Safety and efficacy of domestic porcine small intestinal submucosal decellularized matrix biological mesh in laparoscopic inguinal hernia repair: a multicenter clinical study_CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Authors：

JIN Cuihong ¹ , SHI Li ² , HUANG Ting ² , ZHANG Dong ² ,  CHEN Jie ³ , WANG Yinlong ⁴ , YAN Likun ⁵ , LI Zanlin ⁶ , KELIMU·Abudoureyimu ⁶ , WANG Ping ⁷ , HUANG Yonggang ⁷ , TANG Liming ⁸

1. Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, P. R. China;
2. Research Department, Shaanxi Bio-regeneration Medicine Co., Ltd., Xi’an 710000, P. R. China;
3. Department of Hernia and Abdominal Wall Surgery, Peking University People’s Hospital, Beijing 100044, P. R. China;
4. Department of Hernia and Abdominal Wall Surgery, Hernia and Abdominal Wall Surgery, Tianjin Renmin Hospital, Tianjin 300192, P. R. China;
5. Department of General Surgery One, Shanxi Renmin Hospital, Xi’an 710000, P. R. China;
6. Laparoscopy and Abdominal Wall Hernia Surgery, People’s Hospital of Xinjiang Uygur Autonomous Region, Urumqi 830001, P. R. China;
7. Department of Hernia and Abdominal Wall Surgery, Hangzhou First People’s Hospital, Hangzhou 310006, P. R. China;
8. Vascular Hernia Surgery, ShaoxingRenmin Hospital, Shaoxing, Zhejiang, 312000, P. R. China;

Corresponding?author：

CHEN Jie, Email: chenjiejoe@vip.sina.com

Keywords：

inguinal hernia; biologic hernia patch; laparoscopy; hernia repair

DOI：

10.7507/1007-9424.202506022

Video：

Export PDF Favorites Scan Get Citation

Abstract Full text Figures/Tables Video References Cited by

Objective To evaluate the short-term safety and efficacy of domestic porcine small intestinal submucosal decellularized matrix (SIS) mesh in laparoscopic inguinal hernia repair (LIHR), focusing on its clinical outcomes related to tissue repair. Methods A multicenter open-label single-arm study included 169 patients undergoing LIHR with domestic SIS mesh. Primary endpoint was excellent rate at 180 days postoperatively, the secondary efficacy indexes were the hernia recurrence rate, incision healing rate, wound healing time, mesh infection, chronic pain, and discomfort at the repair site at the immediate postoperative period. Results All 169 surgeries were successfully completed, with an excellent healing rate of 100.00% at 180 days postoperatively, significantly higher than the preset target (91%). The incision healing rate was 100%, and the average wound healing time was 8 days. 97.04% of the patients were pain free immediately after surgery, 98.20% of the patients were pain free at 7 days after surgery, and all patients were pain free at 28 days after surgery. Immediately after the operation, 97.04% of the subjects had no discomfort at the repair site, 98.20% at 7 days after the operation, and 100% at 28 days after the operation. There was no recurrence or infection after operation. Conclusion : Domestic SIS mesh is safe and effective in the laparoscopic treatment of inguinal hernia, and is worth popularizing for clinical use.

