Gastrointestinal Dysfunction, Ileus
Conditions
Brief summary
This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration. This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue therapy or to receive conservative standard care. Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.
Detailed description
This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients undergoing colorectal or small bowel resection who develop POI, and its safety and effectiveness in reducing LOS and POI duration. Hypothesis: The investigators hypothesize that the use of alvimopan as rescue therapy in patients undergoing colorectal and small bowel resection surgery who develop POI can shorten their duration of POI and hospital length of stay. Objectives: To perform a prospective RCT to evaluate the effect of alvimopan as rescue therapy compared to standard of care in reducing the duration of post-operative ileus and post-operative LOS after colorectal and small bowel resection surgery. Protocol: This will be a prospective randomized control trial with a total of 58 patients, 29 in each group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection, or ileostomy reversal with small bowel resection that subsequently develop postoperative ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue therapy or to receive conservative standard care. At the time of diagnosis of postoperative ileus and after enrollment and randomization, all patients will be returned to NPO status. Nasogastric tubes (NGT) may be placed for gastric decompression at the discretion of the surgical team if clinically indicated. In the event that an NGT is placed, medications will be given orally or via the NGT, which will be clamped for 30 minutes after administration. Patients will continue on standard ERAS pathways with the exception of reduction of diet. Antiemetics will be given as clinically indicated; however, no prokinetic or promotility agents will be given as scheduled dosages. Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function. All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. The patient and surgical team will be able to know which arm of the study the patient is in based on documentation in the medical record of the administration of Alvimopan. Standard discharge criteria will be applied to all patients, including: Passage of stool, Ability to tolerate solid food and to drink comfortably, Adequate oral analgesia, Patient's willingness to be discharged.
Interventions
DRUGAlvimopan
Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery
Sponsors
Scott Steele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Subjects who have benign or malignant colonic or rectal disease that have undergone laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal with small bowel resection and subsequently developed postoperative ileus, defined as: a. Patients with symptoms of bloating with or without nausea and vomiting, with absence of passage of flatus or stool who require either i. Return to NPO status after initial diet attempts ii. Undergo placement of a nasogastric tube b. Patients with absence of passage of flatus or stool who are either i. More than 5 days after open surgery without recovery of GI function ii. More than 3 days after laparoscopic surgery or ileostomy closure without recovery of GI function 2\. Subjects who are 18 years of age and older 3\. Subjects of either gender 4\. Subjects who are willing and able to adhere to protocol requirements, agree to participate in the study program and provide written and informed consent.
Exclusion criteria
* 1\. Subjects who received Alvimopan preoperatively. 2\. Subjects that have taken therapeutic doses of opioids for more than 7 days immediately prior to surgery. 3\. Subjects with severe hepatic impairment. 4\. Subjects with end-stage renal disease. 5\. Subjects who are pregnant. 6\. Subjects who have undergone imaging suggesting a small bowel obstruction. 7\. Subjects with a medical condition that may interfere with the use of the study medication Alvimopan. 8\. Subjects who have a condition or general disability or infirmity that in the opinion of the investigator precludes further participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Length of Stay | up to 30 days | Number of days from postoperative ileus diagnosis until discharge from hospital |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Return of Bowel Function | up to 30 days | Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet |
| Number of Participants With Re-operation | within 30 days of surgery | Number of participants with re-operations within 30 days of surgery |
| Number of Participants With Re-admissions | up to 30 days | Number of participatnts with re-admissions within 30 days of surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Alvimopan Group Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan doses will be given if there is no return of bowel function or if symptoms of distension and/or nausea persist despite some return of bowel function.
All patients will follow a standard ERAS pathway after surgery, with early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol.
Alvimopan: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery | 31 |
| Control Group Control patients will follow a standard ERAS pathway after surgery, including NPO status, IV fluid rehydration, and nasogastric decompression, early feeding and ambulation, along with opioid minimizing measures as is our standard postoperative protocol. | 32 |
| Total | 63 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Screen Failure- Received Alvimopan Preoperatively | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Total | Alvimopan Group |
|---|---|---|---|
| Age, Continuous | 63 years | 61 years | 56 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 32 participants | 63 participants | 31 participants |
| Sex: Female, Male Female | 12 Participants | 22 Participants | 10 Participants |
| Sex: Female, Male Male | 20 Participants | 41 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 32 |
| other Total, other adverse events | 10 / 31 | 13 / 32 |
| serious Total, serious adverse events | 0 / 31 | 0 / 32 |
Outcome results
Primary
Hospital Length of Stay
Number of days from postoperative ileus diagnosis until discharge from hospital
Time frame: up to 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alvimopan Group | Hospital Length of Stay | 5 days |
| Control Group | Hospital Length of Stay | 6 days |
Secondary
Number of Participants With Re-admissions
Number of participatnts with re-admissions within 30 days of surgery
Time frame: up to 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alvimopan Group | Number of Participants With Re-admissions | 7 Participants |
| Control Group | Number of Participants With Re-admissions | 5 Participants |
Secondary
Number of Participants With Re-operation
Number of participants with re-operations within 30 days of surgery
Time frame: within 30 days of surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alvimopan Group | Number of Participants With Re-operation | 3 Participants |
| Control Group | Number of Participants With Re-operation | 0 Participants |
Secondary
Time to Return of Bowel Function
Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet
Time frame: up to 30 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Alvimopan Group | Time to Return of Bowel Function | 1 days |
| Control Group | Time to Return of Bowel Function | 2 days |