Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy

NCT ID: NCT00544583

Last Updated: 2010-01-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2012-04-30

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.

Conditions

Laparotomy; Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A

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

Group Type: ACTIVE_COMPARATOR

Interrupted sutures

Intervention Type: PROCEDURE

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

B

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

Group Type: EXPERIMENTAL

Continuous sutures

Intervention Type: PROCEDURE

Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops

Interventions

Interrupted sutures

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

Intervention Type: PROCEDURE

Continuous sutures

Continuous sutures for abdominal fascia closure with PDS II equivalent USP 1, 150 cm loops

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Successful source control
• Abdominal lavage

Exclusion Criteria

• Participation in another intervention-trial with interference of intervention and outcome of this study

• Planned re-laparotomy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heidelberg University

OTHER

Sponsor Role: lead

Responsible Party

Department of General, Visceral and Transplantation Surgery

Principal Investigators

Nuh N Rahbari, MD

Role: STUDY_DIRECTOR

Department of Surgery, University of Heidelberg

Markus W Büchler, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, University of Heidelberg

Locations

Department of Surgery

Heidelberg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Nuh N Rahbari, MD

Role: CONTACT

nuh.rahbari@med.uni-heidelberg.de

+49 6221 56 39448

Sabine - Voß, MD

Role: CONTACT

sabine.voss@med.uni-heidelberg.de

+49 6221 56 6986

Facility Contacts

Nuh N Rahbari, MD

Role: primary

nuh.rahbari@med.uni-heidelberg.de

+ 49 6221 56 39448

SDGC Heidelberg

Role: backup

sdgc@med.uni-heidelberg.de

+49 6221 56 6986

References

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.

Reference Type: DERIVED

PMID: 22647387 (View on PubMed)

Other Identifiers

S206/2007

Identifier Type: -

Identifier Source: org_study_id