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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: |
NCT00927849 |
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Date of registration:
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23/03/2009 |
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Primary sponsor: |
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Public title:
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Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy
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Scientific title:
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Idiopathic Hypertensive Anal Canal: a Place of Internal Sphincterotomy |
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Date of first enrolment:
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September 2002 |
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Target sample size:
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63 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00927849 |
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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: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Countries of recruitment
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Egypt
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Contacts
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Name:
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ayman elnakeeb, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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mansoura university hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- all patients with hypertensive anal canal
Exclusion Criteria:
- patients who had any pathological anorectal lesions such as anal fissure, piles,
rectal prolapse, intussusception, anismus, cancer, patients with normal anal pressure
- patients who previously had anorectal surgery, chemical or surgical sphincterotomy,
anal dilatation, IBD, venereal disease, neurological disorder or systemic
gastrointestinal disease
Age minimum:
18 Years
Age maximum:
61 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertensive Anal Canal
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Intervention(s)
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Drug: botulinum toxin injection (BTX A)
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Drug: Glycerin trinitrate (GTN)
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Procedure: lateral internal sphincterotomy (LIS)
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Primary Outcome(s)
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Effect of Closed Lateral Sphincterotomy and Chemical Sphincterotomy on Hypertensive Anal Canal
[Time Frame: one year]
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Relieve of Anal Pain
[Time Frame: one year after the procedure]
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Secondary ID(s)
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hypertensive anal canal
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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