Sclerotherapy with 3% polidocanol foam to treat second-degree haemorrhoidal disease: Three-year follow-up of a multicentre, single arm, IDEAL phase 2b trial.

BACKGROUND: Sclerotherapy with 3% polidocanol foam is becoming increasingly popular for the treatment of symptomatic I-II or III degree haemorrhoidal disease (HD). However, there are no studies that have reported a follow-up of more than 1 year. The purpose of this study was to analyse the long-term outcomes of sclerotherapy with 3% polidocanol foam in the treatment of II-degree HD. METHODS: This was an open label, single-arm, phase 2b trial conducted in 10 tertiary referral centres for HD. A total of 183 patients with II-degree HD, aged between 18 and 75 years with symptomatic HD according to the Goligher classification and unresponsive to medical treatment, were included in the study and underwent sclerotherapy with 3% polidocanol foam. The efficacy was evaluated in terms of bleeding score, haemorrhoidal disease symptom score (HDSS) and short health scale for HD (SHS-HD) score. Successful treatment was defined as the complete absence of bleeding episodes after 7 days (T1) according to the bleeding score. RESULTS: The overall success rate ranged from 95.6% (175/183) at 1 year to 90.2% (165/183) after the final 3 year follow-up. The recurrence rate, based on the primary outcome, ranged from 12% (15/125) to 28% (35/125). The greatest increase in recurrence (15) was recorded between 12 and 18 months of follow-up, then another five between 18 and 24 months. Both the HDSS and the SHS score remained statistically significant (p < 0.001) from a median preoperative value of 11 (10-13) and 18 (15-20) to 0 (0-2) and 4 (0-4), respectively. Symptom-free (HDSS = 0) patients, excluding patients converted to surgery, increased from 55.5% (101/182) at 1 year to 65.1% at 3 years (110/169). There were no intraoperative complications in redo-sclerotherapy nor additional adverse events (AEs) compared to the first 12 months. CONCLUSIONS: Sclerotherapy with 3% polidocanol foam is gradually establishing itself in the treatment of bleeding HD due to its repeatability, safety, convenience in terms of direct and indirect costs with the absence of discomfort for the patient as well as AEs rather than an excellent overall success rate.

Short-Term Results of Sclerotherapy with 3% Polidocanol Foam for Symptomatic Second- and Third-Degree Hemorrhoidal Disease.

BACKGROUND: Hemorrhoidal disease (HD) is defined as the symptomatic enlargement and/or distal displacement of anal cushions and is one of the most common proctological diseases. Sclerotherapy (ST) with 3% polidocanol foam induces an inflammatory reaction with sclerosis of the submucosal tissue and consequent suspension of the hemorrhoidal tissue. The aim of this study was to evaluate the short-term effectiveness and safety of ST with 3% polidocanol foam for the treatment of symptomatic second- and third-degree HD. METHODS: A total of 66 patients with symptomatic second- and third-degree HD underwent a single ST session between March 2017 and July 2018. A visual analog scale score was used to assess post-operative pain and patient satisfaction. The symptoms severity and anal continence were investigated through the Hemorrhoid Severity Score (HSS) and Vaizey score, respectively, at baseline, at 4 weeks and after 1 year. RESULTS: Fifty-seven out of 66 patients were male (86.3%), and the mean age was 52 (29-75; SD ± 12) years. The mean operative time was 4.5 (2-6; SD ± 1.23) minutes. No intraoperative complications and no drug-related side effects occurred. The overall success rate was 78.8% (52/66 patients) after a single ST session and 86% after two ST sessions (57/66 patients). The mean treatment effect, obtained comparing preoperative and 12 months symptom scores in each patient, showed a median change of 8 (p < 0.001). All patients resumed their normal daily activities the day after the procedures. CONCLUSIONS: ST with 3% polidocanol foam is a safe, cost-effective and repeatable conservative treatment.

Symptomatic pile tailored procedure. A new perspective for hemorrhoidal disease treatment.

AIM: Aim of the present paper was to evaluate the role of tailored different single pile treatment in the clinical outcome of hemorrhoids. MATERIAL OF STUDY: The surgical strategy considered to treat only pathological piles with different procedure according to each pathological Goligher's degree, presence of fibrous, inelastic redundant internal pile(F) and presence of external pathological pile (external pile congestion or subversion of dental line (E) and skin tag not tolerated from the patient (S)). We treated with Hemorrhoidopexy second and third degree pile without F or ES; with Hemorrhoidopexy and excision of external component every second and third degree pile with E or S and with complete semi-closed pile excision all third degree with F and IV degree piles. The number of post operative days of self administered analgesics was the primary end point and short/long term post operative complications, hospital stay, re-admission and recurrence were secondary end points. RESULTS: 157 patients were treated. No differences were noted in term of time of discharge between hemorrhoidopexy and complete or external excision. The painkiller assumption increases with the number of treated pile (r= 0.227, p=0.006). We observed 10.2% early complications (48h) all secondary to urinary retention and 7% late complications (2-15days) within only one reoperation for bleeding. After mean follow up of 16 months no patients required further treatments for hemorrhoids. DISCUSSIONS: A tailored approach showed to be effective in terms of short and long term complications and moreover to relapse. CONCLUSIONS: Single pile tailored treatment showed good results. KEY WORDS: Excision, Hemorrhoids, Hemorrhoidectomy, Hemorrhoidopexy, Pain, Tailored.