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

Kyungpook National University

Status and phase: Completed; Phase 3

Conditions: Bowel Preparation Quality

Treatments: Drug: Standard oral preparation (2L of PEG+Asc, "Coolprep®"); Drug: Additional oral preparation (3L of PEG+Asc, "Coolprep®")

Study type: Interventional

Funder types: Other

Identifiers

NCT02540031

2015-06-014-003

Details and patient eligibility

About

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.

Enrollment: 156 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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156 participants in 2 patient groups

Additional oral preparation

Experimental group

Description:

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

Treatment:

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

Standard oral preparation

Active Comparator group

Description:

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

Treatment:

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