Comparison Between Single and Triple Rubber Band Ligation for the Treatment of Hemorrhoids

Summary

Rubber band ligation is a widely adopted treatment of internal hemorrhoids in busy coloproctology institutions. All three major hemorrhoidal clusters (left lateral, right anterior and right posterior) use to be ligated in order to obtain therapeutic success. It is commonly performed either through the ligation of a single hemorrhoid per session spaced by some few weeks to the second and third sessions, or of all three major hemorrhoids in one single session. Advocates of either method of hemorrhoidal ligation have arguments to defend their choice in terms of advantages, supported mainly on personal preferences. The investigators objective is to determine, through a controlled double-blinded randomized study, if there is any superiority of single hemorrhoidal ligation per session (in a total of three sessions) over the method of ligation of all three main hemorrhoids in a sole session in terms of therapeutic success (resolution of pre-ligation symptoms), morbidity, patient satisfaction and costs (institutional, labor and patient-related).

Conditions

• Second-degree Hemorrhoids

Interventions

PROCEDURE

Single hemorrhoidal ligation

Effective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each of three sessions of treatment. Final revision is performed 90 days after first session of hemorrhoidal ligation.

PROCEDURE

Triple hemorrhoidal ligation

The three major hemorrhoidal groups are ligated in the first session of ligation. Sham triple hemorrhoidal ligations are performed 30 and 60 days after the first session. Final revision is done 90 days after first ligation session.

Sponsors & Collaborators

• Federal University of Amazonas

  lead OTHER

Principal Investigators

• Ivan T Costa e Silva, PhD · Universidade Federal do Amazonas

• Érico L Melo, Med Grad · Universidade Federal do Amazonas

• Giselle L Afonso, Med Grad · Universidade Federal do Amazonas

• Felicidad S Gimenez, MSc · Universidade Federal do Amazonas

• Shymmene O Cardoso, BAccount · Universidade Federal do Amazonas

• Daniel Richard M Mota, Med Grad · Universidade Federal do Amazonas

• Rachel M Carvalho, Med Grad · Universidade Federal do Amazonas

• Saskia Regina F Coppens, Med Grad · Universidade Federal do Amazonas

• Themis C Abensur, MSc · Federal University of Amazonas

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2013-02-28

Completion

2013-11-30

Countries

• Brazil

Study Locations