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

Abdominal Compartment Syndrome Clinical Trial

— TACACS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02229695
• Other study ID #: SOR-0167-14
• Status: Not yet recruiting
• Phase: N/A
• First received: August 28, 2014
• Last updated: August 28, 2014
• Start date: October 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2014
• Source: Soroka University Medical Center
• Contact: Gad Shaked
• Email: shakedg[@]bgu.ac.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Abdominal Compartment Syndrome
• Compartment Syndromes
• Hypertension
• Intra Abdominal Hypertension
• Intra-Abdominal Hypertension

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Soroka University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra abdominal hypertension	measured via a Foley catheter	48 hours	No
Secondary	Abdominal compartment syndrome	According to clinical signs (hypotension, increased inspiratory pressure, decreased urinary output).	48 hours	No