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Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation

Primary Purpose

Small Bowel Obstruction

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
urine folly catheter
Sponsored by
Meir Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Small Bowel Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • older than 18 , diagnosis of small bowel obstruction

Exclusion Criteria:

  • younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia

Sites / Locations

  • Meir Medical Center

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

operated patients

Arm Description

small bowel obstrucion patients who needed surgery for treatment of obstruction.

Outcomes

Primary Outcome Measures

intra abdominal pressure
serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation.

Secondary Outcome Measures

Full Information

First Posted
February 27, 2013
Last Updated
August 29, 2013
Sponsor
Meir Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01934283
Brief Title
Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
Official Title
Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Small bowel obstruction (SBO) is a common surgical diagnosis. Most of SBO are related to post operative adhesions and most of them resolve without the need of surgical intervention. The most important thing dealing with SBO is to identify the more complex obstructions that need surgery. Some clinical, physiological and radiological signs are recognized as markers of a more complex obstruction. The pathophysiology of bowel obstruction is explained as damage created by pressure on the abdominal wall causing ischemia. Yet there are no studies, as far as we know, that measure intra-abdominal pressure in SBO patients and it relation to the severity of the obstruction. In this study we will measure the intra-abdominal pressure in SBO patients systematically and we will examine if more severe obstructions are accompanied by elevated intra-abdominal pressure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small Bowel Obstruction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
operated patients
Arm Type
No Intervention
Arm Description
small bowel obstrucion patients who needed surgery for treatment of obstruction.
Intervention Type
Device
Intervention Name(s)
urine folly catheter
Primary Outcome Measure Information:
Title
intra abdominal pressure
Description
serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation.
Time Frame
up to 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: older than 18 , diagnosis of small bowel obstruction Exclusion Criteria: younger then 18 , pregnant women, large bowel obstruction, incarcerated hernia, large ventral hernia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ronen ghinea, MD
Phone
972544388990
Email
rghinea@hotmail.com
Facility Information:
Facility Name
Meir Medical Center
City
Kfar Saba
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ronen ghinea, MD
Phone
972544388990
Email
rghinea@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation

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