Outcomes of surgery for high transsphincteric anal fistulas: prospective randomized trial

Background. Reliable data on the efficacy and safety of fistulectomy with primary sphincter repair for the treatment of high transsphincteric anal fistulas are deficient.

The aim. To compare the efficacy and safety of fistulectomy with advancement muco-muscular flap (F) and fistulectomy with primary sphincter reconstruction (SR) for the treatment of high anorectal fistulas.

Methods. A cohort of 92 consecutive patients with transsphincteric anal fistula involving 1/3 to 2/3 of the sphincteric complex were included in prospective randomized study. The primary endpoint was the recurrence rate. The duration of surgery, blood loss, pain intensity, postoperative complications, the duration of wound healing, incontinence, quality of life were registered.

Results. Forty-six patients were randomized in each group. A statistically significant difference was obtained for operative time (Group “F” – 45 (20–160) min, Group “SR” – 33 (10–55) min). The blood loss was 3 (1–20) and 2 (1–10) ml in Groups “F” and “SR”, respectively (p = 0.482). The return to work in Groups “SR” and “F” occurred after 7 (2–14) and 8 (4–20) days, respectively (p = 0.005). The pain syndrome was significantly greater in Group “F” (p < 0.05) on days 1 and 7. Recurrence rate was in 23.9 % (11 cases) in Group “F” and in 6.5 % (3 cases) in Group “SR” (p = 0.042). Incontinence was in 7 (15.2 %) people in Group “F”, in 10 patients (21.7 %) – in Group “SR” (p = 0.591). There was no statistically significant difference in postoperative complications.

Conclusion. Findings can expand the indications for the treatment of high transsphincteric anorectal fistulas involving from 1/3 to 2/3 of the sphincter complex without statistically significant risk for functional results.

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