Hemorrhoids Clinical Trial
Official title:
Sclerotherapy With Polidocanol Foam In The Management Of First, Second And Third-Grade Hemorrhoidal Disease In Patients With Bleeding Disorders: A Prospective Cohort Study
Treatment of hemorrhoidal disease includes a conservative approach (dietary and behavioral measures, venotropic and topical medication), office-based treatments and surgery. Rubber banding is currently considered the instrumental method of choice in the treatment of hemorrhoidal disease grades I to III (Goligher's classification). However, its use in patients with bleeding disorders is not recommended. Sclerotherapy can be performed in these patients since the hemorrhagic risk is very low. The most commonly used agent for sclerotherapy is liquid polidocanol. Polidocanol foam seems to be more effective than the liquid formulation and is safe in the treatment of hemorrhoidal disease even in patients with coagulation disorders. This study is aimed to evaluate the efficacy and safety of polidocanol foam sclerotherapy in the treatment of hemorrhoidal disease grades I to III in patients with bleeding disorders.
Internal hemorrhoidal disease is classified according to the Goligher classification into
grades I, II, III and IV according to its grade of prolapse and reducibility. The treatment
of patients should be oriented by the presence of symptoms and the impact on life quality,
aspects that are valued on the Sodergren scale.
The hemorrhoidal bleeding, usually mild, may be severe in patients under antithrombotic
medications (antiplatelet or anticoagulant) as well as in patients with bleeding disorders
non-induced by drugs. With the increase of life expectancy and the high prevalence of atrial
fibrillation, the consumption of anticoagulants has also been increasing. Similarly, the use
of antiplatelet medication has also increased, especially through its use in the primary and
secondary prevention of cardiovascular events. Vitamin K antagonists and antiplatelet drugs
are associated with an incidence of digestive bleeding between 1.5% - 4.5% with a short-term
mortality of 10-15%. The relation between the use of new oral anticoagulants (NOACs) and
digestive bleeding remains a matter of debate, with some studies showing different results
when comparing bleeding risk with vitamin K antagonists. Similar to what happen with this
subset of patients, those with inherited bleeding disorders are a known subgroup of patients
predisposed to hemorrhagic complications. Hemophilia represents the main cause of inherited
defects of clotting factors VIII and IX. With the advent of intravenous clotting factors
concentrates, the perioperative mortality in this subgroup as decreased in the mid-20th
century. However patients with this hematologic disease still have a higher risk of bleeding,
delayed wound healing and postoperative infections. To the investigator's knowledge little is
known about the prevalence of hemorrhoidal disease in patients with inherited bleeding
disorders. Bearing in mind the high rate of surgical complications in these patients, they
could represent the ideal candidates for less invasive office-based hemorrhoidal therapy.
Instrumental, office-based treatment is reserved for internal hemorrhoidal disease grades I
to III. Regardless of the applied technique, the goal is to decrease vascularization,
decrease hemorrhoidal volume and increase the fixation of the fibrovascular pedicle to the
rectal wall, thus treating the bleeding and hemorrhoidal prolapse. Rubber band ligation is
considered the method of choice in the treatment of hemorrhoidal disease. However, its use is
associated to bleeding rates after procedure ranging between 3.5 - 50% and late bleeding
rates between 13% - 18,3% that may occur until 7-14 days after treatment. The hemorrhagic
event is significant in 0.8% of cases and may even prove fatal. For this reason, this
technique is contraindicated in patients with bleeding disorders. In patients on
antithrombotic medication, discontinuation of this medication is recommended for 7 days
before the ligation procedure and 7-10 days after the procedure, which substantially
increases the risk of cardioembolic events. In contrast, sclerotherapy is a technique with a
low rate of bleeding complications and can be used to treat hemorrhoidal disease grades I to
III. After intravascular injection of sclerosing agent above the pectineal line - Blanchard
technique - an inflammatory and fibrotic response is obtained that interrupts the blood
supply. Although there are multiple sclerosing agents, in Portugal, the most frequently used
is liquid polidocanol. As a nonionic detergent its use as a foam (obtained by the technique
of Tessari which uses a device that combines two syringes and a three-way tap in which the
polidocanol is mixed with air under mechanical force) appears to be associated with greater
efficacy even with lower doses of sclerosing agent. Sclerotherapy with liquid polidocanol is
effective in the treatment of grade I hemorrhoidal disease with a study demonstrating
superiority of foam formulation in this grade of hemorrhoidal disease. A recently published
Portuguese study sought to study the efficacy and safety of foamed polidocanol sclerotherapy
in patients with grade I to IV hemorrhoidal disease. On the findings, which included 2000
participants, 210 of them on anticoagulant and/or dual antiplatelet therapy, the authors
conclude that this instrumental procedure is effective and safe even in patients on
antithrombotic therapy. However, no comparison was made between the incidence of
complications occurred in this subgroup of patients with the remaining patients without
antithrombotic therapy. As far as we know there are no published studies comparing
polidocanol foam sclerotherapy to other ablative techniques.
The investigators are conducting a multicentric longitudinal prospective study including
adult patients, with or without bleeding disorders, with hemorrhoidal disease grades I to III
submitted to polidocanol foam sclerotherapy in three health institutions during an inclusion
period of 1.5 years. Efficacy is assessed using Sodergren score of symptoms, bleeding and
Goligher grades, and recurrence during follow-up. For the safety evaluation, complications
are recorded. Efficacy and safety outcomes will be compared between two groups of patients:
with bleeding disorders (Group A) and without bleeding disorders (Group B).
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