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Alvimopan as a Rescue Treatment of Postoperative Ileus

Primary Purpose

Ileus, Gastrointestinal Dysfunction

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Alvimopan
Sponsored by
Scott Steele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ileus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cleveland ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Alvimopan Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hospital Length of Stay
Number of days from postoperative ileus diagnosis until discharge from hospital

Secondary Outcome Measures

Time to return of bowel function
Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet
Number of re-operations
Number of re-operations within 30 days of surgery
number of re-admissions
Number of re-admissions within 30 days of surgery

Full Information

First Posted
May 22, 2020
Last Updated
April 7, 2023
Sponsor
Scott Steele
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1. Study Identification

Unique Protocol Identification Number
NCT04405037
Brief Title
Alvimopan as a Rescue Treatment of Postoperative Ileus
Official Title
A Prospective Randomized Control Trial of The Effectiveness of Alvimopan as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Scott Steele

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ileus, Gastrointestinal Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Alvimopan Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Alvimopan
Other Intervention Name(s)
Entereg
Intervention Description
Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery
Primary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Number of days from postoperative ileus diagnosis until discharge from hospital
Time Frame
up to 30 days
Secondary Outcome Measure Information:
Title
Time to return of bowel function
Description
Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet
Time Frame
up to 30 days
Title
Number of re-operations
Description
Number of re-operations within 30 days of surgery
Time Frame
up to 30 days
Title
number of re-admissions
Description
Number of re-admissions within 30 days of surgery
Time Frame
up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Conor Delaney, MD, PhD
Phone
216 444-5576
Email
delanec@ccf.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Conor Delaney, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Conor Delaney, MD, PhD
Email
delanec@ccf.org

12. IPD Sharing Statement

Citations:
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Citation
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Alvimopan as a Rescue Treatment of Postoperative Ileus

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