BACKGROUND: Conventional ultrasonically activated devices use linear mode vibration. Torsional mode ultrasonically activated device (TM) that oscillate around an arc have been recently introduced in the hope that the design may result in faster cutting and better hemostasis. METHODS:Patients undergoing elective laparoscopic cholecystectomy were randomized to TM or linear mode ultrasonically activated device (LM). Intraoperative events were recorded. Postoperatively, a sample of suction fluid was analyzed for hemoglobin concentration to calculate intraoperative blood loss. RESULTS:Seventy-five patients were randomized to TM and 76 patients to LM. Median blood loss was 5 (interquartile range (IQR), 1-19.7) ml with TM and 10.5 (IQR, 2.3-23) ml with LM (p = 0.105). The 95% confidence interval for the difference in median operative blood loss was -1.3 to +9.5 ml. Median gallbladder dissection time was similar in both groups (17 (IQR 11-29) minutes for TM vs. 21 (IQR, 12-29) minutes for LM; p = 0.248). Other modalities of hemostasis were required in 14 patients (19%) in the TM group compared with 21 patients (28%) in the LM group. One patient in the LM group developed postoperative hemoperitoneum and required urgent laparoscopic exploration. No patient required blood transfusion or suffered any other significant complication. CONCLUSION:TM has similar effectiveness to LM for laparoscopic cholecystectomy. REGISTRATION NUMBER: ISRCTN87527062 ( http://www.controlled-trials.com ).
RCT Entities:
BACKGROUND: Conventional ultrasonically activated devices use linear mode vibration. Torsional mode ultrasonically activated device (TM) that oscillate around an arc have been recently introduced in the hope that the design may result in faster cutting and better hemostasis. METHODS:Patients undergoing elective laparoscopic cholecystectomy were randomized to TM or linear mode ultrasonically activated device (LM). Intraoperative events were recorded. Postoperatively, a sample of suction fluid was analyzed for hemoglobin concentration to calculate intraoperative blood loss. RESULTS: Seventy-five patients were randomized to TM and 76 patients to LM. Median blood loss was 5 (interquartile range (IQR), 1-19.7) ml with TM and 10.5 (IQR, 2.3-23) ml with LM (p = 0.105). The 95% confidence interval for the difference in median operative blood loss was -1.3 to +9.5 ml. Median gallbladder dissection time was similar in both groups (17 (IQR 11-29) minutes for TM vs. 21 (IQR, 12-29) minutes for LM; p = 0.248). Other modalities of hemostasis were required in 14 patients (19%) in the TM group compared with 21 patients (28%) in the LM group. One patient in the LM group developed postoperative hemoperitoneum and required urgent laparoscopic exploration. No patient required blood transfusion or suffered any other significant complication. CONCLUSION: TM has similar effectiveness to LM for laparoscopic cholecystectomy. REGISTRATION NUMBER: ISRCTN87527062 ( http://www.controlled-trials.com ).