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
(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.
(Less)
- author
- Zawadzki, Antoni LU ; Johnson, Louis Banka LU ; Bohe, Måns LU ; Johansson, Claes ; Ekelund, Mats LU and Nielsen, Ole Haagen
- organization
- publishing date
- 2017
- 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
-
- pmid:27878619
- wos:000398468400009
- scopus:84996758796
- 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
- 2025-01-12 17:21:34
@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}},
keywords = {{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}},
doi = {{10.1007/s00384-016-2726-z}},
volume = {{32}},
year = {{2017}},
}