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

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

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

Study Overview

• Status: Withdrawn
• Conditions: Pain; Bleeding; Hemorrhoids
• Intervention / Treatment: Procedure: Rubber Band Ligation; Procedure: Hypertonic Saline Infusion

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • American University of Beirut Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: American University of Beirut Medical Center
• Investigators: Principal Investigator: Ala I Sharara, MD, American University of Beirut Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: July 26, 2016
• First Submitted That Met QC Criteria: July 28, 2016
• First Posted (Estimated): August 2, 2016

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Keywords: Pain; Bleeding; Hemorrhoids; Band Ligation; hypertonic saline sclerotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhage; Hemorrhoids
• Other Study ID Numbers: IM.FD.04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In the publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No