Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 15, 2007
First Posted Date  ICMJE October 16, 2007
Last Update Posted Date January 27, 2010
Study Start Date  ICMJE November 2007
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Incisional hernia or burst abdomen within 12 months [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 15, 2007)
Frequency of burst abdomen and incisional hernia [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2009)
Quality of Life [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy
Official Title  ICMJE Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Laparotomy
  • Hernia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: A
    Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm)
    Intervention: Procedure: Interrupted sutures
  • Experimental: B
    Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops)
    Intervention: Procedure: Continuous sutures
Publications * Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic AL, Stern J, Diener MK, Voss S, Rossion I, Büchler MW, Seiler CM. Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial [NCT00544583]. Trials. 2012 May 30;13:72. doi: 10.1186/1745-6215-13-72.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
80
Original Estimated Enrollment  ICMJE
 (submitted: October 15, 2007)
60
Estimated Study Completion Date  ICMJE April 2012
Estimated Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00544583
Other Study ID Numbers  ICMJE S206/2007
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Heidelberg, Germany, Department of General, Visceral and Transplantation Surgery
Study Sponsor  ICMJE Heidelberg University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Nuh N Rahbari, MD Department of Surgery, University of Heidelberg
Principal Investigator: Markus W Büchler, MD Department of Surgery, University of Heidelberg
PRS Account Heidelberg University
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP