It 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.
An 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.
Of 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.
The 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.
Grucela A, Gurland B, Kiran RP (2012) Functional outcomes and quality of life after anorectal surgery. Am Surg 78:952–956 PubMed
Michalopoulos A, Papadopoulos V, Tziris N, Apostolidis S (2010) Perianal fistulas. Tech Coloproctol 14(suppl 1):S15–S17
Johnston MJ, Robertson GM, Frizelle FA (2003) Management of late complications of pelvic radiation in the rectum and anus: a review. Dis Colon rectum 46:247–259
Fukuda Y, Takazoe M, Sugita A, Kosaka T, Kinjo F, Otani Y et al (2008) Oral spherical adsorptive carbon for the treatment of intractable anal fistulas in Crohns disease: a multicenter, randomized, double-blind, placebo-controlled trial. Am J Gastroenterol 103:1721–1729 PubMed
van Koperen PJ, Bemelman WA, Gerhards MF, Janssen LW, van Tets WF, van Dalsen AD et al (2011) The anal fistula plug treatment compared with the mucosal advancement flap for cryptoglandular high transsphincteric perianal fistula: a double-blinded multicenter randomized trial. Dis Colon rectum 54:387–393
Jacob TJ, Perakath B, Keighley MR (2010) Surgical intervention for anorectal fistula. Cochrane Database Syst Rev CD006319
Garg P, Song J, Bhatia A, Kalia H, Menon GR (2010) The efficacy of anal fistula plug in fistula-in-ano: a systematic review. Colorectal Dis 12:965–970
- An open prospective study evaluating efficacy and safety of a new medical device for rectal application of activated carbon in the treatment of chronic, uncomplicated perianal fistulas
Louis Banka Johnson
Ole Haagen Nielsen
- Springer Berlin Heidelberg
Neu im Fachgebiet Chirurgie
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