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

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Zawadzki, AntoniLund University,Lunds universitet,Kirurgi,Forskargrupper vid Lunds universitet,Surgery,Lund University Research Groups,Skåne University Hospital (author)

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

Article/chapterEnglish2017

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2016-11-23
Springer Science and Business Media LLC,2017

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LIBRIS-ID:oai:lup.lub.lu.se:8b689df2-2992-4e68-8624-8fc3b30ce6f3
https://lup.lub.lu.se/record/8b689df2-2992-4e68-8624-8fc3b30ce6f3URI
https://doi.org/10.1007/s00384-016-2726-zDOI
http://kipublications.ki.se/Default.aspx?queryparsed=id:135568585URI

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Language:English
Summary in:English

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Subject category:ref swepub-contenttype

Notes

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.

Subject headings and genre

MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Kirurgi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Surgery hsv//eng
MEDICIN OCH HÄLSOVETENSKAP Klinisk medicin Gastroenterologi hsv//swe
MEDICAL AND HEALTH SCIENCES Clinical Medicine Gastroenterology and Hepatology hsv//eng
Activated carbon
AST-120
Perianal fistula
Rectal instillation
Treatment

Added entries (persons, corporate bodies, meetings, titles ...)

Johnson, Louis BankaLund University,Lunds universitet,Kirurgi,Forskargrupper vid Lunds universitet,Surgery,Lund University Research Groups,Skåne University Hospital(Swepub:lu)kir-ljo (author)
Bohe, MånsLund University,Lunds universitet,Kirurgi,Forskargrupper vid Lunds universitet,Surgery,Lund University Research Groups,Skåne University Hospital(Swepub:lu)kir-mbo (author)
Johansson, ClaesDanderyd Hospital (author)
Ekelund, MatsLund University,Lunds universitet,Kirurgi, Lund,Sektion V,Institutionen för kliniska vetenskaper, Lund,Medicinska fakulteten,Surgery (Lund),Section V,Department of Clinical Sciences, Lund,Faculty of Medicine,Skåne University Hospital(Swepub:lu)ma2622ek (author)
Nielsen, Ole HaagenHerlev Hospital,University of Copenhagen (author)
KirurgiForskargrupper vid Lunds universitet (creator_code:org_t)

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In:International Journal of Colorectal Disease: Springer Science and Business Media LLC32:4, s. 509-5120179-19581432-1262

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