<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/NCT03788980</url>
  </required_header>
  <id_info>
    <org_study_id>2018H0044</org_study_id>
    <nct_id>NCT03788980</nct_id>
  </id_info>
  <brief_title>Risk Factors for Complications After Carotid Endarterectomy</brief_title>
  <official_title>Risk Factors for Complications After Carotid Endarterectomy: A Multicenter International Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      This study may determine the incidence of complications that occur after patients undergo a&#xD;
      surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the&#xD;
      risk of strokes in patients with a condition called carotid stenosis. Medical records will be&#xD;
      accessed to find any information pertaining to postoperative complications. Additionally, it&#xD;
      may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental&#xD;
      Status Examination (MMSE).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a multicenter prospective observational study; data will be collected from two sites:&#xD;
      the lead site in Columbus, Ohio, USA and an international site in Girona, Spain for a total&#xD;
      of 354 patients. The objective of this study is to determine the incidence of complications&#xD;
      that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a&#xD;
      surgery that aims to decrease the risk of strokes in patients with a condition called carotid&#xD;
      stenosis. Patients who undergo CEA are at increased risk of cardiovascular complications&#xD;
      because of the high incidence of coexisting heart disease, high blood pressure, and diabetes.&#xD;
      Common complications that occur after CEA are wound hematoma (collection of blood at the&#xD;
      wound) and intracerebral hemorrhage (bleeding in the brain). Medical records will be accessed&#xD;
      to find any information pertaining to postoperative complications. Another objective of this&#xD;
      study is to determine the cognitive dysfunction of patients undergoing CEA. This will be&#xD;
      measured by a Mini Mental Status Examination (MMSE) which will occur in person before the&#xD;
      surgery and 30 days after the surgery over the phone. This study may provide data that will&#xD;
      help identify how to optimize recovery for future CEA patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of funding and resources&#xD;
  </why_stopped>
  <start_date type="Actual">April 13, 2018</start_date>
  <completion_date type="Actual">July 9, 2019</completion_date>
  <primary_completion_date type="Actual">July 9, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complication rate</measure>
    <time_frame>30 days</time_frame>
    <description>Incidence of postoperative complications and identify the associated risk factors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cognitive Dysfunction</measure>
    <time_frame>30 days</time_frame>
    <description>the incidence of cognitive dysfunction based on Mini Mental Status Examination</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Postoperative Complications</condition>
  <condition>Postoperative Cognitive Dysfunction</condition>
  <arm_group>
    <arm_group_label>carotid endarterectomy group</arm_group_label>
    <description>patients undergoing carotid endarterectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Carotid endarterectomy</intervention_name>
    <description>Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)</description>
    <arm_group_label>carotid endarterectomy group</arm_group_label>
    <other_name>CAE</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Mini Mental Status Examination</intervention_name>
    <description>Short questionnaire used to diagnose cognitive dysfunction</description>
    <arm_group_label>carotid endarterectomy group</arm_group_label>
    <other_name>MMSE</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients 18 years of age or older scheduled to undergo carotid endarterectomy&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients males or females, 18 years of age and older&#xD;
&#xD;
          -  Scheduled to undergo Carotid Endarterectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant women&#xD;
&#xD;
          2. Incarcerated individuals&#xD;
&#xD;
          3. Patients not able to consent for themselves&#xD;
&#xD;
          4. Any disease or condition deemed by the investigator to disqualify the patient&#xD;
&#xD;
          5. Participating in any interventional clinical trial&#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>Sergio Bergese, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Ohio State University Wexner Medical Center Department of Anesthesiology</affiliation>
  </overall_official>
  <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>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari de Girona Dr. Josep Trueta</name>
      <address>
        <city>Girona</city>
        <state>Catalonia</state>
        <zip>17007</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.</citation>
    <PMID>7723155</PMID>
  </reference>
  <reference>
    <citation>Stoneham MD, Thompson JP. Arterial pressure management and carotid endarterectomy. Br J Anaesth. 2009 Apr;102(4):442-52. doi: 10.1093/bja/aep012. Epub 2009 Feb 20.</citation>
    <PMID>19233880</PMID>
  </reference>
  <reference>
