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

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.

Study Overview

• Status: Unknown
• Conditions: Abdominal Compartment Syndrome; Intra Abdominal Hypertension

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.

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.

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients that undergo emergent laparotomy for trauma or non-traumatic surgical emergency condition, and that according to the surgeon decision get their abdominal wall closed by a temporary closure technique.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra abdominal hypertension	measured via a Foley catheter	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Abdominal compartment syndrome	According to clinical signs (hypotension, increased inspiratory pressure, decreased urinary output).	48 hours

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: Gad Shaked, Prof., Soroka university medical center

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (Estimate): September 1, 2014

Study Record Updates

• Last Update Posted (Estimate): September 1, 2014
• Last Update Submitted That Met QC Criteria: August 28, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: Sepsis; Trauma; Temporary abdominal closure; Bogota bag; Vacuum assisted closure
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease; Musculoskeletal Diseases; Muscular Diseases; Hypertension; Syndrome; Compartment Syndromes; Intra-Abdominal Hypertension
• Other Study ID Numbers: SOR-0167-14