Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy

Phase 2

• Conditions: Laparotomy; Hernia
• Interventions: Procedure: Interrupted sutures; Procedure: Continuous sutures

• Registration Number: NCT00544583
• Lead Sponsor: Heidelberg University

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 Timeline

• Study First Submitted: 2007-10-15
• Study First Submitted QC: 2007-10-15
• Study First Posted: 2007-10-16
• Study Start: 2007-11
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-26
• Last Update Posted: 2010-01-27
• Primary Completion: 2011-04
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Interrupted sutures	Interrupted closure with Vicryl equivalent sutures (USP 2, 45 cm)
B	Continuous sutures	Continuous closure with PDS II equivalent sutures (USP 1, 150 cm loops)

Primary Outcome Measures

Name	Time	Method
Incisional hernia or burst abdomen within 12 months	12 months

Secondary Outcome Measures

Name	Time	Method
Quality of Life	12 months

Trial Locations

Locations (1)

Department of Surgery; 🇩🇪 Heidelberg, Germany