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

Second-degree Hemorrhoids Clinical Trial

Official title:

Double-blind Randomized Controlled Study of Single Versus Triple Rubber Band Ligation of Hemorrhoids

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01383577
• Other study ID #: PP-S/0001/2010
• Status: Active, not recruiting
• Phase: N/A
• First received: June 24, 2011
• Last updated: September 24, 2013
• Start date: March 2010
• Est. completion date: November 2013

Study information

• Verified date: September 2013
• Source: Federal University of Amazonas
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 76
• Est. completion date: November 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhoids
• Second-degree Hemorrhoids

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Universitário Getúlio Vargas - Ambulatório Araújo Lima	Manaus	Amazonas

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Amazonas

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Immediate complications	Complications eventually ocurring until 30 days of each session of rubber band ligation of hemorrhoids (effective or sham) are recorded by the investigators.	30 days	Yes
Secondary	Resolutive capacity of rubber band ligation of hemorrhoids	Resolution of pre-ligation hemorrhoidal symptoms is investigated 3 months after first session of rubber band ligation of hemorrhoids.	90 days	No
Secondary	Degree of patient satisfaction	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.	90 days	No
Secondary	Costs of each of the modes of ligation	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.	90 days	No