1.	Alharthi M, Almontashri AI, Alsharif RH, et al. Outcomes of open versus laparoscopic technique in primary inguinal hernia repair: a retrospective study. Cureus, 2023, 15(10): e46419. doi: 10.7759/cureus.46419.
2.	Tanovi? H, Mesihovi? R, Muhovi? S. Randomized trial of TEP laparoscopic hernioplasty versus Bassni inguinal hernia repair. Med Arh, 2005, 59(4): 214-216.
3.	McBee PJ, Walters RW, Fitzgibbons RJ. Current status of inguinal hernia management: a review. Int J Abdom Wall Hernia Surg, 2022, 5(4): 159-164.
4.	劉凱, 左武, 王斌, 等. 腹腔鏡疝修補術與開放式無張力疝修補術治療成人腹股溝疝的效果對比. 中國當代醫藥, 2020, 27(11): 70-72.
5.	張泉. 腹腔鏡下經腹膜前疝無張力修補術治療腹股溝疝患者的臨床效果及對疼痛程度的影響. 中外醫療, 2023, 42(27): 53-56.
6.	Ramsay G, Scott NW, Jansen JO. A 19 year population-based cohort study analysing reoperation for recurrence following laparoscopic and open inguinal hernia repairs. Hernia, 2020, 24(4): 793-800.
7.	Zhao Y, Peng H, Sun L, et al. The application of small intestinal submucosa in tissue regeneration. Mater Today Bio, 2024 Mar 18: 26: 101032.
8.	湯俊, 涂湘炎, 羅特東. 傳統腹股溝疝修補術、無張力疝修補術及腹腔鏡疝修補術的臨床比較. 亞太傳統醫藥, 2010, 6(8): 71-72.
9.	國家藥品監督管理局醫療器械技術審評中心. 疝修補補片臨床試驗指導原則[EB/OL]. (2020-07-09)[2025-06-05]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20200710095533189.html.
10.	中華醫學會外科學分會疝與腹壁外科學組, 中國醫師協會外科醫師分會疝和腹壁外科專家工作組. 腹股溝疝診療指南 (2024版). 中華消化外科雜志, 2025, 24(2): 143-150.
11.	靳翠紅, 申英末, 孫立, 等. 國產新型生物補片的安全性及有效性研究. 中華疝和腹壁外科雜志 (電子版), 2019, 13(1): 16-20.
12.	董尚進. 腹腔鏡疝修補術與開放式無張力疝修補術治療成人腹股溝疝的效果研究. 中文科技期刊數據庫(全文版)醫藥衛生, 2024(002): 000.
13.	Muhammer E, Taygun G. Laparoscopic inguinal hernia repair: A comparison of transabdominal preperitoneal and total extraperitoneal techniques-results of initial experiences. Int J Abdom Wall Hernia Surg, 2023, 6(3): 166-170.
14.	曹金鑫, 王明剛, 陳杰, 等. 腹腔鏡技術在腹股溝疝無張力修補術后感染治療中應用價值研究. 中國實用外科雜志, 2020, 40(7): 797-799,803.
15.	王偉剛, 俞永江. 疝補片材料學的現狀和展望. 中國普外基礎與臨床雜志, 2022, 29(4): 556-560.
16.	Hodde J, Hiles M. Constructive soft tissue remodelling with a biologic extracellular matrix graft: overview and review of the clinical literature. Acta Chir Belg, 2007, 107(6): 641-647.
17.	周曉剛, 王凱, 劉展, 等. 脫細胞基質生物補片與聚丙烯補片在腹股溝嵌頓疝治療中應用效果的前瞻性隨機對照研究. 中華疝和腹壁外科雜志 (電子版), 2018, 12(5): 367-370.
18.	劉靜, 申英末, 陳杰, 等. 不同類型脫細胞基質材料生物補片在青少年腹股溝疝修補術中的應用價值. 中華消化外科雜志, 2020, 19(7): 773-778.
19.	王寶山, 申英末, 陳富強, 等. 豬小腸黏膜下層脫細胞基質材料生物補片在腹腔鏡經腹腹膜前疝修補術中的應用. 中華疝和腹壁外科雜志 (電子版), 2016, 10(2): 85-88.
20.	楊建軍, 李紹春, 李紹杰, 等. 生物材料補片和合成材料補片對老年腹股溝疝修補術后患者血清腫發生率的影響比較. 老年醫學與保健. 2022, 28(4): 887-891.
21.	靳翠紅, 曹金鑫, 吳立勝, 等. 豬小腸黏膜下層脫細胞基質補片在腹腔鏡腹股溝疝修補術中應用價值的多中心前瞻性隨機對照研究. 中華消化外科雜志, 2024, 23(9): 1188-1194.
22.	唐建雄, 黃磊, 李紹杰. 生物材料在腹壁疝治療中的現狀和前景. 中華消化外科雜志, 2020, 19(7): 720-724.

