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

NCT02578576 | Unknown

• 1 other identifier: DoEPR
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn's Disease

Keywords

Diagnostic Techniques; Digestive System

Outcome Measures

Primary Outcomes (1)

• flare-up confirmed by coloscopy

  one month after surgery

Study Arms (2)

patients with flare-up

Disease flare-up is demonstrated by coloscopy at one month after resection.

patients without flare-up

No flare-up is found by coloscopy at one month after resection.

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with Crohn's disease

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jinling Hospital, China: lead

Study Sites (1)

General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 19, 2015
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Last Updated: October 19, 2015

Record last verified: 2015-10

Locations

CN (1)