Prediction Model for Inadequate Weight Loss After Sleeve Gastrectomy

Recruiting

• Conditions: Weight Loss; Bariatric Surgery; Sleeve Gastrectomy

• Registration Number: NCT06157606
• Lead Sponsor: China-Japan Friendship Hospital

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 Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2023-11-27
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-04
• Last Update Submitted: 2023-12-04
• Study First Posted: 2023-12-06
• Last Update Posted: 2023-12-06
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area under receiver operating characteristic curve (AUC) of the prediction model	1 year	AUC reflects the discriminatory ability of the model, which was measured in this study.

Secondary Outcome Measures

Name	Time	Method
Brier score of the prediction model	1 year	Brier score reflects the calibration of the model, which was measured in this study.

Trial Locations

Locations (1)

Yuntao Nie; 🇨🇳 Beijing, China