Trial of Latex Vs Non-latex Hemorrhoid Banding

NCT ID: NCT06625138

Last Updated: 2024-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-30

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Hemorrhoid Hemorrhoid Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Non-latex band

Non-latex bands will be placed on hemorrhoids during banding

Group Type EXPERIMENTAL

Non-Latex Band

Intervention Type DEVICE

Hemorrhoid banding with non-latex bands

Latex band

latex bands will be placed on hemorrhoids during banding

Group Type ACTIVE_COMPARATOR

Latex Band

Intervention Type DEVICE

Hemorrhoid banding with latex band

Interventions

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Latex Band

Hemorrhoid banding with latex band

Intervention Type DEVICE

Non-Latex Band

Hemorrhoid banding with non-latex bands

Intervention Type DEVICE

Eligibility Criteria

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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".
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huntington Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Adam Truong

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Adam Truong, MD

Role: PRINCIPAL_INVESTIGATOR

Huntington Health

Locations

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Huntington Memorial Hospital

Pasadena, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Adam Truong, MD

Role: CONTACT

(626) 397-5896

Facility Contacts

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Maureen PRS Coordinator

Role: primary

(626) 397-3877

Role: backup

Adam Truong, MD

Role: backup

Other Identifiers

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STUDY0003511

Identifier Type: -

Identifier Source: org_study_id

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