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OpenTrials
Completed

NCT Number: NCT04101097

Training and Validation of Models of Factors to Predict Inadequate Bowel Preparation Colonoscopy

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadeqaute bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offerred to achieve better bowel cleasing. Currently, there were three predicting models of inadequate bowel preparation eatablished based on patient-related factors. It remains unclear which model perfroms better in predicting bowel preparation quality. Futhermore, althought those predicting models only composing of patients-related factors are useful for identifing high-risk patients, the preparation-related factors may also be valuable for prediciting inadeqaute bowel preparation before the procedure of colonoscopy.

This study aimed: 1) to compare the values of three availlable models (based on patient-related factors) in predicting inadeqaute bowel preparation in a prospective, multicentered cohort of patients undergoing colonoscopy; 2) to investigate whether a new model based on preparation-related or a combined model based on patient-related and preparation-related factors is comparable to previous models based on patient-related factors.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, Hongai Hospital, Xiamen, Fujian, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-80
  • Using PEG for bowel preparation before colonoscopy

Exclusion criteria

  • Not undergoing standard bowel preparation due to emergency, bleeding or unsuitable for preparation
  • Colon resection
  • Suspected bowel obstruction
  • Hemodynamically unstable
  • Lactating or pregnant women
  • Unwilling to provided informed content

Treatment and study plan

Primary outcomes

  1. Inadequate bowel preparation

    Time frame: 1 hour

    Inadequate bowel preparation was defined by the Boston Bowel Preparation Scale of any segmental<2.

Secondary outcomes

  1. Adequacy of proximal bowel preparation

    Time frame: 1 hour

    Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of right-colon<2 or middle colon<2

  2. Adequacy of distal bowel preparation

    Time frame: 1 hour

    Adequate bowel preparation is defined by the Boston Bowel Preparation Scale of left-colon<2 or middle colon<2

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Collaborators

  • Huaihe Hospital of Henan University
  • Shaanxi Second People's Hospital
  • Shenzhen Hospital of Southern Medical University
  • Xiamen Humanity Hospital

Registry information

Official study title

Training and Validation of Models Based on Patient-related or Procedure-related Factors to Predict Inadequate Bowel Preparation in Patients Undergoing Colonoscopy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 24, 2019
Registry last updated
Jun 16, 2020

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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