    <citation>McCollum PT, da Silva A, Ridler BD, de Cossart L. Carotid endarterectomy in the U.K. and Ireland: audit of 30-day outcome. The Audit Committee for the Vascular Surgical Society. Eur J Vasc Endovasc Surg. 1997 Nov;14(5):386-91. doi: 10.1016/s1078-5884(97)80289-4.</citation>
    <PMID>9413380</PMID>
  </reference>
  <reference>
    <citation>Ferguson GG, Eliasziw M, Barr HW, Clagett GP, Barnes RW, Wallace MC, Taylor DW, Haynes RB, Finan JW, Hachinski VC, Barnett HJ. The North American Symptomatic Carotid Endarterectomy Trial : surgical results in 1415 patients. Stroke. 1999 Sep;30(9):1751-8. doi: 10.1161/01.str.30.9.1751.</citation>
    <PMID>10471419</PMID>
  </reference>
  <reference>
    <citation>Robinson TG, James M, Youde J, Panerai R, Potter J. Cardiac baroreceptor sensitivity is impaired after acute stroke. Stroke. 1997 Sep;28(9):1671-6. doi: 10.1161/01.str.28.9.1671.</citation>
    <PMID>9303008</PMID>
  </reference>
  <reference>
    <citation>Rothwell PM, Giles MF, Chandratheva A, Marquardt L, Geraghty O, Redgrave JN, Lovelock CE, Binney LE, Bull LM, Cuthbertson FC, Welch SJ, Bosch S, Alexander FC, Silver LE, Gutnikov SA, Mehta Z; Early use of Existing Preventive Strategies for Stroke (EXPRESS) study. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison. Lancet. 2007 Oct 20;370(9596):1432-42. doi: 10.1016/S0140-6736(07)61448-2. Erratum In: Lancet. 2008 Feb 2;371(9610):386. Carasco-Alexander, Faye [corrected to Alexander, Faye C].</citation>
    <PMID>17928046</PMID>
  </reference>
  <reference>
    <citation>Asiddao CB, Donegan JH, Whitesell RC, Kalbfleisch JH. Factors associated with perioperative complications during carotid endarterectomy. Anesth Analg. 1982 Aug;61(8):631-7.</citation>
    <PMID>7201265</PMID>
  </reference>
  <reference>
    <citation>Kunkel JM, Gomez ER, Spebar MJ, Delgado RJ, Jarstfer BS, Collins GJ. Wound hematomas after carotid endarterectomy. Am J Surg. 1984 Dec;148(6):844-7. doi: 10.1016/0002-9610(84)90451-3.</citation>
    <PMID>6507761</PMID>
  </reference>
  <reference>
    <citation>Karapanayiotides T, Meuli R, Devuyst G, Piechowski-Jozwiak B, Dewarrat A, Ruchat P, Von Segesser L, Bogousslavsky J. Postcarotid endarterectomy hyperperfusion or reperfusion syndrome. Stroke. 2005 Jan;36(1):21-6. doi: 10.1161/01.STR.0000149946.86087.e5. Epub 2004 Dec 2.</citation>
    <PMID>15576656</PMID>
  </reference>
  <reference>
    <citation>Naylor AR, Evans J, Thompson MM, London NJ, Abbott RJ, Cherryman G, Bell PR. Seizures after carotid endarterectomy: hyperperfusion, dysautoregulation or hypertensive encephalopathy? Eur J Vasc Endovasc Surg. 2003 Jul;26(1):39-44. doi: 10.1053/ejvs.2002.1925.</citation>
    <PMID>12819646</PMID>
  </reference>
  <reference>
    <citation>Russell DA, Gough MJ. Intracerebral haemorrhage following carotid endarterectomy. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):115-23. doi: 10.1016/j.ejvs.2004.03.020.</citation>
    <PMID>15234690</PMID>
  </reference>
  <reference>
    <citation>Nordlander M, Sjoquist PO, Ericsson H, Ryden L. Pharmacodynamic, pharmacokinetic and clinical effects of clevidipine, an ultrashort-acting calcium antagonist for rapid blood pressure control. Cardiovasc Drug Rev. 2004 Fall;22(3):227-50. doi: 10.1111/j.1527-3466.2004.tb00143.x.</citation>
    <PMID>15492770</PMID>
  </reference>
  <reference>
    <citation>Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.</citation>
    <PMID>18806012</PMID>
  </reference>
  <reference>
    <citation>Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.</citation>
    <PMID>18635468</PMID>
  </reference>
  <reference>
    <citation>Ericsson H, Bredberg U, Eriksson U, Jolin-Mellgard A, Nordlander M, Regardh CG. Pharmacokinetics and arteriovenous differences in clevidipine concentration following a short- and a long-term intravenous infusion in healthy volunteers. Anesthesiology. 2000 Apr;92(4):993-1001. doi: 10.1097/00000542-200004000-00016.</citation>
    <PMID>10754618</PMID>
  </reference>
  <reference>
    <citation>Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.</citation>
    <PMID>23043910</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>October 22, 2021</last_update_submitted>
  <last_update_submitted_qc>October 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ohio State University</investigator_affiliation>
    <investigator_full_name>Alberto Uribe, M.D.</investigator_full_name>
    <investigator_title>Professor-Clinical</investigator_title>
  </responsible_party>
  <keyword>Endarterectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Postoperative Cognitive Complications</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The de-identified date from the international site and the data collected at the main site will be analyzed at The Ohio State University Wexner Medical Center.</ipd_description>
  </patient_data>
  <!-- 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/NCT03788980
org study id: 2018H0044
nct id: NCT03788980
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study may determine the incidence of complications that occur after patients undergo a
      surgery called Carotid Endarterectomy (CEA), which is a surgery that aims to decrease the
      risk of strokes in patients with a condition called carotid stenosis. Medical records will be
      accessed to find any information pertaining to postoperative complications. Additionally, it
      may determine the cognitive dysfunction of patients undergoing CEA, assessed by Mini Mental
      Status Examination (MMSE).
