Clinical trial NCT01383577: Comparison Between Single and Triple Rubber Band Ligation for the Treatment of Hemorrhoids
Official title: Double-blind Randomized Controlled Study of Single Versus Triple Rubber Band Ligation of Hemorrhoids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Second-degree Hemorrhoids
Keywords: Hemorrhoids
Ligation
Pain
Morbidity
Patient Satisfaction
Cost-Benefit Analysis
Lead sponsor: Federal University of Amazonas
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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

Primary outcomes:
measure: Ligature-related pain intensity
timeFrame: 7 days
Secondary outcomes:
measure: Immediate complications
timeFrame: 30 days
measure: Resolutive capacity of rubber band ligation of hemorrhoids
timeFrame: 90 days
measure: Degree of patient satisfaction
timeFrame: 90 days
measure: Costs of each of the modes of ligation
timeFrame: 90 days
Other outcomes:
Locations:
city: Manaus
country: Brazil
facility: Hospital Universitário Getúlio Vargas - Ambulatório Araújo Lima
state: Amazonas
Study officials:
affiliation: Universidade Federal do Amazonas
name: Ivan T Costa e Silva, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidade Federal do Amazonas
name: Érico L Melo, Med Grad
role: STUDY_CHAIR
affiliation: Universidade Federal do Amazonas
name: Giselle L Afonso, Med Grad
role: STUDY_CHAIR
affiliation: Universidade Federal do Amazonas
name: Felicidad S Gimenez, MSc
role: STUDY_CHAIR
affiliation: Universidade Federal do Amazonas
name: Shymmene O Cardoso, BAccount
role: STUDY_CHAIR
affiliation: Universidade Federal do Amazonas
name: Daniel Richard M Mota, Med Grad
role: STUDY_CHAIR
affiliation: Universidade Federal do Amazonas
name: Rachel M Carvalho, Med Grad
role: STUDY_CHAIR
affiliation: Universidade Federal do Amazonas
name: Saskia Regina F Coppens, Med Grad
role: STUDY_CHAIR
affiliation: Federal University of Amazonas
name: Themis C Abensur, MSc
role: STUDY_CHAIR
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