<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04405037</url>
  </required_header>
  <id_info>
    <org_study_id>20-321</org_study_id>
    <nct_id>NCT04405037</nct_id>
  </id_info>
  <brief_title>Alvimopan as a Rescue Treatment of Postoperative Ileus</brief_title>
  <official_title>A Prospective Randomized Control Trial of The Effectiveness of Alvimopan as a Rescue Treatment of Postoperative Ileus Following Colorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scott Steele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients&#xD;
      undergoing colorectal or small bowel resection who develop POI, and its safety and&#xD;
      effectiveness in reducing LOS and POI duration.&#xD;
&#xD;
      This will be a prospective randomized control trial with a total of 58 patients, 29 in each&#xD;
      group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection,&#xD;
      or ileostomy reversal with small bowel resection that subsequently develop postoperative&#xD;
      ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will&#xD;
      be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue&#xD;
      therapy or to receive conservative standard care.&#xD;
&#xD;
      Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg&#xD;
      orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative&#xD;
      ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan&#xD;
      doses will be given if there is no return of bowel function or if symptoms of distension&#xD;
      and/or nausea persist despite some return of bowel function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to evaluate the cost effectiveness of Alvimopan as rescue therapy in patients&#xD;
      undergoing colorectal or small bowel resection who develop POI, and its safety and&#xD;
      effectiveness in reducing LOS and POI duration.&#xD;
&#xD;
      Hypothesis:&#xD;
&#xD;
      The investigators hypothesize that the use of alvimopan as rescue therapy in patients&#xD;
      undergoing colorectal and small bowel resection surgery who develop POI can shorten their&#xD;
      duration of POI and hospital length of stay.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      To perform a prospective RCT to evaluate the effect of alvimopan as rescue therapy compared&#xD;
      to standard of care in reducing the duration of post-operative ileus and post-operative LOS&#xD;
      after colorectal and small bowel resection surgery.&#xD;
&#xD;
      Protocol:&#xD;
&#xD;
      This will be a prospective randomized control trial with a total of 58 patients, 29 in each&#xD;
      group. Patients who undergo laparoscopic or open colorectal resection, small bowel resection,&#xD;
      or ileostomy reversal with small bowel resection that subsequently develop postoperative&#xD;
      ileus will be eligible for enrollment. If they meet inclusion/exclusion criteria, they will&#xD;
      be randomized at the time of diagnosis of postoperative ileus to receive Alvimopan as rescue&#xD;
      therapy or to receive conservative standard care.&#xD;
&#xD;
      At the time of diagnosis of postoperative ileus and after enrollment and randomization, all&#xD;
      patients will be returned to NPO status. Nasogastric tubes (NGT) may be placed for gastric&#xD;
      decompression at the discretion of the surgical team if clinically indicated. In the event&#xD;
      that an NGT is placed, medications will be given orally or via the NGT, which will be clamped&#xD;
      for 30 minutes after administration. Patients will continue on standard ERAS pathways with&#xD;
      the exception of reduction of diet. Antiemetics will be given as clinically indicated;&#xD;
      however, no prokinetic or promotility agents will be given as scheduled dosages.&#xD;
&#xD;
      Patients randomized to the study group will be given a maximum of 3 doses of Alvimopan 12mg&#xD;
      orally, 12 hours apart. Alvimopan will be given from the time of diagnosis of postoperative&#xD;
      ileus to the time of return of bowel function or the maximum 3 doses. Subsequent Alvimopan&#xD;
      doses will be given if there is no return of bowel function or if symptoms of distension&#xD;
      and/or nausea persist despite some return of bowel function.&#xD;
&#xD;
      All patients will follow a standard ERAS pathway after surgery, with early feeding and&#xD;
      ambulation, along with opioid minimizing measures as is our standard postoperative protocol.&#xD;
&#xD;
      The patient and surgical team will be able to know which arm of the study the patient is in&#xD;
      based on documentation in the medical record of the administration of Alvimopan.&#xD;
&#xD;
      Standard discharge criteria will be applied to all patients, including: Passage of stool,&#xD;
      Ability to tolerate solid food and to drink comfortably, Adequate oral analgesia, Patient's&#xD;
      willingness to be discharged.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Number of days from postoperative ileus diagnosis until discharge from hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to return of bowel function</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of re-operations</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Number of re-operations within 30 days of surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of re-admissions</measure>
    <time_frame>up to 30 days</time_frame>
    <description>Number of re-admissions within 30 days of surgery</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">58</enrollment>
  <condition>Ileus</condition>
  <condition>Gastrointestinal Dysfunction</condition>
  <arm_group>
    <arm_group_label>Alvimopan Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.&#xD;
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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alvimopan</intervention_name>
    <description>Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery</description>
    <arm_group_label>Alvimopan Group</arm_group_label>
    <other_name>Entereg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. Subjects who have benign or malignant colonic or rectal disease that have undergone&#xD;
             laparoscopic or open colorectal resection, small bowel resection or ileostomy reversal&#xD;
             with small bowel resection and subsequently developed postoperative ileus, defined as:&#xD;
&#xD;
             a. Patients with symptoms of bloating with or without nausea and vomiting, with&#xD;
             absence of passage of flatus or stool who require either&#xD;
&#xD;
             i. Return to NPO status after initial diet attempts&#xD;
&#xD;
        ii. Undergo placement of a nasogastric tube&#xD;
&#xD;
        b. Patients with absence of passage of flatus or stool who are either&#xD;
&#xD;
        i. More than 5 days after open surgery without recovery of GI function&#xD;
&#xD;
        ii. More than 3 days after laparoscopic surgery or ileostomy closure without recovery of GI&#xD;
        function&#xD;
&#xD;
        2. Subjects who are 18 years of age and older&#xD;
&#xD;
        3. Subjects of either gender&#xD;
&#xD;
        4. Subjects who are willing and able to adhere to protocol requirements, agree to&#xD;
        participate in the study program and provide written and informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Subjects who received Alvimopan preoperatively.&#xD;
&#xD;
             2. Subjects that have taken therapeutic doses of opioids for more than 7 days&#xD;
             immediately prior to surgery.&#xD;
&#xD;
             3. Subjects with severe hepatic impairment.&#xD;
&#xD;
             4. Subjects with end-stage renal disease.&#xD;
&#xD;
             5. Subjects who are pregnant.&#xD;
&#xD;
             6. Subjects who have undergone imaging suggesting a small bowel obstruction.&#xD;
&#xD;
             7. Subjects with a medical condition that may interfere with the use of the study&#xD;
             medication Alvimopan.&#xD;
&#xD;
             8. Subjects who have a condition or general disability or infirmity that in the&#xD;
             opinion of the investigator precludes further participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Conor Delaney, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Conor Delaney, MD, PhD</last_name>
    <phone>216 444-5576</phone>
    <email>delanec@ccf.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Conor Delaney, MD, PhD</last_name>
      <email>delanec@ccf.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.</citation>
    <PMID>19590205</PMID>
  </reference>
  <reference>
    <citation>Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.</citation>
    <PMID>15357852</PMID>
  </reference>
  <reference>
    <citation>Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.</citation>
    <PMID>11091234</PMID>
  </reference>
  <reference>
    <citation>Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.</citation>
    <PMID>15017498</PMID>
  </reference>
  <reference>
    <citation>Luckey A, Livingston E, Tache Y. Mechanisms and treatment of postoperative ileus. Arch Surg. 2003 Feb;138(2):206-14. doi: 10.1001/archsurg.138.2.206.</citation>
