NCT01934283

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 4, 2013

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

February 27, 2013

Last Update Submit

August 29, 2013

Conditions

Small Bowel Obstruction

Outcome Measures

Primary Outcomes (1)

  • intra abdominal pressure

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

    up to 1 week

Study Arms (1)

operated patients

NO INTERVENTION

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

Device: urine folly catheter

Interventions

urine folly catheterDEVICE
operated patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 , diagnosis of small bowel obstruction

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, Israel

Location

Central Study Contacts

ronen ghinea, MD

CONTACT

972544388990rghinea@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

September 4, 2013

Study Start

October 1, 2013

Primary Completion

June 1, 2015

Study Completion

December 1, 2015

Last Updated

September 4, 2013

Record last verified: 2013-08

Locations

IL(1)