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

Small Bowel Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01934283
• Other study ID #: mmc-0188-12
• Status: Not yet recruiting
• Phase: N/A
• First received: February 27, 2013
• Last updated: August 29, 2013
• Start date: October 2013
• Est. completion date: December 2015

Study information

• Verified date: August 2013
• Source: Meir Medical Center
• Contact: ronen ghinea, MD
• Phone: 972544388990
• Email: rghinea[@]hotmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 125
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Intestinal Obstruction
• Small Bowel Obstruction

Intervention

Device:
• urine folly catheter

Locations

Country	Name	City	State
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intra abdominal pressure	serial intraabdominal pressure will be measured during hospitalisation up to discharge or operation.	up to 1 week	No