    <PMID>12578422</PMID>
  </reference>
  <reference>
    <citation>Delaney CP, Brady K, Woconish D, Parmar SP, Champagne BJ. Towards optimizing perioperative colorectal care: outcomes for 1,000 consecutive laparoscopic colon procedures using enhanced recovery pathways. Am J Surg. 2012 Mar;203(3):353-5; discussion 355-6. doi: 10.1016/j.amjsurg.2011.09.017. Epub 2012 Jan 20.</citation>
    <PMID>22264739</PMID>
  </reference>
  <reference>
    <citation>Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.</citation>
    <PMID>23575408</PMID>
  </reference>
  <reference>
    <citation>Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.</citation>
    <PMID>17435541</PMID>
  </reference>
  <reference>
    <citation>Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.</citation>
    <PMID>22388106</PMID>
  </reference>
  <reference>
    <citation>Senagore AJ, Bauer JJ, Du W, Techner L. Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use. Surgery. 2007 Oct;142(4):478-86. doi: 10.1016/j.surg.2007.07.004.</citation>
    <PMID>17950339</PMID>
  </reference>
  <reference>
    <citation>Traut U, Brugger L, Kunz R, Pauli-Magnus C, Haug K, Bucher HC, Koller MT. Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004930. doi: 10.1002/14651858.CD004930.pub3.</citation>
    <PMID>18254064</PMID>
  </reference>
  <reference>
    <citation>Zingg U, Miskovic D, Pasternak I, Meyer P, Hamel CT, Metzger U. Effect of bisacodyl on postoperative bowel motility in elective colorectal surgery: a prospective, randomized trial. Int J Colorectal Dis. 2008 Dec;23(12):1175-83. doi: 10.1007/s00384-008-0536-7. Epub 2008 Jul 30.</citation>
    <PMID>18665373</PMID>
  </reference>
  <reference>
    <citation>Al-Mazrou AM, Baser O, Kiran RP. Alvimopan, Regardless of Ileus Risk, Significantly Impacts Ileus, Length of Stay, and Readmission After Intestinal Surgery. J Gastrointest Surg. 2018 Dec;22(12):2104-2116. doi: 10.1007/s11605-018-3846-2. Epub 2018 Jul 9.</citation>
    <PMID>29987738</PMID>
  </reference>
  <reference>
    <citation>Jang J, Kwok B, Zhong H, Xia Y, Grucela A, Bernstein M, Remzi F, Hudesman D, Chen J, Axelrad J, Chang S. Alvimopan for the Prevention of Postoperative Ileus in Inflammatory Bowel Disease Patients. Dig Dis Sci. 2020 Apr;65(4):1164-1171. doi: 10.1007/s10620-019-05839-5. Epub 2019 Sep 14.</citation>
    <PMID>31522323</PMID>
  </reference>
  <reference>
    <citation>Wen Y, Jabir MA, Keating M, Althans AR, Brady JT, Champagne BJ, Delaney CP, Steele SR. Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use? Surg Endosc. 2017 Sep;31(9):3483-3488. doi: 10.1007/s00464-016-5373-0. Epub 2016 Dec 7.</citation>
    <PMID>27928668</PMID>
  </reference>
  <reference>
    <citation>Steele SR, Brady JT, Cao Z, Baumer DL, Robinson SB, Yang HK, Delaney CP. Evaluation of Healthcare Use and Clinical Outcomes of Alvimopan in Patients Undergoing Bowel Resection: A Propensity Score-Matched Analysis. Dis Colon Rectum. 2018 Dec;61(12):1418-1425. doi: 10.1097/DCR.0000000000001181.</citation>
    <PMID>30312222</PMID>
  </reference>
  <reference>
    <citation>Keller DS, Flores-Gonzalez JR, Ibarra S, Mahmood A, Haas EM. Is there value in alvimopan in minimally invasive colorectal surgery? Am J Surg. 2016 Nov;212(5):851-856. doi: 10.1016/j.amjsurg.2016.02.016. Epub 2016 May 10.</citation>
    <PMID>27262754</PMID>
  </reference>
  <reference>
    <citation>Hyde LZ, Kiely JM, Al-Mazrou A, Zhang H, Lee-Kong S, Kiran RP. Alvimopan Significantly Reduces Length of Stay and Costs Following Colorectal Resection and Ostomy Reversal Even Within an Enhanced Recovery Protocol. Dis Colon Rectum. 2019 Jun;62(6):755-761. doi: 10.1097/DCR.0000000000001354.</citation>
    <PMID>30807457</PMID>
  </reference>
  <reference>
    <citation>Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.</citation>
    <PMID>20113944</PMID>
  </reference>
  <reference>
    <citation>Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.</citation>
    <PMID>19610681</PMID>
  </reference>
  <reference>
    <citation>Mao H, Milne TGE, O'Grady G, Vather R, Edlin R, Bissett I. Prolonged Postoperative Ileus Significantly Increases the Cost of Inpatient Stay for Patients Undergoing Elective Colorectal Surgery: Results of a Multivariate Analysis of Prospective Data at a Single Institution. Dis Colon Rectum. 2019 May;62(5):631-637. doi: 10.1097/DCR.0000000000001301.</citation>
    <PMID>30543534</PMID>
  </reference>
  <reference>
