Comparison of Low Volume PEG-Asc and Lower Volume PEG-Asc With Bisacodyl

Sponsor

Korea University Anam Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02980562

Collaborator

(none)

200

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

Recently a low-volume polyethylene glycol containing ascorbic acid (PEG-Asc) formulation has proven as safe and effective as traditional 4-L PEG solutions for colonoscopy preparation. However, currently available aqueous purgative formulations are poorly tolerated. The aim of this study was to compare a split-dose 2-L PEG-Asc and a 1-L PEG-Asc with bisacodyl (10 mg) formulation to determine the quality of bowel cleansing and patient tolerability.

Condition or Disease	Intervention/Treatment	Phase
Bowel Disease Colon Adenoma	Drug: Polyethylene Glycols Drug: Bisacodyl	Phase 3

Detailed Description

Study design A single center, randomized, comparative observer-blinded study was performed from May 2015 to September 2015 at the Department of Gastroenterology and Digestive Endoscopy at Korea University Anam Hospital (Seoul, Korea).

In total, 200 outpatients received lower volume 1-L PEG with ascorbic acid plus bisacodyl (1L-PEG/AB) or low volume 2-L PEG with ascorbic acid (2L-PEG/A) in a 1:1 ratio.

At the time of registration, subjects were randomly allocated to either group. They were randomized by a computer-generated list and were provided with written instructions. All patients provided written informed consent.

Patients All patients between the ages of 20 and 75 years. Patients were excluded from the analysis if they had known or suspected gastrointestinal obstruction, Ileus, severe heart failure, uncontrolled hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg), severe constipation, clinically significant electrolyte abnormalities, any prior bowel resection, or significant gastroparesis.
Bowel preparation In the 2L-PEG/A group, 1 L of PEG containing ascorbic acid was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure.

The 1L-PEG/AB group received 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.

Assessment by endoscopists Colonoscopies were performed by two expert endoscopists who were blinded to the preparation regimen. These two endoscopists worked for more than 5 years at our institution.

Bowel cleansing was scored by the same endoscopist performing the colonoscopy. To assess the cleansing quality of the bowel preparations, the Boston Bowel Preparation Scale (BBPS) and the Aronchick Bowel Preparation Scale (ABPS) were used.

Assessment of patient tolerability and adverse events Before the colonoscopy procedure, patients completed questionnaires about their symptoms associated with the preparations to assess tolerability. Patients were asked to assess the degree of abdominal fullness, abdominal pain, nausea, vomiting, sleep disturbances, and general discomfort using a 5-point scale (i.e., none, mild, moderate, severe, or very severe).

The palatability of the preparation was graded in 5 categories: very good, good, acceptable, disgusting, and bad.

Sample size and statistical analysis A sample size of at least 89 patients group was required for each treatment group to detect a difference in treatment success of a 5% type-I error rate and 80% power for a two-tailed χ2 test. Our sample size was based on the results from a pilot study that was conducted in our hospital and included 35 patients in each group. It was estimated that the efficacy for excellent treatment success would be 49% with PEG-2L/A and 30% with PEG-1L/AB. Based on these data, we decided to collect 100 patients per treatment group for study.

Continuous variables were expressed as mean ± standard deviation (SD), and discontinuous variables were expressed as counts and percentages. SPSS 20.0 for Windows (SPSS Inc., Chicago, IL, US) was used for data entry and statistical analyses. For the analyses between the two treatment groups, Students t-test as appropriate was used to compare continuous variables and either the Chi-square or Fisher's exact test were used for categorical data. The p-values < 0.05 were considered statistically significant.

Study Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Official Title:

Comparison of a Split Dose Bowel Preparation With 2-L Polyethylene Glycol Plus Ascorbic Acid and 1-L Polyethylene Glycol Plus Ascorbic Acid and Bisacodyl Prior to Colonoscopy

Study Start Date :

May 1, 2015

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 2L Polyethylene glycols-Asc 1 L of PEG containing ascorbic acid (PEG A) was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure. All colonoscopies were performed between 9 am and 1 pm.	Drug: Polyethylene Glycols (Split dose 2L PEG-Asc) Other Names: Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea
Active Comparator: 1L PEG-Asc plus bisacodyl 10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.	Drug: Bisacodyl (1L PEG-Asc plus bisacodyl) Other Names: Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea Dulcorax-S®; Boehringer Ingelheim, Seoul, Korea

Arm

Intervention/Treatment

Active Comparator: 2L Polyethylene glycols-Asc

1 L of PEG containing ascorbic acid (PEG A) was taken at 8:00 pm on the day before the colonoscopy, followed by an extra 500 mL of water. The second 1-L of PEG containing ascorbic acid was taken 4 h before the colonoscopy examination, with an additional 500 mL of water. Each liter of preparation and the extra 500 mL water had to be consumed within 2 h of the procedure. All colonoscopies were performed between 9 am and 1 pm.

Drug: Polyethylene Glycols

(Split dose 2L PEG-Asc)

Other Names:

Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea

Active Comparator: 1L PEG-Asc plus bisacodyl

10 mg bisacodyl at 9:00 pm on the day before the colonoscopy. Four hours before the colonoscopy examination, 1 L of PEG containing ascorbic acid was taken, followed by an additional 1 L of water. The preparation was completed 2 h before the examination. All colonoscopies were performed between 9 am and 1 pm.

Drug: Bisacodyl

(1L PEG-Asc plus bisacodyl)

Other Names:

Coolprep®; Taejoon Pharmaceuticals, Seoul, Korea

Dulcorax-S®; Boehringer Ingelheim, Seoul, Korea

Outcome Measures

Primary Outcome Measures

The quality of the bowel preparation using preparation scale [20 minutes]
Preparation scale

Secondary Outcome Measures

The patient's tolerability [30 minutes before the colonoscopy]
Patients were asked with questionnaires about the symptoms

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All patients between the ages of 20 and 75 years who were scheduled to undergo colonoscopy

Exclusion Criteria:

aged more than 75 years.
known or suspected gastrointestinal obstruction, Ileus
severe heart failure
uncontrolled hypertension (systolic pressure > 170 mmHg, diastolic pressure > 100 mmHg)
severe constipation
clinically significant electrolyte abnormalities
any prior bowel resection, or significant gastroparesis.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Korea University Anam Hospital

Investigators

Study Director: Yoon Tae Jeen, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine
Principal Investigator: Seung Hun Kang, Division of Gastroenterology and Hepatology, Department of Internal Medicine, Institute of Gastrointestinal Medical Instrument Research, Korea University College of Medicine