Dataset Information

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean^®) with a polyethylene glycol/bisacodyl kit.

ABSTRACT:

Background

Efficient bowel cleansing is essential for a successful colonoscopy, but the ideal cleansing agent, volume, and pharmaceutical dosage form have yet to be determined. Small-volume cleansers enhance patient compliance.

Aim

To compare the bowel cleansing efficacy of 32-tablet sodium phosphate (Quiklean^®) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax^®) under identical dietary recommendations.

Methods

This multicenter, randomized, parallel-group, noninferiority clinical trial enrolled 472 outpatients, randomized 456 subjects, and scheduled 442 subjects to undergo colonoscopy (Quiklean^® = 222 and Klean-Prep/Dulcolax^® = 220). After bowel preparation, a colonoscopist performed the colonoscopy with video recorded for rating. The primary efficacy endpoint was the bowel cleansing quality using the Aronchick Scale. The secondary endpoints were the bowel cleansing efficacy of three colon segments, tolerability and acceptability, safety using the Ottawa bowel preparation scale, questionnaires by subjects, and monitoring of adverse events.

Results

Success rates (Excellent + Good) of the bowel cleansing quality by Aronchick Scale were 98.6% (n = 205) and 97.6% (n = 204) in the Quiklean^® and Klean-Prep/Dulcolax^® groups, respectively. Quiklean^® demonstrated noninferiority over Klean-Prep/Dulcolax^® in colon cleansing efficacy. Quicken showed better tolerability and acceptability in the overall experience (was rated as excellent; 24.0% vs 17.2%; P = 0.0016) and the taste of the study preparation (was rated as excellent, 23.1% vs 13.4%; P < 0.0001) than Klean-Prep/Dulcolax^®. Safety profiles did not differ between the two groups. Our data indicate that Quiklean^® is an adequate, well-tolerated bowel cleansing preparation compared with the standard comparator Klean-Prep/Dulcolax^®.

Conclusion

Quiklean^® is sodium phosphate tablets available on Taiwan's market for bowel preparation; it potentially offers patients an alternative to standard large-volume bowel preparation regimens and may, therefore, increase positive attitudes toward colonoscopies and participation rates.

SUBMITTER: Hung SY

PROVIDER: S-EPMC7856840 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature

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Publications

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean<sup>®</sup>) with a polyethylene glycol/bisacodyl kit.

Hung Shih-Ya SY Chen Hung-Chang HC Ke Tao-Wei TW Chen Jiann-Hwa JH Hsiao Koung-Hung KH Wang Hwei-Ming HM Chiang Hua-Che HC Chang Sheng-Chi SC Chen Yi-Chang YC Hsieh Ming-Hao MH Tsai Yuan-Yao YY Hsieh Yo-Wen YW Chen William Tzu-Liang WT

World journal of gastroenterology 20210201 5

<h4>Background</h4>Efficient bowel cleansing is essential for a successful colonoscopy, but the ideal cleansing agent, volume, and pharmaceutical dosage form have yet to be determined. Small-volume cleansers enhance patient compliance.<h4>Aim</h4>To compare the bowel cleansing efficacy of 32-tablet sodium phosphate (Quiklean<sup>®</sup>) with 2-L polyethylene glycol (PEG)/bisacodyl (Klean-Prep/ Dulcolax<sup>®</sup>) under identical dietary recommendations.<h4>Methods</h4>This multicenter, random ...[more]

PMID: 33584074

Similar Datasets

Project description:AIM:To evaluate the efficacy, tolerability, acceptability and feasibility of bisacodyl plus low volume polyethyleneglycol-citrate-simeticone (2-L PEG-CS) taken the same day as compared with conventional split-dose 4-L PEG for late morning colonoscopy. METHODS:Randomised, observer-blind, parallel group, comparative trial carried out in 2 centres. Out patients of both sexes, aged between 18 and 85 years, undergoing colonoscopy for diagnostic investigation, colorectal cancer screening or follow-up were eligible. The PEG-CS group received 3 bisacodyl tablets (4 tablets for patients with constipation) at bedtime and 2-L PEG-CS in the morning starting 5 h before colonoscopy. The control group received a conventional 4-L PEG formulation given as split regimen; the morning dose was taken with the same schedule of the low volume preparation. The Ottawa Bowel Preparation Scale (OBPS) score was used as the main outcome measure. RESULTS:A total of 164 subjects were enrolled and 154 completed the study; 78 in the PEG-CS group and 76 in the split 4-L PEG group. The two groups were comparable at baseline. The OBPS score in the PEG-CS group (3.09 ± 2.40) and in the PEG group (2.39 ± 2.55) were equivalent (difference +0.70; 95%CI: -0.09-1.48). This was confirmed by the rate of successful bowel cleansing in the PEG-CS group (89.7%) and in the PEG group (92.1%) (difference -2.4%; 95%CI: -11.40- 6.70). PEG-CS was superior in terms of mucosa visibility compared to PEG (85.7% vs 72.4%, P = 0.042). There were no significant differences in caecum intubation rate, time to reach the caecum and withdrawal time between the two groups. The adenoma detection rate was similar (PEG-CS 43.6% vs PEG 44.7%). No serious adverse events occurred. No difference was found in tolerability of the bowel preparations. Compliance was equal in both groups: more than 90% of subjects drunk the whole solution. Willingness to repeat the same bowel preparations was about 90% for both regimes. CONCLUSION:Same-day PEG-CS is feasible, effective as split-dose 4-L PEG for late morning colonoscopy and does not interfere with work and daily activities the day before colonoscopy.

Dataset Information

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean^®) with a polyethylene glycol/bisacodyl kit.

Background

Aim

Methods

Results

Conclusion

Publications

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean<sup>®</sup>) with a polyethylene glycol/bisacodyl kit.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Dataset Information

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean®) with a polyethylene glycol/bisacodyl kit.

Background

Aim

Methods

Results

Conclusion

Publications

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean<sup>®</sup>) with a polyethylene glycol/bisacodyl kit.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets

Noninferiority clinical trial comparing the bowel cleansing efficacy of sodium phosphate tablets (Quiklean^®) with a polyethylene glycol/bisacodyl kit.