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

Launched by SOCIETA ITALIANA DI CHIRURGIA COLORETTALE · Jan 1, 2019

Keywords

ClinConnect Summary

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 patie...

Gender

ALL

Eligibility 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