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.
Keywords: CLINICAL TRIALS; COLONOSCOPY; ENDOSCOPY; LIPIDS.