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

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ClinicalTrials.gov Identifier: NCT01934283
Recruitment Status : Unknown
Verified August 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 4, 2013
Last Update Posted : September 4, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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.


Condition or disease Intervention/treatment Phase
Small Bowel Obstruction Device: urine folly catheter Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation
Study Start Date : October 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: operated patients
small bowel obstrucion patients who needed surgery for treatment of obstruction.
Device: urine folly catheter



Primary Outcome Measures :
  1. intra abdominal pressure [ Time Frame: up to 1 week ]
    serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT01934283


Contacts
Contact: ronen ghinea, MD 972544388990 rghinea@hotmail.com

Locations
Israel
Meir Medical Center Not yet recruiting
Kfar Saba, Israel
Contact: ronen ghinea, MD    972544388990    rghinea@hotmail.com   
Sponsors and Collaborators
Meir Medical Center

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01934283     History of Changes
Other Study ID Numbers: mmc-0188-12
First Posted: September 4, 2013    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases