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

Study Overview
=================
Brief 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.

Official Title
-----------------
The Effect of Mosapride Citrate on Gastrointestinal Motility After Gastrectomy:

Conditions
-----------------
Stomach Cancer

Intervention / Treatment
-----------------
* Drug: Mosapride citrate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with gastric cancer pathologically before surgery Patients who underwent surgical resection (R0 resection) Patients with an ASA score of 3 or less Exclusion Criteria: Patients over 80 years old When there are multiple or peritoneal metastases Intestinal obstruction before surgery When chemotherapy was performed before surgery When cancer other than stomach cancer is diagnosed If you have a long history of major intra-abdominal surgery or a history of abdominal radiotherapy In case of liver failure or kidney failure When it is judged that uncontrolled diabetes may affect intestinal function

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mosapride group<br>Patients receive placebo or mosapride citrate (5mg/T) three times a day from the first day after surgery. | Drug: Mosapride citrate<br>* Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.<br>|
| Placebo Comparator: Placebo group<br>Patients receive placebo instead of mosapride citrate (5mg/T) three times a day from the first day after surgery | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of radiopaque markers transferred to the large intestine 3 days after surgery | Intestinal motility after gastrectomy | 3 Days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus