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NCT06625138NARecruiting

Trial of Latex Vs Non-latex Hemorrhoid Banding

Huntington Memorial Hospital

Start Date

8/30/2024

Completion Date

10/1/2026

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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".

Interventions

DEVICE

Latex Band

DEVICE

Non-Latex Band

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Conditions

HemorrhoidHemorrhoid Bleeding

Locations

Huntington Memorial Hospital

Pasadena, California 91105

United States