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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04905147
• Other study ID #: COA.MURA2021/328
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: September 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This prospective blinded (participants,researchers,investigators) randomizedcontrolledtrial (RCT) is aimed to study the efficacy of the prokinetic agents, specifically, Mosapride on gastrointestinal recovery in patients under going colorectal cancer surgery. The patients are divided into two groups and each group will receive oral Mosapride and placebo,respectively. The primary outcome is to study the efficacy of Mosapride compared with placebo on gastrointestinal recovery in patients undergoing elective colorectal cancer surgery.

The participants were randomly assigned to receive mosapride (22patients) or to serve as placebo (22patients). Patients first were randomly assigned to one of the two groups. 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. The control group received15 mg of placebo drug with 50ml of water on the same schedule.

Oral feeding was allowed when the first bowel sound and the first passage of flatus was came. A clear liquid diet is the first postoperative meal. If patient well tolerated, next step diet was applied (full liquid diet, soft diet, regular diet). Patients were discharged when the following criteria were fulfilled: 1) regular diet was tolerated without discomfort; 2) bowel movements had returned; and 3) body temperature was normal, with no major complications present.

The duration on first time bowel movement or first passage of flatus, postoperative hospital stay and adverse effects will be evaluated. The This trial was designed to have 90 percent power to detect a 20 percent decrease in median postoperative time to the first of bowel movement at a significance level of 5 percent. The necessary patient accrual to detect this difference was determined to be 20 patients per group and 10 % drop off was calculated so the totally patient was 22 patients per groups.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 44
• Est. completion date: November 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Bowel Ileus
• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Mosapride
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
• Placebo
Placebo drug 15 mg

Locations

Country	Name	City	State
Thailand	Chairat Supsamutchai	Bangkok	Bankok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Length of postoperative hospital stay	Length of postoperative hospital stay, and occurrence of adverse effects	30 day