<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03791775</url>
  </required_header>
  <id_info>
    <org_study_id>274/2018</org_study_id>
    <nct_id>NCT03791775</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease</brief_title>
  <acronym>SCLEROFOAM</acronym>
  <official_title>A Multicentre, Open-label, Single-arm Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3% Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Societa Italiana di Chirurgia ColoRettale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SICCR - Gaetano Gallo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Societa Italiana di Chirurgia ColoRettale</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hemorrhoidal disease (HD) is one of the oldest and most common proctologic diseases that has&#xD;
      been described with an estimated prevalence between 4.4% and 86%. Despite the proposal of&#xD;
      three mechanisms that might underlie haemorrhoidal development - the varicose vein theory,&#xD;
      the vascular hyperplasia theory and the sliding anal-lining theory, the exact pathophysiology&#xD;
      of symptomatic hemorrhoid disease is poorly understood.&#xD;
&#xD;
      HD seems to be the most common cause for rectal bleeding, or hematochezia, and the second&#xD;
      most frequent cause for severe rectorrhagia after diverticulitis. The blood is bright red and&#xD;
      coats the stool at the end of defection. Other symptoms include pain, mucous discharge,&#xD;
      itching or the sensation of tissue prolapse.&#xD;
&#xD;
      The most widely accepted classification is the Goligher classification:&#xD;
&#xD;
        -  Grade I: hemorrhoids bleed but do not prolapse out of the anal canal;&#xD;
&#xD;
        -  Grade II: hemorrhoidal cushions prolapse outside of the anal canal on straining or&#xD;
           during bowel movements, but reduce spontaneously;&#xD;
&#xD;
        -  Grade III: hemorrhoidal cushions prolapse outside the anal canal on straining and&#xD;
           require manual reduction;&#xD;
&#xD;
        -  Grade IV: hemorrhoidal prolapse is irreducible even with manipulation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As reported by the guidelines of the Italian Society of Colorectal Surgery, in case of&#xD;
      failure of conservative therapies the most common outpatient treatments for first- and&#xD;
      second-degree Hemorrhoidal Disease (HD) are rubber band ligation and sclerotherapy.&#xD;
&#xD;
      Sclerotherapy causes an inflammatory reaction with local sclerosis of the submucosal tissue&#xD;
      and a consequent fixation of the haemorrhoidal tissue to the underlying tissue. Moreover, the&#xD;
      effect of sclerosing solutions is that of making vascular damage via producing endothelial&#xD;
      injury.&#xD;
&#xD;
      A 100% improvement in bleeding was reported in patients with II and grade III hemorrhoids,&#xD;
      and a complete resolution of the condition was described in 69% of non-selected patients, 52%&#xD;
      in grade III and 88% in grade I. Resolution of prolapse was reported in 90-100% of patients&#xD;
      affected by grade II hemorrhoids. Complications are rare but serious, and include impotence,&#xD;
      irreversible necrotizing fasciitis and abdominal compartment syndrome [31-33]. In Germany,&#xD;
      sclerotherapy with liquid agents is considered the first choice in treating grade I&#xD;
      hemorrhoids. The only approved medical product by German authorities is polidocanol&#xD;
      (Lauromacrogol 400 (INN), H3C-(CH2)11-(O-CH2-CH2)n∼9-OH), produced by Chemische Fabrik&#xD;
      Kreussler &amp; Co. GmbH.&#xD;
&#xD;
      In Italy, this drug is known as Atossisclerol 3%. The polidocanol is a non-ionic detergent&#xD;
      made up of a chain of hydrophilic polyethylene oxide mixed with aliphatic hydrophobic dodecyl&#xD;
      alcohol and it is recommended for first- and second-degree HD. The effects of polidocanol are&#xD;
      similar to those of phenol oil but less number of side effects.&#xD;
&#xD;
      Based on these experiences, Karl-Heinz Moser introduced the use of polidocanol foam in the&#xD;
      treatment of grade I hemorrhoids. In 2013, the same author published the results of a&#xD;
      randomized, controlled, single blind, multicentre trial on the efficacy and safety of&#xD;
      sclerotherapy with polidocanol foam in comparison with liquid sclerosant agents in treating&#xD;
      grade I hemorrhoids [28]. In the foam group success rate after one sclerotherapy session was&#xD;
      88%, while success rate among patients treated with liquid polidocanol was 69%. Furthermore,&#xD;
