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

NCT03791775 | Completed Phase 2 DMC

• 1 other identifier: 274/2018
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

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

Conditions

Second-degree Hemorrhoids

Keywords

Hemorrhoids; Sclerotherapy; Polidocanol 3%; Non-surgical treatments

Outcome Measures

Primary Outcomes (1)

• Success Rate 1

  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

  12 months follow-up

Secondary Outcomes (5)

• Success Rate 2

  12 months follow-up

• Number of outpatient sessions

  12 months follow-up

• Rate of complications - adverse events

  6 months follow-up

• Quality of Life

  12 months follow-up

• To establish the average time required to reach autonomy

  12 months follow-up

Study Arms (1)

Polidocanol 3% Foam

EXPERIMENTAL

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%)

Interventions

Polidocanol foam (Atossisclerol® 3%) DRUG

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

Polidocanol 3% Foam

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Previous anal surgical procedures
• Previous sclerotherapy or rubber band ligation in the last 12 months
• Positive pregnancy test
• Patients with inability to return for postoperative control visits, to sign the informed consent or to fill out the required clinical diary
• Breast-feeding
• Known allergy to polidocanol
• Acute perianal thrombosis
• Anal fistula
• Anal fissure
• Proctitis
• Fecal incontinence
• Coagulation disorders
• Anticoagulant therapy
• Known HBV, HCV and HIV infection
• Acite Crohn's disease or Ulcerative colitis

Sponsors & Collaborators

• Societa Italiana di Chirurgia ColoRettale: lead
• SICCR - Gaetano Gallo: collaborator

Study Sites (1)

University of Catanzaro

Catanzaro, 88100, Italy

Location

Related Publications (47)

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MeSH Terms

Conditions

Hemorrhoids

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gaetano Gallo, MD

  Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro 88100, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 29, 2018
• First Posted: January 3, 2019
• Study Start: January 2, 2019
• Primary Completion: June 2, 2019
• Study Completion: June 2, 2020
• Last Updated: September 17, 2021

Record last verified: 2021-09

Locations

IT (1)