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Completed

NCT Number: NCT02250196

A Randomized Prospective Trial Comparing Low-volume Bowel Preparation Methods

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Korea University Anam Hospital

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

About this study

  • Study design: endoscopist-blinded, prospective, randomized controlled trial
  • Subjects
  • Entry 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.

  • Sampling design: Consecutive recruitment of consenting patients
  • Variables Predictor
  • 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
  • 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;
  • Primary Outcome: Quality of bowel preparation (Boston Bowel Preparation Scale, Aronchick scale, bubble score)
  • Secondary Outcome: Tolerability, palatability

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Coolprep®; TaeJoon Pharmaceuticals, Seoul, Korea

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

Other names: Picolight(Pharmbio korea, Seoul, Korea)

Primary outcomes

  1. the quality of the bowel preparation using Preparation Scale

    Time frame: 20 minutes

    Preparation Scale

Secondary outcomes

  1. Completeness of the bowel preparation

    Time frame: 30 minutes before the colonoscopy

    Patient compliance was recorded by checking the completeness of the prescribed preparation methods including bowel cleansing agent solution and recommended clear liquid.

  2. the patient's tolerability

    Time frame: 30 minutes before the colonoscopy

    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".

Sponsors and collaborators

Lead sponsor

Korea University Anam Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Sep 26, 2014
Registry last updated
Sep 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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