hemorrhoids,hypertonic saline sclerotherapy,rubber band ligation
Safety and/or Efficacy Study
N/A: Not Applicable
Eligibility and IRB
This is a randomized prospective study conducted at the American University of Beirut Medical Center involving patients suffering from hemorrhoidal disease requiring therapeutic intervention.
Composite pain score from days 0 (day of procedure), day 3 and day 7 following procedure of either hypertonic saline sclerotherapy or rubber band ligation (primary objective)
Pain medication usage (secondary objective)
Bleeding during day 1 through 7 post procedure (secondary objective)
Bleeding and pain during long term follow up (week 1 through week 7 post procedure, month 3, and month 6) (secondary objective)
30 consecutive patients presenting to the private clinics for assessment of their hemorrhoidal disease and found to require therapeutic intervention will be enrolled in this study. Patients will be randomized to either hypertonic saline sclerotherapy or rubber band ligation for their hemorrhoidal disease.
Patients will be consecutively recruited from the private clinics following assessment of their hemorrhoidal disease and conclusion of their requirement of therapeutic intervention. Patients will be randomized to either Rubber band ligation or Hypertonic saline sclerotherapy injection, each procedure to be performed by one endoscopist respectively.
Age 18 or above
Consent to study
Bleeding hemorrhoids grade 1, 2 or 3
Age 18 or younger
Refusal to consent to the study
Prior surgical and non surgical hemorrhoidal procedure/manipulation
active anal fissure
active anal fistula
Grade 4 internal hemorrhoids
Chronic pain requiring analgesics
antiplatelet and anticoagulant intake other than aspirin