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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2010 by Heidelberg University.
Recruitment status was:  Recruiting
Information provided by:
Heidelberg University Identifier:
First received: October 15, 2007
Last updated: January 26, 2010
Last verified: January 2010
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
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

Further study details as provided by Heidelberg University:

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

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

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00544583

Contact: Nuh N Rahbari, MD +49 6221 56 39448
Contact: Sabine - Voß, MD +49 6221 56 6986

Department of Surgery Recruiting
Heidelberg, Germany, 69120
Contact: Nuh N Rahbari, MD    + 49 6221 56 39448   
Contact: SDGC Heidelberg    +49 6221 56 6986   
Sponsors and Collaborators
Heidelberg University
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: University of Heidelberg, Germany, Department of General, Visceral and Transplantation Surgery Identifier: NCT00544583     History of Changes
Other Study ID Numbers: S206/2007
Study First Received: October 15, 2007
Last Updated: January 26, 2010

Keywords provided by Heidelberg University:
Abdominal wall

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes processed this record on August 18, 2017