History of Changes for Study: NCT04905147

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

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Study Record Versions

Version	Submitted Date	Changes
1	May 23, 2021	None (earliest Version on record)
2	May 27, 2021	Outcome Measures and Study Status
3	September 1, 2021	Recruitment Status and Study Status

Comparison Format:

Merged
Side-by-Side

Study Identification


Unique Protocol ID:	COA.MURA2021/328
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
Secondary IDs:

Study Status


Record Verification:	May 2021
Overall Status:	Enrolling by invitation
Study Start:	July 1, 2021
Primary Completion:	July 31, 2023 [Anticipated]
Study Completion:	November 30, 2023 [Anticipated]

First Submitted:	May 23, 2021
First Submitted that Met QC Criteria:	May 23, 2021
First Posted:	May 27, 2021 [Actual]

Last Update Submitted that Met QC Criteria:	May 23, 2021
Last Update Posted:	May 27, 2021 [Actual]

Sponsor/Collaborators


Sponsor:	Mahidol University
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	No

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.

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.

Conditions


Conditions:	Colorectal Cancer Bowel Ileus
Keywords:	Postoperative ileus Colorectal Cancer Surgery

Study Design


Study Type:	Interventional
Primary Purpose:	Other
Study Phase:	Not Applicable
Interventional Study Model:	Parallel Assignment
	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.
Number of Arms:	2
Masking:	Single (Investigator)
Allocation:	Randomized
Enrollment:	44 [Anticipated]

Arms and Interventions

Arms	Assigned Interventions
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 Names: 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 Names: The placebo group

Outcome Measures


Primary Outcome Measures:
1.	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.
2.	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.
3.	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.
Secondary Outcome Measures:
1.	Length of postoperative hospital stay [ Time Frame: 30 day ] Length of postoperative hospital stay, and occurrence of adverse effects

Eligibility


Minimum Age:	15 Years
Maximum Age:	70 Years
Sex:	All
Gender Based:
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/Locations


Study Officials:	Chairat Supsamutchai, MD Study Chair Ramathibodi hospital, Mahidol University.
	Tharin Thampongsa, MD Study Chair Ramathibodi hospital, Mahidol University.
	Bensita Saengsawang, MD Principal Investigator Ramathibodi hospital, Mahidol University.
	Jakrapan Jirasiritham, MD Study Director Ramathibodi hospital, Mahidol University.
Locations:	Thailand, Bankok
	Chairat Supsamutchai Bangkok, Bankok, Thailand, 10400

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: