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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06157606
Other study ID # CJBariatric001
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2017
Est. completion date September 30, 2024

Study information

Verified date December 2023
Source China-Japan Friendship Hospital
Contact Yuntao Nie, M.D.
Phone (+86)18611835860
Email nytnyt1231@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date September 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 16 Years to 70 Years
Eligibility 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

Study Design


Locations

Country Name City State
China Yuntao Nie Beijing

Sponsors (3)

Lead Sponsor Collaborator
China-Japan Friendship Hospital Shandong Jining No.1 People's Hospital, The Second Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area under receiver operating characteristic curve (AUC) of the prediction model AUC reflects the discriminatory ability of the model, which was measured in this study. 1 year
Secondary Brier score of the prediction model Brier score reflects the calibration of the model, which was measured in this study. 1 year
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