Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease
Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease
Background: Hemorrhoidal disease is extremely frequent in the adult population and, as a
 benign pathology, the treatment should be guided by the patient's symptoms. Treatment of
 hemorrhoidal disease includes a conservative approach, office-based treatments and surgery.

 This study is aimed to evaluate and compare the efficacy and safety of the treatment of
 hemorrhoidal disease with non-surgical office-based method polidocanol foam sclerotherapy
 (SP) and the surgical technique doppler-guided hemorrhoidal artery ligation with recto-anal
 repair.

 Methods: Prospective, unicentric study including patients with symptomatic hemorrhoidal
 disease grade II and III refractory to conservative therapy, submitted either to SP (n=24) or
 to HAL-RAR procedure (n=21), during a recruitment period of 6 months.

 Patients were evaluated for efficacy (Sodergren's scale of symptoms and severity of bleeding)
 and safety (complications and implication in personal and professional life), up to one month
 after treatment. In follow-up period (6 months) participants were evaluated for hemorrhoidal
 disease recurrence.
INTRODUCTION:

 Instrumental office-based procedures are usually indicated for internal hemorrhoidal disease
 grade I and II which are refractory to conservative medical treatments and in selected cases
 of grade III hemorrhoidal disease. Despite being invasive, these techniques are more
 conservative than surgical treatments and are also effective. The primary goals are to
 decrease the amount of redundant tissue, reduce vascularity, and affix the hemorrhoidal
 cushions to minimize prolapse. Office-based procedures include rubber band ligation (RBL),
 sclerotherapy (liquid and foam agents), infrared photocoagulation, cryotherapy,
 radiofrequency ablation among others.

 Hemorrhoidal sclerosis is a procedure indicated to treat grade I and II hemorrhoidal disease.
 It has also been used in the treatment of internal grade III hemorrhoidal disease, but there
 are limited data on its efficacy. Performed through an anoscope and according to Blanchard
 technique, internal hemorrhoids are located and injected with a sclerosant material into the
 submucosa at the base of the hemorrhoid, above the anterolateral line. The sclerosant
 subsequently causes an inflammatory response and fibrosis that interrupts the vascular blood
 supply. A variety of sclerosants have been used including ethanolamine, quinine, hypertonic
 saline, aluminum potassium sulfate and tannic acid (ALTA), and 5% phenol in oil. Recently, a
 new sclerosing agent, polidocanol, started to be employed in the treatment of hemorrhoidal
 disease. It is a nonionic detergent and consists of a hydrophilic polyethylene oxide chain
 combined with hydrophobic aliphatic dodecyl alcohol. When injected into varicose veins,
 polidocanol damages the endothelium of blood vessels, allowing platelets to aggregate.
 Eventually, a dense network of platelets, cellular debris, and fibrin occludes the vessel,
 which is subsequently replaced with connective fibrous tissue. In addition to the treatment
 of hemorrhoidal disease, polidocanol is used for sclerotherapy of varicose veins of the lower
 extremities and for the treatment of esophageal varices. The advantages of this sclerosing
 agent include a highly satisfactory efficiency, a low necrotic potential, and a good general
 tolerance. At the same time, it has a local anesthetic effect which permits almost painless
 sclerotherapy. Nevertheless, its use is contraindicated in patients with acute thromboembolic
 diseases and in those with allergy to the drug. Polidocanol can be used in its liquid or foam
 form. It has been proved the foam formulation allows for greater efficacy, since it requires
 lower doses of sclerosant agent. This is because the sclerotic effect is maximized by
 increasing the contact surface area with varices walls. This foam is previously prepared
 according to the Tessari's method, in which two 10 mL syringes are connected by a 3-way
 stopcock. The syringes contain air and a sclerosing agent (3% polydocanol), with a ratio of
 4:1, respectively, and twenty passages from one syringe to the other are made in order to
 obtain a sclerosing foam. Several studies reported the efficacy of the use of sclerotherapy
 with liquid polidocanol in hemorrhoidal disease. Specifically for the treatment of grade I
 hemorrhoids, there is one study showing the superiority of polidocanol foam compared to its
 liquid formulation. However, there's a lack of research about its use in hemorrhoidal disease
 other than grade I. The most common complications of sclerotherapy include minor discomfort
 or bleeding. Although it is a very safe treatment option, some serious side effects,
 including erectile dysfunction and urinary retention, have been reported. The proper
 injection technique of sclerosant is essential to avoid complications such as mucosal
 ulceration or necrosis, prostatic abscess and retroperitoneal sepsis. Sclerotherapy is a
 valid alternative when conservative therapy has failed. Moreover, this procedure can also be
 used for the treatment of patients whose hemorrhage is the main symptom, for patients on
 antithrombotic medication, as well as cirrhotic and immunocompromised patients.