1. Alharthi M, Almontashri AI, Alsharif RH, et al. Outcomes of open versus laparoscopic technique in primary inguinal hernia repair: a retrospective study. Cureus, 2023, 15(10): e46419. doi: 10.7759/cureus.46419.
2. Tanovi? H, Mesihovi? R, Muhovi? S. Randomized trial of TEP laparoscopic hernioplasty versus Bassni inguinal hernia repair. Med Arh, 2005, 59(4): 214-216.
3. McBee PJ, Walters RW, Fitzgibbons RJ. Current status of inguinal hernia management: a review. Int J Abdom Wall Hernia Surg, 2022, 5(4): 159-164.
4. 劉凱, 左武, 王斌, 等. 腹腔鏡疝修補術與開放式無張力疝修補術治療成人腹股溝疝的效果對比. 中國當代醫藥, 2020, 27(11): 70-72.
5. 張泉. 腹腔鏡下經腹膜前疝無張力修補術治療腹股溝疝患者的臨床效果及對疼痛程度的影響. 中外醫療, 2023, 42(27): 53-56.
6. Ramsay G, Scott NW, Jansen JO. A 19 year population-based cohort study analysing reoperation for recurrence following laparoscopic and open inguinal hernia repairs. Hernia, 2020, 24(4): 793-800.
7. Zhao Y, Peng H, Sun L, et al. The application of small intestinal submucosa in tissue regeneration. Mater Today Bio, 2024 Mar 18: 26: 101032.
8. 湯俊, 涂湘炎, 羅特東. 傳統腹股溝疝修補術、無張力疝修補術及腹腔鏡疝修補術的臨床比較. 亞太傳統醫藥, 2010, 6(8): 71-72.
9. 國家藥品監督管理局醫療器械技術審評中心. 疝修補補片臨床試驗指導原則[EB/OL]. (2020-07-09)[2025-06-05]. https://www.cmde.org.cn//flfg/zdyz/zdyzwbk/20200710095533189.html.
10. 中華醫學會外科學分會疝與腹壁外科學組, 中國醫師協會外科醫師分會疝和腹壁外科專家工作組. 腹股溝疝診療指南 (2024版). 中華消化外科雜志, 2025, 24(2): 143-150.
11. 靳翠紅, 申英末, 孫立, 等. 國產新型生物補片的安全性及有效性研究. 中華疝和腹壁外科雜志 (電子版), 2019, 13(1): 16-20.
12. 董尚進. 腹腔鏡疝修補術與開放式無張力疝修補術治療成人腹股溝疝的效果研究. 中文科技期刊數據庫(全文版)醫藥衛生, 2024(002): 000.
13. Muhammer E, Taygun G. Laparoscopic inguinal hernia repair: A comparison of transabdominal preperitoneal and total extraperitoneal techniques-results of initial experiences. Int J Abdom Wall Hernia Surg, 2023, 6(3): 166-170.
14. 曹金鑫, 王明剛, 陳杰, 等. 腹腔鏡技術在腹股溝疝無張力修補術后感染治療中應用價值研究. 中國實用外科雜志, 2020, 40(7): 797-799,803.
15. 王偉剛, 俞永江. 疝補片材料學的現狀和展望. 中國普外基礎與臨床雜志, 2022, 29(4): 556-560.
16. Hodde J, Hiles M. Constructive soft tissue remodelling with a biologic extracellular matrix graft: overview and review of the clinical literature. Acta Chir Belg, 2007, 107(6): 641-647.
17. 周曉剛, 王凱, 劉展, 等. 脫細胞基質生物補片與聚丙烯補片在腹股溝嵌頓疝治療中應用效果的前瞻性隨機對照研究. 中華疝和腹壁外科雜志 (電子版), 2018, 12(5): 367-370.
18. 劉靜, 申英末, 陳杰, 等. 不同類型脫細胞基質材料生物補片在青少年腹股溝疝修補術中的應用價值. 中華消化外科雜志, 2020, 19(7): 773-778.
19. 王寶山, 申英末, 陳富強, 等. 豬小腸黏膜下層脫細胞基質材料生物補片在腹腔鏡經腹腹膜前疝修補術中的應用. 中華疝和腹壁外科雜志 (電子版), 2016, 10(2): 85-88.
20. 楊建軍, 李紹春, 李紹杰, 等. 生物材料補片和合成材料補片對老年腹股溝疝修補術后患者血清腫發生率的影響比較. 老年醫學與保健. 2022, 28(4): 887-891.
21. 靳翠紅, 曹金鑫, 吳立勝, 等. 豬小腸黏膜下層脫細胞基質補片在腹腔鏡腹股溝疝修補術中應用價值的多中心前瞻性隨機對照研究. 中華消化外科雜志, 2024, 23(9): 1188-1194.
22. 唐建雄, 黃磊, 李紹杰. 生物材料在腹壁疝治療中的現狀和前景. 中華消化外科雜志, 2020, 19(7): 720-724.

CHINESE JOURNAL OF BASES AND CLINICS IN GENERAL SURGERY

Latest ArticlesSafety and efficacy of domestic porcine small intestinal submucosal decellularized matrix biological mesh in laparoscopic inguinal hernia repair: a multicenter clinical study

Abstract Full text Figures/Tables Video References Cited by

Format

Content