      patients treated with foam were more satisfied than those treated with liquid polidocanol&#xD;
      (99% vs. 84% p=0.009). Finally, the quantity of polidocanol injected in the foam group was&#xD;
      significantly lower (p&lt;0.001), as well as the number of sessions requested (p&lt;0.001).&#xD;
&#xD;
      In summary, according to the authors, these results suggest that polidocanol foam can be used&#xD;
      as the treatment of choice in grade I HD.&#xD;
&#xD;
      The aim of this study is to evaluate the efficacy and safety of sclerotherapy with 3%&#xD;
      polidocanol foam (PF) on patients affected by second-degree HD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">June 2, 2020</completion_date>
  <primary_completion_date type="Actual">June 2, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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 &amp; Co. GmbH, Wiesbaden, Germany).&#xD;
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_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Success Rate 1</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>To establish the success rate after one sclerotherapy session, in terms of complete resolution of bleeding episodes one week after the injection&#xD;
Bleeding will be assessed using both the Hemorrhoidal Disease Symptoms Score and the Giamundo score.&#xD;
Rørvik HD et al (2019) Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum; 62:333-342&#xD;
Giamundo et al (2018) Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial. Tech Coloproctol; 25:635-643</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Success Rate 2</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>To establish the success rate in terms of partial or complete resolution of the symptoms&#xD;
Symptoms will be assessed using the Hemorrhoidal Disease Symptom Score described by Rorvik HD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of outpatient sessions</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>To evaluate the average number of outpatient sessions necessary for treatment success</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of complications - adverse events</measure>
    <time_frame>6 months follow-up</time_frame>
    <description>To establish the rate of complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>Short Health Scale HD&#xD;
4 questions with 7-point Liker scale each (1 = very dissatisfied, 7 = very satisfied)&#xD;
Minimum = 4&#xD;
Maximum = 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To establish the average time required to reach autonomy</measure>
    <time_frame>12 months follow-up</time_frame>
    <description>We considered autonomy as the return to normal activity: it includes also the return to work apart from cases of retired patients in which we considered it as the complete return to daily activities</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">183</enrollment>
  <condition>Second-degree Hemorrhoids</condition>
  <arm_group>
    <arm_group_label>Polidocanol 3% Foam</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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 &amp; Co. GmbH, Wiesbaden, Germany).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polidocanol foam (Atossisclerol® 3%)</intervention_name>
    <description>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</description>
    <arm_group_label>Polidocanol 3% Foam</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients above 18 and below 75 years of age with a confirmed diagnosis of&#xD;
             second-degree HD (proctological examination, proctoscopy and, if required,&#xD;
             colonoscopy)&#xD;
&#xD;
          2. Patients who report persistent perianal bleeding as a typical symptom of second-degree&#xD;
             HD&#xD;
&#xD;
          3. Informed consent from each patient must be obtained&#xD;
&#xD;
          4. Participating centres will be asked to confirm that they have gained formal approval&#xD;
             at their site&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous anal surgical procedures&#xD;
&#xD;
          2. Previous sclerotherapy or rubber band ligation in the last 12 months&#xD;
&#xD;
          3. Positive pregnancy test&#xD;
&#xD;
          4. Patients with inability to return for postoperative control visits, to sign the&#xD;
             informed consent or to fill out the required clinical diary&#xD;
&#xD;
          5. Breast-feeding&#xD;
&#xD;
          6. Known allergy to polidocanol&#xD;
&#xD;
          7. Acute perianal thrombosis&#xD;
&#xD;
          8. Anal fistula&#xD;
&#xD;
          9. Anal fissure&#xD;
&#xD;
         10. Proctitis&#xD;
&#xD;
         11. Fecal incontinence&#xD;
&#xD;
         12. Coagulation disorders&#xD;
&#xD;
         13. Anticoagulant therapy&#xD;
&#xD;
         14. Known HBV, HCV and HIV infection&#xD;
&#xD;
         15. Acite Crohn's disease or Ulcerative colitis&#xD;
&#xD;
         16. Diabetes mellitus I and II&#xD;
&#xD;
         17. COPD&#xD;
&#xD;
         18. Any kind of tumour&#xD;
&#xD;
         19. Previous pelvic radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gaetano Gallo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro 88100, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Catanzaro</name>
      <address>
        <city>Catanzaro</city>
        <zip>88100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
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    <citation>Akerud L (1995) Sclerotherapy of haemorrhoids: a prospective randomised trial of polidocanol and phenol in oil. Coloproctology 17:73-86</citation>
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  </results_reference>
  <results_reference>
    <citation>Barwell J, Watkins RM, Lloyd-Davies E, Wilkins DC. Life-threatening retroperitoneal sepsis after hemorrhoid injection sclerotherapy: report of a case. Dis Colon Rectum. 1999 Mar;42(3):421-3. doi: 10.1007/BF02236364.</citation>
    <PMID>10223767</PMID>
  </results_reference>
  <results_reference>
    <citation>Kaman L, Aggarwal S, Kumar R, Behera A, Katariya RN. Necrotizing fascitis after injection sclerotherapy for hemorrhoids: report of a case. Dis Colon Rectum. 1999 Mar;42(3):419-20. doi: 10.1007/BF02236363.</citation>
    <PMID>10223766</PMID>
  </results_reference>
  <results_reference>
    <citation>Wollmann JC. The history of sclerosing foams. Dermatol Surg. 2004 May;30(5):694-703; discussion 703. doi: 10.1111/j.1524-4725.2004.30208.x. Erratum In: Dermatol Surg. 2005 Feb;31(2):249.</citation>
    <PMID>15099310</PMID>
  </results_reference>
  <results_reference>
    <citation>Yamaki T, Nozaki M, Iwasaka S. Comparative study of duplex-guided foam sclerotherapy and duplex-guided liquid sclerotherapy for the treatment of superficial venous insufficiency. Dermatol Surg. 2004 May;30(5):718-22; discussion 722. doi: 10.1111/j.1524-4725.2004.30202.x.</citation>
    <PMID>15099313</PMID>
  </results_reference>
  <results_reference>
    <citation>Rabe E, Otto J, Schliephake D, Pannier F. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg. 2008 Feb;35(2):238-45. doi: 10.1016/j.ejvs.2007.09.006. Epub 2007 Nov 7.</citation>
    <PMID>17988905</PMID>
  </results_reference>
  <results_reference>
    <citation>Ouvry P, Allaert FA, Desnos P, Hamel-Desnos C. Efficacy of polidocanol foam versus liquid in sclerotherapy of the great saphenous vein: a multicentre randomised controlled trial with a 2-year follow-up. Eur J Vasc Endovasc Surg. 2008 Sep;36(3):366-70. doi: 10.1016/j.ejvs.2008.04.010. Epub 2008 Jun 3.</citation>
    <PMID>18524643</PMID>
  </results_reference>
  <results_reference>
    <citation>BARRON J. Office ligation of internal hemorrhoids. Am J Surg. 1963 Apr;105:563-70. doi: 10.1016/0002-9610(63)90332-5. No abstract available.</citation>
    <PMID>13969563</PMID>
  </results_reference>
  <results_reference>
    <citation>Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.</citation>
    <PMID>30451751</PMID>
  </results_reference>
  <results_reference>
    <citation>Giamundo P, Braini A, Calabro' G, Crea N, De Nardi P, Fabiano F, Lippa M, Mastromarino A, Tamburini AM. Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial. Tech Coloproctol. 2018 Aug;22(8):635-643. doi: 10.1007/s10151-018-1839-5. Epub 2018 Aug 29.</citation>
    <PMID>30159627</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>September 11, 2021</last_update_submitted>
  <last_update_submitted_qc>September 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemorrhoids</keyword>
  <keyword>Sclerotherapy</keyword>
  <keyword>Polidocanol 3%</keyword>
  <keyword>Non-surgical treatments</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Polidocanol</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03791775
org study id: 274/2018
nct id: NCT03791775
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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
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.
allocation: N/A
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
primary purpose: Treatment
masking: None (Open Label)
measure: Success Rate 1
time frame: 12 months follow-up
description: To establish the success rate after one sclerotherapy session, in terms of complete resolution of bleeding episodes one week after the injection
Bleeding will be assessed using both the Hemorrhoidal Disease Symptoms Score and the Giamundo score.
