Defining High-resolution Manometry Thresholds of Backward Pressure Across the Lower Esophageal Sphincter Through Straight Leg Raise Maneuver in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Acid exposure time
研究概览
简要总结
There is an increasing interest in High resolution manometry (HRM) in the preoperative assessment of patients with obesity, in order to identify the best surgical option. Sleeve gastrectomy (SG) has been known to increase the risk of gastro-esophageal reflux disease (GERD). Different techniques have been recently developed and validated to offer to these patients protection against pathologic GERD after SG.
A recent study found a significant correlation between straight leg raise (SLR) maneuver during HRM and a positive pH-study. However, these maneuver has not been validated in an obese population, therefore the normality cut-off remain unknown.
A multicenter study with a large number of patients undergoing pre-operative assessment for bariatric surgery could provide a precise threshold to predict pathologic esophageal acid exposure time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Complete and adequate HRM and pH-impedance study performed within 2 weeks
- •Successfully performed SLR maneuver (adequate intra-abdominal pressure augmentation)
- •Obese with BMI>35 Kg/m2
排除标准
- •Patients under the age of 18
- •Patients with prior foregut surgery
- •Paraesophageal hiatal hernia
- •Scleroderma
- •Eosinophilic esophagitis
- •Pregnancy
结局指标
主要结局
Acid exposure time
时间窗: January-March 2024
次要结局
未报告次要终点