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

NCT02851940 | Withdrawn DMC

• 1 other identifier: IM.FD.04
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Hemorrhoids; Bleeding; Pain

Keywords

Pain; Bleeding; Hemorrhoids; Band Ligation; hypertonic saline sclerotherapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Bleeding

  Days 1 to 7 after the procedure

• Pain Medication Usage

  Days 1 to 7 after the procedure

• Bleeding

  week 1-week 7 post procedure, 3 months, 6 months

• Pain

  week 1-week 7 post procedure, 3 months, 6 months

Study Arms (2)

A (Rubber Band Ligation)

EXPERIMENTAL

15 patients

Procedure: Rubber Band Ligation

B (Hypertonic Saline Infusion)

EXPERIMENTAL

15 patients

Procedure: Hypertonic Saline Infusion

Interventions

Rubber Band Ligation PROCEDURE

Anoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator)

A (Rubber Band Ligation)

Hypertonic Saline Infusion PROCEDURE

Endoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline)

B (Hypertonic Saline Infusion)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18+
• Consent to the study
• Bleeding grade 1,2 and 3 hemorrhoids

You may not qualify if:

• 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

Sponsors & Collaborators

• American University of Beirut Medical Center: lead

Study Sites (1)

American University of Beirut Medical Center

Beirut, Lebanon

Location

MeSH Terms

Conditions

Hemorrhoids; Hemorrhage; Pain

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ala I Sharara, MD

  American University of Beirut Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 2, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 31, 2024

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will share

Locations

LE (1)