Effect of Mosapride on Postoperative Ileus in Patients Undergoing Colorectal Surgery
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
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.