A Randomized Prospective Trial Comparing Low-volume Bowel Preparation Methods

Colorectal Cancer Clinical Trial

Official title:

A Randomized, Prospective Tiral on Efficacy and Tolerability of Low-volume Bowel Preparation Methods for Colonoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02250196
• Other study ID #: Korea University Prep
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2014
• Last updated: September 24, 2014
• Start date: March 2013
• Est. completion date: November 2013

Study information

• Verified date: September 2014
• Source: Korea University Anam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Colonoscopy is a common screening method to detect polyps and CRC. With the early detection of CRC through screening colonoscopy, patients could have better therapeutic effects and outcomes. In population screening programs, an increase in completed colonoscopies is related to a decrease in mortality from CRC. However, the miss rate for detecting colorectal neoplastic polyps of colonoscopy is 5-28%. The reluctance of participants to undergo bowel preparation results in the relatively low rate of detection of polyps and CRC, because poor preparation interferes with successful colon mucosa examination during a colonoscopy.

Low-volume bowel preparations provide equivalent cleansing effect compared with standard 4 liter polyethylene glycol. However, studies comparing the superiority between low-volume bowel preparations are rare, and results are controversial. This study aimed to compare the bowel cleansing quality and tolerability between split-dose sodium picosulfate/magnesium citrate and polyethylene glycol with ascorbic acid.

Description:

1. Study design: endoscopist-blinded, prospective, randomized controlled trial

2. Subjects

1. Entry criteria: Male or female patients, aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study.

2. Exclusion criteria:

patients who had chronic kidney disease, severe heart failure(New York Heart Association [NYHA] class III or IV), uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg), severe constipation, any bowel resection, significant gastroparesis, or suspected bowel obstruction or perforation.

3. Sampling design: Consecutive recruitment of consenting patients

4. Variables Predictor

1. group 1 (SPMC 2) received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure

2. group 2 (PEG-Asc) received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure;

5. Primary Outcome: Quality of bowel preparation (Boston Bowel Preparation Scale, Aronchick scale, bubble score)

6. Secondary Outcome: Tolerability, palatability

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female patients, aged between18 and 80 years undergoing elective outpatient colonoscopy were eligible for the study

Exclusion Criteria:

• patients who had chronic kidney disease, severe heart failure(New York Heart Association [NYHA] class III or IV), uncontrolled hypertension (systolic pressure =170 mm Hg, diastolic pressure =100 mm Hg), severe constipation, any bowel resection, significant gastroparesis, or suspected bowel obstruction or perforation.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Adenoma
• Colorectal Cancer

Intervention

Drug:
• PEG-Asc
received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure
• SPMC 2
received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul	Anamdong 5-ga, Seongbuk-gu

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the quality of the bowel preparation using Preparation Scale	Preparation Scale	20 minutes	No
Secondary	Completeness of the bowel preparation	Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.	30 minutes before the colonoscopy	No
Secondary	the patient's tolerability	Patients were asked with questionnaires about the symptoms associated with the preparation to assess the patients' tolerability before the colonoscopy. Patients were asked whether they experienced any of the following : abdominal fullness, cramping, nausea, vomiting, sleep disturbance, and overall discomfort, and these symptoms were scored on a 5-point scale where 1 = "none", 2 = "mild", 3 = "moderate", 4 = "severe", and 5 = "very severe".	30 minutes before the colonoscopy	Yes