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

• Status: Completed
• Trial end date: 2020-06-02
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Societa Italiana di Chirurgia ColoRettale
• Collaborator: SICCR - Gaetano Gallo
• Treatments: Polidocanol

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