Prediction Model for Anemia After Bariatric Surgery

December 14, 2023 updated by: Yuntao Nie, China-Japan Friendship Hospital
To develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study aims to develop and validate a prediction model for estimating the probability of anemia for patients with obesity one, three, and five years after sleeve gastrectomy and Roux-en-Y gastric bypass, using preoperative clinical and laboratory data.

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

This study aims to include patients with obesity who will undergo bariatric surgery.

Description

Inclusion Criteria:

  • aged between 16-70 years;
  • body mass index (BMI) ≥ 27.5 kg/m2;
  • complete preoperative and follow-up data.

Exclusion Criteria:

  • vegetarian;
  • other bariatric procedures;
  • renal failure at baseline;
  • postoperative bleeding (it was defined as a drop in hemoglobin levels > 3 g/dL or a confirmed blood loss requiring treatment after surgery);
  • incomplete preoperative and follow-up data.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCs of the prediction model at 1, 3, 5 years
Time Frame: 5 years
This metric shows the discrimination ability of the prediction model.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brier score
Time Frame: 5 years
This metric shows the calibration of the model. The Brier score (on a scale ranging from 0 to 1), which calculates the difference between the estimated and observed risk for malignancy with values closer to 0 indicating better calibration, was used to evaluate model calibration.
5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
AUCs of the prediction model in different subgroups
Time Frame: 5 years
AUCs of the prediction model in different subgroups, including age (≤ 40 years/>40 years), sex, BMI (≤37.5kg/m2/>37.5kg/m2), smoking history, alcohol consumption, hypertension, and T2DM history.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Collaborators

The Third Xiangya Hospital of Central South University
The Second Hospital of Shandong University
Jining First People's Hospital

Investigators

  • Principal Investigator: Yuntao Nie, M.D., China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

December 6, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 14, 2023

Study Record Updates

Last Update Posted (Estimated)

December 20, 2023

Last Update Submitted That Met QC Criteria

December 14, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CJBariatric003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Due to the medical privacy implications of the study data, the principal investigator needs to be contacted for access.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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