This trial will compare the tolerance to 2 different methods for colon cleansing before colonoscopy in diabetic patients.
Consecutive diabetic patients undergoing an ambulatory colonoscopy at the participating sites will be randomized to 2 different methods of colon cleansing before the procedure. Both will be based on the oral ingestion of a fluid solution (half of it on the evening before the procedure is planned and the rest on the morning of the same day), and the main difference between them will be the volume of fluid that will be ingested in each case. Analogic visual scales and standardized questionnaires on various aspects that may influence the degree of satisfaction about the preparation will be answered by the participants and collected before the colonoscopy. The endoscopist, blinded to the preparation method, will grade the adequacy of the preparation. Adverse events will be recorded up to 1 month after the procedure
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
158
Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team. Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 2 sachets (labelled A and B) of the investigational product and take their contents diluted in 1 liter of water. Two other sachets, also labelled A and B, will be taken diluted in 1 liter of water 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken.
Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team. Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken.
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Tolerability of the bowel preparation (analogue visual scale)
Each participant will rate his/her experience in an analogue visual scale.
Time frame: 6 hours after finishing bowel preparation
Ease of consumption and taste of the laxative (analogue visual scale)
Each participant will rate his/her experience in an analogue visual scale.
Time frame: 6 hours after finishing bowel preparation
Abdominal pain, nausea and bloating (analogue visual scale)
Each participant will rate his/her experience in an analogue visual scale.
Time frame: 6 hours after finishing bowel preparation
Acceptability of the preparation (interference with work, leisure activities or sleep questionnaire)
Each participant will rate his/her experience in a questionnaire.
Time frame: 6 hours after finishing bowel preparation
Adherence to the planned bowel cleansing method (questionnaire)
Each participant will rate his/her experience in a questionnaire.
Time frame: 6 hours after finishing bowel preparation
Efficacy of the bowel preparation (Boston Bowel Preparation Scale (BBPS)
Rating of the Boston Bowel Preparation Scale (BBPS) by the endoscopist
Time frame: 10 minutes after the colonoscopy
Adverse events
Description of any adverse event occurred during the study period
Time frame: 30 days after the colonoscopy
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