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Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

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ClinicalTrials.gov Identifier: NCT06157606
Recruitment Status : Recruiting
First Posted : December 6, 2023
Last Update Posted : December 6, 2023
Sponsor:
Collaborators:
The Second Hospital of Shandong University
Jining First People's Hospital
Information provided by (Responsible Party):
Yuntao Nie, China-Japan Friendship Hospital

Study Description
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Brief Summary:
This study aims to develop and validate a prediction model for estimating the probability of inadequate weight loss one year after sleeve gastrectomy.

Condition or disease
Bariatric Surgery Sleeve Gastrectomy Weight Loss

Detailed Description:
Inadequate weight loss (IWL) is a major problem after sleeve gastrectomy, leading to the recurrence of obesity-related comorbidities and increased risk of revision surgery. It is important to identify the high-risk individuals for IWL before surgery so that clinicians can initiate more rigorous weight monitoring and management strategies. Therefore, this study aims to develop a prediction model using preoperative clinical and laboratory data to estimate the risk of IWL one year after sleeve gastrectomy, and then validate it using two separate datasets.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Area under receiver operating characteristic curve (AUC) of the prediction model [ Time Frame: 1 year ]
    AUC reflects the discriminatory ability of the model, which was measured in this study.


Secondary Outcome Measures :
  1. Brier score of the prediction model [ Time Frame: 1 year ]
    Brier score reflects the calibration of the model, which was measured in this study.


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The population included patients with obesity who received sleeve gastrectomy between September 2017 and September 2024. All patients were followed up for at least 1 year.
Criteria

Inclusion Criteria:

  • BMI ≥ 27.5 kg/m2;
  • 16 years ≤ age ≤ 70 years;
  • Complete preoperative data and one-year follow-up information

Exclusion Criteria:

  • Patients who did not undergo SG;
  • Incomplete follow-up information;
  • Patients with a history of pituitary or thyroid disease;
  • Female patients who conceived within one year after surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06157606


Contacts
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Contact: Yuntao Nie, M.D. (+86)18611835860 nytnyt1231@163.com
Contact: Hua Meng, M.D. (+86)18611457779 menghuade@hotmail.com

Locations
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China
Yuntao Nie Recruiting
Beijing, China, 100029
Contact: Yuntao Nie, M.D.    +8618611835860    nytnyt1231@163.com   
Contact: Hua Meng, M.D.    +8618611457779    menghuade@hotmail.com   
Principal Investigator: Yuntao Nie, M.D.         
Sub-Investigator: Yinlu Ding, M.D.         
Sub-Investigator: Ming Zhu, M.D.         
Sponsors and Collaborators
China-Japan Friendship Hospital
The Second Hospital of Shandong University
Jining First People's Hospital
Investigators
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Principal Investigator: Yuntao Nie, M.D. China-Japan Friendship Hospital
Study Director: Yinlu Ding, M.D. The Second Hospital of Shandong University
Study Director: Ming Zhu, M.D. Jining First People's Hospital
More Information
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Responsible Party: Yuntao Nie, Medical doctor, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT06157606    
Other Study ID Numbers: CJBariatric001
First Posted: December 6, 2023    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: December 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuntao Nie, China-Japan Friendship Hospital:
Sleeve Gastrectomy
Weight Loss
Prediction Model
Additional relevant MeSH terms:
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Body Weight
Weight Loss
Body Weight Changes