Clinical trial NCT02851940: Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids
Official title: Pain and Bleeding Following Hypertonic Saline Sclerotherapy Compared to Brand Ligation for Symptomatic Hemorrhoids: A Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hemorrhoids
Bleeding
Pain
Keywords: Pain
Bleeding
Hemorrhoids
Band Ligation
hypertonic saline sclerotherapy
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Pain Score
timeFrame: Days 0 after procedure
measure: Composite Pain Score
timeFrame: Day 3 after procedure
measure: Composite Pain Score
timeFrame: Day 7 after procedure
Secondary outcomes:
measure: Bleeding
timeFrame: Days 1 to 7 after the procedure
measure: Pain Medication Usage
timeFrame: Days 1 to 7 after the procedure
measure: Bleeding
timeFrame: week 1-week 7 post procedure, 3 months, 6 months
measure: Pain
timeFrame: week 1-week 7 post procedure, 3 months, 6 months
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut Medical Center
Study officials:
affiliation: American University of Beirut Medical Center
name: Ala I Sharara, MD
role: PRINCIPAL_INVESTIGATOR
References: