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

• Conditions: Crohn's Disease

• Registration Number: NCT02578576
• Lead Sponsor: Jinling Hospital, China

Brief 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.

Detailed Description

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

Study Timeline

• Status Verified: 2015-10
• Study First Submitted: 2015-10-15
• Study First Submitted QC: 2015-10-16
• Last Update Submitted: 2015-10-16
• Study First Posted: 2015-10-19
• Last Update Posted: 2015-10-19
• Study Start: 2015-12
• Primary Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
flare-up confirmed by coloscopy	one month after surgery

Trial Locations

Locations (1)

General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China; 🇨🇳 Nanjing, Jiangsu, China