European Institute of Oncology
Milan, 20141, Italy
NCT Number: NCT01685853
The present study is intended to evaluate the effectiveness, tolerability, compliance, and feasibility of the low volume bowel preparation, bisacodyl tablets followed by 2L Polyethylene glycol (PEG) with citrate and simethicone (CS) given the same day of colonoscopy, vs the standard 4L split PEG solution.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 3
Milan, 20141, Italy
Eligible patients will be informed about the aims, procedures, benefits and possible risks of the study prior to sign the informed consent form from day -30 to day-3. They will provide medical history and undergo a physical examination. Patients will be evaluated by a Physician other than the blind Endoscopist. The same responsible person will instruct the patients about administration procedures in both oral and written form. The patients will be assigned to receive one of the dosing schedule bowel preparation according to a computer generated block-randomisation list. Patients will take the study treatment at home according to the given instructions. Patients will return to the clinic for colonoscopy. The colonoscopy will be performed by an Endoscopist who will be unaware of the bowel dose-regimen preparation taken by the patient. Completed colonoscopic exam will be performed with time recorded (intubation and withdrawal from ceacum). The unblind Investigator will ask the patients about safety, tolerability, overall acceptance and compliance.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: LOVOLdyl plus LOVOLesse
Other names: SELG 1000
Time frame: 20 min
Evaluation of the quality of bowel preparation according to the Ottawa Scale
Time frame: 20 min
Evaluation of the mucosal visibility according to a 3 point scale (0-2)
Time frame: 20 min
Adenoma detection rate
Time frame: 24 hours
Recording of all adverse events occurred during the study by patient questioning
Time frame: 24 hours
rate of patients in the two groups who developed GI symptoms related to bowel preparation
Time frame: 24 hours
willingness to repeat the preparation
Time frame: 24 hours
rate of patient with intake of at least 75% of bowel preparation
European Institute of Oncology
Other
Bowel Cleansing for Colonoscopy: Comparison Between a Same Day Low-Volume Preparation and a Conventional 4L Split One. A Randomized, Observer-blind, Parallel Group, Comparative Study.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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