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

Bowel Preparation Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02540031
• Other study ID #: 2015-06-014-003
• Status: Completed
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: June 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Bowel Preparation Quality

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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. — View Citation

Outcome

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