Effect of Mosapride on Postoperative Ileus in Patients Undergoing Colorectal Surgery

NCT02056405 | Unknown Phase 4 DMC

• 1 other identifier: 2104
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Ileus

Keywords

Postoperative Ileus; Mosapride; Colorectal laparoscopic surgery; Prolonged postoperative ileus

Outcome Measures

Primary Outcomes (1)

• Number of days after Surgery until the recovery of bowel movement

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

  1 to 5 days after surgery

Secondary Outcomes (1)

• Number of patients to develop adverse reactions to Mosapride

  1 to 5 days after surgery

Other Outcomes (1)

• Number of days of Hospital stay after surgery.

  18 months (end of protocol)

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Mosapride

ACTIVE COMPARATOR

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

Interventions

Mosapride DRUG

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.

Also known as: Mosar

Mosapride

Placebo DRUG

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.

Also known as: Lactose

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 derivative stoma or who underwent simultaneous resection of other organs

Sponsors & Collaborators

• Hospital Italiano de Buenos Aires: lead

Study Sites (1)

Italian Hospital of Buenos Aires

Buenos Aires, State Capital, 1199, Argentina

RECRUITING

Related Publications (8)

• Toyomasu Y, Mochiki E, Morita H, Ogawa A, Yanai M, Ohno T, Fujii T, Tsutsumi S, Asao T, Kuwano H. Mosapride citrate improves postoperative ileus of patients with colectomy. J Gastrointest Surg. 2011 Aug;15(8):1361-7. doi: 10.1007/s11605-011-1567-x. Epub 2011 May 24.

  PMID: 21607794 BACKGROUND

• Narita K, Tsunoda A, Takenaka K, Watanabe M, Nakao K, Kusano M. Effect of mosapride on recovery of intestinal motility after hand-assisted laparoscopic colectomy for carcinoma. Dis Colon Rectum. 2008 Nov;51(11):1692-5. doi: 10.1007/s10350-008-9407-0. Epub 2008 Jun 27.

  PMID: 18584249 BACKGROUND

• Seta ML, Kale-Pradhan PB. Efficacy of metoclopramide in postoperative ileus after exploratory laparotomy. Pharmacotherapy. 2001 Oct;21(10):1181-6. doi: 10.1592/phco.21.15.1181.33888.

  PMID: 11601663 BACKGROUND

• Davidson ED, Hersh T, Brinner RA, Barnett SM, Boyle LP. The effects of metoclopramide on postoperative ileus. A randomized double-blind study. Ann Surg. 1979 Jul;190(1):27-30. doi: 10.1097/00000658-197907000-00006.

  PMID: 582360 BACKGROUND

• Furness JB, Costa M. Adynamic ileus, its pathogenesis and treatment. Med Biol. 1974 Apr;52(2):82-9. No abstract available.

  PMID: 4365867 BACKGROUND

• Jepsen S, Klaerke A, Nielsen PH, Simonsen O. Negative effect of Metoclopramide in postoperative adynamic ileus. A prospective, randomized, double blind study. Br J Surg. 1986 Apr;73(4):290-1. doi: 10.1002/bjs.1800730414.

  PMID: 3516299 BACKGROUND

• Tollesson PO, Cassuto J, Rimback G, Faxen A, Bergman L, Mattsson E. Treatment of postoperative paralytic ileus with cisapride. Scand J Gastroenterol. 1991 May;26(5):477-82. doi: 10.3109/00365529108998569.

  PMID: 1871540 BACKGROUND

• Brown TA, McDonald J, Williard W. A prospective, randomized, double-blinded, placebo-controlled trial of cisapride after colorectal surgery. Am J Surg. 1999 May;177(5):399-401. doi: 10.1016/s0002-9610(99)00071-9.

  PMID: 10365879 BACKGROUND

MeSH Terms

Interventions

mosapride; Lactose

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Carlos A Vaccaro, MD

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

Central Study Contacts

Virginia M Cano Busnelli, MD

CONTACT

54 11 66128852; virginia.cano@hospitalitaliano.org.ar

Natalia L Gomez, MD

CONTACT

54 11 68364732; natalia.gomez@hospitalitaliano.org.ar

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 31, 2014
• First Posted: February 6, 2014
• Study Start: December 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

AR (1)