复合化学性医用胶用于TAPP 术中固定补片的安全性与有效性评价：一项前瞻性随机对照研究

doi:10.3877/cma.j.issn.1674-392X.2025.02.013

中华疝和腹壁外科杂志(电子版) ›› 2025, Vol. 19 ›› Issue (02) : 189 -194. doi: 10.3877/cma.j.issn.1674-392X.2025.02.013

论著

复合化学性医用胶用于TAPP 术中固定补片的安全性与有效性评价：一项前瞻性随机对照研究

郑志¹, 郑若彤², 靳翠红², 孙立², 杜华栋², 刘静², 邹振玉², 申英末²^,^†(

)

^1. 101300 北京市顺义区医院普外一科疝与腹壁外科
^2. 100043 首都医科大学附属北京朝阳医院疝和腹壁外科

收稿日期:2024-09-26 出版日期:2025-04-18
通信作者: 申英末
基金资助:
吴阶平医学基金会临床科研专项资助基金（320.6750.2021-04-35）

Safety and efficacy evaluation of a composite chemical medical adhesive for mesh fixation in TAPP:a prospective randomized controlled trial

Zhi Zheng¹, Ruotong Zheng², Cuihong Jin², Li Sun², Huadong Du², Jing Liu², Zhenyu Zou², Yingmo Shen²^,^†()

^1. Department of Hernia and Abdominal Wall Surgery,General Surgery I, Shunyi District Hospital, Beijing 101300, China
^2. Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University, Beijing 100043, China

Received:2024-09-26 Published:2025-04-18
Corresponding author: Yingmo Shen

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引用本文：

郑志, 郑若彤, 靳翠红, 孙立, 杜华栋, 刘静, 邹振玉, 申英末. 复合化学性医用胶用于TAPP 术中固定补片的安全性与有效性评价：一项前瞻性随机对照研究[J/OL]. 中华疝和腹壁外科杂志(电子版), 2025, 19(02): 189-194.

Zhi Zheng, Ruotong Zheng, Cuihong Jin, Li Sun, Huadong Du, Jing Liu, Zhenyu Zou, Yingmo Shen. Safety and efficacy evaluation of a composite chemical medical adhesive for mesh fixation in TAPP:a prospective randomized controlled trial[J/OL]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2025, 19(02): 189-194.

目的

评价复合化学性医用胶在腹腔镜下经腹腹膜前腹股沟疝修补术（transabdominal preperitoneal herniorrhaphy，TAPP）术中用于固定补片的安全性和有效性。

方法

本研究为前瞻性、等效性、随机对照研究，共纳入2023 年1—7 月在首都医科大学附属北京朝阳医院疝和腹壁外科接受TAPP 术式的腹股沟疝患者108 例，其中试验组52 例，对照组56 例。在术中固定补片环节，试验组使用国产复合成分化学性医用胶，对照组使用国产单一成分化学性医用胶固定补片。记录2 组患者一般临床资料、手术前后临床参数、术后并发症发生例数、住院费用等，并进行统计学分析。

结果

108 例患者均顺利完成TAPP 术式。术后随访12～18 个月，2 组均无复发，无伤口愈合不良、补片感染，无发热、过敏，无术后慢性疼痛。试验组术后腹股沟区血清肿8 例，对照组4 例，均为I 型血清肿，差异无统计学意义（P=0.173）。试验组3 例患者术后6 个月以上仍感腹股沟区不适，对照组2 例，差异无统计学意义（P=0.587）。试验组未出现阴囊血肿，对照组出现1 例，差异无统计学意义（P=0.333）。试验组住院费用中位数为10 937.1 元，对照组11 443.2 元，差异无统计学意义（P=0.127）。

结论

腹股沟疝TAPP 术式中应用国产复合成分化学性医用胶固定补片安全且有效。

关键词: 疝,腹股沟, 疝修补术, 腹腔镜, 化学性医用胶, 随机对照试验

Objective

To evaluate the safety and efficacy of a composite chemical medical adhesive for mesh fixation in transabdominal preperitoneal herniorrhaphy (TAPP).

