New Technique for Anal Fistula Showing Success - Cook Medical

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New Technique for Anal
Fistula Showing Success
Early Data Indicate Closure Rates of 87%
Over the decades, several techniques have
been developed that allow surgeons to
repair anal fistulas. These include conventional
fistulotomy, endorectal/anal sliding flaps,
the use of setons, fibrin glue, and most recently,
the anal fistula plug.
Just last year, the US Food and Drug Administration
cleared the only device for treating
anal fistulas—the Surgisis ® AFP Anal Fistula
plug (Cook Incorporated). Made from porcine
small intestinal submucosa, the device is
placed in the fistula tract where it serves as a
bio-scaffold for native tissue regeneration. Data
suggest that the technique is safe, easy to perform,
and has few complications.
This Special Report, based on a satellite
symposium conducted at the 2005 Clinical
Congress of the American College of Surgeons,
explores the scientific findings associated
with the Surgisis AFP plug and other
fistula repair techniques, and offers surgeons
suggestions on selecting the best option for
their individual patients.
Fistulotomy, Endorectal/
Anal Sliding Flaps, and
Seton Drainage
Fistulotomy is the oldest and best studied
of the anal fistula treatments. It also is considered
the best option for superficial fistulas.
This is exemplified by a recent report of a
series of 101 patients requiring surgery for fistula
in ano. 1 Of the 112 fistulas, 72 (64%) were
intersphincteric, 33 (30%) were trans-sphincteric,
6 (5%) were submucosal, and 1 (1%) was
extrasphincteric. After a mean follow-up of 44
weeks, 90 (89%) of the patients were cured.
The 11 recurrences were attributed to wound
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bridging, misdiagnosis of the tract, or blindended
fistulas. The average time to healing
was 12 weeks for simple fistulotomy (range, 3-
21 weeks), 16 weeks for seton (range, 4-28
weeks), and 28 weeks for the Hanley procedure
(range, 8-48 weeks). Four (4%) of the
patients reported postoperative incontinence.
Another recent study demonstrates fistulotomy
is also efficacious when combined with
primary sphincter reconstruction for the management
of complex fistulas. 2 Only 2 of the 35
patients studied had recurrences, and the
patients’ mean incontinence score fell from
7.2 to 2.0 after the procedure (P=0.008).
However, Bradford Sklow, MD, assistant
professor, University of Utah School of Medicine,
Colon and Rectal Surgery, Salt Lake City,
noted at the symposium that fistulotomy is
suboptimal for deep trans-sphincteric or
suprasphincteric fistulas because of the
increased likelihood of fecal incontinence. Dr.
Sklow observed that patients’ distress over
this type of incontinence is one of the greatest
sources of litigation in colorectal surgery.
A seton—a loop of flexible material placed
along the track to maintain drainage for a period
of time—is one alternative, and a team of
Singapore surgeons has reported a 78% healing
rate in a group of 37 patients in whom
setons were used alone, without accompanying
surgery. 3 However, studies have shown a
36% to 50% incidence of fecal incontinence
with stand-alone seton drainage. 4,5 As Dr.
Sklow noted, the seton is also associated with
pain and inconvenience for the patient; thus, it
is generally recommended as a bridge to a
more definitive procedure.
The endorectal/anal sliding advancement
flap is another consideration. There is potential
for a 75% success rate as part of a staged

2
approach to complex anal fistulas, 6 and up to an 83% success
rate when performed alone in selected simpler cases. 7
However, this procedure is invasive and difficult to perform
posteriorly.
Fibrin Glue
When it was first cited regularly in the colorectal literature at
the beginning of the 1990s, fibrin glue was reported to be superior
to other approaches in the treatment of anal fistulas. The
use of fibrin glue also is relatively simple and noninvasive.
“Everyone thought this might be the holy grail for fistulas,”
remarked Dr. Sklow, noting that early, short-term studies indicated
very high closure rates, which made fibrin glue a serious
contender for taking the top spot in surgeons’ treatment choices
for anal fistulas.
