MedTrace Logo

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

NCT03791775 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 183

Last updated 2021-09-17

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • SICCR - Gaetano Gallo

    collaborator UNKNOWN

  • Societa Italiana di Chirurgia ColoRettale

    lead NETWORK

Principal Investigators

  • Gaetano Gallo, MD · Department of Medical and Surgical Sciences, University of Catanzaro, Catanzaro 88100, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-02
Primary Completion
2019-06-02
Completion
2020-06-02

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03791775 on ClinicalTrials.gov