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

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ClinicalTrials.gov Identifier: NCT02056405
Recruitment Status : Unknown
Verified December 2015 by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires.
Recruitment status was:  Recruiting
First Posted : February 6, 2014
Last Update Posted : December 17, 2015
Sponsor:
Information provided by (Responsible Party):
Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires

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

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Mosar




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Number of days of Hospital stay after surgery. [ Time Frame: 18 months (end of protocol) ]
    To assess the effect of Mosapride on the reduction of Hospital stay days



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056405


Contacts
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Contact: Virginia M Cano Busnelli, MD 54 11 66128852 virginia.cano@hospitalitaliano.org.ar
Contact: Natalia L Gomez, MD 54 11 68364732 natalia.gomez@hospitalitaliano.org.ar

Locations
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Argentina
Italian Hospital of Buenos Aires Recruiting
Buenos Aires, State Capital, Argentina, 1199
Principal Investigator: Virginia M Cano Busnelli, MD         
Sub-Investigator: Natalia L Gomez, MD         
Sub-Investigator: Jeremias Goransky Patiño, MD         
Sponsors and Collaborators
Hospital Italiano de Buenos Aires
Investigators
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Study Director: Carlos A Vaccaro, MD Hospital Italiano de Buenos Aires

Publications:

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Responsible Party: Diego Hernan Giunta, MD, Principal Investigator, Hospital Italiano de Buenos Aires
ClinicalTrials.gov Identifier: NCT02056405     History of Changes
Other Study ID Numbers: 2104
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: December 17, 2015
Last Verified: December 2015

Keywords provided by Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires:
Postoperative Ileus
Mosapride
Colorectal laparoscopic surgery
Prolonged postoperative ileus

Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Mosapride
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs