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).

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.

Perineal stapled prolapse resection for full-thickness external rectal prolapse: a multicentre prospective study.

AIM: Many different surgical techniques have been reported for the surgical treatment of full-thickness external rectal prolapse. Perianal stapled prolapse resection (PSP) is a relatively newly reported technique for full thickness external rectal prolapse. The aim of this prospective multicentre study was to evaluate the results of this procedure. METHOD: Consecutive patients who underwent a PSP resection for full-thickness external rectal prolapse at five centres were recruited to the study. Median operating time, hospital stay, complications, recurrence and functional results according to the Wexner Incontinence Scale and obstructive defaecation syndrome score were recorded. RESULTS: There were 27 patients treated by PSP. The median Wexner incontinence score improved from 10 presurgery to 5 after surgery (P < 0.001); the median obstructed defaecation syndrome score improved from 12 presurgery to 5 (range 4-10) after surgery (P < 0.001). A laparoscopically assisted procedure was performed in three patients (11.1%). The median number of cartridges used was six (range four to nine). The median operating time was 48 min. Early complications occurred in six patients (22.2%) and late complications in two (7.4%). The median length of hospital stay was 5 days. The recurrence rate at a median follow-up of 30.3 months was 14.8%. CONCLUSION: PSP appears to be an easy, fast and safe procedure. Early functional results are good. The recurrence rate compares favourably with other perineal procedures like the Delorme or the Altemeier operations. Long-term functional results need to be investigated further.