The Effect of Mosapride Citrate on Gastrointestinal Motility After Gastrectomy: Prospective, Double Blind Placebo-controlled Study

Stomach Cancer Clinical Trial

Official title:

The Effect of Mosapride Citrate on Gastrointestinal Motility After Gastrectomy:

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04493125
• Other study ID #: 3-2020-0175
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 27, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: July 2020
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

"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."

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Patients diagnosed with gastric cancer pathologically before surgery

2. Patients who underwent surgical resection (R0 resection)

3. Patients with an ASA score of 3 or less

Exclusion Criteria:

1. Patients over 80 years old

2. When there are multiple or peritoneal metastases

3. Intestinal obstruction before surgery

4. When chemotherapy was performed before surgery

5. When cancer other than stomach cancer is diagnosed

6. If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy

7. In case of liver failure or kidney failure

8. When it is judged that uncontrolled diabetes may affect intestinal function

Related Conditions & MeSH terms

• Stomach Cancer
• Stomach Neoplasms

Intervention

Drug:
• Mosapride citrate
Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.
• Placebo
Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of radiopaque markers transferred to the large intestine 3 days after surgery	Intestinal motility after gastrectomy	3 Days after surgery