ArticleFrontline gastroenterology2015
Clinical trial: free fatty acid suppositories compared with enema as bowel preparation for flexible sigmoidoscopy.
Article in Frontline gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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0 citing papers in PubMed, 4 citations in OpenAlex.
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesThe 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).
designA controlled, non-inferiority, single-blind, randomised study on outpatients undergoing flexible sigmoidoscopy.
settingDepartment of Gastroenterology, Landspitali-University Hospital and endoscopic clinic. PATIENTS: 53 outpatients undergoing flexible sigmoidoscopy.
interventionParticipants 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. MAIN OUTCOME MEASUREMENTS: Quality of the bowel cleansing, height of scope insertion and safety.
resultsThe 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.
conclusionsThe 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. TRIAL REGISTRATION NUMBER: EudraCT nr.: 2010-018761-35.
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