Background: Management of anal fistulas is challenging, because surgeons must aim to obtain complete healing while sparing the sphincter and avoiding fecal incontinence. The optimal treatment method remains unknown.
Objective: This study assessed the safety and effectiveness of the use of a new synthetic fistula plug made of bioabsorbable polymers in the treatment of cryptoglandular anal fistulas.
Design: This study is a retrospective review of a database of patient records.
Setting: : Patients were treated at a general hospital in Italy.
Patients: Forty-eight patients (39 men and 9 women; mean age, 49.9 years) with 49 fistulas were treated with the synthetic plug between November 2009 and March 2012. Types of fistula were as follows: 24 superficial transsphincteric, 18 medium transsphincteric, 5 deep transsphincteric, and 1 medium intersphincteric.
Interventions: The fistula tract was cleaned by using curettage, and a synthetic plug was sized to fit the tract and inserted. A draining seton was used preoperatively in 1 patient.
Main outcome measures: The outcome measures were complete closure of the fistula, with no discharge/residual fistula (verified by endoanal ultrasonography), perineal pain level (assessed with a visual analog scale), and fecal continence. Follow-up was conducted at 1 week and 1, 3, 6, and 12 months postoperatively.
Results: The overall healing rate was 69.3% (34/49 fistulas, 33/48 patients). Eight patients (24.2%) had healing by 3 months after surgery, 21 patients (63.6%) had healed by 6 months, and 4 patients (12.1%) had healed by 12 months. By 3 months, no patient had perineal pain or fecal incontinence. No plug became dislodged, and no patient had the onset of anal stenosis, bleeding, local infection, or any other complication.
Limitations: The number of patients and the retrospective nonrandomized nature of the investigation are limitations of this study.
Conclusions: In patients with cryptoglandular anal fistulas, the use of a bioabsorbable synthetic plug provided a high rate of healing without causing fecal incontinence or other major adverse effects. Larger and randomized studies of this treatment are warranted.