## Protocol Section
### Identification Module
**NCT ID:** NCT04739579

**Brief Title:** Post-operative CRP Trend After Ileocolic Resection in Crohn's Disease Patients.

**Official Title:** Post-operative CRP Trend May Lead to Early Diagnosis of Anastomotic Leak After Ileocolic Resection in Crohn's Disease Patients.

#### Organization Study ID Info
**ID:** 2020PI287
#### Organization
**Class:** OTHER
**Full Name:** Central Hospital, Nancy, France
### Status Module
#### Completion Date
**Date:** 2021-03-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-07-01

**Type:** ACTUAL

**Last Update Submit Date:** 2021-06-30

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2021-02-01

**Type:** ACTUAL

#### Start Date
**Date:** 2021-01-27

**Type:** ACTUAL

**Status Verified Date:** 2021-06

#### Study First Post Date
**Date:** 2021-02-04
**Type:** ACTUAL
**Study First Submit Date:** 2021-01-28
**Study First Submit QC Date:** 2021-02-01
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Central Hospital, Nancy, France

#### Responsible Party

**Investigator Affiliation:** Central Hospital, Nancy, France

**Investigator Full Name:** ADELINE GERMAIN

**Investigator Title:** Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### 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.

### Conditions Module

**Conditions:**

- Crohn Disease

**Keywords:**

- Crohn Disease

- Anastomotic Leak

- C-Reactive Protein

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 59

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Diagnostic Test: C-Reactive Protein

**Label:** Anastomotic Leak

#### Arm Group 2

**Intervention Names:**

- Diagnostic Test: C-Reactive Protein

**Label:** Non-Anatomotic Leak

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Anastomotic Leak

- Non-Anatomotic Leak

**Description:** C-Reactive Protein trend in post-operative course

**Name:** C-Reactive Protein

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** Presence of a collection in the area of the anastomosis on computed tomography scan or evident anastomotic dehiscence at reoperation for peritonitis.

**Measure:** Anastomotic leak

**Time Frame:** up to 30 days following surgery

### 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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients undergoing ileocolic resection with primary anastomosis

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Nancy

**Country:** France

**Facility:** CHRU de Nancy

#### Overall Officials

**Official 1:**

**Affiliation:** Central Hospital, Nancy, France

**Name:** Adeline Germain, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000015212

- Term: Inflammatory Bowel Diseases

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000011183

- Term: Postoperative Complications

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6638

- Name: Crohn Disease

- Relevance: HIGH

- As Found: Crohn's Disease

- ID: M28891

- Name: Anastomotic Leak

- Relevance: HIGH

- As Found: Anastomotic Leak

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14065

- Name: Postoperative Complications

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003424

- Term: Crohn Disease

- ID: D000057868

- Term: Anastomotic Leak

### Misc Info Module

- Version Holder: 2024-05-24
