Clinical trial: free fatty acid suppositories compared with enema as bowel preparation for flexible sigmoidoscopy.
OBJECTIVE
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).


METHODS
A controlled, non-inferiority, single-blind, randomised study on outpatients undergoing flexible sigmoidoscopy.


METHODS
Department of Gastroenterology, Landspitali-University Hospital and endoscopic clinic.


METHODS
53 outpatients undergoing flexible sigmoidoscopy.


METHODS
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.


METHODS
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.


BACKGROUND
EudraCT nr.: 2010-018761-35.
Department of Paediatric Surgery , Landspitali-University Hospital , Reykjavík , Iceland.
Orri Thor
OT
Ormarsson
Lipid Pharmaceuticals , Reykjavik , Iceland.
Gudrun Marta
GM
Asgrimsdottir
Department of Pharmacy , University of Iceland , Reykjavik , Iceland.
Thorsteinn
T
Loftsson
Department of Ophtalmology , Landspitali-University Hospital , Reykjavík , Iceland.
Einar
E
Stefansson
Department of Gastroenterology , Landspitali-University Hospital , Reykjavík , Iceland.
Jon Orvar
JO
Kristinsson
Department of Public Health , University of Iceland , Reykjavik , Iceland.
Sigrun Helga
SH
Lund
Department of Gastroenterology , Landspitali-University Hospital , Reykjavík , Iceland.
Einar Stefan
ES
Bjornsson
CLINICAL TRIALS; COLONOSCOPY; ENDOSCOPY; LIPIDS