ILEUS: Effect of Mosapride on Postoperative Ileus in Patients Undergoing Colorectal Surgery

Sponsor

Hospital Italiano de Buenos Aires (Other)

Overall Status

Unknown status

CT.gov ID

NCT02056405

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Postoperative Ileus is defined as the transient postoperative functional inhibition of propulsive bowel activity. The ethiology of this process can best be described as multifactorial. In its pathogenesis different mechanisms are involved such as hormones and neuropeptides, inflammation, narcotics and the Autonomic nervous system. Is one of the most common causes of prolonged hospital stays after abdominal surgery, thereby increasing health-care resource utilization. More importantly, it causes patient discomfort in the form of nausea, vomiting, and stomach cramps. It has a variable duration but is usually solved in 3 to 4 days. Prolonged Ileus is associated with postoperative complications like an increase on urinary and pulmonary infections, profound venous thrombosis and wound-site complications.

Mosapride is a prokinetic agent that acts as a selective serotonin agonist (5- HT4) that facilitates acetylcholine release from the intrinsic plexus. This accelerates gastric emptying and propulsive peristaltic movements on the lower intestines. Mosapride has no action over the central nervous system therefore the lesser side effects like cardiac arrhythmias and extrapyramidal symptoms. For being a safer drug we chose it to be the center of our research.

Two randomized controlled trials studied Mosapride concluding it shortens PI after colorectal surgery. However these trials took place on specific populations (Orientals) with less than 50 patients and only one of them included laparoscopic treatment specifically. Also the end point of these studies didn't consider the impact of PI over hospital stay or costs to the health system.

We therefore decided to conduct a prospective randomized study in patients undergoing laparoscopic colorectal surgery for colon cancer. The patients will be randomized to receive treatment or placebo after surgery. With this study we intend to prove that patients treated with mosapride immediately after surgery suffer from shorter postoperative ileus with earlier oral intake and shorter hospital stay.

The primary aim of the trial is to assess the effectiveness of the use of Mosapride in shortening the duration of the Postoperative ileus in patients undergoing colorectal laparoscopic surgery. The trial hypothesis is that the standardized use of Mosapride immediately after colorectal laparoscopic surgery is safe and accelerates the recovery of propulsive bowel activity, thereby shortening postoperative ileus and hospital stay.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus	Drug: Mosapride Drug: Placebo	Phase 4

Detailed Description

Methods. Design. Design A randomized controlled trial, triple blind with placebo. Study population Patients undergoing laparoscopic colorectal surgery. Italian Hospital of Buenos Aires. Argentina.

Inclusion and exclusion criteria

Participants will be eligible provided they are at least 18 years of age and under 85, are about to undergo colonic or upper rectum surgery with the diagnose of cancer o malignant polyp. People will be excluded if:

They refuse to participate from the trial or the process of informed consent
Have known allergies or hypersensitivity to Mosapride or lactose (used for placebo)
Patients with ascites, hepatic metastases or carcinomatosis
Patients who cannot receive Non-steroidal anti-inflammatory drugs
Pregnancy or women at a fertile age who do not use double contraceptive agents
Patients with conversion to laparotomy
Patients with a Rectal tumor beneath 11 cm requiring low or ultralow rectal resection
Patients with an stoma or who underwent simultaneous resection of other organs

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

Effect of Mosapride on Postoperative Ileus in Patients Undergoing Colorectal Surgery

Study Start Date :

Dec 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2016

Anticipated Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Placebo arm: intake of placebo (Lactose). 1 pill of the same characteristics as Mosapride every 8 hs with 30 ml tap water. This will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.	Drug: Placebo 1 pill of the same characteristics as Mosapride every 8 hs with 30 ml tap water. This will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops. Other Names: Lactose
Active Comparator: Mosapride Mosapride arm: intake of active drug (Mosapride). 15 mg per day divided into 3 oral intakes of 5 mg each (1 pill of Mosapride every 8 hs with 30 ml tap water). This treatment will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.	Drug: Mosapride 15 mg per day divided into 3 oral intakes of 5 mg each (1 pill of Mosapride every 8 hs with 30 ml tap water). This treatment will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops. Other Names: Mosar

Arm

Intervention/Treatment

Placebo Comparator: Placebo

Placebo arm: intake of placebo (Lactose). 1 pill of the same characteristics as Mosapride every 8 hs with 30 ml tap water. This will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.

Drug: Placebo

1 pill of the same characteristics as Mosapride every 8 hs with 30 ml tap water. This will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.

Other Names:

Lactose

Active Comparator: Mosapride

Mosapride arm: intake of active drug (Mosapride). 15 mg per day divided into 3 oral intakes of 5 mg each (1 pill of Mosapride every 8 hs with 30 ml tap water). This treatment will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.

Drug: Mosapride

15 mg per day divided into 3 oral intakes of 5 mg each (1 pill of Mosapride every 8 hs with 30 ml tap water). This treatment will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.

Other Names:

Mosar

Outcome Measures

Primary Outcome Measures

Number of days after Surgery until the recovery of bowel movement [1 to 5 days after surgery]
Effect of the administration of mosapride on the immediate postoperative on the recovery of bowel movements.

Secondary Outcome Measures

Number of patients to develop adverse reactions to Mosapride [1 to 5 days after surgery]
To evaluate the safety of the administration of Mosapride after colorectal laparoscopic surgery.

Other Outcome Measures

Number of days of Hospital stay after surgery. [18 months (end of protocol)]
To assess the effect of Mosapride on the reduction of Hospital stay days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 to 85 years old
Underwent colonic or upper rectum laparoscopic surgery with diagnose of cancer or malignant polyp
Were operated on Italian Hospital of Buenos Aires

Exclusion Criteria:

They refuse to participate from the trial or the process of informed consent
Have known allergies or hypersensitivity to Mosapride or lactose (used for placebo)
Patients with ascites, hepatic metastases or carcinomatosis
Patients who cannot receive Non-steroidal anti-inflammatory drugs
Pregnancy or women at a fertile age who do not use double contraceptive agents
Patients with conversion to laparotomy
Patients with a Rectal tumor beneath 11 cm requiring low or ultralow rectal resection
Patients with an derivative stoma or who underwent simultaneous resection of other organs