COOK Medical Biodesign Surgisis Mode D'emploi page 5

NOTE: Failure to locate the rectal opening may lead to persistence of the
fistula. If the rectal opening cannot be reliably identified, an alternative
method of treatment should be considered.
3. Gently clean/debride the fistula tract with a probe or small brush to
remove non-vascularized tissue from the fistula tract. Flush the tract as
thoroughly as possible with sterile saline, or comparable solution. Do not
enlarge the tract.
4. Use a sterile probe, or appropriate measuring instrument, to approximate
the diameter of the fistula tract opening in the rectum. Select the
proper size of plug according to the table below. Refer to the section on
Preparation.
Rectal Fistula Diameter (mm)
>1 to 2
>2 to 4
>4 to 7
5a. I f a seton is not in place, insert a fistula probe, seton, or suitable
instrument through the secondary opening and exiting via the rectal
(primary) opening. Attach the suture connected to the plug to the
instrument at the primary opening end.
5b. I f a seton is in place, cut the seton and attach the suture to the seton at
the rectal (primary) opening end.
Suture tether
6. Draw the suture tie attached to the plug into the primary fistula opening
and through the fistula tract until the plug is drawn completely into the
fistula tract and the plug button is against the rectal wall.
Fistula
Vagina
Recto-vaginal fistula repair
IMPORTANT: The rectal opening is the high-pressure zone of the fistula,
as well as the site of ingress of fecal debris. The flange end of the plug
must therefore be securely snug against the rectal opening to prevent
ingress of fecal debris. In addition, the higher pressures within the rectum
and anal canal assist in maintaining the plug in the fistula tract by simple
mechanical force.
7. When the plug is properly positioned, grip the tether used to draw the
plug into the fistula tract and apply gentle tension to it. This will hold the
plug in place during fixation of the plug on the rectal side. Refer to the
illustration below.
Fistula Plug size (cm)
Flange
Rectum
Anorectal fistula repair
5
0.2 (2 mm)
0.4 (4 mm)
0.7 (7 mm)
Button
Rectal Side