Second-degree Hemorrhoids Clinical Trial
Official title:
Double-blind Randomized Controlled Study of Single Versus Triple Rubber Band Ligation of Hemorrhoids
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).
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03791775 -
Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease
|
Phase 2 |