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Clinical trial: free fatty acid suppositories compared with enema as bowel
preparation for flexible sigmoidoscopy
#MMPMID26500756
Ormarsson OT
; Asgrimsdottir GM
; Loftsson T
; Stefansson E
; Kristinsson JO
; Lund SH
; Bjornsson ES
Frontline Gastroenterol
2015[Oct]; 6
(4
): 278-283
PMID26500756
show ga
OBJECTIVES: 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). DESIGN: A controlled, non-inferiority, single-blind, randomised
study on outpatients undergoing flexible sigmoidoscopy. SETTING: Department of
Gastroenterology, Landspitali-University Hospital and endoscopic clinic.
PATIENTS: 53 outpatients undergoing flexible sigmoidoscopy. INTERVENTION:
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. MAIN OUTCOME
MEASUREMENTS: Quality of the bowel cleansing, height of scope insertion and
safety. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION
NUMBER: EudraCT nr.: 2010-018761-35.
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