Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction

Small Bowel Obstruction Clinical Trial

— PREDIFAIL  

Official title:

Assessment of a Predictive Radiologic Score to Predict the Failure of the Non-operative Management of Adhesive Small Bowel Obstruction: a Prospective Cohort Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517057
• Other study ID #: 2021-099
• Status: Completed
• Start date: September 15, 2021
• Est. completion date: January 15, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The management of acute adhesive small bowel obstruction remains challenging for the digestive surgeon. The Bologna guidelines recommend that conservative management of aSBO. The literature reports that this form of management has a failure rate between 10 and 40%.

A radiological score has been proposed and was associated with an increased risk of failure of conservative management.

This tool is promising to select patients further requiring surgery but it has to be assessed in a multi centric prospective cohort.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: January 15, 2022
• Est. primary completion date: December 15, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all the consecutive patients admitted for initial non-surgical management for aSBO

• during the period of inclusion

Exclusion Criteria:

• the cause of SBO was functional or other than adhesive

• patients requiring initial surgical management.

• absence of computed tomography performed at admission

Related Conditions & MeSH terms

• Imaging
• Intestinal Obstruction
• Small Bowel Obstruction

Locations

Country	Name	City	State
France	university hospital of Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angers CT score	The Angers CT score =5 was considered to be risk factor for failure of the medical management.; Angers CT score was calculated by reading the CT scan as follow: beak sign (+2), if not (0); closed loop (+4), if not (0); focal (+4) or diffuse (+4) intraperitoneal liquid, if not (0); focal (+2) or diffuse (0) mesenteric haziness, if not (0); focal (-3) or diffuse (-3) mesenteric liquid, if not (0); diameter of the most dilated small bowel loop > 40 mm (-2) (if not (0).	immediately after the completion of the CT-scan