Assessment of a Composite Prognostic Score to Predict Sev... | NCT04662268

Studies
Assessment of a Composite Prognostic Score to Predict Severe Forms of Ischemic Colitis

NCT04662268

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Dec 10, 2020Actual

Enrollment

206Actual

Phase

Not provided

Conditions

Ischemic Colitis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2014Actual

Primary Completion Date

Nov 1, 2020Actual

Completion Date

Nov 30, 2020Actual

First Submitted Date

Dec 3, 2020

First Submission Date that Met QC Criteria

Dec 3, 2020

First Posted Date

Dec 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2020

Last Update Posted Date

Dec 10, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Our objective is to determine a prognostic score including CT, clinical and biological criteria predicting the serious (death / surgery) or non-serious (medical treatment) evolution of ischemic colitis and therefore possibly modify the therapeutic management (propose surgical treatment for a severe form based on prognostic score).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

206Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication rate of ischemic colitis	Severe (surgery and/or death) or non severe form of ischemic colitis (medical treatment) : analysis of radiological, biological and clinical data is performed at the time of acute episode of ischemic colitis when the patient is admitted to the hospital or during the stay of the patient previously present in the hospital for another condition	1 day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Age > or = at 18 years old;
Performing an abdomino-pelvic scan injected within 6 hours of the onset of symptoms;
Ischemic colitis proven by endoscopy or surgical data.

Exclusion criteria:

CT scan performed without injection and / or after 6 hours following the onset of symptoms;
Unproven ischemic colitis.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Single-center retrospective cohort (center: CHU de Montpellier) of patients admitted between january 2014 and december 2019 at the CHU, over 18 years of age and having presented ischemic colitis during their stay, with completion of an injected abdomino-pelvic scanner within 6 hours of onset of symptoms, then proven by surgery or endoscopy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Patrice TAOUREL, MD-PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017091	Colitis, Ischemic

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided