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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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.	國家食品藥品監督管理總局. 關于發布可吸收止血產品等3個醫療器械注冊技術審查指導原則的通告(2016年第7號).
4.	姚金芳, 張雷. 止血防粘連耗材的管控. 中國醫療設備, 2016, 31(6): 129-131.
5.	國務院辦公廳. 關于印發治理高值醫用耗材改革方案的通知. 2019.
6.	武俠. 新醫改環境下醫院耗材管理的探索. 中國醫療器械信息, 2017, 23(23): 141-142, 147.
7.	馮靖祎, 黃進, 吳航. 醫療機構止血材料管理專家共識. 中國醫院建筑與裝備, 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. 可吸收再生氧化纖維素在肺癌手術中的臨床效果評價. 中國肺癌雜志, 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.	張士舉, 王小啟, 閆鵬, 等. 心臟手術中胸骨正中切口胸骨斷面使用骨蠟填塞止血必要性的探討. 中國循環雜志, 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.	秦利榮, 彌昉, 吳建高. 不同止血材料對患者住院費用的影響分析. 中華醫院管理雜志, 2017, 33(5): 363-365.
19.	張爽, 徐慶華, 童琳, 等. 可吸收止血材料的研究現狀與應用. 中國組織工程研究, 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應用現狀及其研究進展. 醫學研究生學報, 2018, 31(1): 109-112.
24.	Sayan M, ?elik A, ?at?r 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.	國家藥品監督管理局. 真實世界數據用于醫療器械臨床評價技術指導原則(試行). 2020.
28.	孫鑫, 譚婧, 王雯, 等. 真實世界證據助推藥械評價與監管決策. 中國循證醫學雜志, 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. 國家食品藥品監督管理總局. 關于發布可吸收止血產品等3個醫療器械注冊技術審查指導原則的通告(2016年第7號).
4. 姚金芳, 張雷. 止血防粘連耗材的管控. 中國醫療設備, 2016, 31(6): 129-131.
5. 國務院辦公廳. 關于印發治理高值醫用耗材改革方案的通知. 2019.
6. 武俠. 新醫改環境下醫院耗材管理的探索. 中國醫療器械信息, 2017, 23(23): 141-142, 147.
7. 馮靖祎, 黃進, 吳航. 醫療機構止血材料管理專家共識. 中國醫院建筑與裝備, 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. 可吸收再生氧化纖維素在肺癌手術中的臨床效果評價. 中國肺癌雜志, 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. 張士舉, 王小啟, 閆鵬, 等. 心臟手術中胸骨正中切口胸骨斷面使用骨蠟填塞止血必要性的探討. 中國循環雜志, 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. 秦利榮, 彌昉, 吳建高. 不同止血材料對患者住院費用的影響分析. 中華醫院管理雜志, 2017, 33(5): 363-365.
19. 張爽, 徐慶華, 童琳, 等. 可吸收止血材料的研究現狀與應用. 中國組織工程研究, 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應用現狀及其研究進展. 醫學研究生學報, 2018, 31(1): 109-112.
24. Sayan M, ?elik A, ?at?r 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. 國家藥品監督管理局. 真實世界數據用于醫療器械臨床評價技術指導原則(試行). 2020.
28. 孫鑫, 譚婧, 王雯, 等. 真實世界證據助推藥械評價與監管決策. 中國循證醫學雜志, 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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