Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2022 Aug;26(8):627-636.
doi: 10.1007/s10151-022-02609-w. Epub 2022 Mar 25.

A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM)

G Gallo  1   2   3 , R Pietroletti  4 , E Novelli  5 , A Sturiale  6 , R Tutino  7 , P Lobascio  8 , R Laforgia  8 , E Moggia  9 , M Pozzo  10 , M Roveroni  11 , V Bianco  12 , A Realis Luc  13 , A Giuliani  14 , E Diaco  15 , G Naldini  6 , M Trompetto  13 , R Perinotti  10 , G Sammarco  16
Affiliations
Clinical Trial

A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM)

G Gallo et al. Tech Coloproctol. 2022 Aug.

Abstract

Background: The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids.

Methods: A multicentre, open-label, single-arm, phase 2 trial involving 10 tertiary referral centres for haemorrhodal disease (HD) was performed. Between January and June 2019, patients with 2nd-degree haemorrhoids were prospectively included in this study. The primary outcome was to establish the success rate after one sclerotherapy session in terms of complete resolution of bleeding episodes one week after the injection. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey incontinence score were used to assess symptoms and their impact on quality of life and continence. Pain after the procedure, subjective symptoms and the amount and type of painkillers used were recorded. Patients were followed up for 1 year.

Results: There were 183 patients [111 males; 60.7%, mean age 51.3 ± 13.5 (18-75) years]. Complete resolution of bleeding was reached in 125/183 patients (68.3%) at 1 week and the recurrence rate was 12% (15/125). Thirteen patients (7.4%) underwent a second sclerotherapy session, while only 1 patient (1.8%) had to undergo a third session. The overall 1-year success rate was 95.6% (175/183). The HDSS and the SHS score significantly improved from a median preoperative value of 11 and 18 to 0 and 0, respectively (p < 0.001). There were 3 episodes of external thrombosis. No serious adverse events occurred.

Conclusions: Sclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.

Keywords: Bleeding haemorrhoids; Haemorrhoidal disease; Polidocanol foam; Safety; Sclerotherapy.

PubMed Disclaimer

Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Schematic view of the effects of polidocanol on the cell membrane. The surface-active polidocanol molecules generate aggregations of molecules in the form of micelles that interact with the membrane of cells. The micelles dissolve essential molecules from the membrane, causing the affected cells to die
Fig. 2
Fig. 2
The procedure was performed in an outpatient setting with the patient in the Sims position with an open-ended anoscope and a 20G needle. 2 ml of polidocanol foam was injected above the dentate line, in each of the three classical piles
Fig. 3
Fig. 3
Kaplan–Meier curve concerning freedom from recurrence
Fig. 4
Fig. 4
Boxplots of HDSS score (a) and of SHS (b) from T0 to T5. HDSS Haemorrhoidal Disease Symptom Score, SHS Short Health Scale
See this image and copyright information in PMC

Comment in

  • The comeback of hemorrhoidal sclerotherapy?
    de Parades V, Aubert M, Fathallah N, Alam AA, Spindler L, Benfredj P. de Parades V, et al. Tech Coloproctol. 2022 Aug;26(8):599-601. doi: 10.1007/s10151-022-02640-x. Tech Coloproctol. 2022. PMID: 35737212 No abstract available.

References

    1. Gallo G, Sacco R, Sammarco G. Epidemiology of hemorrhoidal disease. In: Ratto C, Parello A, Litta F, editors. Hemorrhoids Coloproctology. Cham: Springer; 2018. pp. 3–7.
    1. Cosman BC. Piles of money: “Hemorrhoids” are a billion-dollar industry. Am J Gastroenterol. 2019;114(5):716–717. doi: 10.14309/ajg.0000000000000234. - DOI - PubMed
    1. Gallo G, Martellucci J, Sturiale A, Clerico G, Milito G, Marino F, Cocorullo G, Giordano P, Mistrangelo M, Trompetto M. Consensus statement of the Italian society of colorectal surgery (SICCR): management and treatment of hemorrhoidal disease. Tech Coloproctol. 2020;24(2):145–164. doi: 10.1007/s10151-020-02149-1. - DOI - PMC - PubMed
    1. Elbetti C, Giani I, Novelli E, Martellucci J, Feroci F. Symptomatic pile tailored procedure. A new perspective for hemorrhoidal disease treatment. Ann Ital Chir. 2017;88:348–351. - PubMed
    1. Lee MJ, Morgan J, Watson A, Jones GL, Brown SR. A validated severity score for haemorrhoids as an essential prerequisite for future haemorrhoid trial. Tech Coloproctol. 2019;23(1):33–41. doi: 10.1007/s10151-019-01936-9.]. - DOI - PMC - PubMed

Publication types