A Randomized Prospective Trial Comparing Low-volume Bowel Preparation Methods

NCT02250196 | Completed Phase 3 DMC

• 1 other identifier: Korea University Prep
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Colon Adenoma

Keywords

Bowel preparation; Polyethylene glycol with ascorbic acid; Sodium picosulfate with magnesium citrate

Outcome Measures

Primary Outcomes (1)

• the quality of the bowel preparation using Preparation Scale

  Preparation Scale

  20 minutes

Secondary Outcomes (2)

• Completeness of the bowel preparation

  30 minutes before the colonoscopy

• the patient's tolerability

  30 minutes before the colonoscopy

Study Arms (2)

PEG-Asc

ACTIVE COMPARATOR

group 1 (PEG-Asc, N=100) 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

Drug: PEG-Asc

SPMC 2

ACTIVE COMPARATOR

group 2 (SPMC 2, N=100) received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure

Drug: SPMC 2

Interventions

PEG-Asc DRUG

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

Also known as: Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea

PEG-Asc

SPMC 2 DRUG

received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure

Also known as: Picolight(Pharmbio korea, Seoul, Korea)

SPMC 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Korea University Anam Hospital: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, Anamdong 5-ga, Seongbuk-gu, 136-705, South Korea

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Eun Sun Kim, PhD

  Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  STUDY DIRECTOR

• In Kyung Yoo, MD

  Division of Gastroenterology, Department of Internal Medicine, Korea University College of Medicine, Seoul, Republic of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: fellow

Study Record Dates

• First Submitted: September 8, 2014
• First Posted: September 26, 2014
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2013
• Last Updated: September 26, 2014

Record last verified: 2014-09

Locations

KR (1)