Clinical trial NCT04905147: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Bowel Ileus
Keywords: Postoperative ileus
Colorectal Cancer Surgery
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 44
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Postoperative time to the first passage of flatus.
timeFrame: 24 hours
measure: Postoperative time to the first passage of flatus.
timeFrame: 48 hours
measure: Postoperative time to the first passage of flatus.
timeFrame: 72 hours
Secondary outcomes:
measure: Length of postoperative hospital stay
timeFrame: 30 day
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chairat Supsamutchai
state: Bankok
Study officials:
affiliation: Ramathibodi hospital, Mahidol University.
name: Chairat Supsamutchai, MD
role: STUDY_CHAIR
affiliation: Ramathibodi hospital, Mahidol University.
name: Tharin Thampongsa, MD
role: STUDY_CHAIR
affiliation: Ramathibodi hospital, Mahidol University.
name: Bensita Saengsawang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ramathibodi hospital, Mahidol University.
name: Jakrapan Jirasiritham, MD
role: STUDY_DIRECTOR
References: