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
• Status: Recruiting
• 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
• 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
• 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)

Related Conditions & MeSH terms

• Anemia
• Bariatric Surgery

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