Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease
Condition: Second-degree Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional
Phase: Phase 2

Summary: 
      Hemorrhoidal disease (HD) is one of the oldest and most common proctologic diseases that has
      been described with an estimated prevalence between 4.4% and 86%. Despite the proposal of
      three mechanisms that might underlie haemorrhoidal development - the varicose vein theory,
      the vascular hyperplasia theory and the sliding anal-lining theory, the exact pathophysiology
      of symptomatic hemorrhoid disease is poorly understood.

      HD seems to be the most common cause for rectal bleeding, or hematochezia, and the second
      most frequent cause for severe rectorrhagia after diverticulitis. The blood is bright red and
      coats the stool at the end of defection. Other symptoms include pain, mucous discharge,
      itching or the sensation of tissue prolapse.

      The most widely accepted classification is the Goligher classification:

        -  Grade I: hemorrhoids bleed but do not prolapse out of the anal canal;

        -  Grade II: hemorrhoidal cushions prolapse outside of the anal canal on straining or
           during bowel movements, but reduce spontaneously;

        -  Grade III: hemorrhoidal cushions prolapse outside the anal canal on straining and
           require manual reduction;

        -  Grade IV: hemorrhoidal prolapse is irreducible even with manipulation
    

Detailed description: 
      As reported by the guidelines of the Italian Society of Colorectal Surgery, in case of
      failure of conservative therapies the most common outpatient treatments for first- and
      second-degree Hemorrhoidal Disease (HD) are rubber band ligation and sclerotherapy.

      Sclerotherapy causes an inflammatory reaction with local sclerosis of the submucosal tissue
      and a consequent fixation of the haemorrhoidal tissue to the underlying tissue. Moreover, the
      effect of sclerosing solutions is that of making vascular damage via producing endothelial
      injury.

      A 100% improvement in bleeding was reported in patients with II and grade III hemorrhoids,
      and a complete resolution of the condition was described in 69% of non-selected patients, 52%
      in grade III and 88% in grade I. Resolution of prolapse was reported in 90-100% of patients
      affected by grade II hemorrhoids. Complications are rare but serious, and include impotence,
      irreversible necrotizing fasciitis and abdominal compartment syndrome [31-33]. In Germany,
      sclerotherapy with liquid agents is considered the first choice in treating grade I
      hemorrhoids. The only approved medical product by German authorities is polidocanol
      (Lauromacrogol 400 (INN), H3C-(CH2)11-(O-CH2-CH2)n∼9-OH), produced by Chemische Fabrik
      Kreussler & Co. GmbH.

      In Italy, this drug is known as Atossisclerol 3%. The polidocanol is a non-ionic detergent
      made up of a chain of hydrophilic polyethylene oxide mixed with aliphatic hydrophobic dodecyl
      alcohol and it is recommended for first- and second-degree HD. The effects of polidocanol are
      similar to those of phenol oil but less number of side effects.

      Based on these experiences, Karl-Heinz Moser introduced the use of polidocanol foam in the
      treatment of grade I hemorrhoids. In 2013, the same author published the results of a
      randomized, controlled, single blind, multicentre trial on the efficacy and safety of
      sclerotherapy with polidocanol foam in comparison with liquid sclerosant agents in treating
      grade I hemorrhoids [28]. In the foam group success rate after one sclerotherapy session was
      88%, while success rate among patients treated with liquid polidocanol was 69%. Furthermore,
      patients treated with foam were more satisfied than those treated with liquid polidocanol
      (99% vs. 84% p=0.009). Finally, the quantity of polidocanol injected in the foam group was
      significantly lower (p<0.001), as well as the number of sessions requested (p<0.001).

      In summary, according to the authors, these results suggest that polidocanol foam can be used
      as the treatment of choice in grade I HD.

      The aim of this study is to evaluate the efficacy and safety of sclerotherapy with 3%
      polidocanol foam (PF) on patients affected by second-degree HD.
    

Intervention name(s): Polidocanol foam (Atossisclerol® 3%)
Intervention type(s): Drug
Intervention description(s): The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding
Intervention MeSH terms: Polidocanol
Intervention model: Single Group Assignment
Intervention model description: Patients enrolled in the study, according to the inclusion and exclusion criteria, will undergo sclerotherapy performed with polidocanol foam (Atossisclerol® 3%, Chemische Fabrik Kreussler & Co. GmbH, Wiesbaden, Germany).
The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemorrhoids; Sclerotherapy; Polidocanol 3%; Non-surgical treatments