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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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ChiCTR |
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Last refreshed on:
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11 June 2019 |
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Main ID: |
ChiCTR1900023696 |
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Date of registration:
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2019-06-08 |
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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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Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial
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Scientific title:
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Endoscopic balloon dilatation combined with local betamethasone injection to prevent recurrence of anastomotic stenosis after ileocolic resection for Crohn's disease: a single-center prospective randomized controlled trial |
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Date of first enrolment:
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2019-07-01 |
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Target sample size:
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Group 1:45;Group 2:45; |
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Recruitment status: |
Pending |
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URL:
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http://www.chictr.org.cn/showproj.aspx?proj=39458 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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N/A
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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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Sun Jiachen
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Address:
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26 Erheng Road, Yuancun, Tianhe District, Guangzhou, Guangdong, China
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Telephone:
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+86 17876767620 |
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Email:
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sjc211@126.com |
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Affiliation:
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The Sixth Affiliated Hospital of Sun Yat-sen University |
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Name:
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Chen Junrong
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Address:
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26 Erheng Road, Yuancun, Tianhe District, Guangzhou, Guangdong, China
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Telephone:
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+86 15918779711 |
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Email:
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chenjunrong1985@126.com |
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Affiliation:
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The Sixth Affiliated Hospital of Sun Yat-sen University |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Aged 18 to 75 years old;
2. Confirmation of Crohn's disease;
3. After ileocolic resection, conventional endoscopy could not pass through the anastomotic stoma smoothly, and the Rutgeerts score of enteroscopy was less than i2;
4. There are clinical symptoms of proximal ileus after ileocolic resection;
5. Imaging findings showed that the proximal intestinal dilatation of the anastomotic stoma was more than 3 cm after ileocolic resection;
6. If there is intestinal fistula, the distance between the stricture and intestinal fistula is more than 5 cm.
Exclusion criteria: 1. Severe coexistence diseases;
2. Malignant tumors;
3. Pregnancy or recent pregnancy intention;
4. Endoscopic contraindications;
5. contraindication of betamethasone injection.
Age minimum:
18
Age maximum:
75
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chron's disease
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Intervention(s)
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Group 1:EBD;Group 2:EBD combined with local injection of betamethasone;
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Primary Outcome(s)
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Relapse rate;
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Source(s) of Monetary Support
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self-finance
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Ethics review
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Status: Approved
Approval date:
Contact:
Huang Ling
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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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