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

Recruiting

• Conditions: Anemia; Bariatric Surgery

• Registration Number: NCT06218953
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2023-12-25
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-12
• Last Update Submitted: 2024-01-12
• Study First Posted: 2024-01-23
• Last Update Posted: 2024-01-23
• Primary Completion: 2024-01-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Odds ratio (OR) for anemia by preoperative anemia status	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of ferritin deficiency	1 year	Percentage of ferritin deficiency, which is defined as ferritin less than 30 ng/mL.
Percentage of anemia severity	1 year	Percentage of anemia severity (mild: hemoglobin≥110g/L; moderate: hemoglobin≥80g/L; severe: hemoglobin\<80g/L).
Percentage of postoperative anemia	1 year	Percentage of postoperative anemia,, , and low transferrin saturation level.
Percentage of folate deficiency	1 year	Percentage of folate deficiency, which is defined as folate less than 10 nmol/L.
Percentage of vitamin B12 deficiency	1 year	Percentage of ferritin deficiency, which is defined as vitamin B12 less than 150 pmol/L.
Percentage of low transferrin saturation level	1 year	Percentage of low transferrin saturation level, which is defined as transferrin saturation less than 20%.

Trial Locations

Locations (1)

Yuntao Nie; 🇨🇳 Beijing, China