95% CI -0.59 to -0.17; I2 = 98%, p < 0.00001 Random-effect), and healthcare costs (8 studies, 1138 vs 1129 patients, SMD 1.05; 95% CI -0.06 to 2.16; I2 = 99%, p < 0.00001 Random-effect). The rate of overall intraoperative complications was significantly different between both groups (25 studies, 2804 vs 2775 patients; RR 0.88, 95% CI 0.80 to 0.97; I2 = 38%, p = 0.03 Random-effect), but the sensitivity analysis did not find a statistically significant difference (6 studies, 605 vs 594 patients, RR; 95% CI to; I2 = 0%, p = 0.50, Random-effect). There was no difference in the subgroup analysis for the occurrence of transient and permanent RLN palsy, nor hematoma formation and hypocalcaemia.
DISCUSSION
CONCLUSIONS
Though findings of our systematic review and metanalysis are limited by heterogeneous data, surgeons, hospital managers, and policymakers should note that the use of High Energy Devices compared to conventional clamp and tie technique have reduced operative times, intra-operative blood loss, length of stay, and hospital costs in patients underwent to tyroid surgery. Future work must explore issues of equity to mitigate barriers to patient access to safe thyroid surgical care and define better this initial results.
Identifiants
pubmed: 39017727
doi: 10.1007/s00423-024-03399-5
pii: 10.1007/s00423-024-03399-5
doi:
Types de publication
Systematic Review
Meta-Analysis
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
217Informations de copyright
© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.
Références
Smith RB, Andrew CA (2016) Thyroidectomy Hemostasis. Otolaryngol Clin North Am 49(3):727–748
pubmed: 27267022
doi: 10.1016/j.otc.2016.03.006
Botteri E, Podda M, Arezzo A et al (2021) Current status on the adoption of high energy devices in Italy: An Italian Society for Endoscopic Surgery and New Technologies (SICE) national survey. Surg Endosc 35(11):6201–6211
pubmed: 33155075
doi: 10.1007/s00464-020-08117-y
Cirocchi R, D’Ajello F, Trastulli S et al (2010) Meta-analysis of thyroidectomy with ultrasonic dissector versus conventional clamp and tie. World J Surg Oncol 23(8):112
doi: 10.1186/1477-7819-8-112
Hua N, Quimby AE (2019) Comparing Hematoma Incidence between Hemostatic Devices in Total Thyroidectomy: A Systematic Review and Meta-analysis. Otolaryngology-Head and Neck Surgery 161(5):770–778
pubmed: 31331260
doi: 10.1177/0194599819865248
Ortenzi M, Agresta F, Vettoretto N et al (2023) Use of High Energy Devices (HEDs) versus electrocautery for laparoscopic cholecystectomy: a systematic review and meta-analysis of ignifican controlled trials. Surg Endosc 37(6):4249–4269
pubmed: 37074420
pmcid: 10235147
doi: 10.1007/s00464-023-10060-7
Vettoretto N, Foglia E, Gerardi C, et al. HTA-HED Collaborative Group. High-energy devices in different surgical settings: lessons learnt from a full health technology assessment report developed by SICE (Società Italiana di Chirurgia Endoscopica). Surg Endosc. 2023 Apr;37(4):2548–2565).
https://osf.io/preprints/metaarxiv/v7gm2/
Cochrane Handbook for Systematic Reviews of Interventions: Cochrane Book Series. Julian P.T. Higgins, James Thomas. 2nd Edition.
