Trial of Latex Vs Non-latex Hemorrhoid Banding
Purpose
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.
Conditions
- Hemorrhoid
- Hemorrhoid Bleeding
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Non-latex band |
Non-latex bands will be placed on hemorrhoids during banding |
|
|
Active Comparator Latex band |
latex bands will be placed on hemorrhoids during banding |
|
Recruiting Locations
Pasadena, California 91105
More Details
- NCT ID
- NCT06625138
- Status
- Recruiting
- Sponsor
- Huntington Memorial Hospital
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.