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Completed

NCT Number: NCT06438237

Validation of a Prediction Model for Inadequate Bowel Preparation

We have developed a novel inadequate bowel preparation prediction model based on a systematic review and meta-analysis. The goal of this multicenter observational study is to validate the accuracy of this model.

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Key information

Conditions

Bowel Preparation Colonoscopy

Age range

18 year–94 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, 110840, China

About this study

The primary outcome is quality of bowel preparation. The secondary outcomes include polyp/adenoma detection rate, willingness of undergoing colonoscopy again and adverse events.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult patients (age is ≥18 years old);
  • patients undergoing colonoscopy;
  • written informed consent.

Exclusion criteria

  • patients undergoing emergent colonoscopy;
  • patients with major psychiatric disorders;
  • pregnant or breast feeding patients;
  • patients with contraindications for colonoscopy (e.g., heart failure, renal insufficiency);
  • patients suspected to have intestinal obstruction, stenosis or perforation;
  • poor compliance with the bowel preparation protocol (poor compliance is indicated if the dose of medication was < 75% of the prescribed dose;
  • incomplete colonoscopy because of other circumstances apart from inadequate cleansing
  • patients previously enrolled in this study.

Treatment and study plan

Bowel preparation before colonoscopy

Procedure

Patients use purgative for bowel cleansing before colonoscopy.

Primary outcomes

  1. Quality of bowel preparation

    Time frame: During the procedure of colonoscopy

    A total BBPS score ≥6 with BBPS score ≥2 for each colon segment was considered to have adequate bowel preparation. Each segment of the colon is scored from 0 to 3, with higher scores indicating superior cleansing, and summed for a total score that can range from 0 to 9.

Secondary outcomes

  1. Adenoma and/or polyp detection rate

    Time frame: During the procedure of colonoscopy

    Proportion of patients with at least one adenoma and/or polyp detected during colonoscopy

  2. Number of polyps and/or adenomas

    Time frame: During the procedure of colonoscopy

    Number of polyps and/or adenomas detected during colonoscopy

  3. Adverse events

    Time frame: Before the procedure of colonoscopy

    Incidence of abdominal pain, bloating, nausea/vomiting after intake of purgative.

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Validation of a Prediction Model for Inadequate Bowel Preparation Before Colonoscopy Based on a Systematic Review and Meta-analysis

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 31, 2024
Registry last updated
Aug 1, 2025

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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