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Status unknownNCT02578576Updated Oct 19, 2015

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

An observational study in Crohn's Disease, sponsored by Jinling Hospital, China. Status unknown at 1 site in China. Open to participants aged 17 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-10-19.

Sponsored by Jinling Hospital, China · Observational

The sponsor has not verified this record recently (last verified Oct 2015), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
300
Ages
17 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed description

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

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Conditions studied

  • Crohn's Disease

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Keywords

  • Diagnostic Techniques
  • Digestive System
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In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

This study's planned enrollment of 300 is above the median of 162 across 608 observational studies indexed under Crohn Disease.

Browse Crohn Disease studies →

Lead sponsor

Jinling Hospital, China is the lead sponsor of 126 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
17 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients with Crohn's disease

Inclusion criteria

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

Exclusion criteria

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
300 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. flare-up confirmed by coloscopy

    Time frame: one month after surgery

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Study locations

1 site
  • General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
    Nanjing, Jiangsu 210000, China
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02578576
Lead sponsor
Jinling Hospital, China
Responsible party
Zhu Weiming (Professor, Jinling Hospital, China) — Principal investigator
First posted
Oct 19, 2015
Start date
Dec 2015
Primary completion
Dec 2017 (estimated)
Last update
Oct 19, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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