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Clinical Trials/NCT02229695
NCT02229695UnknownNot Applicable

The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.

Soroka University Medical Center0 sites42 target enrollmentStarted: October 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
42
Primary Endpoint
Intra abdominal hypertension

Study Overview

Brief Summary

This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.

Patients will be grouped according to the method of temporarily abdominal closure (TAC) procedure:

  1. Vacuum-assisted closure (VAC)
  2. "Bogota bag" (BB), a sterile intravenous bag silo closure. The two methods are currently accepted with no clear cut evidence to prefer one on another. At Soroka Medical Center the decision to choose either of the methods is at the surgeon's discretion.

Intra-abdominal pressure will be measured in all patients by the urinary bladder pressure technique at 6 12 24 ant 48 hours post operation. The measurement is a routine procedure done as part of the monitoring processes of critically ill patients in the General Intensive Care Unit (GICU).

Patients will be evaluated for the development of acute intra abdominal hypertension with or without abdominal compartment syndrome.

Detailed Description

Comparison of intra-Abdominal hypertension development after bogota bag or VAC abdominal closure Protocol

Trial objective:

To investigate and compare in a standardized manner the development of intra-abdominal hypertension (IAH) following VAC closure and "Bogota bag".

Study design:

This is a prospective comparison trial. Patients that will be included in the trial are those that will have operations in which their abdominal closure is temporary, i.e. patients sustaining trauma or septic abdomen.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adults male or female over 18 year old undergoing emergency laparotomy. Patients that have their abdominal wall closed at the end of surgery by a temporary closure technique.

Exclusion Criteria

  • Patients that according to the surgeon estimates will not survive 24 hours.

Outcomes

Primary Outcomes

Intra abdominal hypertension

Time Frame: 48 hours

measured via a Foley catheter

Secondary Outcomes

  • Abdominal compartment syndrome(48 hours)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gad Shaked MD

Professor

Soroka University Medical Center

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