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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 156
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-712
    • Keimyung University Dongsan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: 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; Other Names: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L
Active Comparator: 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	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; Other Names: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of bowel preparation	The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale	Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Principal Investigator: Eun Soo Kim, Keimyung University Dongsan Medical Center

Publications and helpful links

General Publications

• Fatima H, Johnson CS, Rex DK. Patients' description of rectal effluent and quality of bowel preparation at colonoscopy. Gastrointest Endosc. 2010 Jun;71(7):1244-1252.e2. doi: 10.1016/j.gie.2009.11.053. Epub 2010 Apr 1.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: August 8, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimate): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2015-06-014-003