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间断或连续可缓慢吸收缝线——一项评估腹部闭合技术的多中心随机试验的设计:INSECT试验[ISRCTN24023541]

Interrupted or continuous slowly absorbable sutures - design of a multi-centre randomised trial to evaluate abdominal closure techniques INSECT-trial [ISRCTN24023541].

作者信息

Knaebel Hanns-Peter, Koch Moritz, Sauerland Stefan, Diener Markus K, Büchler Markus W, Seiler Christoph M

机构信息

University of Heidelberg, Department of General, Visceral and Trauma Surgery, Im Neuenheimer Feld 110, D-69120 Heidelberg, Germany.

出版信息

BMC Surg. 2005 Mar 8;5:3. doi: 10.1186/1471-2482-5-3.

Abstract

BACKGROUND

The closure of the abdomen after median laparotomy is still a matter of debate among surgeons. Further well designed and performed randomised controlled trials determining the optimal method of abdominal fascial closure are needed.

DESIGN

This is a three armed, multi-centre, intra-operatively randomised, controlled, patient blinded trial. Over 20 surgical departments will enrol 600 patients who are planned for an elective primary abdominal operation. The objective of this study is to compare the frequency of abdominal incisional hernias between two continuous suture techniques with different, slowly absorbable monofilament materials and an interrupted suture using an absorbable braided suture material at one year postoperatively.

CONCLUSION

This trial will answer the question whether the continuous abdominal wall closure with a slowly absorbable material with longitudinal elasticity is superior to the continuous suture with a material lacking elasticity and to interrupted sutures with braided thread.

摘要

背景

正中剖腹术后腹部的关闭方式在外科医生中仍存在争议。需要进一步设计良好且实施的随机对照试验来确定腹部筋膜关闭的最佳方法。

设计

这是一项三臂、多中心、术中随机、对照、患者盲法试验。超过20个外科科室将招募600名计划进行择期原发性腹部手术的患者。本研究的目的是比较术后一年使用两种不同的、可缓慢吸收的单丝材料进行连续缝合技术与使用可吸收编织缝合材料进行间断缝合的腹部切口疝发生频率。

结论

本试验将回答使用具有纵向弹性的可缓慢吸收材料进行连续腹壁关闭是否优于使用缺乏弹性的材料进行连续缝合以及使用编织线进行间断缝合的问题。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c192/554977/f4bdcc1fbe17/1471-2482-5-3-1.jpg

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