In order for flexible sigmoidoscopy to be a successful screening procedure, the bowel must be free of solid matter so the endoscopist has a clear view, increasing the chance of detection of abnormalities. This is achieved through the use of bowel cleansing preparations, which are administered prior to the procedure. Enemas are the preferred method as they clear the lower bowel more quickly than oral formulations and do not require dietary restrictions. The medical device being tested in this clinical investigation is NER1008, an enema which contains PEG3350 (polyethylene glycol 3350). PEG3350 is an osmotic agent, which holds the water content in the rectum and sigmoid colon, consequently increasing stool volume, resulting in rectal distension and subsequent distal colon emptying. The increased colonic luminal content stimulates the motility, propulsive transportation and rectal evacuation of the distal colon content. This study is designed to assess the performance of NER1008 in bowel cleansing and compare this with the performance of Fleet® enema, which is widely used for this purpose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Enrollment
25
NER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
Fleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
BioKinetic Europe Ltd
Belfast, United Kingdom
Success of bowel cleansing
Whether recto-sigmoid bowel cleansing has been successful, based on an endoscopist's assessment of the quality of cleansing in the rectum and colon, according to the modified Harefield cleansing scale.
Time frame: Up to 3 hours
Grade of bowel cleansing
Grade of bowel cleansing (A, B, C or D), based on an endoscopist's assessment.
Time frame: Up to 3 hours
Quality of cleansing in rectum
Quality of cleansing in the rectum based on the modified Harefield cleansing scale (0-4).
Time frame: Up to 3 hours
Quality of cleansing in sigmoid colon
Quality of cleansing in the sigmoid colon based on the modified Harefield cleansing scale (0-4)
Time frame: Up to 3 hours
Quality of cleansing in the descending colon
Quality of cleansing in the descending colon to the splenic flexure based on the modified Harefield cleansing scale (0-4)
Time frame: Up to 3 hours
Depth of scope progression
Prior to removing the endoscope, the depth of progression it has made, in cms
Time frame: Up to 3 hours
Stool weight
Weight of stool during the one hour period after the administration of the enema
Time frame: Up to 3 hours
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