Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT06157606 |
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Recruitment Status :
Recruiting
First Posted : December 6, 2023
Last Update Posted : December 6, 2023
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Sponsor:
China-Japan Friendship Hospital
Collaborators:
The Second Hospital of Shandong University
Jining First People's Hospital
Information provided by (Responsible Party):
Yuntao Nie, China-Japan Friendship Hospital
| Tracking Information | ||||||||||
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| First Submitted Date | November 27, 2023 | |||||||||
| First Posted Date | December 6, 2023 | |||||||||
| Last Update Posted Date | December 6, 2023 | |||||||||
| Actual Study Start Date | September 1, 2017 | |||||||||
| Estimated Primary Completion Date | September 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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.
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures |
Brier score of the prediction model [ Time Frame: 1 year ] Brier score reflects the calibration of the model, which was measured in this study.
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| Original Secondary Outcome Measures | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy | |||||||||
| Official Title | Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy | |||||||||
| 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. | |||||||||
| 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 Type | Observational [Patient Registry] | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Other |
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| Target Follow-Up Duration | 1 Year | |||||||||
| Biospecimen | Not Provided | |||||||||
| 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. | |||||||||
| Condition |
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| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Recruiting | |||||||||
| Estimated Enrollment |
1000 | |||||||||
| Original Estimated Enrollment | Same as current | |||||||||
| Estimated Study Completion Date | September 30, 2024 | |||||||||
| Estimated Primary Completion Date | September 30, 2024 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 16 Years to 70 Years (Child, Adult, Older Adult) | |||||||||
| Accepts Healthy Volunteers | No | |||||||||
| Contacts |
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| Listed Location Countries | China | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT06157606 | |||||||||
| Other Study ID Numbers | CJBariatric001 | |||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | |||||||||
| Current Responsible Party | Yuntao Nie, China-Japan Friendship Hospital | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | China-Japan Friendship Hospital | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | China-Japan Friendship Hospital | |||||||||
| Verification Date | December 2023 | |||||||||