Randomized controlled trial on the curative effect of the Gilbert procedure and single mesh preperitoneal hernia repair

doi:10.3877/cma.j.issn.1674-392X.2024.06.007

Abstract

Abstract:

Objective

To compare the effect of double-layer mesh tension-free hernia repair surgery (Gilbert operation) and single-layer mesh preperitoneal tension-free hernia repair surgery in the treatment of adult inguinal hernia.

Methods

A prospective, single-center, single-blind, randomized controlled clinical trial was conducted.A total of 630 patients who admitted to West China Hospital,Sichuan University from February 2021 to February 2022 were divided into the double-layer mesh group(who underwent double-layer mesh tension-free hernia repair surgery) and the single-layer mesh group(who underwent single-layer mesh preperitoneal tension-free hernia repair surgery) by computer-assisted simple randomization.Operative time, the incidence of postoperative infection, postoperative pain, and recurrence rate were observed in the two groups.

Results

A total of 3 patients were lost to follow-up until October 2024.The single-layer mesh group (n=314) had shorter operation time than that of the double-layer mesh group (n=313) [(24.92±4.87) min vs.(26.93±4.89) min, t=5.153, P＜0.001].The visual analogue scale scores of pain during activity of the single-layer mesh group were lower than those of the double-layer mesh group at discharge, 1 week and 1 month after surgery, and the differences were all statistically significant (P＜0.001).There were 2 cases of postoperative cutaneous hematoma in the double-layer mesh group and 3 cases in the single-layer mesh group.There were 8 cases of scrotal seroma in the double-layer mesh group and 10 cases in the single-layer mesh group.There were no significant differences between the two groups (P=1.000, P=0.812).There was no significant difference in the recurrence rate, mesh removal rate after infection, and chronic pain between the two groups (P＞0.05).

Conclusion

Both surgical procedures are feasible.The single-layer mesh preperitoneal repair surgery can simplify the surgical procedure, reduce the operation time, and reduce the degree of postoperative short-term pain, thereby improving the overall treatment effect and providing more treatment options for patients.

Key words: Hernia, inguinal, Preperitoneal hernia repair, Gilbert operation, Complications, Randomized controlled trial

Dongyang Ma, Bin Li, Anqing Lu, Guanghua Wang, Wenzhang Lei, Yinghan Song. Randomized controlled trial on the curative effect of the Gilbert procedure and single mesh preperitoneal hernia repair[J]. Chinese Journal of Hernia and Abdominal Wall Surgery(Electronic Edition), 2024, 18(06): 629-633.

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URL: https://zhshfbwkzz.cma-cmc.com.cn/EN/10.3877/cma.j.issn.1674-392X.2024.06.007

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Figures/Tables 4

组别	例数	年龄(岁, $\overset{ˉ}{x}$ ±s)	年龄分组[例(%)]			体重指数(kg/m², $\overset{ˉ}{x}$ ±s)	体重指数分组[例(%)]			疝囊大小(cm, $\overset{ˉ}{x}$ ±s)	疝部位[例(%)]		疝内容物回纳情况[例(%)]
组别	例数	年龄(岁, $\overset{ˉ}{x}$ ±s)	＜40岁	40～65岁	≥65岁	体重指数(kg/m², $\overset{ˉ}{x}$ ±s)	＜18.5kg/m²	18.5～24kg/m²	≥24kg/m²	疝囊大小(cm, $\overset{ˉ}{x}$ ±s)	左侧	右侧	可	否
单层补片组	314	59.34±14.21	24(7.6)	191(60.8)	99(31.5)	23.07±2.47	8(2.5)	193(61.5)	113(36.0)	6.02±0.95	173(55.1)	141(44.9)	311(99.0)	3(1.0)
双层补片组	313	60.16±13.84	25(8.0)	180(57.2)	108(34.5)	23.31±2.42	6(1.9)	189(60.4)	118(37.7)	6.13±0.99	149(47.6)	164(52.4)	311(99.4)	2(0.6)
χ²/t/z值		0.734	0.736			1.245	0.434			1.381	3.228		-^a
P值		0.463	0.692			0.214	0.805			0.168	0.072		1.000

