A Phase 3 interventional study of Additional oral preparation (3L of PEG+Asc, "Coolprep®") and Standard oral preparation (2L of PEG+Asc, "Coolprep®") in Bowel Preparation Quality, sponsored by Kyungpook National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by Kyungpook National University Hospital · Phase 3, Interventional, and Diagnostic
Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.
Kyungpook National University Hospital is the lead sponsor of 76 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
The investigational or experimental arm will receive standard oral preparation plus additional oral preparation (1l of polyethylene glycol (PEG)+ascorbic acid (Asc)) for colonoscopy. \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Drug: Additional oral preparation (3L of PEG+Asc, "Coolprep®")
The control arm will receive currently used oral preparation (2L of polyethylene glycol+ascorbic acid) for colonoscopy. \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Drug: Standard oral preparation (2L of PEG+Asc, "Coolprep®")
The interventional or experimental arm will receive 1l of additional PEG+Asc, "Coolprep®" on the day of colonoscopy \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Also known as: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L
The control arm will receive currently used oral preparation (2l of PEG+Asc, "Coolprep®") for colonoscopy \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
Also known as: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L
Quality of bowel preparation
The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale
Time frame: Day 1
Adenoma detection rate
Number of adenomatous polyps
Time frame: Day 1
Patient compliance
Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire
Time frame: Baseline
Patient satisfaction
Patient's perception of the preparation method as self-reported on a pre-procedure questionnaire.
Time frame: Baseline
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Kyungpook National University Hospital