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

NCT ID: NCT02578576

Last Updated: 2015-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Brief Summary

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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

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

Conditions

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Crohn's Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with flare-up

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

No interventions assigned to this group

patients without flare-up

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jinling Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Zhu Weiming

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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DoEPR

Identifier Type: -

Identifier Source: org_study_id

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