Evaluating the Clinical Effectiveness of Portable Ultrasonic Scalpel Applied in Urology Surgery
Author(s)
Juntao Yan, Doctoral Candidate, Yi Yang, Ph.D, Yingyao Chen, Ph.D;
Fudan University, NHC Key Lab of Health Technology Assessment, China, Shanghai, China
Fudan University, NHC Key Lab of Health Technology Assessment, China, Shanghai, China
Presentation Documents
OBJECTIVES: Ultrasonic scalpels are widely used in urology surgery. Although portable ultrasonic scalpels have appeared, which are easy and convenient to use and install, the existing evidence on their safety and effectiveness is scarce. This study aimed to evaluate clinical effectiveness of portable ultrasonic scalpels applied in urology surgery and compare their safety and effectiveness with traditional ultrasonic scalpels.
METHODS: From February to August 2023, a multi-center, non-randomized, prospective, controlled clinical trial was conducted in three tertiary hospitals in China. 45 urological patients treated by portable ultrasonic scalpels were prospectively included as the intervention group, and 45 urological patients treated by traditional scalpels with the same period of hospitalization were selected as the control. The basic information and clinical data of patients in the study were collected. The quality-of-life data were obtained by the EQ-5D-5L scale at preoperative, discharge, one month, and three months after surgery, respectively. The descriptive analysis and generalized linear model were used in data analysis.
RESULTS: A total of 82 patients were included in the study: 39 in the intervention group and 43 in the control group. The average hospital stays, intraoperative blood loss, and postoperative blood loss in the intervention group were lower than those in the control group (P > 0.05). From baseline to discharge, the decrease in QALYs in the intervention group was smaller (-0.134 vs. -0.287, P<0.05). There were no significant differences in the changes in QALYs between the two groups. The decline in QALYs was significantly influenced by variables like intraoperative blood loss and surgical site.
CONCLUSIONS: There were no significant differences in changes in QALY between the intervention and control groups. Portable ultrasonic scalpels in urology surgery may be equally effective as traditional ones in clinical outcomes, with additional benefits in reducing QALY decline at discharge. Further research with long-term follow-up should be conducted.
METHODS: From February to August 2023, a multi-center, non-randomized, prospective, controlled clinical trial was conducted in three tertiary hospitals in China. 45 urological patients treated by portable ultrasonic scalpels were prospectively included as the intervention group, and 45 urological patients treated by traditional scalpels with the same period of hospitalization were selected as the control. The basic information and clinical data of patients in the study were collected. The quality-of-life data were obtained by the EQ-5D-5L scale at preoperative, discharge, one month, and three months after surgery, respectively. The descriptive analysis and generalized linear model were used in data analysis.
RESULTS: A total of 82 patients were included in the study: 39 in the intervention group and 43 in the control group. The average hospital stays, intraoperative blood loss, and postoperative blood loss in the intervention group were lower than those in the control group (P > 0.05). From baseline to discharge, the decrease in QALYs in the intervention group was smaller (-0.134 vs. -0.287, P<0.05). There were no significant differences in the changes in QALYs between the two groups. The decline in QALYs was significantly influenced by variables like intraoperative blood loss and surgical site.
CONCLUSIONS: There were no significant differences in changes in QALY between the intervention and control groups. Portable ultrasonic scalpels in urology surgery may be equally effective as traditional ones in clinical outcomes, with additional benefits in reducing QALY decline at discharge. Further research with long-term follow-up should be conducted.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
CO180
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Urinary/Kidney Disorders, STA: Surgery