A Monocentric Randomized Controlled Prospective Study to Evaluate the Antireflux Efficacy of Primary Crural Closure During Sleeve Gastrectomy for Obese Patients With Incompetents Oeso-gastric Valves
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- De novo GastroEsophageal Reflux Disease (GERD) onset
研究概览
简要总结
This is a monocentric randomized controlled prospective study. A total of 122 patients will be recruited and randomized 1: 1 in the experimental group - Laparoscopic Sleeve Gastrectomy and Diaphragmatic Pillar Closure - or in the control group - Laparoscopic Sleeve Gastrectomy.
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GastroEsophageal Reflux Disease and hiatal hernia appearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-65 years
- •Patient with BMI between 35 and 50 Kg/m2 for whom laparoscopic sleeve gastrectomy indication was made
- •Patients with no preoperative gastroesophageal reflux disease symptoms
- •Hill 2-3 or 4 (with HH <2 cm) hypogastric valve diagnosed preoperatively
排除标准
- •Gastroesophageal reflux disease with daily symptoms or daily use of proton pump inhibitors drugs or daily use of anti-H2 drugs
- •Hiatal Hernia >2cm and/or esophagitis and/or Barrett metaplasia
- •Previous bariatric and/or gastric surgery
- •Normal gastroesophageal valve (Hill 1)
- •Motility disorders of the esophagus (documented on manometry)
- •PH-study positive for gastro-oesophageal reflux disease (DeMeester Score >14.1)
- •Contraindications to gastroscopy or manometry or ph-study
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- •Patient not legally competent
- •Pregnancy
结局指标
主要结局
De novo GastroEsophageal Reflux Disease (GERD) onset
时间窗: 6 months post surgery
At 6 months post surgery a gastroscopy, an oesophageal manometry and a PH-study will be perform to detect de novo GERD (GastroEsophageal Reflux Disease)
次要结局
- hiatal hernia appearance(6 months post surgery)
- change in patient-reported quality of life using Gastroparesis Cardinal Symptom Index (GCSI) questionnaire(baseline and 6 months post surgery)
- change in patient-reported quality of life using GERD-Health Related Quality of Life Questionnaire (GERD-HRQL) questionnaire(baseline and 6 months post surgery)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(6 months post surgery)
研究者
Fabio Garofalo
Sponsor Investigator
Ente Ospedaliero Cantonale, Bellinzona