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

NCT01383577 | Unknown DMC

• 1 other identifier: PP-S/0001/2010
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hemorrhoids; Ligation; Pain; Morbidity; Patient Satisfaction; Cost-Benefit Analysis

Outcome Measures

Primary Outcomes (1)

• Ligature-related pain intensity

  Patients are asked to record pain intensity related to the hemorrhoidal ligation performed in a chart containing a modified pain intensity visual scale (Wong \& Baker). Investigators inquire patients about immediate pain sensation after a ligation session and at regular intervals, by telephone calls, until the 7th post-treatment day (12 h, 24 h, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day).

  7 days

Secondary Outcomes (4)

• Immediate complications

  30 days

• Resolutive capacity of rubber band ligation of hemorrhoids

  90 days

• Degree of patient satisfaction

  90 days

• Costs of each of the modes of ligation

  90 days

Study Arms (2)

Single hemorrhoidal ligation

EXPERIMENTAL

Effective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each session of treatment.

Procedure: Single hemorrhoidal ligation

Triple hemorrhoidal ligation

EXPERIMENTAL

The three major hemorrhoidal groups are ligated in the first session of ligation. The three following monthly appointments of patients of this arm are for sham hemorrhoidal ligations and final revision.

Procedure: Triple hemorrhoidal ligation

Interventions

Single hemorrhoidal ligation PROCEDURE

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.

Also known as: Rubber band ligation of hemorrhoids, single

Single hemorrhoidal ligation

Triple hemorrhoidal ligation PROCEDURE

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.

Also known as: Rubber band ligation of hemorrhoids, multiple

Triple hemorrhoidal ligation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with second-degree hemorrhoids

You may not qualify if:

• Patients with special needs
• Immunodepression
• Indians
• Infectious, inflammatory or tumoral anorectal comorbidities
• Previous anorectal surgeries
• Patients on anticoagulant therapy or with coagulation disorders

Sponsors & Collaborators

• Federal University of Amazonas: lead

Study Sites (1)

Hospital Universitário Getúlio Vargas - Ambulatório Araújo Lima

Manaus, Amazonas, 69020-160, Brazil

Location

MeSH Terms

Conditions

Hemorrhoids; Pain; Patient Satisfaction

Interventions

Single Person

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Study Officials

• Ivan T Costa e Silva, PhD

  Universidade Federal do Amazonas

  PRINCIPAL INVESTIGATOR

• Érico L Melo, Med Grad

  Universidade Federal do Amazonas

  STUDY CHAIR

• Giselle L Afonso, Med Grad

  Universidade Federal do Amazonas

  STUDY CHAIR

• Felicidad S Gimenez, MSc

  Universidade Federal do Amazonas

  STUDY CHAIR

• Shymmene O Cardoso, BAccount

  Universidade Federal do Amazonas

  STUDY CHAIR

• Daniel Richard M Mota, Med Grad

  Universidade Federal do Amazonas

  STUDY CHAIR

• Rachel M Carvalho, Med Grad

  Universidade Federal do Amazonas

  STUDY CHAIR

• Saskia Regina F Coppens, Med Grad

  Universidade Federal do Amazonas

  STUDY CHAIR

• Themis C Abensur, MSc

  Federal University of Amazonas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 24, 2011
• First Posted: June 28, 2011
• Study Start: March 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 26, 2013

Record last verified: 2013-09

Locations

BR (1)