Abstract
Purpose
The Harmonic Ace ultrasonic scalpel has been popular in abdominal surgery; however, only a few clinical studies have evaluated the efficacy of this device in radical open gastrectomy for gastric cancer.
Methods
The present study was designed as a multicenter, prospective, randomized, controlled trial. Patients with resectable gastric cancer were randomly assigned to gastrectomy using the Harmonic scalpel or conventional monopolar electrosurgery.
Results
A total of 248 patients were enrolled, and 123 patients were included in the Harmonic group and 114 patients were included in the conventional group. The demographics of the patients were well balanced between the groups. There was no significant difference in the length of the operation from skin incision to resection of the gastric specimen (141 ± 36 min in the Harmonic group vs. 147 ± 13 min in the conventional group; p = 0.276) nor in the amount of blood lost (365 ± 293 vs. 336 ± 272 mL; p = 0.434). There was also no significant difference in the incidence of surgical complications or the post-surgical hospital stay between the groups.
Conclusion
The Harmonic scalpel procedure was not superior to the conventional monopolar electrosurgery with regard to reducing the length of the operation, blood loss, postoperative complications, or postoperative hospital stay in radical open gastrectomy.
Similar content being viewed by others
References
Long N, Moore MA, Chen W, Gao CM, Lai MS, Mizoue T, et al. Cancer epidemiology and control in north-East Asia-past, present and future. Asian Pac J Cancer Prev. 2010;11:107–48.
Maruyama K, Okabayashi K, Kinoshita T. Progress in gastric cancer surgery in Japan and its limits of radicality. World J Surg. 1987;11:418–25.
Amaral JF. Ultrasonic dissection. Surg Allied Tech. 1994;2:181–5.
Foschi D, Cellerino P, Corsi F, Taidelli T, Morandi E, Rizzi A, et al. The mechanisms of blood vessel closure in humans by the application of ultrasonic energy. Surg Endosc. 2002;16:814–9.
Holub Z, Jabor A, Kliment L, Lukac J, Voracek J. Laparoscopic lymph node dissection using ultrasonically activated shears: comparison with electrosurgery. J Laparoendosc Adv Surg Tech A. 2002;12:175–80.
Voutilainen PE, Haapiainen RK, Haglund CH. Ultrasonically activated shears in thyroid surgery. Am J Surg. 1998;175:491–3.
Fitz-Gerald AL, Tan J, Chan KW, Polyakov A, Edwards GN, Najjar H, et al. Comparison of ultrasonic shears and traditional suture ligature for vaginal hysterectomy: randomized controlled trial. J Minim Invasive Gynecol. 2013;20:853–7.
Iovino F, Auriemma PP, Ferraraccio F, Antoniol G, Barbarisi A. Preventing seroma formation after axillary dissection for breast cancer: a randomized clinical trial. Am J Surg. 2012;203:708–14.
Khan S, Khan S, Chawla T, Murtaza G. Harmonic scalpel versus electrocautery dissection in modified radical mastectomy: a randomized controlled trial. Ann Surg Oncol. 2014;21:808–14.
Voutilainen PE, Haglund CH. Ultrasonically activated shears in thyroidectomies. A randomized trial. Ann Surg. 2000;231:322–8.
Association Japanese Gastric Cancer. Japanese classification of gastric carcinoma—2nd English edition. Gastric Cancer. 1998;1:10–24.
Japanese Gastric Cancer Society. Guidelines for Diagnosis and treatment of carcinoma of the stomach April. 2004th ed. Tokyo: Kanehara; 2004.
Sano T, Sasako M, Yamamoto S, Nashimoto A, Kurita A, Hiratsuka M, et al. Gastric cancer surgery: morbidity and mortality results from a prospective randomized controlled trial comparing D2 and extended para-aortic lymphadenectomy—Japan Clinical Oncology Group study 9501. J Clin Oncol. 2004;22:2767–73.
Fujita J, Takiguchi S, Nishikawa K, Kimura Y, Imamura H, Tamura S, et al. Randomized controlled trial of the LigaSure vessel sealing system versus conventional open gastrectomy for gastric cancer. Surg Today. 2014;44:1723–9.
Takiguchi N, Nagata M, Soda H, Nomura Y, Takayama W, Yasutomi J, et al. Multicenter randomized comparison of LigaSure versus conventional surgery for gastrointestinal carcinoma. Surg Today. 2010;40:1050–4.
Tsimoyiannis EC, Jabarin M, Tsimoyiannis JC, Betzios JP, Tsilikatis C, Glantzounis G. Ultrasonically activated shears in extended lymphadenectomy for gastric cancer. World J Surg. 2002;26:158–61.
Inoue K, Nakane Y, Michiura T, Yamada M, Mukaide H, Fukui J, et al. Ultrasonic scalpel for gastric cancer surgery: a prospective randomized study. J Gastrointest Surg. 2012;16:1840–6.
Dechartres A, Boutron I, Trinquart L, Charles P, Ravaud P. Single-center trials show larger treatment effects than multicenter trials: evidence from a meta-epidemiologic study. Ann Intern Med. 2011;155:39–51.
MacDonald JD, Bowers CA, Chin SS, Burns G. Comparison of the effects of surgical dissection devices on the rabbit liver. Surg Today. 2014;44:1116–22.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Conflict of interest
Ryohei Kawabata, Shuji Takiguchi, Yutaka Kimura, Hiroshi Imamura, Junya Fujita, Shigeyuki Tamura, Kazumasa Fujitaki, Kentaro Kishi, Kazuyoshi Yamamoto, Shinichi Fujiwara, Yukinori Kurokawa, Masaki Mori and Yuichiro Doki have no conflicts of interest to declare in association with this study.
Rights and permissions
About this article
Cite this article
Kawabata, R., Takiguchi, S., Kimura, Y. et al. A randomized phase II study of the clinical effects of ultrasonically activated coagulating shears (Harmonic scalpel) in open gastrectomy for gastric cancer. Surg Today 46, 561–568 (2016). https://doi.org/10.1007/s00595-015-1213-4
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00595-015-1213-4