A Phase 3 interventional study of Alvimopan and Control Group in Colorectal Surgery and Ileus, sponsored by Sharon Stein. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-18.
Sponsored by Sharon Stein · Phase 3, Interventional, and Treatment
This will be a prospective randomized control trial with a total of 142 patients. 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 Entereg as rescue therapy or to receive conservative standard care.
Patients randomized to the Entereg group will be given 12mg of Entereg two times daily from the time of randomization until the return of bowel function or 5 days. Both groups will be treated with conservative standard care, including bowel rest, reduction in oral diet, and placement of nasogastric tube as clinically indicated.
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.
Primary outcome will be hospital length of stay. Secondary outcomes will include time to return of bowel function, 30-day morbidity/mortality, complications, reoperation and readmission.
Total number of patients: 142 Patients in each study group: 71
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 12mg of Entereg orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Patients randomized to the control group receive standard postoperative care.
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 Entereg.
Patients in both groups will remain NPO until the return of bowel function, defined as passage of stool, decrease in nasogastric tube output. At this point, the nasogastric tube will be removed and a trial of oral diet will be attempted per surgeon's discretion.
Standard discharge criteria will be applied to all patients, including:
Data to be collected The medical/surgical information below will be collected as part of this research study and is all information already available as part of the patients medical chart.
Study Completion Completion of participation in the study will be 30 days after the date of surgery. Any readmission up to 30 days post-operatively to the hospital as a direct result of their surgery will be followed. The patients will follow-up with the surgeon in the office in approximately 3-6 weeks, which is considered standard of care for all patients undergoing colorectal surgery and is not considered part of the research study. Any patient for whom follow-up documentation is missing or incomplete shall be contacted via telephone. The purpose of the call will be to simply determine return to function and outcome. Only a co-investigator shall contact the subject and will identify themselves at the beginning of the call. Any subject can reserve the right not to participate in the phone call interview; they would remain in the study.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 14 is below the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →This is the only study on the registry with Sharon Stein as lead sponsor.
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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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In addition to standard postoperative care, patients randomized to the study group will be given 12mg of alvimopan orally twice a day, from the time of diagnosis of postoperative ileus to the time of return of bowel function or for 5 days.
Drug: Alvimopan
Patients randomized to the control group receive standard postoperative care which includes but is not limited to NPO status, IV fluid rehydration, and nasogastric decompression.
Other: Control Group
Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
Also known as: Entereg
Standard postoperative care
Hospital Length of Stay
Date of surgery until discharge
Time frame: up to 30 days
Time to Return of Bowel Function
Date ileus identified to time of passing flatus, stool and tolerating diet
Time frame: 30 days
Complications
All adverse events
Time frame: 30 days
Number of Reoperations
Any reoperations within 30 days of surgery
Time frame: 30 days
Number of Readmissions
Any readmissions within 30 days of surgery
Time frame: 30 days
| Milestone | Alvimopan Group | Control Group |
|---|---|---|
| Started | 6 | 8 |
| Completed | 5 | 8 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
Date of surgery until discharge
| Days | Alvimopan Group | Control Group |
|---|---|---|
| Hospital Length of Stay | 9 ± 4.56 | 8.5 ± 1.48 |
Date ileus identified to time of passing flatus, stool and tolerating diet
No measurements were reported for this outcome.
All adverse events
| Number of AEs | Alvimopan Group | Control Group |
|---|---|---|
| Complications | 4 | 6 |
Any reoperations within 30 days of surgery
| Number of reoperations | Alvimopan Group | Control Group |
|---|---|---|
| Number of Reoperations | 0 | 0 |
Any readmissions within 30 days of surgery
| Number of readmissions | Alvimopan Group | Control Group |
|---|---|---|
| Number of Readmissions | 0 | 0 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Alvimopan Group | 0/6 (0%) | 1/6 (16.7%) | 3/6 (50%) |
| Control Group | 0/8 (0%) | 1/8 (12.5%) | 5/8 (62.5%) |
| Event | Alvimopan Group | Control Group |
|---|---|---|
| Recurrent ileuGeneral disorders | 1/6 | 0/8 |
| LeukocytosisBlood and lymphatic system disorders | 0/6 | 1/8 |
| Event | Alvimopan Group | Control Group |
|---|---|---|
| LeukocytosisBlood and lymphatic system disorders | 1/6 | 0/8 |
| Acute Kidney injuryRenal and urinary disorders | 1/6 | 0/8 |
| Urinary tract infectionRenal and urinary disorders | 1/6 | 0/8 |
| Bloody NG outputGastrointestinal disorders | 0/6 | 1/8 |
| Urinary retentionRenal and urinary disorders | 0/6 | 1/8 |
| ThrushGeneral disorders | 0/6 | 1/8 |
| HallucinationsPsychiatric disorders | 0/6 | 1/8 |
| Exacerbation hypertensionGeneral disorders | 0/6 | 1/8 |
| Age, Categorical(Participants) | Alvimopan Group | Control Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 2 | 5 | 7 |
| >=65 years | 4 | 3 | 7 |
| Sex: Female, Male(Participants) | Alvimopan Group | Control Group | Total |
|---|---|---|---|
| Female | 4 | 3 | 7 |
| Male | 2 | 5 | 7 |
| Race (NIH/OMB)(Participants) | Alvimopan Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 4 |
| White | 4 | 6 | 10 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Alvimopan