Methods

This study was a prospective, equivalent, randomized controlled trial, which included a total of 108 patients with inguinal hernia who received TAPP between January 2023 and July 2023 in the Department of Hernia and Abdominal Wall Surgery, Beijing Chaoyang Hospital, Capital Medical University.There were 52 cases in the experimental group and 56 cases in the control group.During the mesh fixation session, a domestic composite chemical medical adhesive was used in the experimental group, while another domestic single component chemical medical adhesive was used in the control group.The general clinical data, pre- and post-operative clinical parameters, the number of cases of postoperative complications, and hospitalization costs of the two groups were recorded and statistically analyzed.

Results

All 108 cases of TAPP were successfully completed.During 12-18 months postoperative follow-up, there was no recurrence, no wound healing disorder, no mesh infection, no fever, no allergy, and no chronic postoperative pain in both groups.There were 8 cases of postoperative seroma in the inguinal area in the experimental group and 4 cases in the control group, all of which were type I seromas, and the difference between the two groups was not statistically significant (P=0.173).There were 3 cases in the experimental group who still felt discomfort in the inguinal area more than 6 months after surgery and 2 cases in the control group, with no statistical significant difference between the two groups (P=0.587).There was no scrotal hematoma in the experimental group, and one scrotal hematoma in the control group, and the difference between the two groups was not statistically significant (P=0.333).The median hospitalization cost was ¥10,937.1 in the experimental group and ¥11,443.2 in the control group, with no statistical significant difference between the two groups (P=0.127).

Conclusion

The application of the domestic composite chemical medical adhesive in TAPP operation for mesh fixation is safe and effective.

Key words: Hernia, inguinal, Herniorrhaphy, Laparoscopes, Chemical medical adhesive, Randomized controlled trial

表1 2 组患者基本资料比较

组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	性别[例(%)]		BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	男性	女性	BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
试验组	52	62.48±9.20	48(92.3)	4(7.7)	24.45±2.84	17(32.7)	2(3.8)	0(0.0)	0(0.0)	4(7.7)	4(7.7)	0(0.0)
对照组	56	64.57±9.46	53(94.6)	3(5.4)	23.77±2.36	15(26.8)	2(3.6)	1(1.8)	3(5.4)	9(16.1)	1(1.8)	0(0.0)
统计值		t=-1.163	χ ²=0.243		t=1.364	χ ²=0.451	χ ²=0.006	χ ²=0.937	χ ²=2.865	χ ²=1.788	χ ²=2.131	-
P值		0.584	0.622		0.106	0.502	0.940	0.333	0.091	0.181	0.144	-

表1 2 组患者基本资料比较

组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	性别[例(%)]		BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
组别	例数	年龄(岁, $\overset{ˉ}{x}$ ± s )	男性	女性	BMI(kg/m², $\overset{ˉ}{x}$ ± s )	吸烟[例(%)]	便秘[例(%)]	慢性咳嗽[例(%)]	COPD[例(%)]	糖尿病[例(%)]	前列腺增生[例(%)]	肝硬化[例(%)]
试验组	52	62.48±9.20	48(92.3)	4(7.7)	24.45±2.84	17(32.7)	2(3.8)	0(0.0)	0(0.0)	4(7.7)	4(7.7)	0(0.0)
对照组	56	64.57±9.46	53(94.6)	3(5.4)	23.77±2.36	15(26.8)	2(3.6)	1(1.8)	3(5.4)	9(16.1)	1(1.8)	0(0.0)
统计值		t=-1.163	χ ²=0.243		t=1.364	χ ²=0.451	χ ²=0.006	χ ²=0.937	χ ²=2.865	χ ²=1.788	χ ²=2.131	-
P值		0.584	0.622		0.106	0.502	0.940	0.333	0.091	0.181	0.144	-

表2 2 组患者术中情况比较

组别	例数	疝的侧别[例(%)]		疝的类型[例(%)]				疝环最大径[cm,M(Q₁,Q₃)]	手术时间[min,M(Q₁,Q₃)]	出血量[ml,M(Q₁,Q₃)]
组别	例数	左侧	右侧	斜疝	直疝	马鞍疝	股疝	疝环最大径[cm,M(Q₁,Q₃)]	手术时间[min,M(Q₁,Q₃)]	出血量[ml,M(Q₁,Q₃)]
试验组	52	18(34.6)	34(65.4)	39(75.0)	10(19.2)	2(3.8)	1(1.9)	2.0(2.0,3.0)	40.0(35.0,45.0)	10.0(8.0,10.0)
对照组	56	24(42.9)	32(57.1)	36(64.3)	16(28.6)	0(0.0)	4(7.1)	2.0(2.0,3.0)	37.5(32.3,47.5)	8.0(5.8,10.0)
统计值		χ ²=0.771			χ ²=5.164			Z=-0.250	Z=-0.533	Z=-1.252
P值		0.380			0.160			0.802	0.594	0.211

