Bioabsorbable synthetic plug in the treatment of anal fistulas.

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.