Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy

Hernia Clinical Trial

— CONTINT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00544583
• Other study ID #: S206/2007
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 15, 2007
• Last updated: January 26, 2010
• Start date: November 2007
• Est. completion date: April 2012

Study information

• Verified date: January 2010
• Source: Heidelberg University
• Contact: Nuh N Rahbari, MD
• Phone: +49 6221 56 39448
• Email: nuh.rahbari[@]med.uni-heidelberg.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Preoperative Inclusion criteria:

• Age equal or greater than 18 years

• Expected survival time more than 12 months

• Patients undergoing primary and emergency midline laparotomy (patients with prior laparoscopy (not colon resections) or minor abdominal operation (e.g. appendectomy, cholecystectomy, hysterectomy, sectio) may be included into the trial)

• Suspected septic abdominal focus (e.g. perforated stomach ulcer, perforated diverticulitis)

• Informed consent

2. Intraoperative inclusion criteria before closure:

• Successful source control

• Abdominal lavage

Exclusion Criteria:

1. Preoperative exclusion criteria:

• Participation in another intervention-trial with interference of intervention and outcome of this study

2. Intraoperative exclusion criteria before closure:

• Planned re-laparotomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Laparotomy

Intervention

Procedure:
• Interrupted sutures
Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
• Continuous sutures
Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops

Locations

Country	Name	City	State
Germany	Department of Surgery	Heidelberg

Sponsors (1)

Lead Sponsor	Collaborator
Heidelberg University

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incisional hernia or burst abdomen within 12 months		12 months	Yes
Secondary	Quality of Life		12 months	Yes