表2 2 组患者术中情况比较

组别	例数	疝的侧别[例(%)]		疝的类型[例(%)]				疝环最大径[cm,M(Q₁,Q₃)]	手术时间[min,M(Q₁,Q₃)]	出血量[ml,M(Q₁,Q₃)]
组别	例数	左侧	右侧	斜疝	直疝	马鞍疝	股疝	疝环最大径[cm,M(Q₁,Q₃)]	手术时间[min,M(Q₁,Q₃)]	出血量[ml,M(Q₁,Q₃)]
试验组	52	18(34.6)	34(65.4)	39(75.0)	10(19.2)	2(3.8)	1(1.9)	2.0(2.0,3.0)	40.0(35.0,45.0)	10.0(8.0,10.0)
对照组	56	24(42.9)	32(57.1)	36(64.3)	16(28.6)	0(0.0)	4(7.1)	2.0(2.0,3.0)	37.5(32.3,47.5)	8.0(5.8,10.0)
统计值		χ ²=0.771			χ ²=5.164			Z=-0.250	Z=-0.533	Z=-1.252
P值		0.380			0.160			0.802	0.594	0.211

表3 2 组患者术后并发症及住院费用比较

组别	例数	血清肿[例(%)]			阴囊血肿[例(%)]	补片感染[例(%)]	伤口愈合不良[例(%)]	发热[例(%)]	过敏[例(%)]	术后慢性疼痛[例(%)]	腹股沟区不适[例(%)]	复发[例(%)]	住院费用[元,M(Q₁,Q₃)]
组别	例数	Ⅰ型	Ⅱ型(Ⅱa+Ⅱb)	Ⅲ型+Ⅳ型	阴囊血肿[例(%)]	补片感染[例(%)]	伤口愈合不良[例(%)]	发热[例(%)]	过敏[例(%)]	术后慢性疼痛[例(%)]	腹股沟区不适[例(%)]	复发[例(%)]	住院费用[元,M(Q₁,Q₃)]
试验组	52	8(15.4)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	3(5.8)	0(0.0)	10 937.1(10 245.0,11 798.4)
对照组	56	4(7.1)	0(0.0)	0(0.0)	1(1.8)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	2(3.6)	0(0.0)	11 443.2(10 645.7,11 911.7)
统计值			χ ²=1.854		χ ²=0.937	-	-	-	-	-	χ ²=0.295	-	Z=-1.525
P值			0.173		0.333	-	-	-	-	-	0.587	-	0.127

表3 2 组患者术后并发症及住院费用比较

组别	例数	血清肿[例(%)]			阴囊血肿[例(%)]	补片感染[例(%)]	伤口愈合不良[例(%)]	发热[例(%)]	过敏[例(%)]	术后慢性疼痛[例(%)]	腹股沟区不适[例(%)]	复发[例(%)]	住院费用[元,M(Q₁,Q₃)]
组别	例数	Ⅰ型	Ⅱ型(Ⅱa+Ⅱb)	Ⅲ型+Ⅳ型	阴囊血肿[例(%)]	补片感染[例(%)]	伤口愈合不良[例(%)]	发热[例(%)]	过敏[例(%)]	术后慢性疼痛[例(%)]	腹股沟区不适[例(%)]	复发[例(%)]	住院费用[元,M(Q₁,Q₃)]
试验组	52	8(15.4)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	3(5.8)	0(0.0)	10 937.1(10 245.0,11 798.4)
对照组	56	4(7.1)	0(0.0)	0(0.0)	1(1.8)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	0(0.0)	2(3.6)	0(0.0)	11 443.2(10 645.7,11 911.7)
统计值			χ ²=1.854		χ ²=0.937	-	-	-	-	-	χ ²=0.295	-	Z=-1.525
P值			0.173		0.333	-	-	-	-	-	0.587	-	0.127

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Safety and efficacy evaluation of a composite chemical medical adhesive for mesh fixation in TAPP:a prospective randomized controlled trial

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Safety and efficacy evaluation of a composite chemical medical adhesive for mesh fixation in TAPP:a prospective randomized controlled trial