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OpenTrials
Completed

NCT Number: NCT04290715

Development and Validation for Predicting Inadequate Bowel Preparation

High-quality colonoscopy is considered the gold standard for the detection and prevention of colorectal cancer, and its efficacy is predicated on optimal colon cleansing.However, about 18%-35% of patients were still reported to suffer inadequate bowel preparation. Although several predictive models exist, the current guideline indicates that there is insufficient evidence to recommend the use of a predictive model for clinical practice.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ningbo First Hospital

Ningbo, Zhejiang, 315010, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients undergoing colonoscopy.
  • patients older than 18 years.

Exclusion criteria

  • Emergency colonoscopy.
  • Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
  • Pregnant or breastfeeding.
  • No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives < 90% of prescribed dose).
  • Refuse to sign informed consent.
  • The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation.
  • Temporarily change to colonoscopy for other reasons.
  • Incomplete colonoscopy due to insufficient parenteral preparation.
  • Lack of complete data.

Treatment and study plan

No intervention

Other

no intervention

Primary outcomes

  1. quality of bowel preparation

    Time frame: A colonoscopy procedure

    The OBPS is a validated scoring system with scores between 0 and 14, where 0 is the best score. The score comprises a sub score 0-4 for each colon segment: right, transverse and rectosigmoid colon. In addition, a score 0-2 is added to indicate the total amount of luminal fluid.

    For all participants, OBPS score will be used when the colonscopy is inserting.

  2. quality of bowel preparation

    Time frame: A colonoscopy procedure

    The BBPS is another validated scoring system with scores between 0 and 9, where 9 is the best score. The score comprises a sub score 0-3 for each colon segment: right, transverse and left colon.

    For all participants, BBPS score will be used when colonscopy is withdrawing.

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

Development and Validation for Predicting Inadequate Bowel Preparation Before Colonoscopy in Patients

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 2, 2020
Registry last updated
Aug 30, 2021

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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