NCT04607161

Brief Summary

In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. However, the current guideline indicates that there is insufficient evidence to recommend the use of a specialized predictive model for clinical practice.There are few studies on external validation of existing prediction models.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

4 months

First QC Date

October 25, 2020

Last Update Submit

June 27, 2021

Conditions

ColonoscopyPredictive ModelExternal Validation

Outcome Measures

Primary Outcomes (1)

  • discrimination

    Compare the area under the curve (AUC) between predictive models and acutal bowel preparation.

    cross-sectional analyses in 2020

Interventions

no interventionOTHER

no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients undergoing colonoscopy

You may qualify if:

  • patients undergoing colonoscopy.
  • patients older than 18 years.

You may not qualify if:

  • Emergency colonoscopy.
  • Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv.
  • Pregnant or breastfeeding.
  • No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives \< 90% of prescribed dose).
  • Refuse to sign informed consent.
  • The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation.
  • Temporarily change to colonoscopy for other reasons.
  • Incomplete colonoscopy due to insufficient parenteral preparation.
  • Lack of complete data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo first hospital

Ningbo, Zhejiang, 315000, China

Location

Related Publications (1)

  • Yuan X, Gao H, Liu C, Wang W, Xie J, Zhang Z, Xu L. External validation of two prediction models for adequate bowel preparation in Asia: a prospective study. Int J Colorectal Dis. 2022 Jun;37(6):1223-1229. doi: 10.1007/s00384-022-04156-0. Epub 2022 Apr 25.

    PMID: 35467123DERIVED

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2020

First Posted

October 29, 2020

Study Start

August 1, 2020

Primary Completion

December 1, 2020

Study Completion

December 31, 2020

Last Updated

June 30, 2021

Record last verified: 2021-06

Locations

CN(1)