Clinical Research Details

Descriptive Information
Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Band Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study

Ala Sharara


Clinical Research - Clinical Trials (phase 0, 1,2 3 & 4)  

Phase 4  

  • Fady Daniel
  • Rani Shayto
Louma Rustam
Extension: 5909
Conditions and Keywords
hemorrhoids,hypertonic saline sclerotherapy,rubber band ligation
Study Design
Safety and/or Efficacy Study
Single Blind 
N/A: Not Applicable
Eligibility and IRB
Min: 18
In Progress

This is a randomized prospective study conducted at the American University of Beirut Medical Center involving patients suffering from hemorrhoidal disease requiring therapeutic intervention. 

  1. 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)
  2. Pain medication usage (secondary objective)
  3. Bleeding during day 1 through 7 post procedure (secondary objective)
  4. 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.

  1. Age 18 or above
  2. Consent to study
  3. Bleeding hemorrhoids grade 1, 2 or 3

  1. Age 18 or younger
  2. Refusal to consent to the study
  3. Prior surgical and non surgical hemorrhoidal procedure/manipulation
  4. external hemorrhoids
  5. thrombosed hemorrhoids
  6. active anal fissure
  7. active anal fistula
  8. Immunocompromised
  9. Grade 4 internal hemorrhoids
  10. Chronic pain requiring analgesics
  11. antiplatelet and anticoagulant intake other than aspirin