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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06170749
Other study ID # CJBariatric003
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 31, 2025

Study information

Verified date December 2023
Source China-Japan Friendship Hospital
Contact Yuntao Nie, M.D.
Phone +8618611835860
Email nytnyt1231@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 600
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 16 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Yuntao Nie Beijing

Sponsors (4)

Lead Sponsor Collaborator
China-Japan Friendship Hospital Jining First People's Hospital, The Second Hospital of Shandong University, The Third Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other AUCs of the prediction model in different subgroups 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
Primary AUCs of the prediction model at 1, 3, 5 years This metric shows the discrimination ability of the prediction model. 5 years
Secondary Brier score 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
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