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
1 other identifier
observational
279
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2021
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2022
CompletedFirst Submitted
Initial submission to the registry
August 20, 2022
CompletedFirst Posted
Study publicly available on registry
August 26, 2022
CompletedAugust 26, 2022
August 1, 2022
3 months
August 20, 2022
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
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.
Eligibility Criteria
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.
You may qualify if:
- all the consecutive patients admitted for initial non-surgical management for aSBO
You may not qualify if:
- the cause of SBO was functional or other than adhesive
- patients requiring initial surgical management.
- absence of computed tomography performed at admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
university hospital of Angers
Angers, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2022
First Posted
August 26, 2022
Study Start
September 15, 2021
Primary Completion
December 15, 2021
Study Completion
January 15, 2022
Last Updated
August 26, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share