Trial of Latex Vs Non-latex Hemorrhoid Banding

Last updated: October 24, 2024
Sponsor: Huntington Memorial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemorrhoids

Treatment

Latex Band

Non-Latex Band

Clinical Study ID

NCT06625138
STUDY0003511
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 164
Treatment Group(s): 2
Primary Treatment: Latex Band
Phase:
Study Start date:
August 30, 2024
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • Huntington Memorial Hospital

    Pasadena, California 91105
    United States

    Active - Recruiting

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