Post-operative CRP Trend After Ileocolic Resection in Cro... | NCT04739579

Studies
Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.

NCT04739579

Sponsor

Central Hospital, Nancy, France

Status

Completed

Last Update Posted

Jul 1, 2021Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Crohn Disease

Interventions

C-Reactive Protein

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

Jun 2021

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 27, 2021Actual

Primary Completion Date

Feb 1, 2021Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Jan 28, 2021

First Submission Date that Met QC Criteria

Feb 1, 2021

First Posted Date

Feb 4, 2021Actual

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

Jun 30, 2021

Last Update Posted Date

Jul 1, 2021Actual

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 aim is to analyze C-Reactive Protein trends during the post-operative course in Crohn's Disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.

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

59Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Anastomotic Leak			Diagnostic Test: C-Reactive Protein
Non-Anatomotic Leak			Diagnostic Test: C-Reactive Protein

Interventions

Name	Type	Description	Arm Group Labels	Other Names
C-Reactive Protein	Diagnostic Test	C-Reactive Protein trend in post-operative course	Anastomotic Leak Non-Anatomotic Leak

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anastomotic leak	Presence of a collection in the area of the anastomosis on computed tomography scan or evident anastomotic dehiscence at reoperation for peritonitis.	up to 30 days following surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Crohn's disease patients
Primary ileocolic anastomosis
C-Reactive Protein data available in medical file

Exclusion Criteria:

Protective stoma
Associated resection with or without anastomosis during intervention

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

Patients undergoing ileocolic resection with primary anastomosis

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adeline Germain, MD, PhD	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Nancy		Nancy			France

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D057868	Anastomotic Leak

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided