Small Bowel ObstructionPREDIFAILNCT05517057
Radiologic Score and Failure of Conservative Management of Adhesive Small Bowel Obstruction
An observational study of Small Bowel Obstruction and Conservative Management, run by University Hospital, Angers at 1 site in France.
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%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction, Conservative Management, Imaging
- How many people
- 279 participants
- Where
- 1 siteFrance
- Study dates
- 15 Sep 2021to 15 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- all the consecutive patients admitted for initial non-surgical management for aSBO
- during the period of inclusion
Who cannot join
- the cause of SBO was functional or other than adhesive
- patients requiring initial surgical management.
- absence of computed tomography performed at admission
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Small Bowel Obstruction, Conservative Management, Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: immediately after the completion of the CT-scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start15 Sep 2021
- Primary completion15 Dec 2021
- Study completion15 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517057
- Sponsor's protocol ID
- 2021-099
- Acronym
- PREDIFAIL
- Status last verified
- Aug 2022
- First submitted
- 20 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05517057
- Acronym / sponsor ID
- PREDIFAIL / 2021-099
- Conditions
- Small Bowel Obstruction, Conservative Management, Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- all the consecutive patients admitted for initial non-surgical management for aSBO
- during the period of inclusion
Key exclusion criteria (3 listed)
- the cause of SBO was functional or other than adhesive
- patients requiring initial surgical management.
- absence of computed tomography performed at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Angers CT score
Time frame: immediately after the completion of the CT-scan
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Small Bowel Obstruction
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Management of Non Emergency Adhesive Small Bowel Obstruction:
SBO - Small Bowel Obstruction
RecruitingObservational study
Indiana University Gastrointestinal Motility Diagnosis Registry
Eosinophilic Esophagitis, Gastroesophageal Reflux Disease (GERD)
Recruiting
The Effect of Nasogastric Tube Placement on Complications in Patients With Small Bowel Obstruction - the SBO-TUBE Trial
Small Bowel Obstruction, Intestinal Obstruction and Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small Bowel Obstruction and Conservative Management, run by University Hospital, Angers at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angers CT score (time frame: immediately after the completion of the CT-scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.