The Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy: Prospective, Double Blind Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- The number of radiopaque markers transferred to the large intestine 3 days after surgery
研究概览
简要总结
"Mosapride citrate is a 5-hydroxytryptamine 4 receptor agonist, and is widely used as an agent to increase intestinal motility. Mosapride citrate has been demonstrated in in vitro and in vivo studies to increase both gastric and colon motility. In a case-control study of patients undergoing colonectomy, mosapride citrate was found to significantly reduce gas passing and defecation time.
Recently, a study reported that mosapride citrate acts on the α7nACh receptor and, consequently, suppresses the inflammatory response of macrophages, thereby suppressing the mechanism that induces paralysis after surgery.
To date, this study is intended to analyze whether mosapride citrate significantly affects the improvement of bowel movement after surgery after gastrectomy."
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with gastric cancer pathologically before surgery
- •Patients who underwent surgical resection (R0 resection)
- •Patients with an ASA score of 3 or less
排除标准
- •Patients over 80 years old
- •When there are multiple or peritoneal metastases
- •Intestinal obstruction before surgery
- •When chemotherapy was performed before surgery
- •When cancer other than stomach cancer is diagnosed
- •If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy
- •In case of liver failure or kidney failure
- •When it is judged that uncontrolled diabetes may affect intestinal function
研究组 & 干预措施
Mosapride group
Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery.
干预措施: Mosapride citrate (Drug)
Placebo group
Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery
干预措施: Placebo (Drug)
结局指标
主要结局
The number of radiopaque markers transferred to the large intestine 3 days after surgery
时间窗: 3 Days after surgery
Intestinal motility after gastrectomy
次要结局
未报告次要终点
研究者
In Gyu Kwon
Assistnat Professor
Gangnam Severance Hospital