Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06625138

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

Led by Huntington Memorial Hospital · Updated on 2024-10-28

164

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of latex versus non-latex bands in rubber band ligation for adult patients with symptomatic grade 2-3 internal hemorrhoids. The study aims to compare how well non-latex bands perform compared to latex bands in treating these hemorrhoids and to assess related side effects such as pain, bleeding, and other complications both immediately and within three weeks after the procedure. Participants will be randomly assigned to receive hemorrhoid banding with either latex or non-latex bands. The treatments are applied during the banding procedure, and both types of bands will be studied to observe their effectiveness and any adverse events. The study is single-blinded and focuses on the comparison of these two types of banding devices. During the study, participants will be monitored over 2 to 4 months to measure the success of the hemorrhoid banding and to record any banding-related adverse effects. Researchers will collect data on pain, bleeding, and other complications following the banding procedure. The overall goal is to determine the safety and performance of non-latex bands compared to latex bands in this patient population.

CONDITIONS

Brief Title

Trial of Latex Vs Non-latex Hemorrhoid Banding

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation
Not Eligible

You will not qualify if you...

  • Previous hemorrhoidal banding within the past year
  • Known latex allergy
  • Pregnancy
  • Use of anticoagulation medication
  • Bleeding disorder
  • Portal hypertension
  • Inflammatory bowel disease
  • Immunosuppression
  • Functional neurologic disorder
  • Pelvic floor dysfunction
  • Any records flagged "break the glass" or "research opt out"

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single treatment session

Participants receive hemorrhoid banding using either latex or non-latex bands as part of the treatment.

1 treatment visit (in-person)

Post-operative Follow-up

Duration - Up to 3 weeks

Participants are monitored for banding-related adverse effects including pain, bleeding, and complications immediately and within 3 weeks following hemorrhoidal banding.

Approximately 2 follow-up visits (in-person)

Trial Site Locations

Total: 1 location

1

Huntington Memorial Hospital

Pasadena, California, United States, 91105

Actively Recruiting

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Research Team

A

Adam Truong, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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