Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT02229695
Status:
UNKNOWN
Last Update Posted:
2014-09-01
First Post:
2014-08-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension.
Sponsor:
Soroka University Medical Center
Organization:
Study Overview
Official Title:
The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.
Status:
UNKNOWN
Status Verified Date:
2014-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TACACS
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.
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: