Trial of Latex Vs Non-latex Hemorrhoid Banding (NO-Tex)

Huntington Memorial Hospital

Status: Enrolling

Conditions: Hemorrhoid; Hemorrhoid Bleeding

Treatments: Device: Non-Latex Band; Device: Latex Band

Study type: Interventional

Funder types: Other

Identifiers

NCT06625138

STUDY0003511

Details and patient eligibility

About

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.

Full 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.

Enrollment: 164 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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".

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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164 participants in 2 patient groups

Non-latex band

Experimental group

Description:

Non-latex bands will be placed on hemorrhoids during banding

Treatment:

Device: Non-Latex Band

Latex band

Active Comparator group

Description:

latex bands will be placed on hemorrhoids during banding

Treatment:

Device: Latex Band