Comparison of different ORC uses in VATS for lung cancer resection based on real-world data_Chinese Journal of Evidence-Based Medicine

Authors：

PAN Yanjun ¹ , SUN Jing ^1,2 , PAN Jin ¹ , WU Tao ^1,2 , HU Jian ^2,3 ,  FENG Jingyi ^1,2

1. Department of Clinical Engineering and Material Supplies, the First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou 310003, P. R. China;
2. Key Laboratory of Clinical Evaluation Technology for Medical Device of Zhejiang Province, Hangzhou 310003, P. R. China;
3. Department of Thoracic Surgery, the First Affiliated Hospital of Zhejiang University, Zhejiang University School of Medicine, Hangzhou 310003, P. R. China;

Corresponding author：

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

Keywords：

Real-world study; Propensity score; Absorbable hemostatic gauze; Video-assisted thoracoscopic surgery; Safety; Efficacy

DOI：

10.7507/1672-2531.202307063

Video：

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Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the safety, efficacy, and cost-effectiveness of different uses of oxidized regenerated cellulose (ORC) in video-assisted thoracoscopic surgery (VATS) for lung cancer resection to provide a reference for the selection, clinical use, and rational utilization of absorbable hemostatic materials. Methods A retrospective analysis of relevant data from inpatients who underwent VATS for lung cancer resection at a tertiary hospital from July 2019 to January 2020 and from July 2020 to December 2020 was conducted. Patients were divided into two groups based on the use of ORC: 1) combined use group (ORC and collagen sponge) and 2) sole-use group (ORC). Safety, efficacy, and economic outcome indicators were compared between the two groups. Results The main analysis included a total of 904 patients, with 466 in the combined use group and 438 in the sole-use group. Compared to the combined use group, the sole-use group had a significantly longer hospital stay, used fewer hemostatic drugs, had a lower average cost of hemostatic materials, and a lower median total hospitalization cost (P<0.05). No statistically significant difference was found between the two groups in terms of intraoperative blood loss volume, massive blood loss rate, perioperative transfusion rate, reoperation rate, postoperative 48-hour drainage volume, bloody drainage fluid rate, or postoperative laboratory test indicators. Conclusion There was no significant difference in the safety or efficacy of VATS for lung cancer resection between the sole use of ORC and the combined use of ORC, but the sole use of ORC was associated with a lower cost of hemostatic materials and a lower total hospitalization cost. The sole use of hemostatic gauze in VATS for lung cancer resection may be a more cost-effective choice.

Citation： PAN Yanjun, SUN Jing, PAN Jin, WU Tao, HU Jian, FENG Jingyi. Comparison of different ORC uses in VATS for lung cancer resection based on real-world data. Chinese Journal of Evidence-Based Medicine, 2024, 24(5): 550-556. doi: 10.7507/1672-2531.202307063 Copy

