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Clinical Trials/NCT00544583
NCT00544583UnknownPhase 2

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

Heidelberg University2 sites in 1 country80 target enrollmentStarted: November 2007Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Enrollment
80
Locations
2
Primary Endpoint
Incisional hernia or burst abdomen within 12 months

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incisional hernia or burst abdomen within 12 months

Time Frame: 12 months

Secondary Outcomes

  • Quality of Life(12 months)

Investigators

Sponsor Class
Other

Study Sites (2)

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