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NCT06218953 Clinical Trial

The Impact of Preoperative Anemia on Postoperative Anemia and Related Nutrient Abnormalities After Bariatric Surgery

Anemia Clinical Trial

Official title:
The Impact of Preoperative Anemia on Postoperative Anemia and Related Nutrient Abnormalities After Bariatric Surgery

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06218953
Other study ID # CJBariatric004
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date December 31, 2024

Study information
Verified date January 2024
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

This study aims to assess the impact of preoperative anemia status on anemia and related nutrient abnormalities 1 year after bariatric surgery.

Description:

This study aims to assess the impact of preoperative anemia status on anemia and related nutrient abnormalities (ferritin deficiency, vitamin B12 deficiency, folate deficiency, and low transferrin saturation level) at 1 year after bariatric surgery.

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date December 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers
Gender All
Age group 16 Years to 70 Years
Eligibility Inclusion Criteria: - Patients who underwent bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass) - Age between 16 and 70 years - Patients who have complete 1-year follow-up data Exclusion Criteria: - Baseline renal failure - Vegetarian - Postoperative bleeding (it was defined as a drop in hemoglobin levels > 3 g/dL or a confirmed blood loss requiring treatment after surgery)

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Yuntao Nie Beijing

Sponsors (1)
Lead Sponsor Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Odds ratio (OR) for anemia by preoperative anemia status Multivariable logistic regression will be performed to assess the association between preoperative anemia and postoperative anemia. Several factors will be adjusted: sex, age, BMI, waist circumference, hip circumference, surgery, smoking, alcohol, hypertension, diabetes, hyperuricemia, hypercholesterolemia, and hypertriglyceridemia. 1 year
Secondary Percentage of postoperative anemia Percentage of postoperative anemia,, , and low transferrin saturation level. 1 year
Secondary Percentage of anemia severity Percentage of anemia severity (mild: hemoglobin=110g/L; moderate: hemoglobin=80g/L; severe: hemoglobin<80g/L). 1 year
Secondary Percentage of ferritin deficiency Percentage of ferritin deficiency, which is defined as ferritin less than 30 ng/mL. 1 year
Secondary Percentage of vitamin B12 deficiency Percentage of ferritin deficiency, which is defined as vitamin B12 less than 150 pmol/L. 1 year
Secondary Percentage of folate deficiency Percentage of folate deficiency, which is defined as folate less than 10 nmol/L. 1 year
Secondary Percentage of low transferrin saturation level Percentage of low transferrin saturation level, which is defined as transferrin saturation less than 20%. 1 year
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