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临床试验/NCT05966246
NCT05966246已完成不适用

The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study

Gangnam Severance Hospital2 个研究点 分布在 2 个国家目标入组 106 人开始时间: 2022年1月25日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
2
主要终点
Quantitative intestinal motility measurement using radio-opaque markers

研究概览

简要总结

In order to improve postoperative ileus in patients undergoing gastrointestinal surgery, digestive medications and prokinetics have been routinely used. Among them, mosapride citrate is widely used as a representative drug, as it is a 5-hydroxytryptamine 4 receptor agonist that increases gastrointestinal motility.

Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4 receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride (a benzamide derivative) which belongs to the same class of drugs. Prucalopride succinate has been demonstrated to increase both gastric and colonic motility through in vivo and in vitro studies. As mentioned earlier, it exhibits high specificity for the 5-HT4 receptor. The 5-HT4 receptor is not expressed in the gastric mucosa but is expressed at low concentrations in the small intestine, whereas it is highly expressed in the colonic mucosa. Therefore, prucalopride is widely used as a therapeutic agent for chronic constipation by increasing colonic motility. Furthermore, Prucalopride succinate stimulates the 5-HT4 receptors present in the nerve terminals of the myenteric plexus, promoting the release of acetylcholine. The released acetylcholine acts on α7nAch receptors located on the surface of enteric smooth muscle cells, inhibiting inflammatory responses and reducing postoperative ilues.

A randomized controlled trial (RCT) conducted on 110 patients who underwent gastrointestinal surgery demonstrated that prucalopride succinate showed significant improvement in gastrointestinal motility compared to the control group. Currently, mosapride citrate is widely used as a prokinetic agent in clinical practice. However, preliminary studies have shown no significant efficacy, and when comparing abdominal X-ray images taken on the third day after surgery, there is no significant difference compared to the placebo group. As a result, it can be observed that the recovery of gastrointestinal motility after surgery is not primarily due to small bowel motility but rather delayed gas passing caused by colon motility. Therefore, it can be assumed that using drugs that increase colon motility may be effective in improving gastrointestinal motility after surgery.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with gastric adenocarcinoma pathologically before surgery
  • Patients who underwent complete surgical resection (R0 resection)
  • Patients with an ASA score of 3 or less

排除标准

  • Patients over 80 years of age
  • Ascites or peritoneal metastasis
  • If you have intestinal obstruction before surgery
  • If chemotherapy was performed before surgery
  • If cancer other than gastric cancer is diagnosed
  • If there is a history of previous major intra-abdominal long-term surgery or abdominal radiation therapy
  • In case of liver failure or renal failure
  • Pregnant women
  • If it is judged that uncontrolled diabetes can affect intestinal function
  • If you have a stoma

结局指标

主要结局

Quantitative intestinal motility measurement using radio-opaque markers

时间窗: Every day from the 1st day to the 5th day after surgery

次要结局

  • Measurement of the amount of food intake, first flatus time and first defecation time(Every day from the 1st day to the 5th day after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

In Gyu Kwon

Associate professor

Gangnam Severance Hospital

研究点 (2)

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