This is a multicenter prospective observational study; data will be collected from two sites:
      the lead site in Columbus, Ohio, USA and an international site in Girona, Spain for a total
      of 354 patients. The objective of this study is to determine the incidence of complications
      that occur after patients undergo a surgery called Carotid Endarterectomy (CEA), which is a
      surgery that aims to decrease the risk of strokes in patients with a condition called carotid
      stenosis. Patients who undergo CEA are at increased risk of cardiovascular complications
      because of the high incidence of coexisting heart disease, high blood pressure, and diabetes.
      Common complications that occur after CEA are wound hematoma (collection of blood at the
      wound) and intracerebral hemorrhage (bleeding in the brain). Medical records will be accessed
      to find any information pertaining to postoperative complications. Another objective of this
      study is to determine the cognitive dysfunction of patients undergoing CEA. This will be
      measured by a Mini Mental Status Examination (MMSE) which will occur in person before the
      surgery and 30 days after the surgery over the phone. This study may provide data that will
      help identify how to optimize recovery for future CEA patients.
observational model: Case-Only
time perspective: Prospective
measure: Complication rate
time frame: 30 days
description: Incidence of postoperative complications and identify the associated risk factors.
measure: Cognitive Dysfunction
time frame: 30 days
description: the incidence of cognitive dysfunction based on Mini Mental Status Examination
arm group label: carotid endarterectomy group
description: patients undergoing carotid endarterectomy
intervention type: Procedure
intervention name: Carotid endarterectomy
description: Patients will undergo a surgery called carotid endarterectomy where a surgeon will remove material that causes carotid stenosis (i.e. plaque)
arm group label: carotid endarterectomy group
other name: CAE
intervention type: Diagnostic Test
intervention name: Mini Mental Status Examination
description: Short questionnaire used to diagnose cognitive dysfunction
arm group label: carotid endarterectomy group
other name: MMSE
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sergio Bergese, MD
role: Principal Investigator
affiliation: The Ohio State University Wexner Medical Center Department of Anesthesiology
facility: 
facility: 
country: Spain
country: United States
citation: Endarterectomy for asymptomatic carotid artery stenosis. Executive Committee for the Asymptomatic Carotid Atherosclerosis Study. JAMA. 1995 May 10;273(18):1421-8.
PMID: 7723155
citation: Stoneham MD, Thompson JP. Arterial pressure management and carotid endarterectomy. Br J Anaesth. 2009 Apr;102(4):442-52. doi: 10.1093/bja/aep012. Epub 2009 Feb 20.
PMID: 19233880
citation: McCollum PT, da Silva A, Ridler BD, de Cossart L. Carotid endarterectomy in the U.K. and Ireland: audit of 30-day outcome. The Audit Committee for the Vascular Surgical Society. Eur J Vasc Endovasc Surg. 1997 Nov;14(5):386-91. doi: 10.1016/s1078-5884(97)80289-4.
PMID: 9413380
citation: Ferguson GG, Eliasziw M, Barr HW, Clagett GP, Barnes RW, Wallace MC, Taylor DW, Haynes RB, Finan JW, Hachinski VC, Barnett HJ. The North American Symptomatic Carotid Endarterectomy Trial : surgical results in 1415 patients. Stroke. 1999 Sep;30(9):1751-8. doi: 10.1161/01.str.30.9.1751.
PMID: 10471419
citation: Robinson TG, James M, Youde J, Panerai R, Potter J. Cardiac baroreceptor sensitivity is impaired after acute stroke. Stroke. 1997 Sep;28(9):1671-6. doi: 10.1161/01.str.28.9.1671.
