Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction (PREDIFAIL)

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

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.

Study Overview

• Status: Completed
• Conditions: Small Bowel Obstruction; Imaging; Conservative Management

• Study Type: Observational
• Enrollment (Actual): 279

Contacts and Locations

Study Locations

• France
  • Angers, France
    • University Hospital of Angers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This was an observational multicentric cohort study including all the consecutive patients admitted for initial non-surgical management for aSBO. The study took place over a period of 3 months (September 15 - December 15, 2021) in 15 French centers.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
success of the medical management; Patients that recovered flatus and stools, and that tolerated solid food within the 3 days after the admission
failure of the medical management; Patients that did not recover flatus and stools, and that did not tolerate solid food within the 3 days after the admission. These patients had an indication for surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Angers

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2021
• Primary Completion (ACTUAL): December 15, 2021
• Study Completion (ACTUAL): January 15, 2022

Study Registration Dates

• First Submitted: August 20, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (ACTUAL): August 26, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction
• Other Study ID Numbers: 2021-099

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No