https://training.cochrane.org/handbook/current
Sista F, Schietroma M, Ruscitti C, De Santis G, De Vita F, Carlei F, Amicucci G (2012) New ultrasonic dissector versus conventional hemostasis in thyroid surgery: a randomized pro- spective study. J Laparoendosc Adv Surg Tech A 22:220–224
pubmed: 22393922
doi: 10.1089/lap.2011.0266
Minni A, Rosati D, Cavaliere C, De Carlo A, Illuminati G, Scarano Catanzaro V, Bodoni M (2016) Study on the use of focus harmonic scalpel in thyroidectomies: Is it useful also in preserving voice function? Eur Rev Med Pharmacol Sci 20:3544–3551
pubmed: 27649653
Miccoli P, Materazzi G, Miccoli M, Frustaci G, Fosso A, Berti P (2010) Evaluation of a new ultrasonic device in thyroid surgery: comparative randomized study. Am J Surg 199:736–740
pubmed: 20609718
doi: 10.1016/j.amjsurg.2009.04.003
Chavez KV, Barajas EM, Ramírez J, Pantoja JP, Sierra M, Velázquez-Fernandez D, Herrera MF (2017) Comparative anal- ysis between a bipolar vessel sealing and cutting device and the tie and suture technique in thyroidectomy: a randomized clinical trial. Surgery 161:477–484
pubmed: 27614416
doi: 10.1016/j.surg.2016.07.036
Cordón C, Fajardo R, Ramírez J et al (2005) A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Clinical Trial Surgery 137(3):337–341
pubmed: 15746789
Koh YW, Park JH, Lee SW, Choi EC (2008) The harmonic scal- pel technique without supplementary ligation in total thyroid- ectomy with central neck dissection: a prospective randomized study. Ann Surg 247:945–949
pubmed: 18520221
doi: 10.1097/SLA.0b013e31816bcd61
Hallgrimsson P, Lovén L, Westerdahl J, Bergenfelz A (2008) Use of the harmonic scalpel versus conventional haemostatic techniques in patients with Grave disease undergoing total thy- roidectomy: a prospective randomised controlled trial. Langen- becks Arch Surg 393:675–680
doi: 10.1007/s00423-008-0361-z
Kilic M, Keskek M, Ertan T, Yoldas O, Bilgin A, Koc M (2007) A prospective randomized trial comparing the harmonic scal- pel with conventional knot tying in thyroidectomy. Adv Ther 24:632–638
pubmed: 17660174
doi: 10.1007/BF02848788
Witzel K, von Rahden BH, Stein HJ (2009) The effect of ultra- sound dissection in thyroid surgery. Eur Surg Res 43:241–244
pubmed: 19571545
doi: 10.1159/000226257
Basurto-Kuba EOP, Robles-Estrada M, Hurtado-López LM, Oca- Duran EDM, Campos-Castillo C, Zaldivar-Ramirez FR, Pulido- Cejudo A (2017) Safety and cost-effectiveness in thyroidectomy using the HARMONIC scalpel compared to traditional hemosta- sis: a controlled clinical assay. Surg Technol Int 30:141–147
pubmed: 28537355
Yildirim O, Umit T, Ebru M, Bulent U, Belma K, Betul B, Mete D, Omer C (2008) Ultrasonic harmonic scalpel in total thyroid- ectomies. Adv Ther 25:260–265
pubmed: 18324377
doi: 10.1007/s12325-008-0024-z
Duan YF, Xue W, Zhu F, Sun DL (2013) FOCUS harmonic scal- pel compared to conventional hemostasis in open total thyroid- ectomy—a prospective randomized study. J Otolaryngol Head Neck Surg 42(1):62
pubmed: 24359618
pmcid: 3892114
doi: 10.1186/1916-0216-42-62
Cannizzaro MA, Lo455 Bianco S, Borzì L, Cavallaro A, Buffone A (2014) The use of FOCUS Harmonic scalpel compared to conventional haemostasis (knot and tie ligation) for thyroid surgery: a prospective randomized study. Springerplus 3:639
Ferri E, Armato E, Spinato G, Spinato R (2011) Focus harmonic scalpel compared to conventional haemostasis in open total thy- roidectomy: a prospective randomized trial. Int J Otolaryngol 2011:357195
pubmed: 22187563
pmcid: 3236473
doi: 10.1155/2011/357195
Konturek A, Barczyński M, Stopa M, Nowak W (2012) Total thyroidectomy for non-toxic multinodular goiter with versus without the use of harmonic FOCUS dissecting shears—a pro- spective randomized study. Wideochir Inne Tech Maloinwazyjne 7:268–274
pubmed: 23362426
pmcid: 3557734
Mourad M, Rulli F, Robert A, Scholtes JL, De Meyer M, De Pauw L (2011) Randomized clinical trial on harmonic focus shears versus clamp-and-tie technique for total thyroidectomy. Am J Surg 202:168–174
pubmed: 21810497
doi: 10.1016/j.amjsurg.2010.07.047