    <citation>Tevis SE, Carchman EH, Foley EF, Harms BA, Heise CP, Kennedy GD. Postoperative Ileus--More than Just Prolonged Length of Stay? J Gastrointest Surg. 2015 Sep;19(9):1684-90. doi: 10.1007/s11605-015-2877-1. Epub 2015 Jun 24.</citation>
    <PMID>26105552</PMID>
  </reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>April 7, 2023</last_update_submitted>
  <last_update_submitted_qc>April 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Scott Steele</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ileus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alvimopan</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04405037
org study id: 20-321
nct id: NCT04405037
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hospital Length of Stay
time frame: up to 30 days
description: Number of days from postoperative ileus diagnosis until discharge from hospital
measure: Time to return of bowel function
time frame: up to 30 days
description: Number of days between Ileus diagnosis and time of passing flatus, stool and tolerating diet
measure: Number of re-operations
time frame: up to 30 days
description: Number of re-operations within 30 days of surgery
measure: number of re-admissions
time frame: up to 30 days
description: Number of re-admissions within 30 days of surgery
arm group label: Alvimopan Group
arm group type: Experimental
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 group label: Control Group
arm group type: No Intervention
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: Alvimopan
description: Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery
arm group label: Alvimopan Group
other name: Entereg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Conor Delaney, MD, PhD
role: Principal Investigator
affiliation: The Cleveland Clinic
last name: Conor Delaney, MD, PhD
phone: 216 444-5576
email: delanec@ccf.org
facility: 
status: Recruiting
contact: 
country: United States
citation: Story SK, Chamberlain RS. A comprehensive review of evidence-based strategies to prevent and treat postoperative ileus. Dig Surg. 2009;26(4):265-75. doi: 10.1159/000227765. Epub 2009 Jul 3.
PMID: 19590205
citation: Bauer AJ, Boeckxstaens GE. Mechanisms of postoperative ileus. Neurogastroenterol Motil. 2004 Oct;16 Suppl 2:54-60. doi: 10.1111/j.1743-3150.2004.00558.x.
PMID: 15357852
citation: Holte K, Kehlet H. Postoperative ileus: a preventable event. Br J Surg. 2000 Nov;87(11):1480-93. doi: 10.1046/j.1365-2168.2000.01595.x.
PMID: 11091234
citation: Behm B, Stollman N. Postoperative ileus: etiologies and interventions. Clin Gastroenterol Hepatol. 2003 Mar;1(2):71-80. doi: 10.1053/cgh.2003.50012.
PMID: 15017498
citation: Luckey A, Livingston E, Tache Y. Mechanisms and treatment of postoperative ileus. Arch Surg. 2003 Feb;138(2):206-14. doi: 10.1001/archsurg.138.2.206.
PMID: 12578422
citation: Delaney CP, Brady K, Woconish D, Parmar SP, Champagne BJ. Towards optimizing perioperative colorectal care: outcomes for 1,000 consecutive laparoscopic colon procedures using enhanced recovery pathways. Am J Surg. 2012 Mar;203(3):353-5; discussion 355-6. doi: 10.1016/j.amjsurg.2011.09.017. Epub 2012 Jan 20.
PMID: 22264739
citation: Zhuang CL, Ye XZ, Zhang XD, Chen BC, Yu Z. Enhanced recovery after surgery programs versus traditional care for colorectal surgery: a meta-analysis of randomized controlled trials. Dis Colon Rectum. 2013 May;56(5):667-78. doi: 10.1097/DCR.0b013e3182812842.
PMID: 23575408
citation: Delaney CP, Wolff BG, Viscusi ER, Senagore AJ, Fort JG, Du W, Techner L, Wallin B. Alvimopan, for postoperative ileus following bowel resection: a pooled analysis of phase III studies. Ann Surg. 2007 Mar;245(3):355-63. doi: 10.1097/01.sla.0000232538.72458.93.
PMID: 17435541
citation: Delaney CP, Craver C, Gibbons MM, Rachfal AW, VandePol CJ, Cook SF, Poston SA, Calloway M, Techner L. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection. Ann Surg. 2012 Apr;255(4):731-8. doi: 10.1097/SLA.0b013e31824a36cc.
PMID: 22388106
citation: Senagore AJ, Bauer JJ, Du W, Techner L. Alvimopan accelerates gastrointestinal recovery after bowel resection regardless of age, gender, race, or concomitant medication use. Surgery. 2007 Oct;142(4):478-86. doi: 10.1016/j.surg.2007.07.004.
PMID: 17950339
citation: Traut U, Brugger L, Kunz R, Pauli-Magnus C, Haug K, Bucher HC, Koller MT. Systemic prokinetic pharmacologic treatment for postoperative adynamic ileus following abdominal surgery in adults. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD004930. doi: 10.1002/14651858.CD004930.pub3.
