Crohn's DiseaseNCT02578576
The Diagnostic Methods of Early Postoperative Flare-up of Crohn's Disease
An observational study of Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 17 to 75 years
- Conditions the study is for
- Crohn's Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients with Crohn's disease
Who may be able to join
- patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
General Surgery Institute,Jinling Hospital,Nanjing,Jiangsu,China
Nanjing, Jiangsu, 210000
About this study
Official title: The Diagnostic Methods of Crohn's Disease Flare-up Within One Month After Resection
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.
- Conditions
- Crohn's Disease
- Keywords
- Diagnostic Techniques, Digestive System
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
flare-up confirmed by coloscopy
Measured: one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jinling Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhu Weiming, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02578576
- Sponsor's protocol ID
- DoEPR
- Status last verified
- Oct 2015
- First submitted
- 15 Oct 2015
- Last updated
- 19 Oct 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Diagnostic Methods of Crohn's Disease Flare-up Within One Month After Resection
- ClinicalTrials.gov ID
- NCT02578576
- Acronym / sponsor ID
- DoEPR
- Conditions
- Crohn's Disease
- Keywords
- Diagnostic Techniques, Digestive System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Jinling Hospital, ChinaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2017 (estimated)
- First posted
- 19 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 17 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients with Crohn's disease
Key inclusion criteria (1 listed)
- patients undergoing intestinal resection of all macroscopic disease, with an endoscopically accessible anastomosis,
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
flare-up confirmed by coloscopy
Time frame: one month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Jinling Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
flare-up confirmed by coloscopy (time frame: one month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2015.