Trial of Latex Vs Non-latex Hemorrhoid Banding (NO-Tex)

October 24, 2024 updated by: Adam Truong, Huntington Memorial Hospital

Single-blinded Randomized 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-latex band
Non-latex bands will be placed on hemorrhoids during banding
Device: Non-Latex Band
Hemorrhoid banding with non-latex bands
Active Comparator: Latex band
latex bands will be placed on hemorrhoids during banding
Device: Latex Band
Hemorrhoid banding with latex band

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemorrhoid Band Efficacy
Time Frame: 2-4 months
hemorrhoidal bleeding and prolapse symptoms following ligation.
2-4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Banding-related Adverse events
Time Frame: 2-4 months
banding-related adverse events including pain, bleeding, and complications following hemorrhoidal banding
2-4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huntington Memorial Hospital

Investigators

  • Principal Investigator: Adam Truong, MD, Huntington Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

October 28, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY0003511

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available upon reasonable request

IPD Sharing Time Frame

from start of study for 2 years

IPD Sharing Access Criteria

Data will be available upon reasonable request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemorrhoid

Clinical Trials on Non-Latex Band

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe