The Biodesign Anal Fistula Plug is a minimally invasive treatment for complex fistulas. It doesn’t require cutting into the sphincter.
Watch the video below to see it in action.
View ordering information for the Biodesign Anal Fistula Plug.
The Biodesign Anal Fistula Plug has been called a dramatic leap forward in the surgical treatment of fistulas.
The anal fistula plug treats difficult fistulas while keeping the patient’s sphincter intact. This minimizes the risk of postoperative incontinence.1
A minimally invasive procedure, the Biodesign Anal Fistula Plug is indicated for implantation to reinforce soft tissue where a rolled configuration is required, for repair of anorectal fistulas.
With the patient in the prone jack-knife position, under general anesthesia, prep and drape the perianal region for surgical repair of an anal fistula. Bowel preparation and the use of a small volume enema should be left to the individual surgeon’s preference. Administer a single, preoperative dose of systemic antibiotics prior to beginning the procedure.
If there is evidence of acute inflammation, purulence, or excessive drainage, the placement of a draining seton is required. After seton placement, allow the tract to stabilize for six to eight weeks before placement of the fistula plug.
Following inspection of the seton and fistula, irrigate the tract with hydrogen peroxide. Cut the seton and attach a suture to the cut end. Tie the suture to the Cook Medical Fistula Brush. Cook developed the fistula brush specifically for fistula tract identification and preparation. The brush is designed with loops on either end to help secure the suture and fistula plug to the brush.
Pull the brush catheter into the fistula tract.
Using a back-and-forth motion with the brush, clean and gently debride the fistula tract, removing non-vascularized tissue. The brush does not mechanically debride the fistula tract in such a way that would likely make the tract wider and harder to close.
A small amount of blood present at the tract and on the brush bristles indicates adequate debridement. Remove the brush, leaving an attached suture within the tract. Use hydrogen peroxide again to irrigate the fistula tract.
Next, bring the anal fistula plug to the field and remove the plug from its sterile packaging. Rehydrate the anal fistula plug in sterile saline, fully submerged, until the desired handling characteristics are achieved. The plug should not be allowed to rehydrate for longer than two minutes.
Following adequate hydration, secure the plug to the previously placed suture, and pull it narrow end first through the internal opening of the fistula until slight resistance is felt. Take note of the level at which the plug enters the mucosa.
Perform plug fixation using 2-0 long term, absorbable material, such as coated PGA, on a UR6 or comparable needle.
Gently pull the plug partially out of the internal opening. Adjacent to the internal opening, place a stitch deep to the internal sphincter layer and back out of the internal opening without piercing the plug. Imagine the area of the internal opening as a clock dial; the suture should enter at three o’clock. Continue this stitch by passing the needle directly through the center of the plug at a level sufficiently below the previously noted final mucosal plane.
Next, pass the needle down alongside the anal fistula plug deep to the internal sphincter layer and back out at the nine o’clock position. Repeat the steps, making a stitch perpendicular to the first, from a twelve o’clock to six o’clock direction.
Make the first pass deep to the internal sphincter layer, then through the center of the plug, and finally, through the opposing internal sphincter. Inadequate suturing can lead to premature expulsion of the plug. Please note, loss of the plug within seven days should be considered a technical failure, and reapplication of the anal fistula plug should therefore be considered.
Check the sutures to confirm an adequate bite in the plug and surrounding tissue. Use scissors to trim the plug at the previously noted mucosal level, taking care not to cut the sutures. Pull the plug back to its original, snug position. Pull the suture ends to remove any slack from the fistula tract.
Tie off the sutures over the top of the plug, effectively pulling the mucosal layer over the top, and burying the plug from sight. A small mucosal flap can be used to assure complete coverage and to minimize dimpling at the internal opening. Slightly enlarge the external opening to facilitate drainage.
Drainage is to be expected for a minimum of two weeks and can continue for up to twelve weeks.
Further treatment of the fistula, sooner than twelve weeks, is not recommended, unless problems such as abscess arise. Do not suture closed the external opening.
Finally, trim the external end of the plug flush with the skin. To help minimize postoperative pain, local anesthesia can be administered. Restrict patient physical activity for a minimum of six weeks post operatively.
Provide the patient with the Fistula Post-Procedure Care Guide. It includes guidelines on diet, activity, drainage, and use of stool softeners and other medications. Patient compliance directly affects the success of the plug.
1 Adamina M, Ross T, Guenin MO, et al. Anal fistula plug: a prospective evaluation of success, continence and quality of life in the treatment of complex fistulae. Colorectal Dis. 2014;16(7):547-554.