The Diagnostic Methods of Early Postoperative Flare-up of Crohn's Disease

Crohn's Disease Clinical Trial

Official title:

The Diagnostic Methods of Crohn's Disease Flare-up Within One Month After Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02578576
• Other study ID #: DoEPR
• Status: Not yet recruiting
• Phase: N/A
• First received: October 15, 2015
• Last updated: October 16, 2015
• Start date: December 2015

Study information

• Verified date: October 2015
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Jinling Hospital
• Study type: Observational

Clinical Trial Summary

Crohn's disease is a chronic inflammatory transmural bowel disorder characterized by high rate of postoperative anastomotic complications and recurrences. Surgery itself can influence immunologic function and trigger inflammatory response, which may result in the flare of Crohn's disease soon after surgery (within one month), especially near the anastomosis. Early flare-up of Crohn's disease can negatively impact the outcomes of operation. However, due to the the complexity of perioperative period and dangerous of invasive examine, it is difficult to distinguish disease flare from postoperative complications.

In this study, the investigators aim to development a diagnostic method of flare-up within one month after surgery, which can help us to detect and then treat disease flare in time.

Description:

HBI score, serum CRP, ESR, WBC, Hb, PLT, IL-6，PCT and fecal Calprotectin will be monitored within one month after resection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 75 Years

Eligibility

Inclusion Criteria:

• patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis,

Exclusion Criteria:

• patients have an anastomosis which is endoscopically inaccessible by standard colonoscopy;

• patients withs persisting macroscopic abnormality after surgical resection;

• patients with an end stoma (ileostomy or colostomy);

• patients are not suitable to undergo endoscopy because of co-morbidities or an unwell clinical state;

• patients who are unable to give informed consent;

• patients who are pregnant

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Locations

Country	Name	City	State
China	General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flare-up confirmed by coloscopy		one month after surgery	Yes