NCT05517057

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

87
On Track

Trial Health Score

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

Enrollment
279

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 26, 2022

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

3 months

First QC Date

August 20, 2022

Last Update Submit

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

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

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

Location

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

Locations