Prediction Model for Anemia After Bariatric Surgery

Anemia Clinical Trial

Official title:

Prediction Model for Anemia After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06170749
• Other study ID #: CJBariatric003
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Anemia
• Bariatric Surgery

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