Kowalski LP, Sanabria A, Vartanian JG, Lima RA, de Men- donca UB, dos Santos CR, Boldrini D Jr, de Mello LE, Pinto FP, Lehn CN, Correa LA, Dedivitis RA, Guimarães AV, Pedru- zzi PA, Ramos GH, Gonçalves AJ, Suehara AB, Kanda JL, Capuzzo Rde C, de Oliveira JC, Curado MP, de Góis Filho JF, Fukuyama E, Beserra IM Jr, de Carvalho Neto PB, Carvalho AL (2012) Total thyroidectomy with ultrasonic scalpel: a mul- ticenter, randomized controlled trial. Head Neck 34:805–812
Papavramidis TS, Sapalidis K, Michalopoulos N, Triantafil-lopoulou K, Gkoutzamanis G, Kesisoglou I, Papavramidis ST (2010) UltraCision harmonic scalpel versus clamp-and-tie total thyroidectomy: a clinical trial. Head Neck 32:723–727
pubmed: 19787787
doi: 10.1002/hed.21240
Aziz W, Sohaib Khan M, Assad S, et al. Suture-less Thyroidectomy Using Harmonic Scalpel versus Conventional Thyroidectomy: A Randomized Controlled Trial. Journal of Pakistan Medical Students 6(2):48–51
Blanchard C, Pattou F, Brunaud L et al (2017) Randomized clinical trial of ultrasonic scissors versus conventional haemostasis to compare complications and economics after total thyroidectomy (FOThyr). BJS Open 1:2–10
pubmed: 29951599
pmcid: 5989994
doi: 10.1002/bjs5.2
Karaca AS, Ali R, Çapar M et al (2015) Suturless Thyroidectomy. J Clin Anal Med 6(2):180–182
Noori IF, Mohammad MA (2018) Sutureless Focus Harmonic Thyroidectomy versus Conventional Clamping and Knot-Tying Technique. Medical Journal of Babylon 15(4):267–400
doi: 10.4103/MJBL.MJBL_45_18
Zanghì A, Cavallaro A, Di Vita M, 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. International Journal of Surgery 12 (2014) S132eS135
Ortega J, Sala C, Flor B et al (2004) Efficacy and cost-effectiveness of the UltraCision harmonic scalpel in thyroid surgery: an analysis of 200 cases in a randomized trial. J Laparoendosc Adv Surg Tech A 14:9–12
pubmed: 15035837
doi: 10.1089/109264204322862289
Defechereux T, Rinken F, Maweja S et al (2003) Evaluation of the ultrasonic dissector in thyroid surgery. A prospective randomised study. Acta Chir Belg 103:274–7
pubmed: 12914361
doi: 10.1080/00015458.2003.11679422
Docimo G, Ruggiero R, Gubitosi A et al (2012) Ultrasound scalpel in thyroidectomy. Prospective randomized study. Ann Ital Chir 83(6):491–6
pubmed: 22801381
Barczyński M, Konturek A, Cichoń S (2008) Minimally invasive video-assisted thyreoidectomy (MIVAT) with and without use of harmonic scalpel: a randomized study. Langenbecks Arch Surg 393:647–654
pubmed: 18600342
doi: 10.1007/s00423-008-0373-8
Lombardi CP, Raffaelli M, Cicchetti A, Marchetti M, De Crea C, Di Bidino R, Oragano L, Bellantone R (2008) The use of “harmonic scalpel” versus “knot tying” for conventional “open” thyroidectomy: results of a prospective randomized study. Lan- genbecks Arch Surg 393:627–631
doi: 10.1007/s00423-008-0380-9
Su L, Tang X, Sang J (2016) Therapeutic effects of bipolar coagulation forceps on open thyroid surgery. Rev Inves Clin 68:256–261
Al-Dhahiry JK, Hameed HM (2015) Total thyroidectomy: con- ventional suture ligation technique versus sutureless techniques using harmonic scalpel or maxium. Ann Med Surg (Lond) 5:29–34
pubmed: 26858831
doi: 10.1016/j.amsu.2015.11.010
Cipolla C, Graceffa G, Sandonato L, Fricano S, Vieni S, Lat-teri MA (2008) LigaSure in total thyroidectomy. Surg Today 38:495–498
pubmed: 18516527
doi: 10.1007/s00595-007-3665-7
Barbaros U, Erbil Y, Bozbora A et al (2006) The use of LigaSure in patients with hyperthyroidism. Langenbecks Arch Surg 391:575–579
pubmed: 16955301
doi: 10.1007/s00423-006-0082-0
Franko J, Kish KJ, Pezzi CM et al (2006) Safely increasing the efficiency of thyroidectomy using a new bipolar electrosealing device (LigaSure) versus conventional clamp-and-tie technique. Am Surg 72(2):132–136
pubmed: 16536242
doi: 10.1177/000313480607200207
Kirdak T, Korun N, Ozguc H (2005) Use of Ligasure in Thyroidectomy Procedures: Results of a Prospective Comparative Study. World J Surg 29:771–774
pubmed: 15883664
doi: 10.1007/s00268-005-7788-y
