Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy

NCT ID: NCT04493125

Last Updated: 2025-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-27

Study Completion Date

2021-03-30

Brief Summary

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"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."

Detailed Description

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Conditions

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Stomach Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mosapride group

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

Group Type EXPERIMENTAL

Mosapride citrate

Intervention Type DRUG

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

Placebo group

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Mosapride citrate

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

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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In Gyu Kwon

Assistnat Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GangnamSeverance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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3-2020-0175

Identifier Type: -

Identifier Source: org_study_id

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