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Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy (CONTINT)

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ClinicalTrials.gov Identifier: NCT00544583
Recruitment Status : Unknown
Verified January 2010 by Heidelberg University.
Recruitment status was:  Recruiting
First Posted : October 16, 2007
Last Update Posted : January 27, 2010
Sponsor:
Information provided by:
Heidelberg University

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

Condition or disease Intervention/treatment Phase
Laparotomy Hernia Procedure: Interrupted sutures Procedure: Continuous sutures Phase 2 Phase 3

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study
Study Start Date : November 2007
Estimated Primary Completion Date : April 2011
Estimated Study Completion Date : April 2012
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A
Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm)
 Procedure: Interrupted sutures
Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
Experimental: B
Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops)
 Procedure: Continuous sutures
Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops


Outcome Measures
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Primary Outcome Measures :
  1. Incisional hernia or burst abdomen within 12 months [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00544583


Contacts
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Contact: Nuh N Rahbari, MD +49 6221 56 39448 nuh.rahbari@med.uni-heidelberg.de
Contact: Sabine - Voß, MD +49 6221 56 6986 sabine.voss@med.uni-heidelberg.de

Locations
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Germany
Department of Surgery Recruiting
Heidelberg, Germany, 69120
Contact: Nuh N Rahbari, MD    + 49 6221 56 39448    nuh.rahbari@med.uni-heidelberg.de   
Contact: SDGC Heidelberg    +49 6221 56 6986    sdgc@med.uni-heidelberg.de   
Sponsors and Collaborators
Heidelberg University
Investigators
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Study Director: Nuh N Rahbari, MD Department of Surgery, University of Heidelberg
Principal Investigator: Markus W Büchler, MD Department of Surgery, University of Heidelberg
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Heidelberg, Germany, Department of General, Visceral and Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00544583    
Other Study ID Numbers: S206/2007
First Posted: October 16, 2007    Key Record Dates
Last Update Posted: January 27, 2010
Last Verified: January 2010
Keywords provided by Heidelberg University:
Abdominal wall
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes