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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bowel Preparation Quality

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Investigators

Study Groups

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Additional oral preparation

The investigational or experimental arm will receive standard oral preparation plus additional oral preparation (1l of polyethylene glycol (PEG)+ascorbic acid (Asc)) 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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Standard oral preparation

The control arm will receive currently used oral preparation (2L of polyethylene glycol+ascorbic acid) 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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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Additional 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

Intervention Type DRUG

Standard 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

Intervention Type DRUG

Other Intervention Names

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Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes