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)

Colonoscopy Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04474002
• Other study ID #: PICO-PEG trial
• Status: Recruiting
• Phase: Phase 4
• Start date: December 7, 2020
• Est. completion date: December 2022

Study information

• Verified date: September 2022
• Source: Queen Elizabeth Hospital, Hong Kong
• Contact: Yau Kan Tso
• Phone: 00852 35067479
• Email: tyk895[@]ha.org.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This is a prospective, randomized, single-center, single-blinded, non-inferiority trial.

Participants with out patient colonoscopy arranged will be included and randomized in a 1:1 ratio to receive either a split dose of 4L PEG + Electrolyte (Klean-prep® ) or 1L Klean-prep® plus 2 sachets SPMC (Picoprep®).

Trained endoscopists will be using the Boston Bowel Preparation Scale (BBPS) to assess the quality of bowel preparation. Patient would also rate the tolerance, compliance and adverse effect by filling the questionnaire before the colonoscopy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 158
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patient who mentally capable to consent for participating the trial

2. 18 - 65 years old

3. Scheduled for 1st colonoscopy

4. Elective outpatient colonoscopy

Exclusion Criteria:

1. Prior colorectal or abdominal-pelvic surgery

2. Inflammatory bowel disease

3. Active bowel condition eg intestinal obstruction

4. Gastrointestinal disorders eg active ulcer, gastric outlet obstruction, gastroparesis and hypomotility syndrome

5. Recent myocardial infarction, congestive heart failure, uncontrolled hypertension

6. Renal dysfunction, hepatic disease

7. Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative or antidiarrhoeal agents

8. Hypersensitivity to PEG or SPMC solution

9. Pregnant or breastfeeding women

10. Inability to give informed consent

Related Conditions & MeSH terms

• Bowel Preparation Solutions
• Colonoscopy

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hong Kong	Queen Elizabeth Hospital	Kowloon

Sponsors (1)

Lead Sponsor	Collaborator
Queen Elizabeth Hospital, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Boston Bowel Preparation Score (BBPS)	Adequate bowel preparation is defined as a total BPPS score >/= 6 in which all three segments had score >/=2	Up to 24 weeks
Secondary	Patient tolerability to bowel preparation using Likert scale	Patient are requested to fill in questionnaire on the day of colonoscopy. Candidate are asked to rate the frequency of complications between 'none', 'mild', 'moderate' and 'severe'. 'None' being the best outcome and 'severe' being the worst outcome.	Up to 24 weeks
Secondary	Patient compliance towards bowel preparation	Proportion of patient able to complete the whole bowel preparation as instructed by protocol	Till the day of procedure
Secondary	Proportion of patient requiring repeat colonoscopy	Proportion of incomplete colonoscopy due to inadequate bowel preparation Patient will be attended by physicians and blood taking will be arranged	Up to 24 weeks
Secondary	Incidence of treatment related adverse events	Patient will be monitored after colonoscopy for any complications	Up to 24 weeks