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


METHODS
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.


CONCLUSIONS
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.
Knaebel
Hanns-Peter
HP
University of Heidelberg, Department of General, Visceral and Trauma Surgery, Im Neuenheimer Feld 110, D-69120 Heidelberg, Germany. hanns-peter_knaebel@med.uni-heidelberg.de <hanns-peter_knaebel@med.uni-heidelberg.de>
Koch
Moritz
M
Sauerland
Stefan
S
Diener
Markus K
MK
Büchler
Markus W
MW
Seiler
Christoph M
CM
D034861:Abdominal Wall / Q000601:surgery*; D002985:Clinical Protocols; D005500:Follow-Up Studies; D006555:Hernia, Ventral / Q000517:prevention & control*; D006801:Humans; D007813:Laparotomy / Q000379:methods*; D015337:Multicenter Studies as Topic; D011183:Postoperative Complications / Q000517:prevention & control*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013536:Suture Techniques; D013537:Sutures