Between March 2017 to July 2018, 66 patients with symptomatic second- and third-degree HD underwent to a single ST session with 3% polidocanol foam. Demographic data, the degree and symptoms of HD, patient satisfaction and operative details were collected in our prospective PC database.
Patients who had history of coagulopathy, cardiac disease, anticoagulant therapies, colorectal or anal neoplasia, inflammatory bowel disease (IBD), other proctological disease (anal fistulas and fissures), or pelvic radiotherapy were excluded. The inability to return for post-operative control visits and a well-known allergy to polidocanol were also considered exclusion criteria. Written informed consent was obtained from all the patients.
Proctological examination and proctoscopy were performed to assess the grade of HD according the Goligher classification [18] and to exclude any associated anorectal pathology.
All patients underwent treatment performed by the same colorectal surgeon.
After the procedure the patients were observed for two hours before being discharged in order to exclude serious adverse drug reactions or post-operative complications. A visual analogue scale (VAS) score was used to assess post-operative pain and patient satisfaction (0 = minimum, 10 = maximum). Vaizey incontinence score [19] was used to evaluate the anal continence, before the procedure, at 4 weeks and 1 year after surgery.
At each visit patients were also asked about pruritus ani, tenesmus, soiling and thrombosis using a dichotomous parameter (yes or not) based on a clinical diary delivered at the time of discharge. Furthermore, the symptoms severity was investigated through a self-reported questionnaire [20] before the operation, at 4 weeks and at the final follow-up visit 1 year after surgery.
The severity of bleeding was assessed by the number of bleeding episodes per day. Bleeding was defined as persistent in cases of more than 3 episodes after day 2 following ST. Conversely, we defined occasional as less than 3 episodes.
The occurrence of adverse drug reactions was recorded as well.
Patients were followed up by the same colorectal surgeon who had performed the procedures after 1 week (T1), 4 weeks (T2), 3 months (T3), 6 months (T4) and 12 months (T5).
Follow-up consisted of clinical external evaluation at T1, and clinical evaluation, rectal digital exploration and anoscopy from T2 to T5.
No antibiotics were prescribed during the post-operative period, but stool softeners were prescribed for 7 days, and simple analgesics were prescribed in cases of pain or discomfort (1000 mg of paracetamol and/or 10 mg of ketorolac tromethamine every 4–6 hours maximum).
Successful treatment was defined as the absence of any episode of persistent bleeding or prolapse within T5.
Autonomy was defined as the return to normal daily activities, including work.
Recurrences were defined as the presence of persistent bleeding in case of second-degree HD or persistent bleeding and prolapse in case of third-degree HD.
Technique
The mousse was obtained following the Moser technique [10], and the amount of foam injected for each single pile was 2 mL of 3% polidocanol. Before each injection, the foam already obtained was re-emulsified for 20 seconds.
All patients were treated in the Sims position in our outpatient clinic using a modified Blonde-Blanchard technique with injections of polidocanol foam in the three “classical” piles at 3, 7 and 11 o’clock [21]. The patients were not sedated, and no local anaesthetic was used.
Different from previous techniques, we injected polidocanol into the haemorrhoidal piles and not into the submucosa. Furthermore, by injecting at the base of each haemorrhoidal pile above the dentate line to reduce post-operative pain, we ensured the maximum efficacy of the technique due to the fibrotic suspensory reaction.
The inclination of the needle should be tangential, especially at the level of the right anterior pile (11 o’clock position) in order to avoid prostatic and urinary complications in male patients. At the end of the procedure, patients were asked to walk for approximately 20 minutes (before the pre-discharge check).
Statistical analysis
Continuous variables are expressed as the mean ± standard deviation (SD) (range), and categorical variables are expressed as counts and percentages. The chi-square test was used to compare the success rates between II- and III degree HD. The disease-free survival was evaluated as the time elapsed from the procedure to the relapse of disease. Kaplan-Meier curves were used to evaluate disease-free survival, and the log-rank test was used to evaluate differences between II- and III degree HD. The changes on Nyström- and Vaizey scores over time have been analysed with Friedman test, because that scores were not normally-distributed.
The results associated with a p-value <0.05 were considered statistically significant.Statistical data analysis was performed using SPSS version 17.0 (Chicago, IL, USA) software for Windows.