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

Primary Purpose

Laparotomy, Hernia

Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Interrupted sutures
Continuous sutures
Sponsored by
Heidelberg University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparotomy focused on measuring Abdominal wall

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

A

B

Arm Description

Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm)

Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops)

Outcomes

Primary Outcome Measures

Incisional hernia or burst abdomen within 12 months

Secondary Outcome Measures

Quality of Life

Full Information

First Posted
October 15, 2007
Last Updated
January 26, 2010
Sponsor
Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT00544583
Brief Title
Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy
Acronym
CONTINT
Official Title
Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparotomy, Hernia
Keywords
Abdominal wall

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Active Comparator
Arm Description
Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm)
Arm Title
B
Arm Type
Experimental
Arm Description
Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops)
Intervention Type
Procedure
Intervention Name(s)
Interrupted sutures
Intervention Description
Interrupted sutures for abdominal fascia closure with Vicryl equivalent sutures (USP 2, 45 cm)
Intervention Type
Procedure
Intervention Name(s)
Continuous sutures
Intervention Description
Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops
Primary Outcome Measure Information:
Title
Incisional hernia or burst abdomen within 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Intraoperative inclusion criteria before closure: Successful source control Abdominal lavage Exclusion Criteria: Preoperative exclusion criteria: Participation in another intervention-trial with interference of intervention and outcome of this study Intraoperative exclusion criteria before closure: Planned re-laparotomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuh N Rahbari, MD
Phone
+49 6221 56 39448
Email
nuh.rahbari@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine - Voß, MD
Phone
+49 6221 56 6986
Email
sabine.voss@med.uni-heidelberg.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuh N Rahbari, MD
Organizational Affiliation
Department of Surgery, University of Heidelberg
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Markus W Büchler, MD
Organizational Affiliation
Department of Surgery, University of Heidelberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuh N Rahbari, MD
Phone
+ 49 6221 56 39448
Email
nuh.rahbari@med.uni-heidelberg.de
First Name & Middle Initial & Last Name & Degree
SDGC Heidelberg
Phone
+49 6221 56 6986
Email
sdgc@med.uni-heidelberg.de

12. IPD Sharing Statement

Citations:
PubMed Identifier
22647387
Citation
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.
Results Reference
derived

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Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy

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