NCT00544583

Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy

Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity.

Detailed description

More than 700.000 open abdominal surgeries (laparotomies) are performed each year in Germany (2). A major surgical complication after laparotomy is abdominal fascia dehiscence which might appear either as early (burst abdomen with evisceration) or as late complication (incisional hernia). These patients usually undergo surgery for secondary fascial closure associated with markedly increased morbidity (3) including high recurrence rates (up to 45%) (4). The applied surgical strategy of abdominal wall closure (i.e. the combination of suture technique and material) is of high relevance for prevention of fascia dehiscence and, moreover, constitutes the main factor directly controllable by the surgeon. While several randomized controlled trials (RCT) (3; 5-8) as well as meta-analyses (9-12) exist that address the issue of optimal fascia closure in elective laparotomies, there is no RCT dealing exclusively with the emergency setting. As a result abdominal fascia closure is performed according to the surgeon's individual preference rather than according to evidence-based data. Therefore, the present RCT is designed to compare the most established strategies (continuous slowly absorbable sutures and interrupted rapidly absorbable sutures) for abdominal wall closure in order to determine differences between both strategies after midline incisions.

Conditions

• Laparotomy
• Hernia

Interventions

Type	Name	Description
PROCEDURE	Interrupted sutures	Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
PROCEDURE	Continuous sutures	Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops

Timeline

• Start date: 2007-11-01
• Primary completion: 2011-04-01
• Completion: 2012-04-01
• First posted: 2007-10-16
• Last updated: 2010-01-27

Locations

1 site across 1 country: Germany