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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00725244 |
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Date of registration:
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28/07/2008 |
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Primary sponsor: |
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Public title:
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Trial of Endoscopy Bipolar and Argon of Chronic Rectal Bleeding From Radiation Telangiectasias
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Scientific title:
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A Randomized Prospective Study of Endoscopy Bipolar Eletrocoagulation and Argon Plasma Coagulation of Chronic Rectal Bleeding From Radiation Telangiectasias |
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Date of first enrolment:
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May 2005 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00725244 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Angelo Ferrari, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of São Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- active (at least one episode last week) and chronic (persist or appear 6 months after
the conclusion of radiotherapy) rectal bleeding.
- previous radiotherapy at least 6 months ago
- presence of colonic or rectal telangiectasias
- patients that agreed to participate of the study and signed the Term of Free Consent
and Cleared
Exclusion Criteria:
- prior endoscopic treatment
- rectal or colonic surgery
- stenosis rectal
- rectal bleeding before radiotherapy
- severe cardiac disease
Age minimum:
18 Years
Age maximum:
88 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Radiation Injuries
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Telangiectasis
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Intervention(s)
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Device: Argon Plasma Coagulation
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Device: Bipolar eletrocoagulation
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Primary Outcome(s)
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Improve of rectal bleeding
[Time Frame: 6 months]
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Secondary Outcome(s)
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Complications of each group
[Time Frame: 6 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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