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[腹疝修补术的结果:开放和腹腔镜入路下缝合修补与补片植入(覆盖法与衬入法)的比较——前瞻性、随机、多中心研究]

[Results of ventral hernia repair: comparison of suture repair with mesh implantation (onlay vs sublay) using open and laparoscopic approach--prospective, randomized, multicenter study].

作者信息

Wéber György, Horváth Ors Péter

机构信息

Pécsi Tudományegyetem AOK Sebészeti Klinika, 7624 Pécs, Ifjúság útja 13.

出版信息

Magy Seb. 2002 Oct;55(5):285-9.

Abstract

Incisional hernias is a frequent complication following abdominal surgery, it develops in 11-20% of patients who had laparotomies. Different operative techniques are used for repair but results are often poor. In the absence of valid scientific data, there is no general agreement on the best surgical treatment. To provide evidence based surgery a nation-wide multi-center, prospective, randomized study is set up. The present study compares suture and mesh repairs in different positions, using open and laparoscopic approach to define standard indication for the treatment of incisional hernias. The study was started in March, 2002, with 23 surgical departments participating. Each report about 100 patients with incisional hernia repair. The 2300 consecutive patients (who are 18 to 70 years old) with primary incisional hernia or first recurrent umbilical hernia are randomized. Patients are divided in two groups. If the hernia is between 5-25 cm2 (Group I) they are selected at random either for prosthetic (sublay) or suture repair. In patients with a hernia larger than 25 cm2 (Group II) mesh is implanted at random as either sublay or onlay position using a computer randomization program. After a short learning period, in Group II the laparoscopic approach will also be randomized. Postoperative outcome, complications and recurrence are recorded. The study will run for five years. All collected data are sent to the coordinating center via internet to be entered into database.

摘要

切口疝是腹部手术后常见的并发症,在接受剖腹手术的患者中发生率为11% - 20%。虽然采用了不同的手术技术进行修复,但效果往往不佳。由于缺乏有效的科学数据,对于最佳手术治疗方法尚无普遍共识。为了提供循证医学的手术依据,开展了一项全国性多中心、前瞻性、随机研究。本研究比较了不同位置的缝合修补和补片修补,采用开放和腹腔镜手术方式来确定切口疝治疗的标准指征。该研究于2002年3月启动,有23个外科科室参与。每个科室报告约100例切口疝修补患者。将2300例连续的原发性切口疝或首次复发性脐疝患者(年龄在18至70岁之间)随机分组。患者分为两组。如果疝面积在5 - 25平方厘米之间(第一组),则随机选择进行假体(腹膜前)修补或缝合修补。对于疝面积大于25平方厘米的患者(第二组),使用计算机随机程序随机将补片植入腹膜前或腹膜外位置。经过短暂的学习期后,第二组患者的腹腔镜手术方式也将进行随机选择。记录术后结果、并发症和复发情况。该研究将持续五年。所有收集的数据通过互联网发送至协调中心并录入数据库。

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