Prediction Model for Early Biliary Stasis After Bariatric Surgery

Not yet recruiting

• Conditions: Diabetes; Gallstones; Obesity; Biliary Stasis

• Registration Number: NCT06385860
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

Developing and validating a predictive model to estimate the risk of early biliary stasis following bariatric surgery

Detailed Description

This study aims to create and validate a model that predicts the likelihood of early biliary stasis in obese patients following bariatric surgery (sleeve gastrectomy and Roux-en-Y gastric bypass)

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-23
• Study First Submitted QC: 2024-04-23
• Study First Posted: 2024-04-26
• Last Update Submitted: 2024-04-28
• Last Update Posted: 2024-04-30
• Study Start: 2024-07
• Primary Completion: 2024-09
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. BMI ≥32.5 kg/m2 with one or more obesity-related comorbidities.
2. BMI >35 kg/m2 without coexisting medical problems
3. complete preoperative and follow-up data.

Exclusion Criteria

1. other bariatric procedures.
2. contraindications for bariatric surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prediction model	six months	Area under the curve (AUC) of the prediction model
early biliary stasis	one month	The incidence of early biliary stasis after bariatric surgery