Compare Polyethylene Glycol and Sodium Picosulfate Alone or Combined

NCT03965182 | Unknown DMC

• 1 other identifier: A10801001
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief Summary

Sodium picosulfate/magnesium citrate (SPMC) is generally better tolerated than PEG, its cleansing effect remains uncertain. While most studies showed SPMC was non-inferior to PEG, some studies reported that SPMC was less effective than PEG. To improve the bowel cleansing effect of SPMC, splitting the dose by using one sachet the evening before colonoscopy and the other sachet 4 to 5 hours before colonoscopy in the morning, has been proposed.Adding bisacodyl to the regimen also has been shown to be helpful. Some side effects, such as hyponatremia, dehydration and sleep disturbance, were reported to be more commonly associated with SPMC than with PEG. To enhance the efficacy and reduce the side effects, two studies have evaluated the combination of SPMC and PEG, with conflicting results.The effect of combining PEG and SPMC should be best appreciated with head-to-head comparison with PEG and SPMC alone at the same time. Therefore we designed this head-to-head comparison study for 2 L PEG, 1L PEG plus one sachet of SPMC and 2 sachet of SPMC, all with split-dose and the addition of 10 ml bisacodyl. Our hypothesis is the bowel cleansing effect of the combination regimen was not inferior to PEG alone. The tolerability, acceptability and side effects of the 3 regimen will also be evaluated. Patients will be randomly assigned to either PEG, PEG plus SPMC or SPMC group, in a 1:1:1 ratio using a computer-generated sequence. The treatment allocation will be concealed and revealed by non-research medical personnel at the screening visit.

Conditions

Bowel Preparation

Keywords

colon preparation, ,; polyethylene glycol; sodium picosulfate/magnesium citrate

Outcome Measures

Primary Outcomes (2)

• Aronchick scale

  a validated assessment that describes the visual appearance of the colon on a four-point scale.

  through study completion, average 30 minutes

• Boston Bowel Preparation Scale

  BBPS is based on the summation of the preparation scores from three segments of the colon (cecum and ascending, transverse colon and left colon). A segment score of 0 describes an"unprepared colon segment with mucosa not well seen due to solid stool that cannot be cleared"; segment score 1: "portion of mucosa of the colon segment seen, but other areas of the colon are not well seen due to staining, residual stool and⁄or opaque liquid"; segment score 2: "minor amount of residual staining, small fragments of stool and⁄or opaque liquid, but mucosa of colon segment seen well"; segment score 3: "entire mucosa of the colon segment seen well with no residual staining, small fragments of stool and⁄or opaque liquid".

  through study completion, average 30 minutes

Secondary Outcomes (1)

• Adenoma detection rate

  when pathology of polyps become available, average in one week.

Study Arms (3)

PEG group

ACTIVE COMPARATOR

Patients in the PEG group were instructed to take the first sachet of PEG at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.

Drug: PEG

PEG plus SPMC group

ACTIVE COMPARATOR

Patients in the PEG plus SPMC group will be instructed to take the SPMC sachet at 19:00 hours the day before colonoscopy and the PEG sachet at 6:00 hours on the morning of the day of colonoscopy.

Drug: PEG plus SPMC

SPMC group

ACTIVE COMPARATOR

Patients in the SPMC group were instructed to take the first sachet of SPMC at 19:00 hours the day before colonoscopy and the second one at 06:00 hours on the morning of the day of colonoscopy.

Drug: SPMC

Interventions

PEG DRUG

2 sachets of PEG will be used as the bowel prep regimen.

PEG group

PEG plus SPMC DRUG

one sachet of PEG and one sachet will be administered as the bowel prep regimen

PEG plus SPMC group

SPMC DRUG

2 sachets will be administered as the bowel prep regimen.

SPMC group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will include those anticipated to undergo colonoscopy, aged 20 to 80 at the time of enrollment.

You may not qualify if:

• previous colon resection, gastrointestinal obstruction, ileus, intestinal perforation, toxic megacolon, active stage of inflammatory bowel disease, congestive heart failure (New York Heart Association Class III or IV),acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure \>170 mmHg, diastolic pressure\>100 mmHg), severe liver cirrhosis (Child-Pugh score C) or renal failure (creatinine clearance\<30 mL/minute) or any allergy to, PEG, or sodium picosulfate solution, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency.

Sponsors & Collaborators

• Dalin Tzu Chi General Hospital: lead

Related Publications (23)

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Study Officials

• Yu-Hsi Hsieh, MD

  Buddhist Dalin Tzu Chi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Hsi Hsieh, MD

CONTACT

886-5-2648000; hsiehyuhsi1112@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: June 1, 2019
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: May 28, 2019

Record last verified: 2019-04