Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

Weight Loss Clinical Trial

Official title:

Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157606
• Other study ID #: CJBariatric001
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery
• Body Weight
• Sleeve Gastrectomy
• Weight Loss

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