Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy

Yonsei University Health System (YUHS)

Status: Completed

Conditions: Stomach Cancer

Treatments: Drug: Mosapride citrate; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04493125

3-2020-0175

Details and patient eligibility

About

"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."

Enrollment: 104 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups, including a placebo group

Mosapride group

Experimental group

Description:

Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery.

Treatment:

Drug: Mosapride citrate

Placebo group

Placebo Comparator group

Description:

Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery

Treatment:

Drug: Placebo