Rørvik HD et al (2019) Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum; 62:333-342
Giamundo et al (2018) Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial. Tech Coloproctol; 25:635-643
measure: Success Rate 2
time frame: 12 months follow-up
description: To establish the success rate in terms of partial or complete resolution of the symptoms
Symptoms will be assessed using the Hemorrhoidal Disease Symptom Score described by Rorvik HD
measure: Number of outpatient sessions
time frame: 12 months follow-up
description: To evaluate the average number of outpatient sessions necessary for treatment success
measure: Rate of complications - adverse events
time frame: 6 months follow-up
description: To establish the rate of complications
measure: Quality of Life
time frame: 12 months follow-up
description: Short Health Scale HD
4 questions with 7-point Liker scale each (1 = very dissatisfied, 7 = very satisfied)
Minimum = 4
Maximum = 28
measure: To establish the average time required to reach autonomy
time frame: 12 months follow-up
description: We considered autonomy as the return to normal activity: it includes also the return to work apart from cases of retired patients in which we considered it as the complete return to daily activities
arm group label: Polidocanol 3% Foam
arm group type: Experimental
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).
intervention type: Drug
intervention name: Polidocanol foam (Atossisclerol® 3%)
description: 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
arm group label: Polidocanol 3% Foam
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Gaetano Gallo, MD
role: Principal Investigator
affiliation: Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro 88100, Italy
facility: 
country: Italy
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citation: Barwell J, Watkins RM, Lloyd-Davies E, Wilkins DC. Life-threatening retroperitoneal sepsis after hemorrhoid injection sclerotherapy: report of a case. Dis Colon Rectum. 1999 Mar;42(3):421-3. doi: 10.1007/BF02236364.
PMID: 10223767
citation: Kaman L, Aggarwal S, Kumar R, Behera A, Katariya RN. Necrotizing fascitis after injection sclerotherapy for hemorrhoids: report of a case. Dis Colon Rectum. 1999 Mar;42(3):419-20. doi: 10.1007/BF02236363.
PMID: 10223766
citation: Wollmann JC. The history of sclerosing foams. Dermatol Surg. 2004 May;30(5):694-703; discussion 703. doi: 10.1111/j.1524-4725.2004.30208.x. Erratum In: Dermatol Surg. 2005 Feb;31(2):249.
PMID: 15099310
citation: Yamaki T, Nozaki M, Iwasaka S. Comparative study of duplex-guided foam sclerotherapy and duplex-guided liquid sclerotherapy for the treatment of superficial venous insufficiency. Dermatol Surg. 2004 May;30(5):718-22; discussion 722. doi: 10.1111/j.1524-4725.2004.30202.x.
PMID: 15099313
citation: Rabe E, Otto J, Schliephake D, Pannier F. Efficacy and safety of great saphenous vein sclerotherapy using standardised polidocanol foam (ESAF): a randomised controlled multicentre clinical trial. Eur J Vasc Endovasc Surg. 2008 Feb;35(2):238-45. doi: 10.1016/j.ejvs.2007.09.006. Epub 2007 Nov 7.
PMID: 17988905
citation: Ouvry P, Allaert FA, Desnos P, Hamel-Desnos C. Efficacy of polidocanol foam versus liquid in sclerotherapy of the great saphenous vein: a multicentre randomised controlled trial with a 2-year follow-up. Eur J Vasc Endovasc Surg. 2008 Sep;36(3):366-70. doi: 10.1016/j.ejvs.2008.04.010. Epub 2008 Jun 3.
PMID: 18524643
citation: BARRON J. Office ligation of internal hemorrhoids. Am J Surg. 1963 Apr;105:563-70. doi: 10.1016/0002-9610(63)90332-5. No abstract available.
PMID: 13969563
citation: Rorvik HD, Styr K, Ilum L, McKinstry GL, Dragesund T, Campos AH, Brandstrup B, Olaison G. Hemorrhoidal Disease Symptom Score and Short Health ScaleHD: New Tools to Evaluate Symptoms and Health-Related Quality of Life in Hemorrhoidal Disease. Dis Colon Rectum. 2019 Mar;62(3):333-342. doi: 10.1097/DCR.0000000000001234.
PMID: 30451751
citation: Giamundo P, Braini A, Calabro' G, Crea N, De Nardi P, Fabiano F, Lippa M, Mastromarino A, Tamburini AM. Doppler-guided hemorrhoidal dearterialization with laser (HeLP): a prospective analysis of data from a multicenter trial. Tech Coloproctol. 2018 Aug;22(8):635-643. doi: 10.1007/s10151-018-1839-5. Epub 2018 Aug 29.
PMID: 30159627
responsible party type: Sponsor
mesh term: Hemorrhoids
mesh term: Polidocanol