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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04434625
Enrollment
900
Registered
2020-06-17
Start date
2020-06-14
Completion date
2021-03-01
Last updated
2021-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bowel Preparation, Colonoscopy, Predictive Model

Keywords

factors, bowel preparation, colonoscopy

Brief summary

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

Interventions

DRUGPolyethylene glycol

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

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Adequate bowel preparation6 monthsDefined by each segmental BBPS≥2

Secondary

MeasureTime frameDescription
Adenoma detection rate6 monthsThe proportion of participants with at least one adenoma in each group
Overall complication related to bowel preparation6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026