AnemiaNCT06170749
Prediction Model for Anemia After Bariatric Surgery
An observational study of Anemia and Bariatric Surgery, run by China-Japan Friendship Hospital at 1 site in China.
Trial summary
To develop and validate a prediction model for estimating the short and long-term risk of anemia 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
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2017to 31 May 2025
- How long will I take part?
- 5 Years
- 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: This study aims to include patients with obesity who will undergo bariatric surgery.
Who may be able to join
- aged between 16-70 years;
- body mass index (BMI) ≥ 27.5 kg/m2;
- complete preoperative and follow-up data.
Who cannot join
- vegetarian;
- other bariatric procedures;
- renal failure at baseline;
- postoperative bleeding (it was defined as a drop in hemoglobin levels > 3 g/dL or a confirmed blood loss requiring treatment after surgery);
- incomplete preoperative and follow-up data.
Trial locations and contacts
1 site in 1 country.
About this study
To develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.
Read the detailed description
This study aims to develop and validate a prediction model for estimating the probability of anemia for patients with obesity one, three, and five years after sleeve gastrectomy and Roux-en-Y gastric bypass, using preoperative clinical and laboratory data.
- Conditions
- Anemia, Bariatric Surgery
- Keywords
- Anemia, Bariatric surgery, Prediction model
- Medical subject headings
- Anemia
What is being measured
The primary outcome is the main question the study is designed to answer.
AUCs of the prediction model at 1, 3, 5 years
This metric shows the discrimination ability of the prediction model.
Measured: 5 years
Secondary outcomes (1)
Brier score
This metric shows the calibration of the model. The Brier score (on a scale ranging from 0 to 1), which calculates the difference between the estimated and observed risk for malignancy with values closer to 0 indicating better calibration, was used to evaluate model calibration.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start1 Sep 2017
- Primary completion31 Dec 2024
- Study completion31 May 2025
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.
- 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
- 600 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Xiangya Hospital of Central South University, Jining First People's Hospital, The Second Hospital of Shandong University
- 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
- NCT06170749
- Sponsor's protocol ID
- CJBariatric003
- Status last verified
- Jul 2025
- First submitted
- 6 Dec 2023
- Last updated
- 8 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Due to the medical privacy implications of the study data, the principal investigator needs to be contacted for access.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for Anemia After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT06170749
- Acronym / sponsor ID
- CJBariatric003
- Conditions
- Anemia, Bariatric Surgery
- Keywords
- Anemia, Bariatric surgery, Prediction model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Collaborators
- The Third Xiangya Hospital of Central South University, Jining First People's Hospital, The Second Hospital of Shandong University
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 14 Dec 2023 (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.
To develop and validate a prediction model for estimating the short and long-term risk of anemia after bariatric surgery.
Detailed description
This study aims to develop and validate a prediction model for estimating the probability of anemia for patients with obesity one, three, and five years after sleeve gastrectomy and Roux-en-Y gastric bypass, using preoperative clinical and laboratory data.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- This study aims to include patients with obesity who will undergo bariatric surgery.
Key inclusion criteria (3 listed)
- aged between 16-70 years;
- body mass index (BMI) ≥ 27.5 kg/m2;
- complete preoperative and follow-up data.
Key exclusion criteria (5 listed)
- vegetarian;
- other bariatric procedures;
- renal failure at baseline;
- postoperative bleeding (it was defined as a drop in hemoglobin levels > 3 g/dL or a confirmed blood loss requiring treatment after surgery);
- incomplete preoperative and follow-up data.
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
AUCs of the prediction model at 1, 3, 5 years
Time frame: 5 years
This metric shows the discrimination ability of the prediction model.
1 secondary outcome
Brier score
Time frame: 5 years
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 8 Jul 2025.
- Individual participant dataSharing planned: Undecided. Due to the medical privacy implications of the study data, the principal investigator needs to be contacted for access.
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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 5 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 8 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?
AUCs of the prediction model at 1, 3, 5 years (time frame: 5 years). 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 8 Jul 2025.