Polidocanol Foam VS Artery Ligation in Hemorrhoidal Disease

NCT ID: NCT04675177

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2020-03-25

Brief Summary

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.

Detailed Description

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.

Conditions

Hemorrhoids

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Polidocanol foam sclerotherapy

Patients submitted to polidocanol foam sclerotherapy

Group Type: ACTIVE_COMPARATOR

Polidocanol foam sclerotherapy

Intervention Type: DRUG

i. Patients underwent preparation, two hours before the intervention, with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed.

ii. Preparation of the polidocanol (Aethoxysklerol 3%) foam according to Tessari technique immediately before application, so that the "microbubbles" of the foam did not disintegrate; iii. The procedure was performed in the medical office. Application according to the Blanchard technique through a disposable transparent anoscope, in jackknife position, using a 20mL disposable syringe of the mixture (polidocanol + air) and a reusable 10 cm syringe extender adapted to an intravenous needle; iv. Patients were treated in a maximum of 3 sessions, at 3 weeks intervals; v. Maximum dose per treatment session of 20mL of mixture of 4mL of polidocanol 3% with 16mL of air; i. In each session, the sclerosant was injected in one or more hemorroidary cushion;

Doppler-guided hemorrhoidal artery ligation

Patients submitted to doppler-guided hemorrhoidal artery ligation

Group Type: ACTIVE_COMPARATOR

Doppler-guided hemorrhoidal artery ligation

Intervention Type: PROCEDURE

i. Patients underwent preparation with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed.

ii. The procedure was performed in the operating room of an outpatient surgery unit, under regional anestesia.

iii. A proctoscope with a Doppler transducer in its tip was introduced inside the anal canal to search for the superior rectal artery.

iv. Each branch was ligated with suture above the dentate line. The device was rotated slowly in clockwise direction to locate further arteries at that level.

v. Rectoanal repair consisted in a continuous running suture was applied longitudinally just over every prolapsed hemorrhoid.

Interventions

Polidocanol foam sclerotherapy

i. Patients underwent preparation, two hours before the intervention, with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed.

ii. Preparation of the polidocanol (Aethoxysklerol 3%) foam according to Tessari technique immediately before application, so that the "microbubbles" of the foam did not disintegrate; iii. The procedure was performed in the medical office. Application according to the Blanchard technique through a disposable transparent anoscope, in jackknife position, using a 20mL disposable syringe of the mixture (polidocanol + air) and a reusable 10 cm syringe extender adapted to an intravenous needle; iv. Patients were treated in a maximum of 3 sessions, at 3 weeks intervals; v. Maximum dose per treatment session of 20mL of mixture of 4mL of polidocanol 3% with 16mL of air; i. In each session, the sclerosant was injected in one or more hemorroidary cushion;

Intervention Type: DRUG

Doppler-guided hemorrhoidal artery ligation

i. Patients underwent preparation with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed.

ii. The procedure was performed in the operating room of an outpatient surgery unit, under regional anestesia.

iii. A proctoscope with a Doppler transducer in its tip was introduced inside the anal canal to search for the superior rectal artery.

iv. Each branch was ligated with suture above the dentate line. The device was rotated slowly in clockwise direction to locate further arteries at that level.

v. Rectoanal repair consisted in a continuous running suture was applied longitudinally just over every prolapsed hemorrhoid.

Intervention Type: PROCEDURE

Other Intervention Names

Aethoxysklerol 3%); HAL-RAR

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade do Porto

OTHER

Sponsor Role: lead

Responsible Party

Paulo Sérgio Durão Salgueiro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paulo Salgueiro, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Hospitalar Universitário do Porto

Locations

Centro Hospitalar Universitário do Porto

Porto, , Portugal

Countries

Portugal

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Other Identifiers

514741899

Identifier Type: -

Identifier Source: org_study_id