Prospective, Monocentric Study of Dexlansoprazole Absorption Preoperative and 6 and 12 Months After Proximal Roux-en-Y Gastric Bypass Surgery and of the Incidence of Marginal Ulcers 6 and 12 Months After Surgery
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 主要终点
- Change of dexlansoprazole Serum concentration
研究概览
简要总结
In Switzerland, the most commonly performed bariatric procedure is the proximal Roux-en-y gastric Bypass surgery. Since marginal ulceration is a known complication after this Operation, a Proton pump Inhibitor (PPI) prophylaxis is prescribed postoperatively. Bariatric surgery may have an impact on the absorption and consequently on the efficacy of drugs. There are only very little data on the pharmacokinetics of PPIs following PRYGB.
The aim of this study is to analyze the serum concentration of dexlansoprazole preoperative and after PRYGB surgery in patients taking PPI prophylaxis and to examine the incidence of marginal ulcers postoperatively in the same population.
详细描述
This prospective, monocentric study includes 30 patients undergoing a proximal Roux-en-Y gastric Bypass surgery and receiving 6 months of postoperative PPI prophylaxis with Dexilant (dexlansoprazole). The aim is to examine if the LPRYGB has an impact on the absorption of dexlansoprazole. Peripheral blood samples from the study participants are obtained at fixed time points after oral Administration of a capsule Dexilant preoperatively as well as 3 and 6 months after surgery. The incidence of marginal ulceration in the same patient population is assessed by upper endoscopy 6 and 12 months after surgery. The surgery, the PPI prophylaxis and the upper endoscopy 12 months post-surgery aren't for study purpose. Data collection is made by measuring serum drug concentration, patient questionnaires, pill count and upper endoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent for study and surgery as documented by signature
- •Male and Female Patients over 18 years old eligible for bariatric surgery at the Department of General Surgery, Limmattal Hospital, according to criteria of the Swiss Study Group for Morbid Obesity (SMOB) and international Guidelines
- •Failure of conservative Treatment for 2 years
- •Type of surgery: LPRYGB
- •Helicobacter pylori negative
- •Smoker (≥ 1 cigarette daily)
- •Women in reproductive Age: negative pregnancy test
排除标准
- •Contraindication for a bariatric surgery according to SMOB-criteria
- •Contraindication for PPIs
- •Pregnant or breastfeeding women
- •Pre- or intraoperative decision for other type of surgery than LPRYGB
- •Active malignancy
- •Chronic liver disease Child-Pugh B or C
- •Abuse of drugs or alcohol
- •Suspect of non-compliance
研究组 & 干预措施
Dexlansoprazole
The PPI Dexilant (active substance: dexlansoprazole) is administered to the study participants in a prophylactic Regimen for 6 months after the PRYGB-surgery. This drug is already approved by Swissmedic and on the markets in Switzerland. The dosage is 1 capsule 60 mg per os daily in the morning.
干预措施: dexlansoprazole serum concentration (Diagnostic Test)
Dexlansoprazole
The PPI Dexilant (active substance: dexlansoprazole) is administered to the study participants in a prophylactic Regimen for 6 months after the PRYGB-surgery. This drug is already approved by Swissmedic and on the markets in Switzerland. The dosage is 1 capsule 60 mg per os daily in the morning.
干预措施: upper endoscopy (Diagnostic Test)
结局指标
主要结局
Change of dexlansoprazole Serum concentration
时间窗: 6 months
Determination of the dexlansoprazole concentration (ng/ml) in the participants blood at time 0, 60, 90, 120, 210, 300 min after having swallowed a Dosis of dexilant preoperatively and 6 months after surgery
次要结局
- Incidence of Marginal ulceration(6 months)
研究者
Prof Urs Zingg
Prof. Dr. med. Urs Zingg
Spital Limmattal Schlieren