1.	Torzilli G, Makuuchi M, Inoue K, et al. No-mortality liver resection for hepatocellular carcinoma in cirrhotic and noncirrhotic patients: is there a way. A prospective analysis of our approach. Arch Surg, 1999, 134(9): 984-992.
2.	Barnard J, Millner R. A review of topical hemostatic agents for use in cardiac surgery. Ann Thorac Surg, 2009, 88(4): 1377-1383.
3.	国家食品药品监督管理总局. 关于发布可吸收止血产品等3个医疗器械注册技术审查指导原则的通告(2016年第7号).
4.	姚金芳, 张雷. 止血防粘连耗材的管控. 中国医疗设备, 2016, 31(6): 129-131.
5.	国务院办公厅. 关于印发治理高值医用耗材改革方案的通知. 2019.
6.	武侠. 新医改环境下医院耗材管理的探索. 中国医疗器械信息, 2017, 23(23): 141-142, 147.
7.	冯靖祎, 黄进, 吴航. 医疗机构止血材料管理专家共识. 中国医院建筑与装备, 2021, 22(7): 19-28.
8.	Zhang Y, Song D, Huang H, et al. Minimally invasive hemostatic materials: tackling a dilemma of fluidity and adhesion by photopolymerization in situ. Sci Rep, 2017, 7(1): 15250.
9.	Li S, Zhou K, Che G, et al. Enhanced recovery programs in lung cancer surgery: systematic review and meta-analysis of randomized controlled trials. Cancer Manag Res, 2017, 9: 657-670.
10.	俞文峰, 徐金明, 盛宏旭, 等. 可吸收再生氧化纤维素在肺癌手术中的临床效果评价. 中国肺癌杂志, 2020, 23(6): 492-495.
11.	Miyamoto H, Sakao Y, Sakuraba M, et al. The effects of sheet-type absorbable topical collagen hemostat used to prevent pulmonary fistula after lung surgery. Ann Thorac Cardiovasc Surg, 2010, 16: 16-20.
12.	Zheng C, Zeng Q, Pimpi S, et al. Research status and development potential of composite hemostatic materials. J Mater Chem B, 2020, 8(25): 5395-5410.
13.	Ma L, Dai L, Yang Y, et al. Comparison the efficacy of hemorrhage control of surgiflo haemostatic matrix and absorbable gelatin sponge in posterior lumbar surgery: a randomized controlled study. Medicine (Baltimore), 2018, 97(49): e13511.
14.	Chiow AKH, Fuks D, Choi GH, et al. International multicentre propensity score-matched analysis comparing robotic versus laparoscopic right posterior sectionectomy. Br J Surg, 2021, 108(12): 1513-1520.
15.	张士举, 王小启, 闫鹏, 等. 心脏手术中胸骨正中切口胸骨断面使用骨蜡填塞止血必要性的探讨. 中国循环杂志, 2016, 31(6): 593-595.
16.	Wu Y, Gangoli G, Bourcet A, et al. Using flowable gelatin in anterior cervical spine surgery in real-world practice: a retrospective cohort study. J Comp Eff Res, 2019, 8(5): 317-326.
17.	Kakaei F, Seyyed Sadeghi MS, Sanei B, et al. A randomized clinical trial comparing the effect of different haemostatic agents for haemostasis of the liver after hepatic resection. HPB Surg, 2013, 20(4): 12-13.
18.	秦利荣, 弥昉, 吴建高. 不同止血材料对患者住院费用的影响分析. 中华医院管理杂志, 2017, 33(5): 363-365.
19.	张爽, 徐庆华, 童琳, 等. 可吸收止血材料的研究现状与应用. 中国组织工程研究, 2021, 25(10): 1628-1634.
20.	Chiara O, Cimbanassi S, Bellanova G, et al. A systematic review on the use of topical hemostats in trauma and emergency surgery. BMC Surg, 2018, 18(1): 68.
21.	Kim HS, Lee S, Kim JH. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci, 2018, 33(34): e213.
22.	FDA. Use of real-world evidence to support regulatory decision-making for medical devices.
23.	王璐璐. 局部可吸收止血材料的应用现状及其研究进展. 医学研究生学报, 2018, 31(1): 109-112.
24.	Sayan M, Çelik A, Şatır Türk M, et al. Oxidized regenerated cellulose can be a cause of false tumor recurrence on PET/CT in patients with lung cancer treated surgically. Mol Imaging Radionucl Ther, 2023, 32(1): 8-12.
25.	Vitiello A, Abu-Abeid A, Berardi G, et al. Topical hemostatic application on staple line in laparoscopic sleeve gastrectomy: a single-surgeon experience. Minerva Surg, 2023, 78(2): 139-144.
26.	Martyn D, Meckley LM, Miyasato G, et al. Variation in hospital resource use and cost among surgical procedures using topical absorbable hemostats. Clinicoecon Outcomes Res, 2015, 7: 567-574.
27.	国家药品监督管理局. 真实世界数据用于医疗器械临床评价技术指导原则(试行). 2020.
28.	孙鑫, 谭婧, 王雯, 等. 真实世界证据助推药械评价与监管决策. 中国循证医学杂志, 2019, 19(5): 521-526.

