Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas

Michael J. Stamos, Michael Snyder, Bruce Robb, Alex Ky, Marc Singer, David B. Stewart, Toyooki Sonoda, Herand Abcarian

Research output: Contribution to journalArticle

20 Citations (Scopus)

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 RESULTS: Thirteen patients were lost to follow-up and 21 were withdrawn, primarily to undergo an alternative treatment.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.

Original languageEnglish
Pages (from-to)344-351
Number of pages8
JournalDiseases of the Colon and Rectum
Volume58
Issue number3
DOIs
StatePublished - 2015

Fingerprint

Rectal Fistula
Multicenter Studies
Fistula
Prospective Studies
Drainage
Pain
Lost to Follow-Up
Therapeutics
Infection
Crohn Disease
Abscess
Colon
Outcome Assessment (Health Care)
Morbidity

Keywords

  • Anal fistula plug
  • Bioabsorbable fistula plug
  • Fistula-in-ano
  • Sphincter-sparing treatment

ASJC Scopus subject areas

  • Gastroenterology

Cite this

Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. / Stamos, Michael J.; Snyder, Michael; Robb, Bruce; Ky, Alex; Singer, Marc; Stewart, David B.; Sonoda, Toyooki; Abcarian, Herand.

In: Diseases of the Colon and Rectum, Vol. 58, No. 3, 2015, p. 344-351.

Research output: Contribution to journalArticle

Stamos, Michael J. ; Snyder, Michael ; Robb, Bruce ; Ky, Alex ; Singer, Marc ; Stewart, David B. ; Sonoda, Toyooki ; Abcarian, Herand. / Prospective multicenter study of a synthetic bioabsorbable anal fistula plug to treat cryptoglandular transsphincteric anal fistulas. In: Diseases of the Colon and Rectum. 2015 ; Vol. 58, No. 3. pp. 344-351.
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AU - Snyder, Michael

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AU - Singer, Marc

AU - Stewart, David B.

AU - Sonoda, Toyooki

AU - Abcarian, Herand

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N2 - 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.

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