First multicentre prospective study of Fistura® released

Researchers at three French proctology centres conducted a prospective study involving 49 patients who underwent the Fistura® procedure for various forms of fistula-in-ano. Patients were evaluated one, three, six and twelve months after treatment, including MRI examinations at six and twelve months to check for deep healing.

Overall, clinical healing was observed in 17 patients (34.7%) at 6 months, with another 16 (32%) showing narrowing of one or both orifices. Fifteen of the clinically healed patients exhibited deep healing as well. Interestingly, however, the results differed significantly from centre to centre, with one location reporting a 50% healing rate while another showed just 8% success—suggesting that the results obtained with this treatment may improve as physicians optimize their methodology. This is also reflected in the clear correlation between energy delivered and treatment success: healed patients received an average of 2725 joules, while unhealed patients were given an average of 1325 joules. Similarly, the centre with the highest success rate also had the highest average energy usage (3137 vs. 1325 vs. 1275 joules).

Post-operative pain was very low, with an average score of 1/10 in the first week and 0/10 thereafter. Average use of analgesics in the first week was zero. The researchers pointed out the lack of pain as one potential advantage over fistulotomy, which typically requires “repeated post-operative care and time off work.”

Other side effects were low as well (8%), and only three patients experienced recurrences in the form of abscesses. No post-operative bleeding or acute urinary retention was observed. Average anal incontinence scores decreased from 5 pre-treatment to 1.5 at month 6 and 0 at month 12. 

Overall, around two-thirds of patients were satisfied with the procedure, and over 92% said they would repeat it if necessary.