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)

Sponsor

Queen Elizabeth Hospital, Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT04474002

Collaborator

(none)

158

Enrollment

Location

Arms

14.8

Anticipated Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation Solutions Colonoscopy	Drug: 4L Klean Prep® Drug: 1L Klean prep® and 2 sachets Picoprep®	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

158 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Dec 7, 2020

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 4L Klean Prep® Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g	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.
Experimental: 1L Klean prep® and 2 sachets Picoprep® Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl, aspartame 0.0494g, sodium picosulfate 0.01g, magnesium oxide 3.5g, citric acid 12.0g	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.

Arm

Intervention/Treatment

Active Comparator: 4L Klean Prep®

Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl and aspartame 0.0494g

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.

Experimental: 1L Klean prep® and 2 sachets Picoprep®

Drug: 59g polyethylene glycol, 5.685g Na sulphate, 1.685g Na bicarbonate, 1.465g NaCl, 0.7425g KCl, aspartame 0.0494g, sodium picosulfate 0.01g, magnesium oxide 3.5g, citric acid 12.0g

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.

Outcome Measures

Primary Outcome Measures

Boston Bowel Preparation Score (BBPS) [Up to 24 weeks]
Adequate bowel preparation is defined as a total BPPS score >/= 6 in which all three segments had score >/=2

Secondary Outcome Measures

Patient tolerability to bowel preparation using Likert scale [Up to 24 weeks]
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.
Patient compliance towards bowel preparation [Till the day of procedure]
Proportion of patient able to complete the whole bowel preparation as instructed by protocol
Proportion of patient requiring repeat colonoscopy [Up to 24 weeks]
Proportion of incomplete colonoscopy due to inadequate bowel preparation Patient will be attended by physicians and blood taking will be arranged
Incidence of treatment related adverse events [Up to 24 weeks]
Patient will be monitored after colonoscopy for any complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patient who mentally capable to consent for participating the trial
18 - 65 years old
Scheduled for 1st colonoscopy
Elective outpatient colonoscopy

Exclusion Criteria:

Prior colorectal or abdominal-pelvic surgery
Inflammatory bowel disease
Active bowel condition eg intestinal obstruction
Gastrointestinal disorders eg active ulcer, gastric outlet obstruction, gastroparesis and hypomotility syndrome
Recent myocardial infarction, congestive heart failure, uncontrolled hypertension
Renal dysfunction, hepatic disease
Patient on long term tranquilizer, anti-spasmodic, prokinetic, laxative or antidiarrhoeal agents
Hypersensitivity to PEG or SPMC solution
Pregnant or breastfeeding women
Inability to give informed consent