The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 42
- Primary Endpoint
- Intra abdominal hypertension
Study Overview
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:
- Vacuum-assisted closure (VAC)
- "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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Intra abdominal hypertension
Time Frame: 48 hours
measured via a Foley catheter
Secondary Outcomes
- Abdominal compartment syndrome(48 hours)
Investigators
Gad Shaked MD
Professor
Soroka University Medical Center