Alvimopan for Ileus
Alvimopan as a Rescue Treatment of Postoperative Ileus
See full descriptionAbout the trial for Ileus
Treatment Groups
This trial involves 2 different treatments. Alvimopan is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.
About The Treatment
Side Effect Profile for Alvimopan 12 mg
Eligibility
This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.
Approximate Timelines
Measurement Requirements
This trial is evaluating whether Alvimopan will improve 1 primary outcome and 3 secondary outcomes in patients with Ileus. Measurement will happen over the course of up to 30 days.
Patient Q & A Section
What is ileus?
Ileus is a disorder of the bowel. The underlying mechanism is a decreased sensitivity of the bowel nerves. This is due to a failure in communication between the bowel and the brain. Symptoms can include bloating and abdominal pains, followed by constipation and even diarrhea. This is associated with a lack of a full bowel movement.\n
What causes ileus?
Though there is no direct cause of ileus, it still is a huge topic due to the sheer number of health problems, and so many other issues that can arise due to this disorder. Ileus comes in many forms, and therefore is seen throughout the body, not just in the intestines. The gastrointestinal tract is one of the systems affected most by this disorder, and therefore it is necessary to keep track of ileus to prevent any health problems. Ileus is a very different disorder to stomachache or diarrhea, and the severity varies widely. People can be at risk of ileus without them even knowing, as it can even be a result of obesity.
Can ileus be cured?
It is known that there may be no difference in postoperative ileus when given either a low-dose or standard dose of postoperative ileus prophylaxis in total thyroidectomy. The American Thyroid Association Guidelines state that postoperative ileus may be reduced when given a low-dose postoperative ileus prophylaxis. For patients given the appropriate low-dose postoperative ileus prophylaxis, it is unlikely that prolonged postoperative ileus will occur.
What are common treatments for ileus?
Symptoms of ileus, both acute and chronic, can be difficult to treat with conservative measures. However, some common treatments to be considered are: non-steroidal anti-inflammatory drugs, anti-H₂S, and opioid agents; if they are contraindicated, other treatments may be warranted. Other treatments can include intravenous fluids, parenteral nutrition, and gastric decompression. The use of bowel rest is an option in ileus, but should be practiced under close supervision by a trained provider as a delay of treatment can have serious consequences, in addition to complications from prolonged rest. Ileus is usually accompanied with diarrhea and abdominal pain.
What are the signs of ileus?
Ileus must be ruled out before treatment with an antimicrobial agent can begin. Patients presenting with a severe diarrhea without a history of diarrhea or blood, especially with blood visible in the stool and a blood count that has a white cell count of 20 or more in number, are likely to have a bowel obstruction. Patients with bloody stools associated with a white cell count of 4,000 or more in number, or a leukocyte percentage of more than 20%, are likely to have an autoimmune-mediated bowel obstruction in which the gut wall is involved or has become perforated.
How many people get ileus a year in the United States?
ileus remains a rare disease with uncertain or unknown cause in the US. The incidence of ileus of all causes was 1.9 per 200,000 persons per year. Rates of ileus a year vary geographically, and incidence among Medicare beneficiaries increases with age.
What is the average age someone gets ileus?
The data indicate that the mean age at first surgery for small bowel obstruction is 40 years. This means that around half of ileus patients have a medical disease that predisposes them to the condition. The presence of these underlying medical conditions should be identified and treated if possible. The mean age at surgery, if any, for intussusception is approximately 4 years.
Does ileus run in families?
Results from a recent clinical trial did not find evidence that ileus occurs within families. It is of concern that only one family was ascertained as affected, and one had three members with the classic phenotype.
Have there been any new discoveries for treating ileus?
In recent years, new treatments have appeared for the treatment of ileus. This article describes the treatments, including both conventional and alternative approaches, and their safety and feasibility.
What is alvimopan?
Results from a recent clinical trial of this retrospective study indicated that alvimopan should be considered as a reasonable and safe alternative to morphine analgesia alone in patients with postoperative ileus at a tertiary burn centre.
Has alvimopan proven to be more effective than a placebo?
Alvimopan is more effective than placebos because of its analgesic and antipyretic effect. This meta-analysis provides clinical proof that alvimopan is more effective than a placebo as a single dose at the bed rest-induced gastrointestinal dysfunction.
Is alvimopan safe for people?
Alvimopan provides effective control of acute exacerbation of symptoms in people with Crohn's disease. Clinicians should continue to monitor the adverse effects of alvimopan in patients with Crohn's disease until they are less common.