Hemorrhoid, Hemorrhoid Bleeding
Conditions
Keywords
hemorrhoid, banding
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.
Interventions
Hemorrhoid banding with latex band
Hemorrhoid banding with non-latex bands
Sponsors
Study design
Eligibility
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".
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemorrhoid Band Efficacy | 2-4 months | hemorrhoidal bleeding and prolapse symptoms following ligation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Banding-related Adverse events | 2-4 months | banding-related adverse events including pain, bleeding, and complications following hemorrhoidal banding |
Countries
United States
Contacts
Huntington Health