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

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

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

Study Overview

• Status: Unknown
• Conditions: Hernia; Laparotomy
• Intervention / Treatment: Procedure: Interrupted sutures; Procedure: Continuous sutures

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: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany, 69120
    • Recruiting
    • Department of Surgery
    • Contact: Nuh N Rahbari, MD; Phone Number: + 49 6221 56 39448; Email: nuh.rahbari@med.uni-heidelberg.de
    • Contact: SDGC Heidelberg; Phone Number: +49 6221 56 6986; Email: sdgc@med.uni-heidelberg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incisional hernia or burst abdomen within 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Quality of Life	12 months

Collaborators and Investigators

• Sponsor: Heidelberg University
• 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

Publications and helpful links

General Publications

• Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic AL, Stern J, Diener MK, Voss S, Rossion I, Buchler 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Anticipated): April 1, 2011
• Study Completion (Anticipated): April 1, 2012

Study Registration Dates

• First Submitted: October 15, 2007
• First Submitted That Met QC Criteria: October 15, 2007
• First Posted (Estimate): October 16, 2007

Study Record Updates

• Last Update Posted (Estimate): January 27, 2010
• Last Update Submitted That Met QC Criteria: January 26, 2010
• Last Verified: January 1, 2010

More Information

Terms related to this study

• Keywords: Abdominal wall
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: S206/2007