 Surgical treatment is reserved for refractory cases to nonsurgical approaches, grade IV or
 mixed hemorrhoidal disease (internal and external components), symptomatic hemorrhoidal
 disease with concomitant anorectal pathology and lastly if it's the patient's choice.
 Although surgical approach is apparently more effective than instrumental treatment, it is
 also associated with substantial postsurgical morbidity, particularly postoperative pain and
 limitation in day-life activities. Several surgical methods have been described including
 open and closed hemorrhoidectomy, doppler guided hemorrhoidal artery ligation (HAL) and
 hemorrhoidectomy stapler. The choice of each method should consider the grade of hemorrhoidal
 disease and the predominant symptoms of the patient, together with the experience of the
 center.

 HAL technique involves the use of Doppler ultrasound and a specialized anoscope. The
 principles include the use of a Doppler probe to identify the six main feeding arteries
 within the anal canal and their ligation with absorbable suture above the dentate line,
 therefore associated with less pain. Finally, plication of redundant hemorrhoidal mucosa is
 performed (if there is hemorrhoidal or muco-hemorrhoidal prolapse), known as
 recto-anal-repair (RAR), mucopexy or hemorrhoidopexy. The aim of this recent surgical
 procedure is to treat patients' symptoms without tissue destruction. Early results of HAL
 were promising, with lower pain scores than hemorrhoidectomy, and relief of bleeding and
 tissue prolapse in over 90% of patients. Since then, several randomized clinical trials have
 been performed with mixed results. Currently, HAL remains a viable approach to multicolumn
 internal hemorrhoids. However, the short-term benefits regarding postoperative pain have
 recently not been as remarkable as in the earlier studies. Also, there has been a progressive
 increase in long term recurrence rates, especially for grade III and IV hemorrhoids.

 Some studies have been conducted with the purpose of comparing the efficacy of nonsurgical
 office-based treatments with surgical ones.

 A multicentric, open-label, randomized controlled trial, compared RBL and HAL, revealing
 higher efficacy of the surgical procedure. If, however, RBL is considered a course of
 treatment involving repeat banding, the procedures are equally effective. Besides, HAL was
 proved to be more painful than RBL. Another study comparing infrared photocoagulation with
 HAL showed that both procedures are minimally invasive and associated with minimal
 discomfort, but HAL is more effective than infrared photocoagulation in controlling symptoms
 of hemorrhoids. There has been no comparative studies between polidocanol foam sclerotherapy
 and hemorrhoidal artery ligation, to date.

 Therefore, the purpose of the present study is to evaluate and compare the safety and
 efficacy of the treatment of hemorrhoidal disease with polidocanol foam sclerotherapy and
 HAL-RAR.

 METHODS:

 Prospective, unicentric study (Centro Hospitalar Universitário do Porto) which is aimed to
 compare the efficacy and safety of the treatment techniques in patients with hemorrhoidal
 disease grade II and III.

 Patients referred were randomly allocated to one of the two treatments considered in this
 study (SP and HAL-RAR).

 All participants should have had prior endoscopic study, at least sigmoidoscopy, or total
 colonoscopy if they were older than 50 years or younger, with a family history of colorectal
 cancer, colon adenomas, or suspected inflammatory bowel disease.

 Only patients who agreed to informed consent were included, after a clear explanation of the
 type of study and the intervention that was going to be made.

 In screening visits, demographic and anthropometric data (such as age, sex, weight and
 height, education and employment status) were collected, as well as grade of hemorrhoidal
 disease. Baseline questionnaires were used to assess Sodergren's scale of symptoms and the
 severity of bleeding.

 Informed consent and an information brochure, explaining the study and adequate dietary and
 behavioral care, were provided. Additionally, all participants were given a direct contact
 for any doubts and notification of complications, in which case additional observation should
 be made.

 When office-based treatment was performed, an intervention period was considered, in which
 patients were observed at 3-week intervals (the required number of sessions, maximum of 3,
 depended on the clinical response - if 3 weeks after the previous treatment, the participant
 scored zero points in the Sodergren scale and had a hemorrhage grade ≤1, he was not a
 candidate for additional instrumental therapy.).

 Surgical treatment was performed only once. One month after this intervention period,
 Sodergren's scale of symptoms and severity of bleeding were reevaluated. In addition,
 complications registry, and implication in personal and professional life, measured in number
 of work-loss days, if applied, were also assessed. Patients was followed-up every 3 months
 for total of 6 months for evaluation of hemorrhoidal disease symptoms recurrence.
Inclusion Criteria:

 -  Patients older than 18 years with symptomatic hemorrhoidal disease grade II and III
 (Goligher's classification)

 -  Refractory to conservative therapy (dietary modification, intestinal transit
 modifiers, topical and phlebotonic medications) for a period of not less than 4 weeks

 Exclusion Criteria:

 -  Cirrhosis

 -  Pregnant or breast-feeding women

 -  Known allergy to polidocanol

 -  Another perianal disease that can cause symptoms similar to hemorrhoidal disease

 -  Colorectal malignancy

 -  Concomitant presence of external hemorrhoidal disease and/or hemorrhoidal thrombosis -
 - Office or surgical treatment for hemorrhoids within 6 months prior to inclusion

 -  Antiplatelet or hypocoagulant medication

 -  Hematological disorders

 -  Immunosuppressive states

 -  Inflammatory bowel disease

 -  Patients unable to have general or spinal anesthetic