Evidence distribution and reporting characteristics of clinical evaluation studies on ultrasonic surgical systems: a scoping review_Chinese Journal of Evidence-Based Medicine

Authors：

WANG Zhichen ¹ , PAN Yanjun ¹ , LU Ruyi ¹ , SUN Fei ¹ , ZHANG Qing ² ,  FENG Jingyi ^1,3

1. Department of Clinical Engineering, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P. R. China;
2. Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P. R. China;
3. Zhejiang Key Laboratory of Clinical Evaluation Technology for Medical Devices, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P. R. China;

Corresponding?author：

FENG Jingyi, Email: feng.jingyi@zju.edu.cn

Keywords：

Ultrasonic surgical system; Ultrasonic scalpel; Clinical evaluation; Scoping review; Human factors

DOI：

10.7507/1672-2531.202605007

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To conduct a scoping review of clinical evaluation studies on ultrasonic surgical systems (USS) published or registered since 2020, and to summarize the distribution of study types, evaluation domains, and reporting of device-use information. Methods The PubMed, Embase, Web of Science, Cochrane Library, Scopus, CNKI, WanFang Data, and VIP were searched. ClinicalTrials.gov and the Chinese Clinical Trial Registry were also searched. Studies published or registered from January 1, 2020 to April 15, 2026 were included. Two reviewers independently screened the literature and extracted data. Descriptive statistics were used for analysis. Results A total of 217 studies involving 28 261 participants were included, with a median sample size of 82. Randomized controlled trials were the most common study type, accounting for 102 studies (47.0%). Clinical effectiveness and safety were frequently reported, with reporting proportions of 98.2% and 90.8%, respectively. Technical performance and human factors were reported in 15.7% of the studies. A total of 101 studies (46.5%) described the use of USS in specific surgical steps or anatomical planes. In 114 studies (52.5%), only one or two evaluation domains were covered. Eighty-six studies (39.6%) did not report the specific device brand or model. Most studies compared USS with conventional instruments or electrocautery (147 studies, 67.7%), whereas comparisons with advanced bipolar energy devices were uncommon (5 studies, 2.3%). Conclusion Clinical evaluation studies on USS have increased since 2020, but most remain focused on perioperative effectiveness and safety outcomes. Reporting of technical performance, human factors, device brand or model, and surgical task-scene information remains insufficient. Future studies should provide more detailed information on device configuration, operating parameters, surgeon experience, and specific surgical tasks to improve the interpretability of findings.

Citation： WANG Zhichen, PAN Yanjun, LU Ruyi, SUN Fei, ZHANG Qing, FENG Jingyi. Evidence distribution and reporting characteristics of clinical evaluation studies on ultrasonic surgical systems: a scoping review. Chinese Journal of Evidence-Based Medicine, 2026, 26(8): 934-940. doi: 10.7507/1672-2531.202605007 Copy

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1. Zhao JZ, Gao M, Yu Y, et al. Harmonic scalpel versus conventional resection in thyroid surgery: a meta analysis on the safety outcomes[J]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi, 2013, 48(9): 752-757.
2. Ecker T, Carvalho AL, Choe JH, et al. Hemostasis in thyroid surgery: harmonic scalpel versus other techniques--a meta-analysis[J]. Otolaryngol Head Neck Surg, 2010, 143(1): 17-25.
3. Hefermehl LJ, Largo RA, Hermanns T, et al. Lateral temperature spread of monopolar, bipolar and ultrasonic instruments for robot-assisted laparoscopic surgery[J]. BJU Int, 2014, 114(2): 245-252.
4. Moraes ACBK, Bakri SFY, Scherer CK, et al. Systematic review of usability evaluations in medical devices: methodological choices, heuristic application, and confounding factors[J]. Appl Ergon, 2026, 134: 104715.
5. 國家藥品監督管理局. 醫療器械臨床評價技術指導原則[Z]. 2021.
6. U. S. Food and Drug Administration. Applying human factors and usability engineering to medical devices: guidance for industry and food and drug administration staff[Z]. 2016.
7. 國家食品藥品監督管理總局. YY/T 1474-2016 醫療器械可用性工程對醫療器械的應用[Z]. 2016.
8. International Electrotechnical Commission. IEC 62366-1: 2015 medical devices — part 1: application of usability engineering to medical devices[S]. Geneva: IEC, 2015.
9. Peters MD, Marnie C, Tricco AC, et al. Updated methodological guidance for the conduct of scoping reviews[J]. JBI Evid Synth, 2020, 18(10): 2119-2126.
10. Arksey H, O'Malley L. Scoping studies: towards a methodological framework[J]. Int J Soc Res Methodol, 2005, 8(1): 19-32.
11. Tricco AC, Lillie E, Zarin W, et al. PRISMA extension for scoping reviews (PRISMA-ScR): checklist and explanation[J]. Ann Intern Med, 2018, 169(7): 467-473.
12. Khalil H, Peters M, Godfrey CM, et al. An evidence‐based approach to scoping reviews[J]. Worldviews Evid Based Nurs, 2016, 13(2): 118-123.
13. Wilson N, Macefield RC, Hoffmann C, et al. Identification of outcomes to inform the development of a core outcome set for surgical innovation: a targeted review of case studies of novel surgical devices[J]. BMJ Open, 2022, 12(4): e056003.
14. McCulloch P, Cook JA, Altman DG, et al. IDEAL framework for surgical innovation 1: the idea and development stages[J]. BMJ, 2013, 346: f3012.
15. McCulloch P, Altman DG, Campbell WB, et al. No surgical innovation without evaluation: the IDEAL recommendations[J]. Lancet, 2009, 374(9695): 1105-1112.

Chinese Journal of Evidence-Based Medicine

Evidence distribution and reporting characteristics of clinical evaluation studies on ultrasonic surgical systems: a scoping review

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