1. Torzilli G, Makuuchi M, Inoue K, et al. No-mortality liver resection for hepatocellular carcinoma in cirrhotic and noncirrhotic patients: is there a way. A prospective analysis of our approach. Arch Surg, 1999, 134(9): 984-992.
2. Barnard J, Millner R. A review of topical hemostatic agents for use in cardiac surgery. Ann Thorac Surg, 2009, 88(4): 1377-1383.
3. 国家食品药品监督管理总局. 关于发布可吸收止血产品等3个医疗器械注册技术审查指导原则的通告(2016年第7号).
4. 姚金芳, 张雷. 止血防粘连耗材的管控. 中国医疗设备, 2016, 31(6): 129-131.
5. 国务院办公厅. 关于印发治理高值医用耗材改革方案的通知. 2019.
6. 武侠. 新医改环境下医院耗材管理的探索. 中国医疗器械信息, 2017, 23(23): 141-142, 147.
7. 冯靖祎, 黄进, 吴航. 医疗机构止血材料管理专家共识. 中国医院建筑与装备, 2021, 22(7): 19-28.
8. Zhang Y, Song D, Huang H, et al. Minimally invasive hemostatic materials: tackling a dilemma of fluidity and adhesion by photopolymerization in situ. Sci Rep, 2017, 7(1): 15250.
9. Li S, Zhou K, Che G, et al. Enhanced recovery programs in lung cancer surgery: systematic review and meta-analysis of randomized controlled trials. Cancer Manag Res, 2017, 9: 657-670.
10. 俞文峰, 徐金明, 盛宏旭, 等. 可吸收再生氧化纤维素在肺癌手术中的临床效果评价. 中国肺癌杂志, 2020, 23(6): 492-495.
11. Miyamoto H, Sakao Y, Sakuraba M, et al. The effects of sheet-type absorbable topical collagen hemostat used to prevent pulmonary fistula after lung surgery. Ann Thorac Cardiovasc Surg, 2010, 16: 16-20.
12. Zheng C, Zeng Q, Pimpi S, et al. Research status and development potential of composite hemostatic materials. J Mater Chem B, 2020, 8(25): 5395-5410.
13. Ma L, Dai L, Yang Y, et al. Comparison the efficacy of hemorrhage control of surgiflo haemostatic matrix and absorbable gelatin sponge in posterior lumbar surgery: a randomized controlled study. Medicine (Baltimore), 2018, 97(49): e13511.
14. Chiow AKH, Fuks D, Choi GH, et al. International multicentre propensity score-matched analysis comparing robotic versus laparoscopic right posterior sectionectomy. Br J Surg, 2021, 108(12): 1513-1520.
15. 张士举, 王小启, 闫鹏, 等. 心脏手术中胸骨正中切口胸骨断面使用骨蜡填塞止血必要性的探讨. 中国循环杂志, 2016, 31(6): 593-595.
16. Wu Y, Gangoli G, Bourcet A, et al. Using flowable gelatin in anterior cervical spine surgery in real-world practice: a retrospective cohort study. J Comp Eff Res, 2019, 8(5): 317-326.
17. Kakaei F, Seyyed Sadeghi MS, Sanei B, et al. A randomized clinical trial comparing the effect of different haemostatic agents for haemostasis of the liver after hepatic resection. HPB Surg, 2013, 20(4): 12-13.
18. 秦利荣, 弥昉, 吴建高. 不同止血材料对患者住院费用的影响分析. 中华医院管理杂志, 2017, 33(5): 363-365.
19. 张爽, 徐庆华, 童琳, 等. 可吸收止血材料的研究现状与应用. 中国组织工程研究, 2021, 25(10): 1628-1634.
20. Chiara O, Cimbanassi S, Bellanova G, et al. A systematic review on the use of topical hemostats in trauma and emergency surgery. BMC Surg, 2018, 18(1): 68.
21. Kim HS, Lee S, Kim JH. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci, 2018, 33(34): e213.
22. FDA. Use of real-world evidence to support regulatory decision-making for medical devices.
23. 王璐璐. 局部可吸收止血材料的应用现状及其研究进展. 医学研究生学报, 2018, 31(1): 109-112.
24. Sayan M, Çelik A, Şatır Türk M, et al. Oxidized regenerated cellulose can be a cause of false tumor recurrence on PET/CT in patients with lung cancer treated surgically. Mol Imaging Radionucl Ther, 2023, 32(1): 8-12.
25. Vitiello A, Abu-Abeid A, Berardi G, et al. Topical hemostatic application on staple line in laparoscopic sleeve gastrectomy: a single-surgeon experience. Minerva Surg, 2023, 78(2): 139-144.
26. Martyn D, Meckley LM, Miyasato G, et al. Variation in hospital resource use and cost among surgical procedures using topical absorbable hemostats. Clinicoecon Outcomes Res, 2015, 7: 567-574.
27. 国家药品监督管理局. 真实世界数据用于医疗器械临床评价技术指导原则(试行). 2020.
28. 孙鑫, 谭婧, 王雯, 等. 真实世界证据助推药械评价与监管决策. 中国循证医学杂志, 2019, 19(5): 521-526.

Chinese Journal of Evidence-Based Medicine

Comparison of different ORC uses in VATS for lung cancer resection based on real-world data

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