PMID: 9303008
citation: Rothwell PM, Giles MF, Chandratheva A, Marquardt L, Geraghty O, Redgrave JN, Lovelock CE, Binney LE, Bull LM, Cuthbertson FC, Welch SJ, Bosch S, Alexander FC, Silver LE, Gutnikov SA, Mehta Z; Early use of Existing Preventive Strategies for Stroke (EXPRESS) study. Effect of urgent treatment of transient ischaemic attack and minor stroke on early recurrent stroke (EXPRESS study): a prospective population-based sequential comparison. Lancet. 2007 Oct 20;370(9596):1432-42. doi: 10.1016/S0140-6736(07)61448-2. Erratum In: Lancet. 2008 Feb 2;371(9610):386. Carasco-Alexander, Faye [corrected to Alexander, Faye C].
PMID: 17928046
citation: Asiddao CB, Donegan JH, Whitesell RC, Kalbfleisch JH. Factors associated with perioperative complications during carotid endarterectomy. Anesth Analg. 1982 Aug;61(8):631-7.
PMID: 7201265
citation: Kunkel JM, Gomez ER, Spebar MJ, Delgado RJ, Jarstfer BS, Collins GJ. Wound hematomas after carotid endarterectomy. Am J Surg. 1984 Dec;148(6):844-7. doi: 10.1016/0002-9610(84)90451-3.
PMID: 6507761
citation: Karapanayiotides T, Meuli R, Devuyst G, Piechowski-Jozwiak B, Dewarrat A, Ruchat P, Von Segesser L, Bogousslavsky J. Postcarotid endarterectomy hyperperfusion or reperfusion syndrome. Stroke. 2005 Jan;36(1):21-6. doi: 10.1161/01.STR.0000149946.86087.e5. Epub 2004 Dec 2.
PMID: 15576656
citation: Naylor AR, Evans J, Thompson MM, London NJ, Abbott RJ, Cherryman G, Bell PR. Seizures after carotid endarterectomy: hyperperfusion, dysautoregulation or hypertensive encephalopathy? Eur J Vasc Endovasc Surg. 2003 Jul;26(1):39-44. doi: 10.1053/ejvs.2002.1925.
PMID: 12819646
citation: Russell DA, Gough MJ. Intracerebral haemorrhage following carotid endarterectomy. Eur J Vasc Endovasc Surg. 2004 Aug;28(2):115-23. doi: 10.1016/j.ejvs.2004.03.020.
PMID: 15234690
citation: Nordlander M, Sjoquist PO, Ericsson H, Ryden L. Pharmacodynamic, pharmacokinetic and clinical effects of clevidipine, an ultrashort-acting calcium antagonist for rapid blood pressure control. Cardiovasc Drug Rev. 2004 Fall;22(3):227-50. doi: 10.1111/j.1527-3466.2004.tb00143.x.
PMID: 15492770
citation: Aronson S, Dyke CM, Stierer KA, Levy JH, Cheung AT, Lumb PD, Kereiakes DJ, Newman MF. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008 Oct;107(4):1110-21. doi: 10.1213/ane.0b013e31818240db.
PMID: 18806012
citation: Singla N, Warltier DC, Gandhi SD, Lumb PD, Sladen RN, Aronson S, Newman MF, Corwin HL; ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008 Jul;107(1):59-67. doi: 10.1213/ane.0b013e3181732e53.
PMID: 18635468
citation: Ericsson H, Bredberg U, Eriksson U, Jolin-Mellgard A, Nordlander M, Regardh CG. Pharmacokinetics and arteriovenous differences in clevidipine concentration following a short- and a long-term intravenous infusion in healthy volunteers. Anesthesiology. 2000 Apr;92(4):993-1001. doi: 10.1097/00000542-200004000-00016.
PMID: 10754618
citation: Muller L, Bobbia X, Toumi M, Louart G, Molinari N, Ragonnet B, Quintard H, Leone M, Zoric L, Lefrant JY; AzuRea group. Respiratory variations of inferior vena cava diameter to predict fluid responsiveness in spontaneously breathing patients with acute circulatory failure: need for a cautious use. Crit Care. 2012 Oct 8;16(5):R188. doi: 10.1186/cc11672.
PMID: 23043910
responsible party type: Principal Investigator
investigator affiliation: Ohio State University
investigator full name: Alberto Uribe, M.D.
investigator title: Professor-Clinical
mesh term: Postoperative Complications
mesh term: Postoperative Cognitive Complications
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: The de-identified date from the international site and the data collected at the main site will be analyzed at The Ohio State University Wexner Medical Center.