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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

Zawadzki, Antoni LU ; Johnson, Louis Banka LU ; Bohe, Måns LU ; Johansson, Claes; Ekelund, Mats LU and Nielsen, Ole Haagen (2017) In International Journal of Colorectal Disease 32(4). p.509-512
Abstract

Purpose: 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. Methods: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up... (More)

Purpose: 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. Methods: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 (ClinicalTrial.govidentifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted. Results: 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. Conclusions: 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.

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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Activated carbon, AST-120, Perianal fistula, Rectal instillation, Treatment
in
International Journal of Colorectal Disease
volume
32
issue
4
pages
509 - 512
publisher
Springer
external identifiers
  • scopus:84996758796
  • wos:000398468400009
ISSN
0179-1958
DOI
10.1007/s00384-016-2726-z
language
English
LU publication?
yes
id
8b689df2-2992-4e68-8624-8fc3b30ce6f3
date added to LUP
2016-12-09 13:40:48
date last changed
2018-01-07 11:40:06
@article{8b689df2-2992-4e68-8624-8fc3b30ce6f3,
  abstract     = {<p>Purpose: 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. Methods: An open, single-arm, prospective study with active treatment for 8 weeks and an optional follow-up until week 24 (ClinicalTrial.govidentifier NCT01462747) among patients with chronic, uncomplicated perianal fistulas scheduled for surgery was conducted. Results: 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. Conclusions: 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.</p>},
  author       = {Zawadzki, Antoni and Johnson, Louis Banka and Bohe, Måns and Johansson, Claes and Ekelund, Mats and Nielsen, Ole Haagen},
  issn         = {0179-1958},
  keyword      = {Activated carbon,AST-120,Perianal fistula,Rectal instillation,Treatment},
  language     = {eng},
  number       = {4},
  pages        = {509--512},
  publisher    = {Springer},
  series       = {International Journal of Colorectal Disease},
  title        = {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},
  url          = {http://dx.doi.org/10.1007/s00384-016-2726-z},
  volume       = {32},
  year         = {2017},
}