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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ivan Tramujas da Costa e Silva, Federal University of Amazonas
ClinicalTrials.gov Identifier:
NCT01383577
First received: June 24, 2011
Last updated: September 24, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Second-degree Hemorrhoids
Procedure: Single hemorrhoidal ligation
Procedure: Triple hemorrhoidal ligation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind Randomized Controlled Study of Single Versus Triple Rubber Band Ligation of Hemorrhoids

Resource links provided by NLM:


Further study details as provided by Federal University of Amazonas:

Primary Outcome Measures:
  • Ligature-related pain intensity [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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).


Secondary Outcome Measures:
  • Immediate complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    Complications eventually ocurring until 30 days of each session of rubber band ligation of hemorrhoids (effective or sham) are recorded by the investigators.

  • Resolutive capacity of rubber band ligation of hemorrhoids [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Resolution of pre-ligation hemorrhoidal symptoms is investigated 3 months after first session of rubber band ligation of hemorrhoids.

  • Degree of patient satisfaction [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Three months after first session (or single session, according to the arm of treatment) of rubber band hemorrhoidal ligation each patient degree of satisfaction with the method is recorded analogously using the modified visual pain scale of Wong & Baker.

  • Costs of each of the modes of ligation [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Three months after the first rubber band ligation session, the costs involved in each treatment modality is raised. Calculations are done taking into account the value of the material employed in all the ligation sessions that are necessary to treat each individual patient, the value of the fraction of the investigators' salaries compromised in the treatment of each individual patient, how much each patient spends in pain medication and the value of the fraction of the patients' salaries involved in occupational absenteeism.


Estimated Enrollment: 76
Study Start Date: March 2010
Estimated Study Completion Date: November 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single hemorrhoidal ligation
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
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.
Other Name: Rubber band ligation of hemorrhoids, single
Experimental: Triple hemorrhoidal ligation
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
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.
Other Name: Rubber band ligation of hemorrhoids, multiple

Detailed Description:

Because of conflicting results in existing literature in relation to features such as pain and immediate effectiveness of single or multiple rubber band ligation of hemorrhoids and because in the literature consulted no study was found that addressed economical features comparing single with multiple rubber band ligation of hemorrhoids, this study was designed to compare, in a double blinded, randomized and controlled model, the results of single hemorrhoidal ligation in three sessions with triple hemorrhoidal in a sole session in terms of immediate effectiveness, patient satisfaction and costs.

Patients enrolled in the study, after applying inclusion and exclusion criteria, signed the consent form, and responded to a questionaire about epidemiological data and hemorrhoidal symptoms, are (and will be) randomly allocated to one of the two arms of the study: G1: a single major hemorrhoidal group is ligated in each of three sessions of hemorrhoidal ligation, while the two other hemorrhoidal groups are submitted to sham ligation (a McGown aspirating type of hemorrhoidal ligator is employed); G2: all three major hemorrhoidal groups are ligated in the first session of treatment and in the next two sessions only sham ligations are performed. Three sessions of hemorrhoidal and/or sham ligation are performed in all patients, each spaced by one month from the other. A final consultation is held 1 month after the third ligation session in order to gather all the results of the treatment.

After each session of hemorrhoidal ligation patients receive a chart containing a modified level of pain scale (Wong & Baker) and are asked to indicate pain level (from 0 to 5: 0 = no pain, 5 = unbearable pain) at fixed intervals (immediate post-ligation, 12 h post-ligation, 24 h post-ligation and each other day until 7 days post-ligation). Investigators gather this information about pain, and patient well-being post-ligations, from 8 programmed telephone calls to the patients after each session of hemorrhoidal (or sham) ligation.

Three months after the first session of hemorrhoidal ligation all patients are examined in order to observe treatment effectiveness and gather data about complications, patient satisfaction, number of days of occupational absenteeism linked to each session of treatment and number of analgesic pills necessary for pain relief.

Comparative costs of each modality of ligation are raised taking into consideration the salaries of health professionals involved in the treatment, the salaries of the patients (calculation of absenteeism), the value of consumables used in each session of effective ligation, the depreciation price of permanent material employed and the price of medications patients have to buy.

Patients are blinded to the modality of hemorrhoidal ligation employed and the statistician does not know the nature of each treatment group.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with second-degree hemorrhoids

Exclusion Criteria:

  • Patients with special needs
  • Immunodepression
  • Indians
  • Infectious, inflammatory or tumoral anorectal comorbidities
  • Previous anorectal surgeries
  • Patients on anticoagulant therapy or with coagulation disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383577

Locations
Brazil
Hospital Universitário Getúlio Vargas - Ambulatório Araújo Lima
Manaus, Amazonas, Brazil, 69020-160
Sponsors and Collaborators
Federal University of Amazonas
Investigators
Principal Investigator: Ivan T Costa e Silva, PhD Universidade Federal do Amazonas
Study Chair: 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
  More Information

No publications provided

Responsible Party: Ivan Tramujas da Costa e Silva, PhD, Federal University of Amazonas
ClinicalTrials.gov Identifier: NCT01383577     History of Changes
Other Study ID Numbers: PP-S/0001/2010
Study First Received: June 24, 2011
Last Updated: September 24, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Amazonas:
Hemorrhoids
Ligation
Pain
Morbidity
Patient Satisfaction
Cost-Benefit Analysis

Additional relevant MeSH terms:
Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 29, 2014