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Completed

NCT Number: NCT02540031

The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy

Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.

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Key information

Conditions

Bowel Preparation Quality

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy

Exclusion criteria

  • known hypersensitivity to polyethylene glycol
  • severe congestive heart failure [New York Heart Association (NYHA) grade III or grade IV]
  • severe renal insufficiency (creatinine clearance <30 ml/min)
  • hemodynamic instability
  • suspected intestinal obstruction or perforation
  • compromised swallowing reflex or altered mental status
  • pregnancy or lactating woman
  • patients who declined to participate

Treatment and study plan

Additional oral preparation (3L of PEG+Asc, "Coolprep®")

Drug

The interventional or experimental arm will receive 1l of additional PEG+Asc, "Coolprep®" on the day of colonoscopy

  • Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Other names: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L

Standard oral preparation (2L of PEG+Asc, "Coolprep®")

Drug

The control arm will receive currently used oral preparation (2l of PEG+Asc, "Coolprep®") for colonoscopy

  • Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Other names: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L

Primary outcomes

  1. Quality of bowel preparation

    Time frame: Day 1

    The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale

Secondary outcomes

  1. Adenoma detection rate

    Time frame: Day 1

    Number of adenomatous polyps

  2. Patient compliance

    Time frame: Baseline

    Patient compliance with preparation instructions self-reported in a pre-procedure questionnaire

  3. Patient satisfaction

    Time frame: Baseline

    Patient's perception of the preparation method as self-reported on a pre-procedure questionnaire.

Sponsors and collaborators

Lead sponsor

Kyungpook National University Hospital

Other

Registry information

Official study title

The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy in Patients Showing Brown Effluents

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 3, 2015
Registry last updated
Jul 20, 2018

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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