NCT04739579

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 27, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 28, 2021

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

5 days

First QC Date

January 28, 2021

Last Update Submit

June 30, 2021

Conditions

Crohn Disease

Keywords

Crohn DiseaseAnastomotic LeakC-Reactive Protein

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Anastomotic Leak

Diagnostic Test: C-Reactive Protein

Non-Anatomotic Leak

Diagnostic Test: C-Reactive Protein

Interventions

C-Reactive ProteinDIAGNOSTIC_TEST

C-Reactive Protein trend in post-operative course

Anastomotic LeakNon-Anatomotic Leak

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing ileocolic resection with primary anastomosis

You may qualify if:

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

You may not qualify if:

  • Protective stoma
  • Associated resection with or without anastomosis during intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Nancy

Nancy, France

Location

MeSH Terms

Conditions

Crohn DiseaseAnastomotic Leak

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Adeline Germain, MD, PhD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 28, 2021

First Posted

February 4, 2021

Study Start

January 27, 2021

Primary Completion

February 1, 2021

Study Completion

March 1, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations

FR(1)