<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/NCT03812536</url>
  </required_header>
  <id_info>
    <org_study_id>2018H0208</org_study_id>
    <nct_id>NCT03812536</nct_id>
  </id_info>
  <brief_title>Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery</brief_title>
  <official_title>Spontaneous Void Requirements for Patients Undergoing Ambulatory Anorectal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Syed Husain</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to assess if not requiring patients to spontaneous void prior&#xD;
      to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of&#xD;
      stay in the post-anesthesia care unit without increasing hospital readmissions or emergency&#xD;
      room visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will be a prospective clinical trial, in which 100 anorectal surgery patients will&#xD;
      be randomly assigned to a control (spontaneous void) or experimental (no void group). The&#xD;
      spontaneous void group will include 50 patients who will be required to void spontaneously&#xD;
      after anorectal surgeries. The no void group will be 50 patients who will be discharged home&#xD;
      from the PACU once they meet ambulatory surgery center discharge criteria per hospital&#xD;
      guidelines. Patients requiring anorectal surgeries will be consented to take part in the&#xD;
      study during the preoperative outpatient office visit. A post-operative phone call will be&#xD;
      made by designated study personnel to participants on post-op day 30 using a study&#xD;
      questionnaire to assess re-admission and emergency room visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2022</primary_completion_date>
  <phase>N/A</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>Post-Operative Phone Call</measure>
    <time_frame>30 days</time_frame>
    <description>Assess readmissions</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>PACU times</measure>
    <time_frame>24 hours</time_frame>
    <description>Assess time spent in PACU</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Complications, Postoperative</condition>
  <arm_group>
    <arm_group_label>SOC Voiding Protocol</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Void Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No Void</intervention_name>
    <description>Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria.</description>
    <arm_group_label>No Void Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18-80 years old&#xD;
&#xD;
          -  Patients undergoing hemorrhoidectomy, fistulotomy or anal condyloma excision&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 yo or &gt; 80 yo&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Pregnant Women&#xD;
&#xD;
          -  Unable or unwilling to follow the study protocol or any reason the research team&#xD;
             believes the subject is not appropriate candidate for this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Syed Husain, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kayla Diaz, MCR</last_name>
    <phone>614-293-8549</phone>
    <email>kayla.diaz@osumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amen An</last_name>
    <phone>614-293-9964</phone>
    <email>amen.an@osumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Ohio State University Wexner Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kayla Diaz, BA</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 24, 2018</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 15, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Syed Husain</investigator_full_name>
    <investigator_title>Assistant Professor - Colon and Rectal Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 19, 2022</submitted>
    <returned>January 19, 2023</returned>
  </pending_results>
  <!-- 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/NCT03812536
org study id: 2018H0208
nct id: NCT03812536
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to assess if not requiring patients to spontaneous void prior
      to discharge from the post-anesthesia care unit (PACU) will results in shorter lengths of
      stay in the post-anesthesia care unit without increasing hospital readmissions or emergency
      room visits.
This study will be a prospective clinical trial, in which 100 anorectal surgery patients will
      be randomly assigned to a control (spontaneous void) or experimental (no void group). The
      spontaneous void group will include 50 patients who will be required to void spontaneously
      after anorectal surgeries. The no void group will be 50 patients who will be discharged home
      from the PACU once they meet ambulatory surgery center discharge criteria per hospital
      guidelines. Patients requiring anorectal surgeries will be consented to take part in the
      study during the preoperative outpatient office visit. A post-operative phone call will be
      made by designated study personnel to participants on post-op day 30 using a study
      questionnaire to assess re-admission and emergency room visits.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post-Operative Phone Call
time frame: 30 days
description: Assess readmissions
measure: PACU times
time frame: 24 hours
description: Assess time spent in PACU
arm group label: SOC Voiding Protocol
arm group type: No Intervention
description: Patients in the control group will follow the standard of care protocol and are required to void post anorectal surgery before being discharged home.
arm group label: No Void Intervention
arm group type: Experimental
description: Patients in the experimental group (No Void Intervention) will be discharged home without voiding spontaneously.
intervention type: Other
intervention name: No Void
description: Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria.
arm group label: No Void Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Syed Husain, MBBS
role: Principal Investigator
affiliation: Ohio State University
last name: Kayla Diaz, MCR
phone: 614-293-8549
email: kayla.diaz@osumc.edu
last name: Amen An
phone: 614-293-9964
email: amen.an@osumc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Ohio State University
investigator full name: Syed Husain
investigator title: Assistant Professor - Colon and Rectal Surgery
mesh term: Postoperative Complications
sharing ipd: No
submitted: April 19, 2022
returned: January 19, 2023