Ryohei Kawabata1,2, Shuji Takiguchi3, Yutaka Kimura2, Hiroshi Imamura4, Junya Fujita5, Shigeyuki Tamura6, Kazumasa Fujitani7, Kentaro Kishi8, Kazuyoshi Yamamoto9, Shinichi Fujiwara10, Yukinori Kurokawa10, Masaki Mori10, Yuichiro Doki10. 1. Department of Surgery, Osaka Rosai Hospital, Osaka, Japan. 2. Department of Surgery, Sakai City Hospital, Osaka, Japan. 3. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan. stakiguchi@gesurg.med.osaka-u.ac.jp. 4. Department of Surgery, Toyonaka Municipal Hospital, Osaka, Japan. 5. NTT West Osaka Hospital, Osaka, Japan. 6. Department of Surgery, Kansai Rosai Hospital, Hyogo, Japan. 7. Department of Surgery, Osaka General Medical Center, Osaka, Japan. 8. Department of Surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, Japan. 9. Department of Surgery, Osaka National Hospital, Osaka, Japan. 10. Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
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.
RCT Entities:
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.
Entities:
Keywords:
Harmonic scalpel; Open gastrectomy; Randomized controlled trial
Authors: Agnes Dechartres; Isabelle Boutron; Ludovic Trinquart; Pierre Charles; Philippe Ravaud Journal: Ann Intern Med Date: 2011-07-05 Impact factor: 25.391
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