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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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ISRCTN |
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Last refreshed on:
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17 August 2021 |
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Main ID: |
ISRCTN60893979 |
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Date of registration:
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24/09/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Unilateral versus bilateral internal sphincterotomy: a randomised controlled trial for chronic fissure-in-ano
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Scientific title:
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Unilateral versus bilateral internal sphincterotomy: a randomised controlled trial for chronic fissure-in-ano |
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Date of first enrolment:
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01/01/2004 |
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Target sample size:
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200 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN60893979 |
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Study type:
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Interventional |
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Study design:
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Randomised, active controlled trial. Randomisation performed by sealed envelope method. (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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India
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Aswini
Pujahari |
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Address:
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PG Department of Surgery
Command Hospital Air Force Bangalore (CHAFB)
560007
Bangalore
India |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Disease over one year
2. Aged more than 18 years
Exclusion criteria:
1. Oral medication with nitrates, calcium channel blocker
2. Past ano-rectal surgery
3. Elderly lady with old perineal tear
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Chronic fissure-in-ano
Digestive System
Chronic anal fissure
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Intervention(s)
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Group A (active control): single internal lateral sphinterotomy
Group B: (new treatment): double internal lateral sphinterotomy
A minimum follow up of 6 months.
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Primary Outcome(s)
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1. Post-operative pain
2. Recurrences
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Secondary Outcome(s)
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1. Healing of fissure, measured at 3 to 6 months
2. Incontinence to flatuous and faecal matter, measured from the date of surgery until 6 months in the form of use of pad, soiling of undergarment
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Source(s) of Monetary Support
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Investigator initiated and funded (India)
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Ethics review
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Status:
Approval date:
Contact:
Ethics approval received from the Medical Research Committee of the Armed Forces Medical College (AFMC), Pune, India on the 26th December 2003 (ref: 2248/AFMRC/EC).
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/08/2006 |
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URL:
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