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99 Fibrin Glue Sealing in the Treatment of Perineal Fistulas [2003년 5월 DCR] 2011-11-17 3726
 
Oded Zmora, M.D., Nelly Mizrahi, M.D.,Nicolas Rotholtz, M.D., Alon J. Pikarsky, M.D., Eric G. Weiss, M.D.,Juan J. Nogueras, M.D., Steven D. Wexner, M.D.
 
From the Department of Colorectal Surgery, Cleveland Clinic Florida, Weston, Florida
 
PURPOSE: The surgical management of complex perineal fistulas, such as high transsphincteric and suprasphincteric fistulas, or those associated with Crohn’s disease, radiotherapy, surgical trauma, or cavity or a secondary tract, is associated with the risk of sphincter injury and significant discomfort.
Fibrin glue may close fistula tracts without muscle division. Therefore, the aim of this study was to evaluate the use of fibrin glue sealing in treatment of perineal fistulas.
METHODS: A retrospective chart review of all patients in whom fibrin glue was used for the treatment of perineal fistula was performed. Patients were contacted by telephone to establish follow-up.
RESULTS: Thirty-seven patients underwent injection of fibrin glue for complex perineal fistulas. Twenty-four patients had fibrin glue injection as the principal treatment for the perineal fistula, and 13
had fibrin glue in conjunction with an endorectal advancement flap. The fistula was of cryptoglandular origin in 16 (42 percent) cases and associated with Crohn’s disease and trauma in 7 (19 percent) and 14 (38 percent) patients, respectively. At a mean follow-up of 12.1 months, healing occurred in only 15 (41 percent) patients. The healing rate was 33 percent when fibrin glue was the principal treatment, and 54 percent when used with an endorectal advancement flap. Fistulas of noncryptoglandular origin had a
higher success rate, although this difference did not reach statistical significance. There was no morbidity associated with the injection of fibrin glue.
CONCLUSION: In this study, fibrin glue had moderate success in the definitive treatment of perineal fistulas. However, 33 percent of the patients in whom fibrin glue was the only treatment used were able to avoid more extensive surgery. Fibrin glue is associated with minimal risk, therefore its application
should be considered in patients with complex anal fistulas.
 
DISCUSSION
The surgical treatment of complex perineal fistulas carries a significant risk of fecal incontinence and a
relatively high recurrence rate. Traditionally, a staged division of the sphincter muscles encompassed within the fistula was used, to allow gradual fibrosis and healing of the muscles. This goal was achieved by a cutting seton, which was gradually tightened, or by a staged surgical division of the muscle in two different sessions. This technique, however, was associated with open perineal wounds and significant discomfort, while not eliminating the risk of incontinence. Endorectal advancement flap uses a full-thickness bowel wall flap to seal the internal opening. In this technique, the external sphincter muscles are not divided, and the fistula tract heals by secondary intention. Despite this preservation, Schouten et al. reported a rate of postoperative incontinence of 35 percent and a 25 percent recurrence rate. Similarly, in our own series of 105 endorectal advancement flaps, there was an overall 9 percent incidence of postoperative incontinence and a long-term failure rate of 40 percent. Thus, new methods for the treatment of perineal fistulas that preserve continence are desired. Because fibrin glue injection does not affect the sphincter muscles, is simple to perform, and carries a low risk, it has the potential of being an ideal treatment for these fistulas.
 
Aitola et al. reported a 100 percent failure rate in a series of ten patients who had fibrin glue injection
for the treatment of perianal fistula. However, other studies have reported success rates ranging from 60 to 85 percent. The current study failed to achieve a high success rate when fibrin glue was used as the only treatment. This result may be partially explained by different patient selection. Nineteen percent
of the patients in the current study had fistulas associated with Crohn’s disease, and 38 percent had
postsurgical or posttraumatic fistulas. Surprisingly, patients having these types of fistulas had a lower recurrence rate compared with patients with fistulas of cryptoglandular origin (31 vs. 52 percent). When comparing all patients with fistula of cryptoglandular origin or associated with Crohn’s disease (23 patients) in whom the pathophysiology of the fistula is inflammatory or infectious in nature with patients with various types of trauma causing the fistula (14 patients), the success rate was higher in the latter group (35 vs. 57 percent, respectively). Thus, the high proportion of fistulas associated with trauma in the noncryptoglandular group in the current study may partially explain the relatively high success rate in this group.
 
There were several differences in the treatment protocols, such as the use of bowel preparation, antibiotic treatment, and bowel confinement among the different studies, which may also have contributed to the difference in the results. Theoretically, failure of fibrin glue installation may be attributed to elevated pressures in the rectum or to infection. Although the utility of mechanical bowel preparation and antibiotic treatment used by several other authors was never proven specifically to augment the success rate, the lower success rate that we experienced with our protocol may potentially
attest to the usefulness of these measures.
 
Instillation of fibrin glue in conjunction with endorectal advancement flap was aimed at sealing the
fistula tract and facilitating healing. However, in the current study, the addition of fibrin glue did not improve healing of fistulas, compared with a 60 percent healing rate in our study of endorectal advancement flap without fibrin glue. A selection bias, however, may in part explain this finding, as it is possible that the more complicated cases were selected for the combined procedure. Because both studies were retrospective in nature and included a variety of patients, comparison between these results is difficult. In addition, when performing endorectal advancement flap without fibrin glue, the external opening is enlarged and a drain is used, whereas the use of fibrin glue actually obliterates drainage and may potentially contribute to failure.
 
The relationship between the length and width of the fistula and the success of fibrin glue application is
not yet well defined; some believe that the success rate is higher with long and narrow fistulas. In this
study, preoperative fistulogram was not routinely used and the assessment of the length and width ratio
based on the anal ultrasound report is inaccurate, specifically with retrospective assessment. Thus, further study is required to clarify the role of the fistula length and width ratio in the selection criteria for this procedure.
 
Several studies suggested that repeat injections may improve overall success rates. In this study, only four patients were reinjected, with only one successful outcome. Repeat injections should be reserved for patients who have failed the first attempt and wish to avoid extensive surgery.
 
The common denominator among many studies is the safety of the technique. Fibrin glue application is
associated with a minimal risk. Infection transmission through a commercial product has been minimized by viral inactivation using a heating process and careful selection of plasma donors. Rare cases of allergic reaction to the fibrin glue have been reported. Like previous published studies, there were no injection-related complications in the current study. Thus, when compared with the morbidity associated with other surgical procedures for complex perineal fistulas, fibrin glue can be justified as a preliminary step. One should be cognizant of the limited expectations for success, and thus the patient should be counseled for potential subsequent procedures.