Prospective Multicenter Study of a Synthetic Bioabsorbable Anal Fistula Plug to Treat Cryptoglandular Transsphincteric Anal Fistulas. Issue 3 (March 2015)

• Record Type: Journal Article
• Authors: Stamos, Michael J.; Snyder, Michael; Robb, Bruce W.; Ky, Alex; Singer, Marc; Stewart, David B.; Sonoda, Toyooki; Abcarian, Herand
• Is Part Of: Diseases of the colon & rectum. Volume 58:Issue 3(2015:Mar.)
• Publication Date: 2015-03
• Subjects: Fistula-in-ano -- Anal fistula plug -- Bioabsorbable fistula plug -- Sphincter-sparing treatment; Colon (Anatomy) -- Diseases -- Periodicals; Rectum -- Diseases -- Periodicals; Colonic Diseases -- Periodicals; Colorectal Surgery -- Periodicals; 616.34
• DOI: 10.1097/DCR.0000000000000288
• Languages: English
• ISSNs: 0012-3706

Abstract

Abstract : BACKGROUND: Although interest in sphincter-sparing treatments for anal fistulas is increasing, few large prospective studies of these approaches have been conducted. OBJECTIVE: The study assessed outcomes after implantation of a synthetic bioabsorbable anal fistula plug. DESIGN: A prospective, multicenter investigation was performed. SETTING: The study was conducted at 11 colon and rectal centers. PATIENTS: Ninety-three patients (71 men; mean age, 47 years) with complex cryptoglandular transsphincteric anal fistulas were enrolled. Exclusion criteria included Crohn's disease, an active infection, a multitract fistula, and an immunocompromised status. INTERVENTION: Draining setons were used at the surgeon's discretion. Patients had follow-up evaluations at 1, 3, 6, and 12 months postoperatively. MAIN OUTCOME MEASURES: The primary end point was healing of the fistula, defined as drainage cessation plus closure of the external opening, at 6 and 12 months. Secondary end points were fecal continence, duration of drainage from the fistula, pain, and adverse events during follow-up. RESULTS: Thirteen patients were lost to follow-up and 21 were withdrawn, primarily to undergo an alternative treatment. The fistula healing rates at 6 and 12 months were 41% (95% CI, 30%–52%; total n = 74) and 49% (95% CI, 38%–61%; total n = 73). Half the patients in whom a previous treatment failed had healing. By 6 months, the mean Wexner score had improved significantly ( p = 0.0003). By 12 months, 93% of patients had no or minimal pain. Adverse events included 11 infections/abscesses, 2 new fistulas, and 8 total and 5 partial plug extrusions. The fistula healed in 3 patients with a partial extrusion. LIMITATIONS: The study was nonrandomized and had relatively high rates of loss to follow-up. CONCLUSION: Implantation of a synthetic bioabsorbable fistula plug is a reasonably efficacious treatment for complex transsphincteric anal fistulas, especially given the simplicity and low morbidity of the procedure.