One of the earliest studies of fibrin glue in the treatment of
anal fistulas was conducted by a team of Danish surgeons. 8 In
a series of 23 patients, 12 patients (52%) showed complete and
permanent fistula closure after 1 application of fibrin glue.
Another 5 (22%) showed fistula healing after 2 or 3 attempts.
The method failed in the remaining 6 patients (26%).
Jose R. Cintron, MD, and his colleagues at the University of
Illinois Medical Center, Chicago, had similar results in their
study, published 9 years later in 2000. Patients treated with
autologous fibrin glue (14/26) had a 54% complete-closure
rate at 1 year, and there was a 64% rate among those treated
with commercial fibrin sealant (34/53). 9 Moreover, Ian Lindsey,
MD, and his team in Oxford, England, completed a small randomized,
controlled trial that revealed fibrin glue healed 50%
(3/6) of simple fistulas and 69% (9/13) of complex fistulas. 10
The respective numbers for fistulotomy were 100% (7/7) and
13% (2/16). A higher closure rate of anal fistulas—85%
(17/20)—was documented after a mean follow-up of 10 months
by Stephen M. Sentovich, MD, and colleagues, in 2001. 11 However,
Dr. Sentovich noted the healing rate dropped to 69%
(33/48) after a mean follow-up of 22 months. 12
Indeed, other research corroborates the finding that healing
rates decrease as follow-up times increase. One randomized
study of anal fistulas with a mean 27-month follow-up by a team
that included Dr. Cintron and Herand Abcarian, MD, FACS, Turi
Josefsen professor and chairman, Department of Surgery, University
of Illinois College of Medicine at Chicago, revealed a
40% (10/25) healing rate at an average of 27 months when surgical
closure of the internal fistula opening was used. 13 However,
there was only a 31% healing rate with the combination of
surgical closure and fibrin sealant (8/26) and a 21% rate when
fibrin glue and cefoxitin were used (5/24).
Similarly, a team of St. Louis researchers documented a 38%
success rate at an average of 26 months among complex-fistula
patients given a first treatment with fibrin glue, and a 22%
healing rate among those with previously treated fistulas. 14
Most of the failures occurred within 3 months.
“So glue may not be as great as we once thought, but it certainly
has a role [in first-line treatment of anal fistulas],” Dr.
Sklow concluded.
Dr. Abcarian agreed.
“Is glue past its due? No,” he said. “It has its place in the surgeon’s
armamentarium. It is definitely ineffective in rectovaginal
fistulas—[that is], it is ineffective in short, wide tracts. But it is
much more effective in long, complex tracts, and may be used
in Crohn’s disease. You have nothing to lose if you use it as
first-line treatment. If it fails, repeat it once. If it fails again or the
fistula recurs, move to endorectal advancement flap, dermalisland
flap anoplasty, seton drainage, or the anal fistula plug.”
David Armstrong, MD, program director, Georgia Colon and
Rectal Surgical Clinic, Atlanta, is more wary of fibrin glue.
“I think that half the time, the patients have extruded the glue
before they even get in the car to drive home,” he told meeting
attendees.
Newest Treatment for Anal Fistulas: the
Surgisis AFP Plug
The FDA cleared the Surgisis AFP plug, Cook Incorporated,
Bloomington, Ind., March 9, 2005, as the first surgical device for
the repair of anal fistulas. The slender, cone-shaped device is
made from porcine small intestinal submucosa. It is placed in the
fistula channel, where it serves as a bio-scaffold for native tissue
regeneration, and hence safely closes the fistula tract. Some surgeons
have been using the Surgisis AFP plug for as long as 4
years and appear to be very satisfied with it.
Dr. Sklow was highly involved in the development of the Surgisis
AFP plug. He has been using it since April 2002, when the
device was in its earliest form—he rolled a sheet of porcine material
before insertion into the fistula. At the American Society of
Colon and Rectal Surgeons’ 2004 annual meeting, Dr. Sklow
and his colleagues reported on the rolled form of the plug in 17
patients. 15 The patients were treated between April 2002 and
May 2003, their average age at diagnosis was 53.8 years
(range, 28-79 years), and 14 (82%) were men. One of the subjects
had Crohn’s disease, another had ulcerative colitis, and
one more had a restorative proctocolectomy for ulcerative colitis.
Sixteen of the 18 simple or complex fistulas (88.9%) were fistulas
in ano, while 1 (5.6%) was a pouch-cutaneous fistula, and
the remaining fistula (5.6%) was of the recto-pelvic form. There
had been previous attempts to close 5 of the fistulas (27.8%).
The mean fistula length was 5.9 cm (range, 3-10 cm).
The investigators documented a 61% closure rate (11/18) of
the patients’ after an average of 12 months. Four of the patients
(24%) required only local anesthesia, 11 (65%) required spinal
anesthesia, and the remaining 2 (12%) were given general
anesthesia.
Of the fistulas, 13 (72%) were closed with insertion of the
plug combined with closure of the internal opening with
sutures. Seven of these patients (54%) successfully healed.
The remaining 5 involved using the plug together with an
advancement flap, after failure of the internal opening to close
with sutures. All 5 were posterior midline fistulas. Four of these
5 fistulas (80%) healed. Four of the successfully healed
patients had failed previous surgical attempts at closure. One
patient required an additional surgical procedure for a second
missed fistula tract. The average time to closure was 4.9 weeks
(range, 2-9 weeks). There was only 1 complication: a patient
with Crohn’s disease developed an abscess at the external
opening. The abscess was drained, and the fistula healed.
The overall rate of closure after the first attempt at plug
placement was 44% (8/18). Dr. Sklow explained that this low
rate can be partly explained by the fact that 3 of the patients
whose fistulas failed to heal after the first attempt should not
have been given the Surgisis AFP plug because they had short,
superficial fistulas. The explanation for most of the other failures
was surgeon technique; it should be noted that these surgeons
were early in the learning curve.
“The installation of the Surgisis AFP plug is easy to perform,
safe, noninvasive, and associated with few complications and
minimal discomfort for the patient,” Dr. Sklow said. “It certainly
can be repeated if it fails initially and may be the procedure of
choice for reoperative complex fistulas. Moreover, the commercially
available conical shape may yield superior results.”

Surgisis ® AFP
Anal Fistula Plug.
Photo courtesy of Cook Biotech, Inc.
The plug is rehydrated
and inserted into the
primary opening until
resistance is first met.
The excess plug is
trimmed at the level of the
primary opening and
sutured in place with a
deep figure-of-eight suture,
using 2-0 Vicryl. It is
essential to use a deep,
secure suture at the
primary opening to prevent
extrusion of the plug.
The plug undergoes
resorption and remodeling
into the native tissue, and
six weeks later the fistula
is firmly closed.
Photos courtesy of David N. Armstrong, MD.
Multiple perianal fistulas
and extensive perianal
induration after multiple
(failed) procedures (see
radial incision in the right
gluteal region). Setons are
inserted to decrease the
induration, and to
“mature” the fistula tracts.
Six weeks later, the
induration has resolved,
and the patient returns for
surgery for definitive fistula
closure. All five secondary
openings and fistula tracts
were found to arise from
the inner (primary) opening,
which was closed
using one fistula plug.
Six weeks following
surgery, all drainage had
resolved; all fistula tracts
are closed.
Photos courtesy of David N. Armstrong, MD.
The next step was a prospective comparison of the Surgisis
AFP plug to fibrin glue for the closure of anal fistulas, undertaken
by Dr. Armstrong and his team. They have been using the
Surgisis AFP plug for more than 2 years for complex fistulas
that have failed at least 1 previous attempt at closure.
“We were exploring ways to work with patients with these
complex fistulas,” explained Dr. Armstrong. “We decided on the
Surgisis AFP plug because it seemed like it was made from an
ideal material. It comes from porcine small intestinal submucosa—which
is very similar to the human equivalent. There’s no
foreign-body reaction, [so] it allows tissue ingrowth and it’s
resistant to infection.”
Dr. Armstrong and his colleagues enrolled 25 patients in a
prospective trial. The team used the Surgisis AFP plug on 15
patients and treated 10 with fibrin glue. Patients with Crohn’s
disease were excluded from the study. There were no significant
differences between the 2 groups in average age, number
of men and women, number of prior fistula surgeries, or number
of secondary fistula openings. All of the patients underwent
mechanical bowel preparation accompanied by application of
enteric antibiotics.
