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Efficacy and Safety of Split-Dose versus Single-Dose Administration of Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid Powder for Bowel Preparation in the Elderly Population: A Prospective, Multicenter, Randomized Controlled Trial

Efficacy and Safety of Split-Dose versus Single-Dose Administration of Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate and Ascorbic Acid Powder for Bowel Preparation in the Elderly Population: A Prospective, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125879
Enrollment
Unknown
Registered
2026-06-01
Start date
2026-06-10
Completion date
Unknown
Last updated
2026-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Split-dose group:A split-dose regimen will be administered, with dosing on the afternoon before the examination and the morning of the examination day.
Single-dose group:A single-dose regimen administered on the morning of the examination day (D0) will be adopted.

Sponsors

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age between >=60 years and <=80 years. 2. No cognitive or language/communication impairment. 3. Provide informed consent to participate in this study. 4. Outpatients meeting indications for colonoscopy. 5. ECOG Performance Status score <=2.

Exclusion criteria

Exclusion criteria: 1. Allergy to any component of the PEG-ASC preparation (e.g., polyethylene glycol, vitamin C, etc.). 2. Severe heart failure (NYHA class III–IV), chronic kidney disease stage 4–5, or requirement for dialysis. 3. Contraindications to colonoscopy, such as severe intestinal obstruction, perforation, or acute peritonitis. 4. Currently participating in another interventional clinical trial. 5. Inability to comply with study drug administration or follow-up (e.g., due to cognitive impairment).

Design outcomes

Primary

MeasureTime frame
Rate of adequate bowel preparation;

Secondary

MeasureTime frame
Proportion of patients who found the bowel preparation "good-tasting";Full-dose completion rate;Patient satisfaction;Full-dose completion rate;Polyp and adenoma detection;Segment scores and total score of the Boston Bowel Preparation Scale (BBPS);Polyp and adenoma detection;Willingness to retake;Sleep disruption;Withdrawal time;Incidence of adverse events;

Countries

China

Contacts

Public ContactHong Zhu

Jiangsu Province Hospital (The First Affiliated Hospital with Nanjing Medical University)

zhuhong1059@126.com+86 25 87115593

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026