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Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00544583
Acronym
CONTINT
Enrollment
80
Registered
2007-10-16
Start date
2007-11-30
Completion date
2012-04-30
Last updated
2010-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Laparotomy

Keywords

Abdominal wall

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.

Interventions

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

PROCEDUREContinuous sutures

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

Sponsors

Heidelberg University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Incisional hernia or burst abdomen within 12 months12 months

Secondary

MeasureTime frame
Quality of Life12 months

Countries

Germany

Contacts

Primary ContactNuh N Rahbari, MD
nuh.rahbari@med.uni-heidelberg.de+49 6221 56 39448
Backup ContactSabine - Voß, MD
sabine.voss@med.uni-heidelberg.de+49 6221 56 6986

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026