Abstract
PurposeIt has been proposed that biological/chemical substances in the intestine might play a role in the occurrence and deterioration of perianal fistulas. Elimination of such unidentified factors from the lower gastrointestinal tract might offer a new strategy for the management of anal fistulas. The aim of this study was to evaluate the clinical effects on non-Crohn’s disease perianal fistula healing, and the safety and tolerability of a new medical device that applies high-purity, high-activity granular activated carbon locally into the rectum twice daily of patients with perianal fistulas without any concomitant medication.MethodsAn open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 (ClinicalTrial.gov identifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted.ResultsOf 28 patients included, 10 patients (35.7%) showed complete fistula healing (closed, no discharge on palpation) after 8 weeks; seven of these patients, corresponding to 25% of the enrolled patients, remained in remission for up to 31 weeks. At week 8, there was a statistically significant reduction in the discharge visual analog scale (p = 0.04), a significant improvement in the patient-perceived quality of life for the category of embarrassment (p = 0.002), and a trend toward improvement in the other assessment categories.ConclusionsThe treatment was well tolerated, and patient acceptance was high. The results support the efficacy and safety of locally administered activated carbon for the treatment of patients with chronic uncomplicated perianal fistulas not receiving any other medication for fistula problems.
Highlights
Perianal fistulas are often bothersome to affected patients and may be considered to be a chronic disease because the spontaneous cure rate is low
Available treatment options are limited; usually, surgery is performed [1] with its associated risks
The etiology of perianal fistulas is believed to be cryptoglandular infection, often in individuals with a previous history of an anorectal abscess [3], they may arise due to more specific causes, e.g., Crohn’s disease (CD) [4], malignancy, or following radiation therapy [5]
Summary
Perianal fistulas are often bothersome to affected patients and may be considered to be a chronic disease because the spontaneous cure rate is low. Available treatment options are limited; usually, surgery is performed [1] with its associated risks. There is a dire need for new treatment options for this condition. The local microbial flora in these situations may facilitate an inflammatory cascade and initiate production of tissuedamaging chemical/biological substances in the perianal area (e.g., endotoxins, oxygen-reactive species, cytokines, and arachidonate metabolites). Such factors combined with other tissue-damaging fecal substances like bile acids and enzymes might lead to a local functional derangement with epithelial defects and the occurrence of perianal fistulas. Int J Colorectal Dis (2017) 32:509–512 elimination of unidentified substances from the gastrointestinal tract might offer a novel therapeutic strategy
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