Trial of Latex Vs Non-latex Hemorrhoid Banding

Not Applicable

Recruiting

• Conditions: Hemorrhoid; Hemorrhoid Bleeding
• Interventions: Device: Non-Latex Band; Device: Latex Band

• Registration Number: NCT06625138
• Lead Sponsor: Huntington Memorial Hospital

Brief Summary

This study will involve the recruitment of adult patients with hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our goal will be to measure the performance of latex bands vs non-latex bands.

Detailed Description

This study will involve the recruitment of adult patients with symptomatic grade 2-3 internal hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our hypothesis is that non-latex hemorrhoidal bands are non-inferior to latex bands for the treatment of grade 2-3 internal hemorrhoids.

The secondary objective of the study is to compare banding-related adverse effects including pain, bleeding, and complications assessed both immediately and within 3 weeks following each hemorrhoidal banding.

Study Timeline

• Study Start: 2024-08-30
• Study First Submitted: 2024-09-11
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Submitted: 2024-10-24
• Last Update Posted: 2024-10-28
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

• Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation

Exclusion Criteria

• Previous hemorrhoidal banding within the past year
• Known latex allergy
• Pregnancy
• Anticoagulation use
• Bleeding disorder
• Portal hypertension
• Inflammatory bowel disease
• Immunosuppression
• Functional neurologic disorder
• Pelvic floor dysfunction
• Any records flagged "break the glass" or "research opt out".

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-latex band	Non-Latex Band	Non-latex bands will be placed on hemorrhoids during banding
Latex band	Latex Band	latex bands will be placed on hemorrhoids during banding

Primary Outcome Measures

Name	Time	Method
Hemorrhoid Band Efficacy	2-4 months	hemorrhoidal bleeding and prolapse symptoms following ligation.

Secondary Outcome Measures

Name	Time	Method
Banding-related Adverse events	2-4 months	banding-related adverse events including pain, bleeding, and complications following hemorrhoidal banding

Trial Locations

Locations (1)

Huntington Memorial Hospital; 🇺🇸 Pasadena, California, United States