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

This study is not yet open for participant recruitment.
Verified August 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01934283
First received: February 27, 2013
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

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 Intervention
Small Bowel Obstruction
Device: urine folly catheter

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Intrabdominal Pressure in Small Bowel Obstruction as a Possible Predictor for the Need of Operation

Resource links provided by NLM:


Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • intra abdominal pressure [ Time Frame: up to 1 week ] [ Designated as safety issue: No ]
    serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation.


Estimated Enrollment: 125
Study Start Date: October 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: operated patients
small bowel obstrucion patients who needed surgery for treatment of obstruction.
Device: urine folly catheter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01934283     History of Changes
Other Study ID Numbers: mmc-0188-12
Study First Received: February 27, 2013
Last Updated: August 29, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on April 21, 2014