• This is a composed polymer
• It is biosuitable and
• Not antigenic
• A reabsorbable process which
generally completes itself in 6
The plug is indicated in the
treatment of transphincteric
This is an alternative way of
operating instead of traditional
It doesn’t damage anal
PERIOD November 2009 - Jen 2011
AVERAGE 36,4 YEARS
ANESTHESIA GENERAL / EPIDURAL
OPERATION TIME 20 MINUTES
HOSPITAL STAY 1 DAY (DAY SURGERY)
Dis Colon Rectum. 2010 May;53(5):798-802.
Long-term outcomes with the use of bioprosthetic plugs for the management
of complex anal fistulas.
Ellis CN, ROsas JW, Greiner FG
Department of Surgery, University of South Alabama, Mobile, Alabama, USA. email@example.com
PURPOSE: This study was undertaken to determine the long-term outcomes of patients whose anal
fistulas were managed by use of bioprosthetic plugs. METHOD: A retrospective analysis was
performed of all patients whose anal fistula was managed by use of a bioprosthetic plug between
May 2005 and September 2006, who had a minimum of 1 year of follow-up since their last
treatment. Patients whose fistulas were clinically healed were offered MRI to confirm healing of the
fistula. RESULTS: The bioprosthetic fistula plug was used to treat an anal fistula in 63 patients with
clinical healing of the fistula in 51 (81%). Multivariate analysis showed that tobacco smoking,
posterior fistula, and history of previous failure of the bioprosthetic plug was predictive of failure of
the bioprosthetic plug. Eight patients with clinical healing after a minimum of 1 year since their last
treatment underwent MRI. No evidence of residual fistula tract or fluid in the area of the previous
fistula was found in 6 (75%) of these patients.
CONCLUSION: Bioprosthetic plugs are effective for the long-term closure of complex
fistulas-in-ano. Randomized clinical trials comparing bioprosthetic plugs with other
sphincter-preserving methods for fistula management need to be conducted to further
determine the role of bioprosthetics in the management of anal fistulas.
Dis Colon Rectum. 2009 Sep;52(9):1578-83.
Surgical treatment of complex anal fistulas with the anal fistula plug: a
prospective, multicenter study.
Schwandner T, Roblick MH, Kierer W, Brom A, Padberg W, Hirschbumer M
Department of General, Visceral, Thoracic, Transplantation and Pediatric Surgery, University Hospital
Giessen, Giessen, Germany. firstname.lastname@example.org
PURPOSE: This study was designed to analyze the efficacy of the Surgisis Anal Fistula Plug for the closure of
transsphincteric anorectal fistulas. METHODS: Patients with single transsphincteric anorectal fistulas were
prospectively enrolled. Setons were used in all tracts for at least eight weeks before surgery. Continence,
surgical variables, complications, and healing rates were recorded. Surgery was performed in a standardized
manner. The fistula tract and external opening were debrided, the tract was irrigated, and the plug was placed.
The external opening was left open. Success was defined as the absence of drainage and closure of the
external opening. Follow-up examinations were performed at 2 days, 2, 4, 6, and 12 weeks, and 6 and 12
months after surgery. RESULTS: Sixty patients were enrolled. Seventeen patients were smokers, and ten had
diabetes mellitus. The mean surgical time was 23 (range, 13-50) minutes; no morbidity occurred. The overall
success rate after 12 months was 62%. Nineteen fistulas recurred, and four fistulas never completely healed.
The success rate was significantly lower in smokers and diabetics. Two patients had a plug dislodgement, and
plugs were successfully replaced. No change in continence was observed.
CONCLUSION: Because there is still no standard for the treatment of high transsphincteric fistulas and
because recurrence rates are high for all procedures performed, new techniques are needed for this complex
disease. Our success rate of 62% is promising because this technique can be used as a first approach to
close the fistula tract without destruction of the sphincter muscle.
Surgery. 2010 Jan; 147(1):72-8. Epub 2009 Sep 6.
To plug or not to plug: a cost-effectiveness analysis for complex anal fistula.
Adamina M, Hoch JS, Burnstein MJ.
Department of Surgery, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
BACKGROUND: Complex anal fistulas are unsuitable for fistulotomy because of the risk of fecal incontinence. The anal
fistula plug (AFP) has demonstrated fistula healing without sphincter division. This study aims to evaluate the cost-
effectiveness of the AFP compared to the endoanal advancement flap (EAAF) as an alternative sphincter-preserving option
for complex anal fistulas. METHODS: The study included 24 patients who underwent treatment for complex anal fistulas.
Healing and complication rates of a prospective cohort of AFP patients (n=12) were compared to a retrospective cohort of
patients who underwent EAAF (n=12). Cost data were collected after validated healthcare reporting standards. A cost-
effectiveness analysis was performed, including extensive modeling of fistula healing rates. RESULTS: Both cohorts (12 AFP
patients and 12 EAAF patients) had similar patient demographics and fistula characteristics. Fistula healing was achieved in
50% (5/12) of AFP patients and 33% (4/12) of EAAF patients (P=.680). Median clinical follow-up was 28 weeks for the AFP
patients and 14 weeks for the EAAF patients, whereas median recurrence time was 17.6 weeks (range, 0.4-43.9) and 12.6
weeks (range, 2-34.3), respectively. Use of the AFP instead of the EAAF saved $1,588 (95% confidence interval [CI], $1,211-
$1,965; P<.0001), and 1.5 hospital days per healed fistula (P=.0002). This cost-saving effect persisted and amounted to $825
(95% CI, $133-$1,517; P=.022) when the cost estimates were adjusted for the reduction in the hospital length of stay.
Extensive modeling over a large range of fistula healing rates confirmed the cost-effectiveness of the AFP.
CONCLUSION: The AFP is a cost-saving procedure for complex anal fistulas compared to