NCT06218953

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2017

Completed
6.3 years until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

January 23, 2024

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

July 9, 2025

Status Verified

July 1, 2025

Enrollment Period

6.4 years

First QC Date

December 25, 2023

Last Update Submit

July 4, 2025

Conditions

AnemiaBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Percentage of postoperative anemia

    1 year

  • Percentage of anemia severity

    1 year

  • Percentage of ferritin deficiency

    1 year

  • Percentage of vitamin B12 deficiency

    1 year

  • Percentage of folate deficiency

    1 year

  • +1 more secondary outcomes

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent bariatric surgery aged between 16 and 70 years will receive follow-up for at least 1 year.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuntao Nie

Beijing, 100029, China

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Yuntao Nie, M.D.

    China-Japan Friendship Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 23, 2024

Study Start

September 1, 2017

Primary Completion

January 31, 2024

Study Completion

December 31, 2024

Last Updated

July 9, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Patient data must be obtained with the consent of the principal investigator.

Locations

CN(1)