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Efficacy, Tolerance and Safety of Split Dose Bowel Preparation for Colonoscopy: 4L Polyethylene Glycol (PEG) Versus 1L Polyethylene Glycol Plus Sodium Picosulfate-magnesium Citrate (SPMC)

NCT04474002 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 158

Last updated 2025-08-26

No results posted yet for this study

Summary

4L split dose PEG is the gold standard for bowel preparation, however it comes with poor tolerability and poor compliance. Combination of PEG with different agent is useful in reducing total volume, improving compliance and tolerance of patient.

The objective of this study is to demonstrate that combination bowel preparation, PEG plus SPMC solution, has similar efficacy and safety profile whereas with a better tolerance when compared to large volume PEG.

Conditions

  • Bowel Preparation Solutions
  • Colonoscopy

Interventions

DRUG

4L Klean Prep®

Patients allocated to the control group shall mix two sachets of PEG in 2L water. At 6pm the evening before examination, they shall consume 250ml solution every 15mins, and finish in 2hours. At 7am the day of examination, drink another 2L Klean-prep in 2 hours.

DRUG

1L Klean prep® and 2 sachets Picoprep®

Patients allocated to the study group shall mix each sachet of Picoprep® in 150ml warm water. The patient shall take the 1st dose at 4pm the day before procedure followed by at least five 250ml drinks of clear fluid before the next dose. The 2nd dose shall be taken approximately 6hrs later and followed by at least three 250ml drinks of clear fluid before bed. On 7am the day of procedure, they shall take 1L PEG in 1 hour.

Sponsors & Collaborators

  • Queen Elizabeth Hospital, Hong Kong

    lead OTHER

Principal Investigators

  • Yau Kan Tso · Queen Elizabeth Hospital, Hospital Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-07
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04474002 on ClinicalTrials.gov