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Trial of Latex vs Non-latex Hemorrhoid Banding

Single-blinded Randomized Trial of Latex vs Non-latex Hemorrhoid Banding

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06625138
Acronym
NO-Tex
Enrollment
164
Registered
2024-10-03
Start date
2024-08-30
Completion date
2026-12-01
Last updated
2026-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhoid, Hemorrhoid Bleeding

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

DEVICELatex Band

Hemorrhoid banding with latex band

DEVICENon-Latex Band

Hemorrhoid banding with non-latex bands

Sponsors

Huntington Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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".

Design outcomes

Primary

MeasureTime frameDescription
Hemorrhoid Band Efficacy2-4 monthshemorrhoidal bleeding and prolapse symptoms following ligation.

Secondary

MeasureTime frameDescription
Banding-related Adverse events2-4 monthsbanding-related adverse events including pain, bleeding, and complications following hemorrhoidal banding

Countries

United States

Contacts

CONTACTAdam Truong, MD
adam.truong@huntingtonhealth.org(626) 397-5896
PRINCIPAL_INVESTIGATORAdam Truong, MD

Huntington Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 18, 2026