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["外置" 补片比 "内置" 重建效果显著更好。仅用缝线或使用外科补片进行腹壁重建的前瞻性随机多中心研究——五年随访结果]

["Onlay" mesh provides significantly better results than "sublay" reconstruction. Prospective randomized multicenter study of abdominal wall reconstruction with sutures only, or with surgical mesh--results of a five-years follow-up].

作者信息

Wéber György, Baracs József, Horváth Ors Péter

机构信息

Pécsi Tudományegyetem, Általános Orvostudományi Kar Sebészeti Klinika 7624 Pécs Kodály Z. u. 20. Pécsi Tudományegyetem, Általános Orvostudományi Kar Sebészeti Oktató és Kutató Intézet Pécs.

出版信息

Magy Seb. 2010 Oct;63(5):302-11. doi: 10.1556/MaSeb.63.2010.5.3.

Abstract

BACKGROUND

There are several well-known procedures to treat abdominal wall hernias, but the results are quite controversial. The aim of study was to compare the results of different surgical modalities - mesh (onlay vs. sublay position) and suture repair - in the treatment of abdominal wall hernias.

METHODS

A five-year randomized, multicentric, internet-based, clinical trial was started in 2002. 953 patients were included in the study and divided into two groups according to the size of hernia orifice. In group 'A' ( n = 494) the surface of hernia orifice was between 5-25 cm 2 (small hernia), and in group 'B' ( n = 459) it was above 25 cm 2 (large hernia). Patients of these two groups were randomized according to surgery: group 'A' (suture vs. mesh) and in group 'B' (mesh in onlay vs. sublay position). In group 'A' suture repair was performed in 247, and sublay mesh implantation in 247 cases. In group 'B' sublay ( n = 235) and onlay ( n = 224) mesh reconstruction was performed. The patients were followed-up for five years.

RESULTS

734 patients - 77% of all randomized cases - have completed the study. In the small hernia group significantly ( p < 0.001) higher recurrences occurred after suture repair ( n = 50-27%) than in mesh repair ( n = 15-8%). In the large hernia group onlay mesh reconstruction provided significantly better ( p < 0.05) results than sublay reconstruction, recurrence rate was much lower in onlay group [ n = 22 (12%) vs. n = 38 (20%)].

CONCLUSION

Mesh repair provides better results than suture repair. In case of large hernias the recurrence rate is higher after sublay reconstruction. The randomized trial was registered on www.ClinicalTrials.gov - ID number: NCT01018524.

摘要

背景

有几种知名的治疗腹壁疝的手术方法,但结果颇具争议。本研究的目的是比较不同手术方式——补片(外置与内置位置)和缝合修补——治疗腹壁疝的效果。

方法

2002年启动了一项为期五年的随机、多中心、基于互联网的临床试验。953例患者纳入研究,根据疝孔大小分为两组。“A组”(n = 494)疝孔面积在5 - 25平方厘米之间(小疝),“B组”(n = 459)疝孔面积大于25平方厘米(大疝)。这两组患者根据手术方式随机分组:“A组”(缝合与补片),“B组”(外置补片与内置补片位置)。“A组”中247例行缝合修补,247例行内置补片植入。“B组”中235例行内置补片,224例行外置补片重建。对患者进行了五年随访。

结果

734例患者——占所有随机分组病例的77%——完成了研究。在小疝组,缝合修补后的复发率(n = 50 - 27%)显著高于补片修补(n = 15 - 8%)(p < 0.001)。在大疝组,外置补片重建的效果显著优于内置补片重建(p < 0.05),外置补片组的复发率低得多[n = 22(12%)对n = 38(20%)]。

结论

补片修补比缝合修补效果更好。对于大疝,内置补片重建后的复发率更高。该随机试验已在www.ClinicalTrials.gov注册——注册号:NCT01018524。

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