Abdominal Compartment Syndrome Clinical Trial
Official title:
The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.
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.
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 <150 torr, hypotension (<90
mmHg systolic pressure not due to hemorrhagic, septic, or neurogenic causes), renal
dysfunction (urine output, <30 mL/hr), and a clinically determined rigid, tense abdomen, and
increased abdominal circumference.
The following data will be recorded. Hemodynamics (mean arterial pressure, heart rate),
lactate, PaO2, partial carbonic dioxide pressure (PaCO2), tidal volume, peak airway
pressure) and renal (urine output) functions will be registered at 24 and 48 hours following
surgery).
Data on the indication for operation, type of trauma, its severity and the operative
procedures.
Acute Physiologic and Chronic Health Evaluation II (APACHE II) and fluid balance at 24 and
48 hours.
Reoperations. Time in ICU and time to final abdominal closure.
Study population:
All patients with severe abdominal trauma or none traumatic acute abdomen, that at the end
of operation the surgeon will decide to use temporary abdominal closure (TAC).
Inclusion Criteria Adults male or female over 18 years old. The surgeon decides the need for
TAC at the end of operation.
Exclusion Criteria Patients that the surgeon estimates they will not survive 24 hours.
End points:
Development of IAH Development of abdominal compartment syndrome (ACS) Need for reoperation
of decompressive laparotomy during first 48 hours. Time to final (on discharge from
hospital) abdominal closure and the type of closure.
Statistical methodology The calculated sample size based on power of 0.80, alpha 0.05, known
incidence of 0.25 and estimated incidence of 0.10 is 42 patients.
;
Observational Model: Cohort, Time Perspective: Prospective
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