Clinical trial NCT00544583: Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy
Official title: Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy: CONTINT - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Laparotomy
Hernia
Keywords: Abdominal wall
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2007-10-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incisional hernia or burst abdomen within 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Department of Surgery
Study officials:
affiliation: Department of Surgery, University of Heidelberg
name: Nuh N Rahbari, MD
role: STUDY_DIRECTOR
affiliation: Department of Surgery, University of Heidelberg
name: Markus W Büchler, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.