Status:
COMPLETED
Efficacy and Safety of Polidocanol Foam 3% in the Treatment of II Degree Hemorrhoidal Disease
Lead Sponsor:
Societa Italiana di Chirurgia ColoRettale
Collaborating Sponsors:
SICCR - Gaetano Gallo
Conditions:
Second-degree Hemorrhoids
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Diabetes mellitus I and II
- COPD
- Any kind of tumour
- Previous pelvic radiotherapy
Key Trial Info
Start Date :
January 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2020
Estimated Enrollment :
183 Patients enrolled
Trial Details
Trial ID
NCT03791775
Start Date
January 2 2019
End Date
June 2 2020
Last Update
September 17 2021
Active Locations (1)
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1
University of Catanzaro
Catanzaro, Italy, 88100