Open Access Highly Accessed Study protocol

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

Hanns-Peter Knaebel1, Moritz Koch1, Stefan Sauerland2, Markus K Diener1, Markus W Büchler1*, Christoph M Seiler1 and the INSECT Study Group of the Study Centre of the German Surgical Society (SDGC)

Author Affiliations

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

2 University of Cologne, Biochemical & Experimental Department, Ostmerheimer Str. 200, D-51109 Cologne, Germany

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BMC Surgery 2005, 5:3  doi:10.1186/1471-2482-5-3

Published: 8 March 2005

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.