Chang LY, O’Neill C, Suliburk J et al (2011) Sutureless total thyroidectomy: a safe and cost-effective alternative. ANZ J Surg 81:510–514
pubmed: 22295369
doi: 10.1111/j.1445-2197.2010.05492.x
Alesina PF, Rolfs T, Walz MK (2010) Bipolar thermofusion vessel sealing system (TVS) versus conventional vessel ligation (CVL) in thyroid surgery—results of a prospective study. Langenbecks Arch Surg 395:115–119
pubmed: 19924433
doi: 10.1007/s00423-009-0571-z
Hahn CH, Trolle W, Sørensen CH (2015) Harmonic focus in thyroidectomy for substernal goiter. Auris Nasus Larynx 42(4):311–317
pubmed: 25752670
doi: 10.1016/j.anl.2014.12.007
Bhettani MK, Rehman M, Khan MS, Altaf HN, Hakeem Khan K, Farooqui F, Amir M, Altaf OS (2019) Safety and cost-effec- tiveness of LigaSure® in total thyroidectomy in comparison with conventional suture tie technique. Cureus 11:e6368
pubmed: 31938650
pmcid: 6957032
Maeda H, Kutomi G, Satomi F, Shima H, Mori M, Takemasa I (2018) Comparison of surgical outcomes and complications between the harmonic FOCUS and conventional surgery for open thyroidectomy. Mol Clin Oncol 8:553–556
pubmed: 29541464
pmcid: 5838298
Chiang FY, Dae Lee K, Tae K et al (2019) Comparison of hypocalcemia rates between LigaSure and clamp-and-tie hemostatic technique in total thyroidectomies. Head Neck 41(10):3677–3683
pubmed: 31347742
doi: 10.1002/hed.25884
Çakabay B, Sevinç MM, Erdinç I et al (2009) LigaSure versus Clamp-and-Tie in Thyroidectomy:a Single-Center Experience. Adv Ther 26(11):1035–1041
pubmed: 20024679
doi: 10.1007/s12325-009-0078-6
Kuboki A, Nakayama T, Konno W et al (2013) New technique using an energy-based device versus conventional technique in open thyroidectomy. Auris Nasus Larynx 40(6):558–562
pubmed: 23746861
doi: 10.1016/j.anl.2013.04.005
Petrakis IE, Kogerakis NE, Lasithiotakis KG et al (2004) LigaSure versus clamp-and-tie thyroidectomy for benign nodular disease. Head Neck 26(10):903–909
pubmed: 15390199
doi: 10.1002/hed.20073
Shen WT, Baumbusch MA, Kebebew E et al (2005) Use of the electrothermal vessel sealing system versus standard vessel ligation in thyroidectomy. Asian J Surg 28(2):86–89
pubmed: 15851359
doi: 10.1016/S1015-9584(09)60268-2
Olasehinde O, Owojuyigbe A, Adeyemo A et al (2022) Use of energy device in general surgical operations: impact on peri-operative outcomes. BMC Surg 22(1):90
pubmed: 35264141
pmcid: 8908598
doi: 10.1186/s12893-022-01540-z
Carlander J, Wagner P, Gimm O et al (2016) Risk of Complications with Energy-Based Surgical Devices in Thyroid Surgery: A National Multicenter Register Study. World J Surg 40:117–123
pubmed: 26470699
doi: 10.1007/s00268-015-3270-7
Manouras A, Markogiannakis H, Koutras AS et al (2008) Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture ligation. Am J Surg 195(1):48–52
pubmed: 18082542
doi: 10.1016/j.amjsurg.2007.01.037
Hozo SP, Djulbegovic B, Hozo I (2005) Estimating the mean and variance from the median, range, and the size of a sample. BMC Med Res Methodol 5:13
pubmed: 15840177
pmcid: 1097734
doi: 10.1186/1471-2288-5-13
Higgins JP, Altman DG (2010) The Cochrane Collaboration’s tool for assessing risk of bias. In: Higgins JP, Green S (eds) Cochrane Handbook for Systematic Reviews of Interventions. John Wiley and Sons, New York, pp 194–202
https://www.ohri.ca/programs/clinical_epidemiology/oxford.asp
https://www.sciencedirect.com/science/article/pii/S089543561000329X?casa_token=w0CiokUGChgAAAAA:FAVtj7MlBJ4qiVp-OA9c1Y3pqko0yJVVPUtgYle-ST31Hg43wJquTNWK87MMUE8jFowIGtVHQlbn
Hartl DM (2011) The place of new haemostatic techniques in thyroid surgery. Eur Ann Ohorinolaryngol Head Neck Dis 128:200–202
doi: 10.1016/j.anorl.2011.02.015
Konturek A, Szpyra B, Stopa-Barzcznska, et al. Energy-based device for hemostasis in thyroid surgery. Gland Surg 2020;9(Suppl 2):S153-S158
Sarda H, Arora V, Sachdeva T et al (2022) Systematic Review of Comparison of use of Ultrasonic Scalpel Versus Conventional Haemostatic Techniques in Performing Thyroid Surgery. Indian J Otolaryngol Head Neck Surg 74(Suppl 3):6285–6291
pubmed: 36742765
pmcid: 9895553
doi: 10.1007/s12070-021-03026-5