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

Phase 3

Completed

• Conditions: Bowel Preparation Quality
• Interventions: Drug: Additional oral preparation (3L of PEG+Asc, "Coolprep®"); Drug: Standard oral preparation (2L of PEG+Asc, "Coolprep®")

• Registration Number: NCT02540031
• Lead Sponsor: Kyungpook National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-08
• Study First Submitted QC: 2015-08-31
• Study Start: 2015-09
• Study First Posted: 2015-09-03
• Primary Completion: 2018-04
• Study Completion: 2018-06
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-18
• Last Update Posted: 2018-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional oral preparation	Additional oral preparation (3L of PEG+Asc, "Coolprep®")	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
Standard oral preparation	Standard oral preparation (2L of PEG+Asc, "Coolprep®")	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

Primary Outcome Measures

Name	Time	Method
Quality of bowel preparation	Day 1	The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale

Secondary Outcome Measures

Name	Time	Method
Adenoma detection rate	Day 1	Number of adenomatous polyps
Patient satisfaction	Baseline	Patient's perception of the preparation method as self-reported on a pre-procedure questionnaire.
Patient compliance	Baseline	Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire

Trial Locations

Locations (1)

Keimyung University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of