Efficacy of Mosapride on Recovery of Intestinal Motility After Elective Colorectal Cancer Surgery

NCT04905147 | Unknown

• 1 other identifier: COA.MURA2021/328
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Postoperative ileus (POI) is one of the most common causes of prolonged hospital stays after abdominal surgery. The pathophysiology of POI is multifactorial and complex.It is known to be associated with sympathetic neural reflexes,local and systemic inflammatory mediators,and changes invarious neural and hormonal transmitters.Sympathetic (adrenergic) hyperactivity results in reduction of propulsive motility,and an increase in sphinctertone.Parasympathetic (cholinergic) hypoactivity results in adecrease in gastrointestinalmotility. Various agents called prokinetic drugs,including erythromycin, metoclopramide, cholinergic agents have been assessed in an effort to improved gastrointestinal motility. Mosapridecitrate is another prokinetic drug that selectively activates 5-HT4 receptors. Mosapride stimulates serotonin receptor in the digestive tract and increases acetylcholine release to promote upper digestive tract (stomach and duodenum) and lower digestive tract (colon) motility and gastric emptying without cardiac side effects. We therefore investigate the effect of mosapride on postoperative gastrointestinal motility after open and laparoscopic colectomy in a prospective randomized, controlled study in patients under going colectomy.

Conditions

Colorectal Cancer; Bowel Ileus

Keywords

Postoperative ileus; Colorectal Cancer Surgery

Outcome Measures

Primary Outcomes (3)

• Postoperative time to the first passage of flatus.

  Postoperative time to the first passage of flatus or the first bowel movement, as evaluated by one of the investigators (surgical resident) who was blinded as to whether the patient had received mosapride.

  24 hours

• Postoperative time to the first passage of flatus.

  Postoperative time to the first passage of flatus or the first bowel movement, as evaluated by one of the investigators (surgical resident) who was blinded as to whether the patient had received mosapride.

  48 hours

• Postoperative time to the first passage of flatus.

  Postoperative time to the first passage of flatus or the first bowel movement, as evaluated by one of the investigators (surgical resident) who was blinded as to whether the patient had received mosapride.

  72 hours

Secondary Outcomes (1)

• Length of postoperative hospital stay

  30 day

Study Arms (2)

The mosapride group

ACTIVE COMPARATOR

The mosapride group received 15 mg of mosapride by mouth or feeding via NG with 50 ml of water three times a day, starting on the morning of postoperative day 1, until hospital discharge or for a maximum of 10 postoperative days if the patient remained hospitalized.

Drug: Mosapride

The control group

PLACEBO COMPARATOR

The control group received 15 mg of placebo drug with 50 ml of water three times a day, starting on the morning of postoperative day 1, until hospital discharge or for a maximum of 10 postoperative days if the patient remained hospitalized.

Drug: Placebo

Interventions

Mosapride DRUG

Mosapride citrate is prokinetic drug that selectively activates 5-HT4receptors. Mosapride stimulates serotonin receptor in the digestive tract and increases acetylcholine release to promote upper digestive tract (stomach and duodenum) and lower digestive tract (colon) motility and gastric emptying without cardiac side effects

Also known as: The mosapride group

The mosapride group

Placebo DRUG

Placebo drug 15 mg

Also known as: The placebo group

The control group

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are undergoing elective colorectal cancer surgery at Ramathibodi hospital both open and laparoscopic surgery.
• Both male and female who age between 15 to 70 years old.
• Physical status American Society of Anesthesiologists (ASA) classification1-2-3.

You may not qualify if:

• Metastatic disease.
• Patients who reject to participate or withdrawal from the research.
• History of Mosapride allergy.
• Pregnancy.
• Emergency colorectal cancer surgery.
• Intestinal perforation or obstruction.
• Patients who have cardiac problem (Side effects of Mosapride may include arrhythmia or QTprolong).
• Physical status American Society of Anesthesiologists (ASA) classification 4-5.

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Chairat Supsamutchai

Bangkok, Bankok, 10400, Thailand

Location

Related Publications (1)

• Thampongsa T, Saengsawang B, Supsamutchai C, Wilasrusmee C, Jirasiritham J, Punmeechao P, Palitnonkiat V, Poprom N, Choikrua P, Singhathas P. The efficacy of mosapride on recovery of intestinal motility after elective colorectal cancer surgery: a randomized controlled trial. Ann Coloproctol. 2025 Jun;41(3):232-238. doi: 10.3393/ac.2024.00892.0127. Epub 2025 Jun 25.

  PMID: 40598989 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Ileus

Interventions

mosapride

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Obstruction

Study Officials

• Chairat Supsamutchai, MD

  Ramathibodi hospital, Mahidol University.

  STUDY CHAIR

• Tharin Thampongsa, MD

  Ramathibodi hospital, Mahidol University.

  STUDY CHAIR

• Bensita Saengsawang, MD

  Ramathibodi hospital, Mahidol University.

  PRINCIPAL INVESTIGATOR

• Jakrapan Jirasiritham, MD

  Ramathibodi hospital, Mahidol University.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The mosapride group received 15 mg of mosapride by mouth or feeding via NG with 50 ml of water three times a day, starting on the morning of postoperative day 1, until hospital discharge or for a maximum of 10 postoperative days if the patient remained hospitalized.

Study Record Dates

• First Submitted: May 23, 2021
• First Posted: May 27, 2021
• Study Start: July 1, 2021
• Primary Completion: July 31, 2023
• Study Completion: November 30, 2023
• Last Updated: September 2, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)