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

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ClinicalTrials.gov Identifier: NCT02229695
Recruitment Status : Unknown
Verified August 2014 by Gad Shaked MD, Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2014
Last Update Posted : September 1, 2014
Sponsor:
Information provided by (Responsible Party):
Gad Shaked MD, Soroka University Medical Center

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.


Condition or disease
Intra Abdominal Hypertension Abdominal Compartment Syndrome

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Different Types of Temporary Abdominal Closure on Intra Abdominal Hypertension and Abdominal Compartment Syndrome.
Study Start Date : October 2014
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Intra abdominal hypertension [ Time Frame: 48 hours ]
    measured via a Foley catheter


Secondary Outcome Measures :
  1. Abdominal compartment syndrome [ Time Frame: 48 hours ]
    According to clinical signs (hypotension, increased inspiratory pressure, decreased urinary output).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02229695


Contacts
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Contact: Gad Shaked shakedg@bgu.ac.il

Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Gad Shaked, Prof. Soroka University Medical Center

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Responsible Party: Gad Shaked MD, Professor, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02229695     History of Changes
Other Study ID Numbers: SOR-0167-14
First Posted: September 1, 2014    Key Record Dates
Last Update Posted: September 1, 2014
Last Verified: August 2014
Keywords provided by Gad Shaked MD, Soroka University Medical Center:
Trauma
Sepsis
Temporary abdominal closure
Bogota bag
Vacuum assisted closure
Additional relevant MeSH terms:
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Compartment Syndromes
Intra-Abdominal Hypertension
Hypertension
Syndrome
Disease
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Muscular Diseases
Musculoskeletal Diseases