Skip to content

The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy

The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy in Patients Showing Brown Effluents

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02540031
Enrollment
156
Registered
2015-09-03
Start date
2015-09-30
Completion date
2018-06-30
Last updated
2018-07-20

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

Conditions

Bowel Preparation Quality

Brief summary

Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.

Interventions

DRUGAdditional oral preparation (3L of PEG+Asc, Coolprep®)

The interventional or experimental arm will receive 1l of additional PEG+Asc, Coolprep® on the day of colonoscopy \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

DRUGStandard oral preparation (2L of PEG+Asc, Coolprep®)

The control arm will receive currently used oral preparation (2l of PEG+Asc, Coolprep®) for colonoscopy \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Sponsors

Kyungpook National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy

Exclusion criteria

* known hypersensitivity to polyethylene glycol * severe congestive heart failure \[New York Heart Association (NYHA) grade III or grade IV\] * severe renal insufficiency (creatinine clearance \<30 ml/min) * hemodynamic instability * suspected intestinal obstruction or perforation * compromised swallowing reflex or altered mental status * pregnancy or lactating woman * patients who declined to participate

Design outcomes

Primary

MeasureTime frameDescription
Quality of bowel preparationDay 1The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale

Secondary

MeasureTime frameDescription
Adenoma detection rateDay 1Number of adenomatous polyps
Patient complianceBaselinePatient compliance with preparation instructions self-reported in a pre-procedure questionnaire
Patient satisfactionBaselinePatient's perception of the preparation method as self-reported on a pre-procedure questionnaire.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026