Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study

Conditions
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Hemorrhoids, Bleeding, Pain

Intervention / Treatment
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* Procedure: Rubber Band Ligation
* Procedure: Hypertonic Saline Infusion


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A (Rubber Band Ligation)<br>15 patients | Procedure: Rubber Band Ligation<br>* Anoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator)<br>|
| Experimental: B (Hypertonic Saline Infusion)<br>15 patients | Procedure: Hypertonic Saline Infusion<br>* Endoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Pain Score | Range 0 (no pain) to 10 (maximum pain) | Days 0 after procedure | 
| Composite Pain Score | Range 0 (no pain) to 10 (maximum pain) | Day 3 after procedure | 
| Composite Pain Score | Range 0 (no pain) to 10 (maximum pain) | Day 7 after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | If any bleeding is noticed upon defecation | Days 1 to 7 after the procedure | 
| Pain Medication Usage |  | Days 1 to 7 after the procedure | 
| Bleeding | If any bleeding is noticed upon defecation | week 1-week 7 post procedure, 3 months, 6 months | 
| Pain | Range 0 (no pain) to 10 (maximum pain) | week 1-week 7 post procedure, 3 months, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Bleeding, Hemorrhoids, Band Ligation, hypertonic saline sclerotherapy