Post Operative Ileus
Conditions
Brief summary
To evaluate the efficacy and safety of Alvimopan(12 mg) in recovery of bowel function in an emergency trauma setting without the pre-operative dosage in patients that will receive abdominal surgery.
Interventions
DRUGAlvimopan
Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive Alvimopan ( post operative dose only) and will monitor for post operative ileus.
DRUGPlacebo
Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive the Placebo Pill (post operative dose only) and will monitor for post operative ileus.
Sponsors
Merck Sharp & Dohme LLC
University of Puerto Rico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Will create a double blind, randomized, parallel design study to evaluate the effectiveness of Alvimopan(post operative dose) in preventing post-operative ileus in poly-traumatized patients
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Ages 18 to 80 * Poly-traumatized patients * Extubated patients after abdominal exploration * Underwent Abdominal exploration, had colon resection with primary anastomosis with closure of abdomen
Exclusion criteria
* Mechanically ventilated patients * Patient not expected to survive Glasgow Coma Scale = 3 * Pregnant patients * Apache score \> 40 (observed mortality 100%) Saas Ahmed Naved et al 2011 * Vasopressor therapy * Septic patients * Thoracotomy * Bogota bag * Intravenous Drug Abuser (IVDA) as evidenced by urine toxicology upon admission to the Trauma Unit * Patients with prior history of gastric surgery and/or colonic surgery * Medical History: of severe cardiovascular disease, Renal diseases, Hepatitis C or Hepatic failure, Autoimmune disease, Crohn and Ulcerative Colitis (In view of the inflammation in the intestinal mucosal which may decrease optimal absorption of the medication) and or bowel obstruction * Prior pancreatic anastomosis or gastric anastomosis; ostomy formation * Chronic use of nonsteroidal anti-inflammatory drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recovery of bowel function in trauma patients who received post operative dose of Alvimopan compared to placebo. | 2 years | Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus hence the bowel recovery will be faster. By physical examination (passage of flatus, bowel movements upon auscultation) will be used to assess recovery of bowel function |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in patients of the same population who receive a placebo. | 5 years | Since Entereg is a peripherally opioid receptor antagonist it will bind to those receptors and will avoid the post operative ileus and all the associated complications that prolonged the length of stay of the patients, hence it will reduce the hospital days of the individual |
Countries
Puerto Rico
Outcome results
None listed