Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Percentage of post-operative GERD based on the trial protocol. Clinical evaluation
研究概览
简要总结
The trial would to try to establish:
- The best post-operative PPI prescription protocol after Sleeve Gastrectomy
- The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)
- The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ
详细描述
45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)
GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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
- 是
入选标准
- •Patients candidates for primary SG
- •Patients adhering to the follow-up protocol
- •Age between 18 and 65 years
- •No BMI limits
排除标准
- •Gastric and/or esophageal diseases (routine preoperative endoscopy)
- •Patients candidate for revisional bariatric surgery
- •Chronic preoperative PPI therapy
- •Using of PPI treatment for postoperative complications
- •Conversion to open surgery
- •Patients allergic to PPI
- •Patients undergoing concomitant surgery
- •Patients with hiatal hernia undergoing concomitant cruroplasty
研究组 & 干预措施
GROUP B PPI 1/day for 6 months
(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
干预措施: Lansoprazole oral tablets 30 mg (Drug)
GROUP C PPI 1/day for 3 months
(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
干预措施: Lansoprazole oral tablets 30 mg (Drug)
结局指标
主要结局
Percentage of post-operative GERD based on the trial protocol. Clinical evaluation
时间窗: 12 months
Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A \<8 no GERD, score A \>8 and B \> 3 GERD worsening normal life)
次要结局
- evaluate in each group of the study (arm type) the endoscopic finding of peptic lesions of the esophagus-gastro-duodenal mucosa at 24 months of follow-up(24 months)
研究者
Angelo Iossa
MD PhD
University of Roma La Sapienza