Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids
- Conditions
- PainHemorrhoidsBleeding
- Interventions
- Procedure: Rubber Band LigationProcedure: Hypertonic Saline Infusion
- Registration Number
- NCT02851940
- Lead Sponsor
- American University of Beirut Medical Center
- Brief Summary
The investigators aim at prospectively comparing procedural pain, adverse events and rebleeding rates of anoscopic rubber band ligation and endoscopic hypertonic saline injection in patients with symptomatic hemorrhoidal disease
- Detailed Description
Hemorrhoidal disease is a common encounter in a gastroenterologist's practice. These are often symptomatic, either bleeding or prolapsing. There are no set guidelines in our institution (The American University of Beirut Medical Center - AUBMC) for the treatment of symptomatic hemorrhoidal disease. Two types of treatment are available at our institution: anoscopic rubber band ligation (RBL) or endoscopic sclerotherapy (ESC) with hypertonic (20%) saline. Both methods have been shown to be effective in the literature, with above 75% complete symptomatic relief from a single application after 8-12 months. Post procedural pain of RBL in two randomized studies ranged 40-47%, while different studies showed post procedural pain following ESC to be 12-39%. However no study has ever compared these two therapeutic methods head-on, neither has any study compared both procedures for tolerability and rebleeding rates.
Research design and methods:
This study is a randomized, prospective study conducted at the American University of Beirut Medical Center which will involve 30 patients suffering from symptomatic hemorrhoidal disease requiring therapeutic intervention. Patients meeting inclusion criteria will be randomized using a computer generated randomization list to either Rubber Band Ligation (RBL) or Hypertonic Saline Sclerotherapy as a therapeutic interventional procedure.
- Patients will be approached by their Gastroenterologist during clinic visits and informed about the study. If participants wish to take part in the study, they will be given additional study information, screened for inclusion criteria, and consented by the research assistant or clinic nurse. Recruitment and randomization will occur during the same visit after patient consent in order to properly schedule patients for their therapeutic interventional procedures. All rubber band ligations will be performed by one endoscopist and all sclerotherapies will be performed by the other endoscopist.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Age 18+
- Consent to the study
- Bleeding grade 1,2 and 3 hemorrhoids
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A (Rubber Band Ligation) Rubber Band Ligation 15 patients B (Hypertonic Saline Infusion) Hypertonic Saline Infusion 15 patients
- Primary Outcome Measures
Name Time Method Composite Pain Score Day 7 after procedure Range 0 (no pain) to 10 (maximum pain)
- Secondary Outcome Measures
Name Time Method Pain Medication Usage Days 1 to 7 after the procedure Bleeding week 1-week 7 post procedure, 3 months, 6 months If any bleeding is noticed upon defecation
Pain week 1-week 7 post procedure, 3 months, 6 months Range 0 (no pain) to 10 (maximum pain)
Trial Locations
- Locations (1)
American University of Beirut Medical Center
🇱🇧Beirut, Lebanon