Clinical trial NCT02250196: A Randomized Prospective Trial Comparing Low-volume Bowel Preparation Methods
Official title: A Randomized, Prospective Tiral on Efficacy and Tolerability of Low-volume Bowel Preparation Methods for Colonoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Colon Adenoma
Keywords: Bowel preparation
Polyethylene glycol with ascorbic acid
Sodium picosulfate with magnesium citrate
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: the quality of the bowel preparation using Preparation Scale
timeFrame: 20 minutes
Secondary outcomes:
measure: Completeness of the bowel preparation
timeFrame: 30 minutes before the colonoscopy
measure: the patient's tolerability
timeFrame: 30 minutes before the colonoscopy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Anamdong 5-ga, Seongbuk-gu
Study officials:
affiliation: Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
name: Eun Sun Kim, PhD
role: STUDY_DIRECTOR
affiliation: Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea
name: In Kyung Yoo, MD
role: PRINCIPAL_INVESTIGATOR
References: