Postoperative IleusPhase 4ILEUSNCT02056405
Effect of Mosapride on Postoperative Ileus in Patients Undergoing Colorectal Surgery
A Phase 4 study testing Mosapride in people with Postoperative Ileus, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Mosapride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteArgentina
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Argentina1 site, 1 recruiting
- Recruiting
Italian Hospital of Buenos Aires
Buenos Aires, State Capital, 1199
Virginia M Cano Busnelli, MD
Natalia L Gomez, MD
About this study
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.
Read more
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.
Read the 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
- Conditions
- Postoperative Ileus
- Being tested
- Mosapride, Placebo
- Keywords
- Postoperative Ileus, Mosapride, Colorectal laparoscopic surgery, Prolonged postoperative ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MosaprideDrug
Also called Mosar
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.
PlaceboDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Mosapride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 to 5 days after surgery
Secondary outcomes (1)
Number of patients to develop adverse reactions to Mosapride
To evaluate the safety of the administration of Mosapride after colorectal laparoscopic surgery.
Measured: 1 to 5 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Italiano de Buenos Aires
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Hernan Giunta, MD, Hospital Italiano de Buenos Aires
- Investigators
- Carlos A Vaccaro, MD, Study director, Hospital Italiano de Buenos Aires
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056405
- Sponsor's protocol ID
- 2104
- Acronym
- ILEUS
- Status last verified
- Dec 2015
- First submitted
- 31 Jan 2014
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21607794Narita 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.
PubMed 18584249Seta 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.
PubMed 11601663Davidson 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.
PubMed 582360Furness JB, Costa M. Adynamic ileus, its pathogenesis and treatment. Med Biol. 1974 Apr;52(2):82-9. No abstract available.
PubMed 4365867Jepsen 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.
PubMed 3516299Tollesson 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.
PubMed 1871540Brown 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.
PubMed 10365879
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mosapride on Postoperative Ileus in Patients Undergoing Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02056405
- Acronym / sponsor ID
- ILEUS / 2104
- Conditions
- Postoperative Ileus
- Keywords
- Postoperative Ileus, Mosapride, Colorectal laparoscopic surgery, Prolonged postoperative ileus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Italiano de Buenos AiresUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
| Mosapride | Active comparator | Drug: MosaprideMosapride 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MosaprideAlso: Mosar15 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 |
| PlaceboAlso: Lactose1 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 |
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.
1 secondary outcome
Number of patients to develop adverse reactions to Mosapride
Time frame: 1 to 5 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Background: PubMed 21607794Toyomasu 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.
- Background: PubMed 18584249Narita 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.
- Background: PubMed 11601663Seta 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.
- Background: PubMed 582360Davidson 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.
- Background: PubMed 4365867Furness JB, Costa M. Adynamic ileus, its pathogenesis and treatment. Med Biol. 1974 Apr;52(2):82-9. No abstract available.
- Background: PubMed 3516299Jepsen 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.
- Background: PubMed 1871540Tollesson 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.
- Background: PubMed 10365879Brown 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos A Vaccaro, MD study director
Hospital Italiano de Buenos Aires
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mosapride in people with Postoperative Ileus, run by Hospital Italiano de Buenos Aires at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Virginia M Cano Busnelli, MD (54 11 66128852, virginia.cano@hospitalitaliano.org.ar), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days after Surgery until the recovery of bowel movement (time frame: 1 to 5 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02056405, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.