Laparotomy Versus Percutaneous Puncture in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis

Mortality Clinical Trial

— DECOMPRESS  

Official title:

Decompressive Laparotomy With Temporary Abdominal Closure Versus Percutaneous Puncture With Placement of Abdominal Catheter in Patients With Abdominal Compartment Syndrome During Acute Pancreatitis:Multicenter, Randomised, Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00793715
• Other study ID #: H231
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2008
• Last updated: July 22, 2010
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: June 2010
• Source: University of Belgrade
• Contact: Ivana Teic, nurse
• Phone: +381 11 366 2266
• Email: ivanateic[@]yahoo.com
• Is FDA regulated: No
• Health authority: Serbia and Montenegro: Agency for Drugs and Medicinal Devices
• Study type: Interventional

Clinical Trial Summary

Decompressive laparotomy with temporary abdominal closure, will decrease of overall mortality and major morbidity in patients with abdominal compartment syndrome during acute pancreatitis in comparison with percutaneous puncture with placement of abdominal catheter.

Description:

We anticipated that decompressive laparotomy with temporary abdominal closure, beside all potentially negative side effects that early open surgery carries in patients with acute pancreatitis, results in decrease of overall mortality and major morbidity. The DECOMPRESS study is designed to compare effects of decompressive laparotomy with temporary abdominal closure and percutaneous puncture with placement of abdominal catheter in patients with abdominal compartment syndrome during acute pancreatitis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• The study population consists of patients with acute pancreatitis complicated with development of abdominal compartment syndrome.

Exclusion Criteria:

• Patients will not be enrolled to the study if any of the following criteria will be present:

• age < 18 and > 80 years

• recent surgical interventions

• psychoses

• pregnancy

• previously history of chronic pancreatitis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Pancreatitis
• Compartment Syndromes
• Intra-Abdominal Hypertension
• Mortality
• Pancreatitis

Intervention

Procedure:
• Decompressive laparotomy with temporary abdominal closure
Surgical intervention including midline incision with temporary abdominal closure and several planed staged relaparotomies
• Percutaneous puncture with placement of abdominal catheter
Installation of abdominal catheter percutaneously via abdominal centesis 2cm bellow the umbilicus

Locations

Country	Name	City	State
Serbia	Clinic for Emergency Surgery, Clinical Center of Serbia and School of Medicine, University of Belgrade	Belgrade
Serbia	Surgical Department, Clinical Center "Bezanijska Kosa" and School of Medicine, University of Belgrade	Belgrade
Serbia	Surgical Department, Clinical Center "Dr Dragisa Misovic," and School of Medicine, University of Belgrade,	Belgrade
Serbia	Surgical Department, Clinical Center "Zvezdara" and School of Medicine, University of Belgrade	Belgrade
Serbia	Surgical Department, Military-Medical Academy	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate during the hospital stay for patients with abdominal compartment syndrome during acute pancreatitis.		2 years	No
Secondary	duration time of organ failure		2 years	No
Secondary	development of a new organ failure		2 years	No
Secondary	number of infectious complications,		2 years	No
Secondary	needs for necrosectomy,		2 years	No
Secondary	intensive care stay		2 years	No
Secondary	total hospital stay		2 years	No