组别	例数	年龄(岁, $\overset{ˉ}{x}$ ±s)	年龄分组[例(%)]			体重指数(kg/m², $\overset{ˉ}{x}$ ±s)	体重指数分组[例(%)]			疝囊大小(cm, $\overset{ˉ}{x}$ ±s)	疝部位[例(%)]		疝内容物回纳情况[例(%)]
组别	例数	年龄(岁, $\overset{ˉ}{x}$ ±s)	＜40岁	40～65岁	≥65岁	体重指数(kg/m², $\overset{ˉ}{x}$ ±s)	＜18.5kg/m²	18.5～24kg/m²	≥24kg/m²	疝囊大小(cm, $\overset{ˉ}{x}$ ±s)	左侧	右侧	可	否
单层补片组	314	59.34±14.21	24(7.6)	191(60.8)	99(31.5)	23.07±2.47	8(2.5)	193(61.5)	113(36.0)	6.02±0.95	173(55.1)	141(44.9)	311(99.0)	3(1.0)
双层补片组	313	60.16±13.84	25(8.0)	180(57.2)	108(34.5)	23.31±2.42	6(1.9)	189(60.4)	118(37.7)	6.13±0.99	149(47.6)	164(52.4)	311(99.4)	2(0.6)
χ²/t/z值		0.734	0.736			1.245	0.434			1.381	3.228		-^a
P值		0.463	0.692			0.214	0.805			0.168	0.072		1.000

组别	例数	疝分类[例(%)]		手术时间(min, $\overset{ˉ}{x}$ ±s)	术中疝囊大小[cm,M(Q1,Q3)]	疝环缺损大小(cm, $\overset{ˉ}{x}$ ±s)
组别	例数	直疝	斜疝	手术时间(min, $\overset{ˉ}{x}$ ±s)	术中疝囊大小[cm,M(Q1,Q3)]	疝环缺损大小(cm, $\overset{ˉ}{x}$ ±s)
单层补片组	314	79(25.2)	235(74.8)	24.92±4.87	6.00(5.50,6.70)	4.01±0.99
双层补片组	313	76(24.3)	237(75.7)	26.93±4.89	6.20(5.40,6.80)	4.05±0.99
χ²/t/z值		0.026		5.153	1.204	0.478
P		0.871		＜0.001	0.228	0.633

组别	例数	疝分类[例(%)]		手术时间(min, $\overset{ˉ}{x}$ ±s)	术中疝囊大小[cm,M(Q1,Q3)]	疝环缺损大小(cm, $\overset{ˉ}{x}$ ±s)
组别	例数	直疝	斜疝	手术时间(min, $\overset{ˉ}{x}$ ±s)	术中疝囊大小[cm,M(Q1,Q3)]	疝环缺损大小(cm, $\overset{ˉ}{x}$ ±s)
单层补片组	314	79(25.2)	235(74.8)	24.92±4.87	6.00(5.50,6.70)	4.01±0.99
双层补片组	313	76(24.3)	237(75.7)	26.93±4.89	6.20(5.40,6.80)	4.05±0.99
χ²/t/z值		0.026		5.153	1.204	0.478
P		0.871		＜0.001	0.228	0.633

时间	例数	出院时	术后1周	术后1个月	术后3个月	术后半年	术后1年	术后2年
单层补片组	314	3.00(3.00,4.00)	4.00(3.00,4.00)	1.00(1.00,2.00)	0.00(0.00,0.00)	0.00(0.00,1.00)	0.00(0.00,1.00)	0.00(0.00,1.00)
双层补片组	313	4.00(4.00,5.00)	4.00(4.00,5.00)	2.00(1.00,2.00)	0.00(0.00,1.00)	1.00(0.00,1.00)	0.00(0.00,1.00)	1.00(0.00,1.00)
Z值		8.696	14.068	5.937	0.022	1.956	1.716	1.832
P值		＜0.001	＜0.001	＜0.001	0.983	0.051	0.078	0.067

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