Clinical Trial: The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Observational

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

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 Summary:

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.

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

  1. VAC closure
  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 GICU. It will be carried out by a nurse who will be blinded as to the type of the abdominal closure.

Patients will be evaluated for the development of acute and significant respiratory compromise, including an elevated inspiratory pressure of >35 mbar and a decreased partial oxygen pressure / fraction of inspired oxygen (PaO2/FIO2) of &
Sponsor: Soroka University Medical Center

Current Primary Outcome: Intra abdominal hypertension [ Time Frame: 48 hours ]

measured via a Foley catheter


Original Primary Outcome: Same as current

Current Secondary Outcome: Abdominal compartment syndrome [ Time Frame: 48 hours ]

According to clinical signs (hypotension, increased inspiratory pressure, decreased urinary output).


Original Secondary Outcome: Same as current

Information By: Soroka University Medical Center

Dates:
Date Received: August 28, 2014
Date Started: October 2014
Date Completion: December 2016
Last Updated: August 28, 2014
Last Verified: August 2014