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

• ClinicalTrials.gov Identifier: NCT04905147
• Recruitment Status: Unknown
• First Posted: May 27, 2021
• Last Update Posted: September 2, 2021
• Sponsor: Mahidol University
• Information provided by (Responsible Party): Mahidol University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Bowel Ileus	Drug: Mosapride; Drug: Placebo	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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.
• Masking: Single (Investigator)
• Primary Purpose: Other
• Official Title: Randomized Controlled Trials of Efficacy of Mosapride on Recovery of Intestinal Motility After Elective Colorectal Cancer Surgery
• Actual Study Start Date: July 1, 2021
• Estimated Primary Completion Date: July 31, 2023
• Estimated Study Completion Date: November 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: The mosapride group; 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; 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; Other Name: The mosapride group
Placebo Comparator: The control group; 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; Placebo drug 15 mg; Other Name: The placebo group

Outcome Measures

Primary Outcome Measures :

1. Postoperative time to the first passage of flatus. [ Time Frame: 24 hours ]
   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.
2. Postoperative time to the first passage of flatus. [ Time Frame: 48 hours ]
   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.
3. Postoperative time to the first passage of flatus. [ Time Frame: 72 hours ]
   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.

Secondary Outcome Measures :

1. Length of postoperative hospital stay [ Time Frame: 30 day ]
   Length of postoperative hospital stay, and occurrence of adverse effects

Eligibility Criteria

• Ages Eligible for Study: 15 Years to 70 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Thailand

Chairat Supsamutchai

Bangkok, Bankok, Thailand, 10400

Sponsors and Collaborators

Mahidol University

Investigators

• Study Chair: Chairat Supsamutchai, MD; Ramathibodi hospital, Mahidol University.
• Study Chair: Tharin Thampongsa, MD; Ramathibodi hospital, Mahidol University.
• Principal Investigator: Bensita Saengsawang, MD; Ramathibodi hospital, Mahidol University.
• Study Director: Jakrapan Jirasiritham, MD; Ramathibodi hospital, Mahidol University.

More Information

• Responsible Party: Mahidol University
• ClinicalTrials.gov Identifier: NCT04905147
• Other Study ID Numbers: COA.MURA2021/328
• First Posted: May 27, 2021
• Last Update Posted: September 2, 2021
• Last Verified: September 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mahidol University:

Postoperative ileus; Colorectal Cancer Surgery

Additional relevant MeSH terms:

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Mosapride; Gastrointestinal Agents; Serotonin Receptor Agonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs