Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583].
BACKGROUND
The optimal strategy for abdominal wall closure has been an issue of ongoing debate. Available studies do not specifically enroll patients who undergo emergency laparotomy and thus do not consider the distinct biological characteristics of these patients. The present randomized controlled trial evaluates the efficacy and safety of two commonly applied abdominal wall closure strategies in patients undergoing primary emergency midline laparotomy.


METHODS
The CONTINT trial is a multicenter, open label, randomized controlled trial with a two-group parallel design. Patients undergoing a primary emergency midline laparotomy are enrolled in the trial. The two most commonly applied strategies of abdominal wall closure after midline laparotomy are compared: the continuous, all-layer suture technique using slowly absorbable monofilament material (two Monoplus loops) and the interrupted suture technique using rapidly absorbable braided material (Vicryl sutures). The primary endpoint within the CONTINT trial is an incisional hernia within 12 months or a burst abdomen within 30 days after surgery. As reliable data on this primary endpoint is not available for patients undergoing emergency surgery, an adaptive interim analysis will be conducted after the inclusion of 80 patients, allowing early termination of the trial if necessary or modification of design characteristics such as recalculation of sample size.


CONCLUSIONS
This is a randomized controlled multicenter trial with a two-group parallel design to assess the efficacy and safety of two commonly applied abdominal wall closure strategies in patients undergoing primary emergency midline laparotomy.


BACKGROUND
NCT00544583.
Department of General, Visceral and Transplant Surgery, University of Heidelberg, Heidelberg, Germany. nuh.rahbari@med.uni-heidelberg.de
Nuh N
NN
Rahbari
Phillip
P
Knebel
Meinhard
M
Kieser
Thomas
T
Bruckner
Detlef K
DK
Bartsch
Helmut
H
Friess
Andre L
AL
Mihaljevic
Josef
J
Stern
Markus K
MK
Diener
Sabine
S
Voss
Inga
I
Rossion
Markus W
MW
Büchler
Christoph M
CM
Seiler
D058107:Abdominal Wound Closure Techniques / Q000009:adverse effects / Q000295:instrumentation; D002985:Clinical Protocols; D004630:Emergencies; D004867:Equipment Design; D005858:Germany; D046449:Hernia, Abdominal / Q000209:etiology; D006801:Humans; D007813:Laparotomy / Q000009:adverse effects; D012107:Research Design; D013536:Suture Techniques / Q000009:adverse effects / Q000295:instrumentation; D013537:Sutures; D013997:Time Factors; D016896:Treatment Outcome