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NCT Number: NCT06625138

Trial of Latex Vs Non-latex Hemorrhoid Banding

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.

Recruiting

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Key information

Conditions

Hemorrhoid Cardiovascular Diseases Digestive System Diseases Gastrointestinal Diseases Hemorrhoid Bleeding Hemorrhoids Intestinal Diseases Rectal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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".

Treatment and study plan

Latex Band

Device

Hemorrhoid banding with latex band

Non-Latex Band

Device

Hemorrhoid banding with non-latex bands

Primary outcomes

  1. Hemorrhoid Band Efficacy

    Time frame: 2-4 months

    hemorrhoidal bleeding and prolapse symptoms following ligation.

Secondary outcomes

  1. Banding-related Adverse events

    Time frame: 2-4 months

    banding-related adverse events including pain, bleeding, and complications following hemorrhoidal banding

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Truong, MD

CONTACT

[email protected]

(626) 397-5896

Sponsors and collaborators

Lead sponsor

Huntington Memorial Hospital

Other

Registry information

Official study title

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

Acronym: NO-Tex

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 3, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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