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Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease

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ClinicalTrials.gov Identifier: NCT03791775
Recruitment Status : Recruiting
First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
SICCR - Gaetano Gallo
Information provided by (Responsible Party):
Societa Italiana di Chirurgia ColoRettale

Brief 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

Condition or disease Intervention/treatment Phase
Second-degree Hemorrhoids Drug: Polidocanol foam (Atossisclerol® 3%) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
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
Official Title: Phase II Trial on the Efficacy and Safety of Sclerotherapy Using 3% Polidocanol Foam to Treat Second-degree Hemorrhoidal Disease
Actual Study Start Date : December 1, 2018
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids
Drug Information available for: Polidocanol

Arm Intervention/treatment
Experimental: Polidocanol 3% Foam
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).
Drug: Polidocanol foam (Atossisclerol® 3%)
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 Outcome Measures :
  1. Success Rate 1 [ Time Frame: 6 months follow-up ]
    To establish the success rate after one sclerotherapy session, in terms of complete resolution of bleeding episodes one week after the injection.


Secondary Outcome Measures :
  1. Success Rate 2 [ Time Frame: 6 months follow-up ]
    To establish the success rate in terms of partial or complete resolution of the symptoms

  2. Success Rate 3 [ Time Frame: 6 months follow-up ]
    To establish the success rate in terms of reduction or resolution of the hemorrhoidal prolapse

  3. Number of outpatient sessions [ Time Frame: 6 months follow-up ]
    To evaluate the average number of outpatient sessions necessary for treatment success

  4. Rate of complications [ Time Frame: 6 months follow-up ]
    To establish the rate of complications

  5. Quality of Life [ Time Frame: 6 months follow-up ]
    To evaluate patient satisfaction (Visual Analog Score 0-99mm)

  6. To establish the average time required to reach autonomy [ Time Frame: 6 months follow-up ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients above 18 and below 75 years of age with a confirmed diagnosis of second-degree HD (proctological examination, proctoscopy and, if required, colonoscopy)
  2. Patients who report persistent perianal bleeding as a typical symptom of second-degree HD
  3. Informed consent from each patient must be obtained
  4. Participating centres will be asked to confirm that they have gained formal approval at their site

Exclusion Criteria:

  1. Previous anal surgical procedures
  2. Previous sclerotherapy or rubber band ligation in the last 12 months
  3. Positive pregnancy test
  4. Patients with inability to return for postoperative control visits, to sign the informed consent or to fill out the required clinical diary
  5. Breast-feeding
  6. Known allergy to polidocanol
  7. Acute perianal thrombosis
  8. Anal fistula
  9. Anal fissure
  10. Proctitis
  11. Fecal incontinence
  12. Coagulation disorders
  13. Anticoagulant therapy
  14. Known HBV, HCV and HIV infection
  15. Acite Crohn's disease or Ulcerative colitis
  16. Diabetes mellitus I and II
  17. COPD
  18. Any kind of tumour
  19. Previous pelvic radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03791775


Contacts
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Contact: Gaetano Gallo, MD +393284385222 gaetanogallo1988@gmail.com

Locations
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Italy
University of Catanzaro Recruiting
Catanzaro, Italy, 88100
Contact: Gaetano Gallo, MD    +393284385222    gaetanogallo1988@gmail.com   
Sponsors and Collaborators
Societa Italiana di Chirurgia ColoRettale
SICCR - Gaetano Gallo
Investigators
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Principal Investigator: Gaetano Gallo, MD Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro 88100, Italy

Publications of Results:

Other Publications:
Akerud L (1995) Sclerotherapy of haemorrhoids: a prospective randomised trial of polidocanol and phenol in oil. Coloproctology 17:73-86
Moser KH (2007) Evaluation of the efficacy and safety of polidocanol foam in the sclerotherapy of first degree bleeding haemorrhoids. Phlebol Rev (Przeglad Flebologiczny) 15:103-106
Blanchard CE (1928) Textbook of ambulant proctology p. 134. Medical Success Press, Youngstown Ohio
Gallo G, Sacco R, Sammarco G (2018) Epidemiology of Hemorrhoidal Disease. In: Hemorrhoids. Coloproctology (eds Ratto C, Parello A, Litta F), vol 2. Cham: Springer pp. 3-7

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Responsible Party: Societa Italiana di Chirurgia ColoRettale
ClinicalTrials.gov Identifier: NCT03791775    
Other Study ID Numbers: 274/2018
First Posted: January 3, 2019    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Societa Italiana di Chirurgia ColoRettale:
Hemorrhoids
Sclerotherapy
Polidocanol 3%
Non-surgical treatments
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Polidocanol
Sclerosing Solutions
Pharmaceutical Solutions