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NCT Number: NCT04434625

The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors

The rate of adequate bowel preparation is one of important quality indicators of colonoscopy. Inadequate bowel preparation negatively affects the outcomes of colonoscopy. If patients with inadequate bowel preparation were identified before the procedure, enhanced strategy could be offered to achieve better bowel cleaning. Currently, there were three predicting models of inadequate bowel preparation established based on patient-related factors. So far, none of predictive models have been tested in other than their validation cohort populations, and no study has attempted to apply a different regimen to patients presenting with risk factors for inadequate colon cleanliness. In previous studies, we established a prediction model based on procedure-related factors, which has better accuracy and can better predict the quality of bowel preparation.

The aim of this study is to compare the quality of bowel preparation by using a predictive model based on procedure-related factors versus the criterion group in unsedation patients

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Key information

Conditions

Colonoscopy Bowel Preparation Predictive Model

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 18~75 years
  • Patients undergoing morning colonoscopy

Exclusion criteria

  • colon resection;
  • suspected bowel obstruction;
  • moderate or severe complications related to drinking the 1st or 2rd dose of PEG
  • hemodynamically unstable;
  • lactating or pregnant women;
  • no need to reach the ileocecal segment
  • unwilling to provided informed content.

Treatment and study plan

Polyethylene glycol

Drug

Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group and those in the control group underwent colonoscopy directly

Primary outcomes

  1. Adequate bowel preparation

    Time frame: 6 months

    Defined by each segmental BBPS≥2

Secondary outcomes

  1. Adenoma detection rate

    Time frame: 6 months

    The proportion of participants with at least one adenoma in each group

  2. Overall complication related to bowel preparation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Air Force Military Medical University, China

Other

Registry information

Official study title

The Effect of a Predictive Model of Bowel Preparation Based on Procedure-related Factors: a Multicenter, Randomized Controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 17, 2020
Registry last updated
Sep 14, 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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