This trial is active, not recruiting.

Condition second-degree hemorrhoids
Treatments single hemorrhoidal ligation, triple hemorrhoidal ligation
Sponsor Federal University of Amazonas
Start date March 2010
End date February 2013
Trial size 76 participants
Trial identifier NCT01383577, PP-S/0001/2010


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Effective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each session of treatment.
single hemorrhoidal ligation Rubber band ligation of hemorrhoids, single
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.
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.
triple hemorrhoidal ligation Rubber band ligation of hemorrhoids, multiple
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.

Primary Outcomes

Ligature-related pain intensity
time frame: 7 days

Secondary Outcomes

Immediate complications
time frame: 30 days
Resolutive capacity of rubber band ligation of hemorrhoids
time frame: 90 days
Degree of patient satisfaction
time frame: 90 days
Costs of each of the modes of ligation
time frame: 90 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Double-blind Randomized Controlled Study of Single Versus Triple Rubber Band Ligation of Hemorrhoids
Principal investigator Ivan T Costa e Silva, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Federal University of Amazonas.