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

Tracking Information

• First Submitted Date: May 23, 2021
• First Posted Date: May 27, 2021
• Last Update Posted Date: September 2, 2021
• Actual Study Start Date: July 1, 2021
• Estimated Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 27, 2021)

• 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.
• 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.
• 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.

Original Primary Outcome Measures (submitted: May 23, 2021)

• Postoperative time to the first passage of flatus. [ Time Frame: 24 hr ]
  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.
• Postoperative time to the first passage of flatus. [ Time Frame: 48 hr ]
  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.
• Postoperative time to the first passage of flatus. [ Time Frame: 72 hr ]
  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.

Current Secondary Outcome Measures (submitted: May 23, 2021)

Length of postoperative hospital stay [ Time Frame: 30 day ]

Length of postoperative hospital stay, and occurrence of adverse effects

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Mosapride on Recovery of Intestinal Motility After Elective Colorectal Cancer Surgery
• Official Title: Randomized Controlled Trials of Efficacy of Mosapride on Recovery of Intestinal Motility After Elective Colorectal Cancer Surgery
• 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.

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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Colorectal Cancer
• Bowel Ileus

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
  Other Name: The mosapride group
• Drug: Placebo
  Placebo drug 15 mg
  Other Name: The placebo group

Study Arms

• 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.
  Intervention: Drug: Mosapride
• 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.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 23, 2021): 44
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: November 30, 2023
• Estimated Primary Completion Date: July 31, 2023 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years to 70 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Thailand

Administrative Information

• NCT Number: NCT04905147
• Other Study ID Numbers: COA.MURA2021/328
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Mahidol University
• Original Responsible Party: Same as current
• Current Study Sponsor: Mahidol University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

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.

• PRS Account: Mahidol University
• Verification Date: September 2021