Of the 15 patients treated with the Surgisis AFP plug, 13
(87%) had complete closure of all fistula tracts. Only 4 patients
treated with fibrin glue (40%) showed complete closure of all
fistula tracts (P

4
Table. Dos and Don’ts of the Surgisis AFP Plug Technique
DOs
Rehydrate the plug for 5 minutes in saline.
Use a 2-0 Vicryl suture.
Insert a figure-of-eight suture through the primary opening, deep to
the internal sphincter and try to get another 1 or 2 bites of the
plug’s head.
Advise patients to avoid strenuous activity for at least 2 weeks after
the procedure.
DON’Ts
Don’t mechanically debride the fistula tract in such a way that would
likely make the tract wider and harder to close.
Don’t use the entire plug. Pull the plug into the fistula tract until
resistance is first met, and trim the excess plug at the level of the
primary opening. If the primary opening is too large, insert a seton
for 6 to 8 weeks to narrow the tract and “mature” the fistula.
Don’t leave any of the plug’s head exposed. Pull the plug into the
tract just deep to the primary opening.
Don’t close the secondary opening. Suture the end of the plug to
the edge of the secondary opening to secure tip. This will help
prevent a closed space infection.
Suture a 6-inch tail to the tip of the plug and cut the excess.
This helps prevent the tie from slipping off as the plug is pulled
into the tract. Pull the plug into the primary opening until resistance
is met. This can be done by a variety of means, such as
tying the tail of the suture to the fistula probe. If there is already
an indwelling seton in the tract, the tail of the suture can be tied
to the seton, which is then cut and used to pull the plug into the
primary opening of the tract. The “cut seton” method is very
simple and straightforward, and avoids having to find the primary
opening again.
The surgeon notes where the plug enters the primary opening.
The plug is withdrawn several millimeters and the excess is
trimmed. It is not unusual to trim as much as half the length of
the plug, as the plugs are oversized.
A 2-0 Vicryl suture is inserted into the head of the plug. The
suture is then tied, leaving a 6-inch tail that will later be used
to close the primary opening. This is best done under direct
visualization to ensure the surgeon gets a good bite of the
plug. The plug is pulled back into the tract, just deep to the
primary opening. No part of the plug is left exposed. A figure-
References
1. Gonzalez-Ruiz C, Kaiser AM, Vukasin P, et al. Intraoperative
physical diagnosis in the management of
anal fistula. Am Surg. 2006;72:11-15.
2. Perez F, Arroyo A, Serrano P, et al. Fistulotomy with
primary sphincter reconstruction in the management
of complex fistula-in-ano: prospective study of
clinical and manometric results. J Am Coll Surg.
2005;200:897-903.
3. Theerapol A, So BY, Ngoi SS. Routine use of setons
for the treatment of anal fistulae. Singapore Med J.
2002;43:305-307.
4. Hasegawa H, Radley S, Keighley MR. Long-term
results of cutting seton fistulotomy. Acta Chir Iugosl.
2000;47(suppl 1):19-21.
5. Joy HA, Williams JG. The outcome of surgery for
complex anal fistula. Colorectal Dis. 2002;4:
254-261.
6. van der Hagen SJ, Baeten CG, Soeters PB, et al.
Staged mucosal advancement flap for the treatment
of complex anal fistulas: pretreatment with
noncutting setons and in case of recurrent multiple
abscesses a diverting stoma. Colorectal Dis.
of-eight suture is inserted through the primary opening, deep
to the internal sphincter, getting another 1 or 2 bites of the
plug’s head. Resistance is felt when the suture passes
through the plug. Finally, the primary opening is closed over
the plug’s head by tying the suture to the 6-inch tail. This
buries the head of the plug, closes the primary opening and
secures the head of the plug deep to the primary opening to
prevent extrusion.
Dr. Armstrong emphasized the need for a deep suture to
secure the head of the plug because of the high pressures that
are generated in the pelvic floor during straining and exercise.
“This has to be a real stitch,” he said. “You’ve got to get a
good, solid, deep bite through the internal sphincter, and also
through the head of the plug and out through the other side of
the internal sphincter. You want to try and stitch this plug so it’s
deep to the internal opening. You need to bury it. At the end of
the procedure, you don’t want to see any plug.”
The tip of the plug is sutured to the edge of the secondary
opening and the excess is trimmed at skin level. The secondary
opening should not be completely closed, as this will
prevent drainage from the fistula tract, and possibly result in an
abscess. Some drainage from the tract generally persists for 2
to 4 weeks after the procedure—sometimes longer—as the plug
undergoes reabsorption and remodeling into native tissue. As
the fistula closes, the drainage decreases and eventually dries
up. This is more a biological closure of the fistula than a
mechanical closure, Dr. Armstrong explained. After the procedure,
patients should be told to avoid any strenuous activity for
at least 2 weeks, bathe standing up (they should not sit in the
bathtub) 2 or 3 times a day, and apply topical 10% metronidazole
externally to help prevent any septic complications. They
should also be instructed to avoid straining during bowel movements—taking
a stool softener will help—and be instructed to
eat a high fiber diet. Patients are reviewed in the office 2 to 4
weeks after the procedure.
Conclusion
2005;7:513-518.
7. Dixon M, Root J, Grant S, et al. Endorectal flap
advancement repair is an effective treatment for
selected patients with anorectal fistulas. Am Surg.
2004;70:925-927.
8. Hjortrup A, Moesgaard F, Kjaergard J. Fibrin adhesive
in the treatment of perianal fistulas. Dis Colon
Rectum. 1991;34:752-754.
9. Cintron JR, Park JJ, Orsay CP, et al. Repair of fistulas-in-ano
using fibrin adhesive: Long-term followup.
Dis Colon Rectum. 2000;43:944-949.
10. Lindsey I, Smilgin-Humphreys MM, Cunningham C,
et al. A randomized, controlled trial of fibrin glue vs.
conventional treatment for anal fistula. Dis Colon
Rectum. 2002;45:1608-1615.
11. Sentovich SM. Fibrin glue for all anal fistulas. J Gastrointest
Surg. 2001;5:158-161.
12. Sentovich SM. Fibrin glue for anal fistulas: long-term
results. Dis Colon Rectum. 2003;46:498-502.
13. Singer M, Cintron J, Nelson R, et al. Treatment of fistulas-in-ano
with fibrin sealant in combination with
Colorectal surgeons have several options for treating simple
and complex fistulas. The most common procedure remains fistulotomy,
although fibrin glue has a role in long, complex tracts
and Crohn’s disease. The Surgisis AFP plug is gaining notable
favor for complex fistulas and repeat surgery. By following the
procedure for insertion of the plugs advised by field leaders,
surgeons can have considerable success in difficult patients.
intra-adhesive antibiotics and/or surgical closure of
the internal fistula opening. Dis Colon Rectum.
2005;48:799-808.
14. Loungnarath R, Dietz DW, Mutch MG, et al. Fibrin
glue treatment of complex anal fistulas has low success
rate. Dis Colon Rectum. 2004;47:432-436.
15. Robb BW, Vogler SA, Nussbaum MN, et al. Early
experience using porcine small intestinal submucosa
to repair fistulas-in-ano. Paper presented at:
American Society of Colon and Rectal Surgery
2004 annual meeting; May 8-13, 2004;
Dallas,Texas. Abstract P9.
16. Johnson EK, Gaw JU, Armstrong D. Efficacy of
biodegradable “collagen plug” versus fibrin glue in
closure of anorectal fistulas. Paper presented at:
American Society of Colon and Rectal Surgery
2005 annual meeting; April 30-May 5, 2005;
Philadelphia, Pa. Abstract S51.
17. Johnson EK, Gaw JU, Armstrong DN. Efficacy of
anal fistula plug vs. fibrin glue in closure of anorectal
fistulas. Dis Colon Rectum. 2006 Jan. 29 [Epub
ahead of print].
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