Effect of Mosapride Citrate on Gastrointestinal Motility After Laparoscopic Gastrectomy

NCT04493125 | Completed

• 1 other identifier: 3-2020-0175
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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."

Conditions

Stomach Cancer

Keywords

Gastrectomy, Intestinal motility, Mosapride, Adhesion, Ileus

Outcome Measures

Primary Outcomes (1)

• The number of radiopaque markers transferred to the large intestine 3 days after surgery

  Intestinal motility after gastrectomy

  3 Days after surgery

Study Arms (2)

Mosapride group

EXPERIMENTAL

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

Drug: Mosapride citrate

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Mosapride citrate DRUG

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

Mosapride group

Placebo DRUG

Placebo

Placebo group

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with gastric cancer pathologically before surgery
• Patients who underwent surgical resection (R0 resection)
• Patients with an ASA score of 3 or less

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms; Tissue Adhesions; Ileus

Interventions

mosapride

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistnat Professor

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: July 30, 2020
• Study Start: July 27, 2020
• Primary Completion: March 30, 2021
• Study Completion: March 30, 2021
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

KR (1)