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| Name | Class |
|---|---|
| Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | INDUSTRY |
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The purpose of this study is to determine if the addition of alvimopan to our care process model for colon resection patients will decrease length of stay. The care process model is a combination of optimal IV fluid management, early feeding, early ambulation, patient education, and pain management.
Narcotic pain medicines bind mu-opioid receptors in the bowel and delay the return of normal function. Alvimopan is a peripherally acting mu-opioid receptor antagonist that blocks mu-opioid receptors in the gastrointestinal tract but does not compromise central nervous system-mediated opioid-based analgesia. Length of stay is an important surrogate measure of quality after colon surgery and the most common reason for prolonged Length of Stay after abdominal surgery is delayed gastrointestinal recovery (postoperative ileus).
The Food and Drug Administration has approved alvimopan (dosed preoperatively and twice daily postoperatively for up to 15 in-hospital doses) for the acceleration of upper and lower gastrointestinal recovery after partial bowel resection with primary anastomosis. In the 5 phase III alvimopan efficacy trials, a simple standardized accelerated postoperative care pathway was used rather than a comprehensive, multidisciplinary colon surgery care process model that is used by Intermountain Healthcare. In the most recently completed alvimopan phase III trial, the mean postoperative length of stay was 5.2 days whereas the mean length of stay at Intermountain Healthcare is 4.4 days without the addition of alvimopan to the multidisciplinary colon care process model.
This trial will investigate if the addition of alvimopan to the Intermountain Healthcare multidisciplinary care process can decrease length of stay compared with the multidisciplinary care process plus placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 300 mg Polyethylene | Placebo Comparator |
| |
| Alvimopan | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alvimopam | Drug | The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of Improvement Over the Standard | Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date. | Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day] |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Cost | Total Cost of hospital stay inflation adjusted to 2010 dollars. | Upon discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bob Moesinger, MD | Intermountain Health Care, Inc. | Principal Investigator |
| Matthew Peters, RN | Intermountain Health Care, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Fork Hospital | American Fork | Utah | 84003 | United States | ||
| Valley View Hospital |
Most common exclusion were patients with history of opioid us > 3 doses in 7 days prior to surgery.
Date of first enrollment5-24-2010 Date of last enrollment 6-13-2012 Patients were identified in surgeons office and then screen by study coordinators for eligibility.
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| ID | Title | Description |
|---|---|---|
| FG000 | 300 mg Polyethylene | Control Group : The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery. |
| FG001 | Alvimopan |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 300 mg Polyethylene | Drug | The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery. |
|
| Cedar City |
| Utah |
| 84721 |
| United States |
| Logan Regional Hospital | Logan | Utah | 84341 | United States |
| Intermoutain Medical Center | Murray | Utah | 84157 | United States |
| McKay-Dee Hospital | Ogden | Utah | 84403 | United States |
| Utah Valley | Provo | Utah | 84604 | United States |
| LDS Hospital | Salt Lake City | Utah | 84103 | United States |
| Alta View Hospital | Sandy City | Utah | 84094 | United States |
| Dixie Regional | St. George | Utah | 84790 | United States |
Treatment Group : The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 300 mg Polyethylene | Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery. |
| BG001 | Alvimopan | Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean BMI | Median | Full Range | Kg/M^2 |
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| Total Cases Using An Open Approach | This only includes those surgical cases that were used in the analysis of the study which had surgery with an open approach versus laparoscopic. | Number | Cases |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Measure of Improvement Over the Standard | Determine if alvimopan addition to the multidisciplinary care process will result in decreased length of stay compared with the multidisciplinary care process plus placebo. Length of stay is determined by how many days a patient stays in the hospital. This is calculated by subtracting the discharge date from the admit date. | The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population. | Posted | Mean | Full Range | Days in the hospital | Number of days the patient stayed in the hospital [Time frame: Inpatient admit day to discharge day] |
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| Secondary | Hospital Cost | Total Cost of hospital stay inflation adjusted to 2010 dollars. | The overall baseline number of participants is 274. The total number of participants that were included in the study was 248. There were 26 participants that either chose to not participate in the study after starting, or had protocol violations that excluded them from being included in the measured population. | Posted | Mean | Full Range | Dollars | Upon discharge |
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30 Days after hospital discharge
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 300 mg Polyethylene | Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery. | 0 | 136 | 13 | 136 | ||
| EG001 | Alvimopan | Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery. | 0 | 138 | 3 | 138 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post Operative Ileus | Gastrointestinal disorders | Systematic Assessment | National Surgical Quality Improvement Project definition-presence of nasogastric tube or order for nothing by mouth > postoperative day 4) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthew Peters RN MS | Intermountain Healthcare | 801-442-3703 | matthew.peters@imail.org |
| ID | Term |
|---|---|
| D045823 | Ileus |
| ID | Term |
|---|---|
| D007415 | Intestinal Obstruction |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C419502 | alvimopan |
| D020959 | Polyethylene |
| ID | Term |
|---|---|
| D011095 | Polyethylenes |
| D011090 | Polyenes |
| D000475 | Alkenes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010969 | Plastics |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| Male |
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