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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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12 February 2024 |
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Main ID: |
NCT02851940 |
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Date of registration:
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26/07/2016 |
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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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Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids
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Scientific title:
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Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study |
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Date of first enrolment:
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September 2016 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02851940 |
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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: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Lebanon
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Contacts
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Name:
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Ala I Sharara, 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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American University of Beirut Medical Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age 18+
- Consent to the study
- Bleeding grade 1,2 and 3 hemorrhoids
Exclusion Criteria:
- Age under 18 years
- Refusal to sign consent
- Prior surgical and non surgical hemorrhoid procedure/manipulation
- External hemorrhoids
- Thrombosed hemorrhoids
- Active Anal Fissure
- Active anal fistula
- Immunocompromised
- Grade 4 internal hemorrhoids
- Chronic Pain requiring analgesics
- Antiplatelets and anticoagulation intake other than Aspirin
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hemorrhoids
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Bleeding
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Pain
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Intervention(s)
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Procedure: Hypertonic Saline Infusion
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Procedure: Rubber Band Ligation
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Primary Outcome(s)
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Composite Pain Score
[Time Frame: Day 7 after procedure]
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Composite Pain Score
[Time Frame: Days 0 after procedure]
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Composite Pain Score
[Time Frame: Day 3 after procedure]
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Secondary Outcome(s)
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Pain
[Time Frame: week 1-week 7 post procedure, 3 months, 6 months]
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Pain Medication Usage
[Time Frame: Days 1 to 7 after the procedure]
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Bleeding
[Time Frame: Days 1 to 7 after the procedure]
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Bleeding
[Time Frame: week 1-week 7 post procedure, 3 months, 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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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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