Clinical trial: free fatty acid suppositories compared with enema as bowel preparation for flexible sigmoidoscopy.
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Authors
Ormarsson, Orri ThorAsgrimsdottir, Gudrun Marta
Loftsson, Thorsteinn
Stefansson, Einar
Kristinsson, Jon Orvar
Lund, Sigrun Helga
Bjornsson, Einar Stefan
Issue Date
2015-10
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Frontline Gastroenterol. 2015, 6 (4):278-283Abstract
The purpose of this trial was to evaluate the efficacy and safety of recently developed suppositories containing free fatty acids as a bowel-cleansing agent prior to flexible sigmoidoscopy and compare them with Klyx (docusate sodium/sorbitol).A controlled, non-inferiority, single-blind, randomised study on outpatients undergoing flexible sigmoidoscopy.
Department of Gastroenterology, Landspitali-University Hospital and endoscopic clinic.
53 outpatients undergoing flexible sigmoidoscopy.
Participants were randomised to receive either free fatty acid suppositories (28) or a standard bowel preparation with Klyx enema (25). In the study group, two suppositories were administered the evening before as well as 2 h prior to the sigmoidoscopy. In the control group, Klyx enema (120 mL) was administered the evening before and repeated 2 h prior to the procedure.
Quality of the bowel cleansing, height of scope insertion and safety.
The mean height of scope insertion and bowel cleansing was 43 cm (SD=13.4) in the study group and 48 cm (SD=10.4) in the control group (NS). The investigating physicians were less satisfied with the bowel preparation in the study group compared with the control group with a difference of 20% (p<0.016). The amount of faeces noted in the rectum was similar in both groups with no significant difference (p<0.56). No serious side effects, toxic reaction or irritation were observed.
The suppositories are well tolerated with no significant side effects. The suppositories had distinct bowel emptying effect and as effective as Klyx in rectal cleansing. Although physician's satisfaction was slightly lower, the height of scope insertion was similar.
EudraCT nr.: 2010-018761-35.
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To access publisher's full text version of this article, please click on the hyperlink in Additional Links field or click on the hyperlink at the top of the page marked Files. This article is open access.Additional Links
http://dx.doi.org/10.1136/flgastro-2014-100497http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4602256/
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Archived with thanks to Frontline gastroenterologyae974a485f413a2113503eed53cd6c53
10.1136/flgastro-2014-100497
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