The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Prucalopride succinate group Taking prucalopride succinate from the first day to the fifth day after surgery. |
Drug: Arm I : Experimental (Prucalopride succinate group)
Experimental group taking prucalopride succinate from day 1 to day 5 after surgery
|
| Placebo Comparator: Control (mosapride citrate) group Taking mosapride citrate from the first day to the fifth day after surgery. |
Drug: Arm II : Control (Mosapride citrate group)
Control gourp taking mosapride citrate from day 1 day 5 after surgery
|
Outcome Measures
Primary Outcome Measures
- Quantitative intestinal motility measurement using radio-opaque markers [Every day from the 1st day to the 5th day after surgery]
Secondary Outcome Measures
- 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]
Quantitatively compare and analyze the amount of food eaten in the test group and the control group. Compare the first flatus appearance time and first defecation time in the test group and the control group.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients diagnosed with gastric adenocarcinoma pathologically before surgery
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Patients who underwent complete surgical resection (R0 resection)
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Patients with an ASA score of 3 or less
Exclusion Criteria:
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Patients over 80 years of age
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Ascites or peritoneal metastasis
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If you have intestinal obstruction before surgery
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If chemotherapy was performed before surgery
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If cancer other than gastric cancer is diagnosed
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If there is a history of previous major intra-abdominal long-term surgery or abdominal radiation therapy
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In case of liver failure or renal failure
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Pregnant women
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If it is judged that uncontrolled diabetes can affect intestinal function
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If you have a stoma
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GangnamSeverance Hospital | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Gangnam Severance Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 3-2021-0480