AnemiaNCT06218953
The Impact of Preoperative Anemia on Postoperative Anemia and Related Nutrient Abnormalities After Bariatric Surgery
An observational study of Anemia and Bariatric Surgery, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
This study aims to assess the impact of preoperative anemia status on anemia and related nutrient abnormalities 1 year after bariatric surgery. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Anemia, Bariatric Surgery
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Patients who underwent bariatric surgery aged between 16 and 70 years will receive follow-up for at least 1 year.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the impact of preoperative anemia status on anemia and related nutrient abnormalities 1 year after bariatric surgery.
Read the 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.
- Conditions
- Anemia, Bariatric Surgery
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
Percentage of postoperative anemia
Percentage of postoperative anemia,, , and low transferrin saturation level.
Measured: 1 year
Percentage of anemia severity
Percentage of anemia severity (mild: hemoglobin≥110g/L; moderate: hemoglobin≥80g/L; severe: hemoglobin<80g/L).
Measured: 1 year
Percentage of ferritin deficiency
Percentage of ferritin deficiency, which is defined as ferritin less than 30 ng/mL.
Measured: 1 year
Percentage of vitamin B12 deficiency
Percentage of ferritin deficiency, which is defined as vitamin B12 less than 150 pmol/L.
Measured: 1 year
Percentage of folate deficiency
Percentage of folate deficiency, which is defined as folate less than 10 nmol/L.
Measured: 1 year
Percentage of low transferrin saturation level
Percentage of low transferrin saturation level, which is defined as transferrin saturation less than 20%.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Sep 2017
- Primary completion31 Jan 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuntao Nie, China-Japan Friendship Hospital
- Investigators
- Yuntao Nie, M.D., Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218953
- Sponsor's protocol ID
- CJBariatric004
- Status last verified
- Jul 2025
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data must be obtained with the consent of the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Preoperative Anemia on Postoperative Anemia and Related Nutrient Abnormalities After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06218953
- Acronym / sponsor ID
- CJBariatric004
- Conditions
- Anemia, Bariatric Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent bariatric surgery aged between 16 and 70 years will receive follow-up for at least 1 year.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Odds ratio (OR) for anemia by preoperative anemia status
Time frame: 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.
6 secondary outcomes
Percentage of postoperative anemia
Time frame: 1 year
Percentage of anemia severity
Time frame: 1 year
Percentage of ferritin deficiency
Time frame: 1 year
Percentage of vitamin B12 deficiency
Time frame: 1 year
Percentage of folate deficiency
Time frame: 1 year
Percentage of low transferrin saturation level
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No. Patient data must be obtained with the consent of the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuntao Nie, M.D. principal investigator
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Bariatric Surgery, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Odds ratio (OR) for anemia by preoperative anemia status (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.