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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Heidelberg.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00544583
First received: October 15, 2007
Last updated: January 26, 2010
Last verified: January 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Laparotomy
Hernia
 Procedure: Interrupted sutures
Procedure: Continuous sutures
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study

Resource links provided by NLM:

MedlinePlus related topics: Hernia
U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:
  • Incisional hernia or burst abdomen within 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2007
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00544583

Contacts
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
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
University of Heidelberg
Investigators
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

No publications provided

Responsible Party: University of Heidelberg, Germany, Department of General, Visceral and Transplantation Surgery
ClinicalTrials.gov Identifier: NCT00544583     History of Changes
Other Study ID Numbers: S206/2007
Study First Received: October 15, 2007
Last Updated: January 26, 2010
Health Authority: Germany: Ethics Commission

Keywords provided by University of Heidelberg:
Abdominal wall

Additional relevant MeSH terms:
Emergencies
Hernia
Disease Attributes
Pathologic Processes
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 17, 2012