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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03185624 |
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Date of registration:
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11/06/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effectiveness of Rifaximin on Preventing Postoperative Recurrence in Crohn's Disease
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Scientific title:
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Effectiveness of Rifaximin on Preventing Postoperative Endoscopic Recurrence in Crohn's Disease Patients Without Risk Factor for Recurrence: A Multicenter Randomized Controlled Trial |
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Date of first enrolment:
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July 25, 2017 |
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Target sample size:
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80 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03185624 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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China
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Contacts
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Name:
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Xiang Gao, MD, PhD |
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Address:
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Telephone:
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020-38663423 |
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Email:
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gaoxiangmed@163.com |
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Affiliation:
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Name:
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Xiang Gao, MD, PhD |
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Address:
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Telephone:
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020-38663423 |
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Email:
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gaoxiangmed@163.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Consecutive patients with Crohn's disease undergoing intestinal resection of all
macroscopic diseased bowel, with an endoscopically accessible ileocolic anastomosis;
2. Enrolled patients without risk factor for the development of postoperative recurrence
including penetrating disease behaviour, prior bowel resection, and active smoking.
Exclusion Criteria:
1. Severe comorbidities;
2. With a stoma;
3. With malignancy;
4. Pregnancy;
5. With contraindication of using rifaximin.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn Disease
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Intervention(s)
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Drug: Rifaximin
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Primary Outcome(s)
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difference of incidence of endoscopic recurrence
[Time Frame: 6 months after surgery]
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Secondary Outcome(s)
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Adverse effect
[Time Frame: 6 months after surgery]
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Secondary ID(s)
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2017-ZSLY-07
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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