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Completed

NCT Number: NCT03704571

A Predictive Model for Inadequate Bowel Preparation

We aimed to develop a predictive model of inadequate bowel preparation and to further validate it by a randomized controlled trial.

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Key information

Conditions

Bowel Preparation Adenoma Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18-75 years undergoing colonoscopy

Exclusion criteria

  • known or suspected bowel obstruction, stricture or perforation
  • compromised swallowing reflex or mental status
  • severe chronic renal failure(creatinine clearance < 30 ml/min)
  • severe congestive heart failure (New York Heart Association class III or IV)
  • uncontrolled hypertension (systolic blood pressure > 170 mm Hg, diastolic blood pressure > 100 mm Hg)
  • dehydration
  • disturbance of electrolytes
  • pregnancy or lactation
  • hemodynamically unstable
  • unable to give informed consent

Treatment and study plan

Polyethylene glycol

Drug

In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.

In the control group, all the patients are given routine regimens.

Primary outcomes

  1. Quality of Bowel Preparation

    Time frame: 10 months

    The quality of bowel preparation is evaluated using BBPS.

Secondary outcomes

  1. Adenoma Detection Rate

    Time frame: 10 months

    The proportion of patients from whom at least one adenoma can be detected.

  2. Polyp Detection Rate

    Time frame: 10 months

    The proportion of patients from whom at least one polyp can be detected.

  3. Adverse Events

    Time frame: 10 months

    Including nausea, bloating, stomachache, vomiting, vertigo and belching and so on.

Sponsors and collaborators

Lead sponsor

Shandong University

Other

Registry information

Official study title

A Predictive Model for Inadequate Bowel Preparation: Development and Validation With a Randomized Controlled Trial

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 15, 2018
Registry last updated
Nov 1, 2019

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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