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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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 w

Detailed Summary:

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

Sponsor: Hospital Italiano de Buenos Aires

Current Primary Outcome: Number of days after Surgery until the recovery of bowel movement [ Time Frame: 1 to 5 days after surgery ]

Effect of the administration of mosapride on the immediate postoperative on the recovery of bowel movements.


Original Primary Outcome: Same as current

Current Secondary Outcome: Number of patients to develop adverse reactions to Mosapride [ Time Frame: 1 to 5 days after surgery ]

To evaluate the safety of the administration of Mosapride after colorectal laparoscopic surgery.


Original Secondary Outcome: Same as current

Information By: Hospital Italiano de Buenos Aires

Dates:
Date Received: January 31, 2014
Date Started: December 2015
Date Completion: December 2017
Last Updated: December 16, 2015
Last Verified: December 2015