PMID: 18254064
citation: Zingg U, Miskovic D, Pasternak I, Meyer P, Hamel CT, Metzger U. Effect of bisacodyl on postoperative bowel motility in elective colorectal surgery: a prospective, randomized trial. Int J Colorectal Dis. 2008 Dec;23(12):1175-83. doi: 10.1007/s00384-008-0536-7. Epub 2008 Jul 30.
PMID: 18665373
citation: Al-Mazrou AM, Baser O, Kiran RP. Alvimopan, Regardless of Ileus Risk, Significantly Impacts Ileus, Length of Stay, and Readmission After Intestinal Surgery. J Gastrointest Surg. 2018 Dec;22(12):2104-2116. doi: 10.1007/s11605-018-3846-2. Epub 2018 Jul 9.
PMID: 29987738
citation: Jang J, Kwok B, Zhong H, Xia Y, Grucela A, Bernstein M, Remzi F, Hudesman D, Chen J, Axelrad J, Chang S. Alvimopan for the Prevention of Postoperative Ileus in Inflammatory Bowel Disease Patients. Dig Dis Sci. 2020 Apr;65(4):1164-1171. doi: 10.1007/s10620-019-05839-5. Epub 2019 Sep 14.
PMID: 31522323
citation: Wen Y, Jabir MA, Keating M, Althans AR, Brady JT, Champagne BJ, Delaney CP, Steele SR. Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use? Surg Endosc. 2017 Sep;31(9):3483-3488. doi: 10.1007/s00464-016-5373-0. Epub 2016 Dec 7.
PMID: 27928668
citation: Steele SR, Brady JT, Cao Z, Baumer DL, Robinson SB, Yang HK, Delaney CP. Evaluation of Healthcare Use and Clinical Outcomes of Alvimopan in Patients Undergoing Bowel Resection: A Propensity Score-Matched Analysis. Dis Colon Rectum. 2018 Dec;61(12):1418-1425. doi: 10.1097/DCR.0000000000001181.
PMID: 30312222
citation: Keller DS, Flores-Gonzalez JR, Ibarra S, Mahmood A, Haas EM. Is there value in alvimopan in minimally invasive colorectal surgery? Am J Surg. 2016 Nov;212(5):851-856. doi: 10.1016/j.amjsurg.2016.02.016. Epub 2016 May 10.
PMID: 27262754
citation: Hyde LZ, Kiely JM, Al-Mazrou A, Zhang H, Lee-Kong S, Kiran RP. Alvimopan Significantly Reduces Length of Stay and Costs Following Colorectal Resection and Ostomy Reversal Even Within an Enhanced Recovery Protocol. Dis Colon Rectum. 2019 Jun;62(6):755-761. doi: 10.1097/DCR.0000000000001354.
PMID: 30807457
citation: Asgeirsson T, El-Badawi KI, Mahmood A, Barletta J, Luchtefeld M, Senagore AJ. Postoperative ileus: it costs more than you expect. J Am Coll Surg. 2010 Feb;210(2):228-31. doi: 10.1016/j.jamcollsurg.2009.09.028. Epub 2009 Nov 18.
PMID: 20113944
citation: Iyer S, Saunders WB, Stemkowski S. Economic burden of postoperative ileus associated with colectomy in the United States. J Manag Care Pharm. 2009 Jul-Aug;15(6):485-94. doi: 10.18553/jmcp.2009.15.6.485.
PMID: 19610681
citation: Mao H, Milne TGE, O'Grady G, Vather R, Edlin R, Bissett I. Prolonged Postoperative Ileus Significantly Increases the Cost of Inpatient Stay for Patients Undergoing Elective Colorectal Surgery: Results of a Multivariate Analysis of Prospective Data at a Single Institution. Dis Colon Rectum. 2019 May;62(5):631-637. doi: 10.1097/DCR.0000000000001301.
PMID: 30543534
citation: Tevis SE, Carchman EH, Foley EF, Harms BA, Heise CP, Kennedy GD. Postoperative Ileus--More than Just Prolonged Length of Stay? J Gastrointest Surg. 2015 Sep;19(9):1684-90. doi: 10.1007/s11605-015-2877-1. Epub 2015 Jun 24.
PMID: 26105552
responsible party type: Sponsor-Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Scott Steele
investigator title: Principle Investigator
mesh term: Ileus
mesh term: Alvimopan