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

NCT ID: NCT05966246

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-25
• Study Completion Date: 2023-06-30

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Prucalopride succinate group

Taking prucalopride succinate from the first day to the fifth day after surgery.

Group Type: EXPERIMENTAL

Arm I : Experimental (Prucalopride succinate group)

Intervention Type: DRUG

Experimental group taking prucalopride succinate from day 1 to day 5 after surgery

Control (mosapride citrate) group

Taking mosapride citrate from the first day to the fifth day after surgery.

Group Type: PLACEBO_COMPARATOR

Arm II : Control (Mosapride citrate group)

Intervention Type: DRUG

Control gourp taking mosapride citrate from day 1 day 5 after surgery

Interventions

Arm I : Experimental (Prucalopride succinate group)

Experimental group taking prucalopride succinate from day 1 to day 5 after surgery

Intervention Type: DRUG

Arm II : Control (Mosapride citrate group)

Control gourp taking mosapride citrate from day 1 day 5 after surgery

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with gastric adenocarcinoma pathologically before surgery

2. Patients who underwent complete surgical resection (R0 resection)

3. Patients with an ASA score of 3 or less

Exclusion Criteria

1. Patients over 80 years of age

2. Ascites or peritoneal metastasis

3. If you have intestinal obstruction before surgery

4. If chemotherapy was performed before surgery

5. If cancer other than gastric cancer is diagnosed

6. If there is a history of previous major intra-abdominal long-term surgery or abdominal radiation therapy

7. In case of liver failure or renal failure

8. Pregnant women

9. If it is judged that uncontrolled diabetes can affect intestinal function

10. If you have a stoma

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Gyu Kwon

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

GangnamSeverance Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

3-2021-0480

Identifier Type: -

Identifier Source: org_study_id