<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/NCT03038945</url>
  </required_header>
  <id_info>
    <org_study_id>377</org_study_id>
    <nct_id>NCT03038945</nct_id>
  </id_info>
  <brief_title>Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure</brief_title>
  <official_title>Barbed vs Standard Suture for Laparoscopic Vaginal Cuff Closure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CES University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CES University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of&#xD;
      the problems described for this procedure has to do with the closure of the vaginal vault,&#xD;
      increased surgical time when suture laparoscopically, complications such as dehiscence of the&#xD;
      dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare&#xD;
      two different techniques for closure of the vaginal vault.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cuff closure time</measure>
    <time_frame>20 minutes</time_frame>
    <description>time spend for vaginal Cuff closure (in minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra or postoperative complications</measure>
    <time_frame>10 days</time_frame>
    <description>Clinical follow-up to complications during the surgery and ten days after, through questions and clinical exam.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspareunia</measure>
    <time_frame>12 weeks</time_frame>
    <description>the visual scale was used to analyze the dyspareunia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Gynecologic Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>2/0 barbed suture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use barbed suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vicryl suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use VICRYL suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2/0 barbed suture</intervention_name>
    <description>Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology</description>
    <arm_group_label>2/0 barbed suture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>0/0 Vicryl suture</intervention_name>
    <description>Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology</description>
    <arm_group_label>Vicryl suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients scheduled for total laparoscopic hysterectomy without other simultaneous&#xD;
             procedures , for benign causes , who were agree to participate in the trial and give&#xD;
             their written consent.&#xD;
&#xD;
          -  Patients ASA (American Society of Anesthesiologists) 1 and 2&#xD;
&#xD;
          -  Patients who are able to communicate by telephone and answer questions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with coagulation disorders, chronic use of corticosteroids, COPD (chronic&#xD;
             obstructive pulmonary disease), collagen diseases, diabetes.&#xD;
&#xD;
          -  Endometriosis III / IV&#xD;
&#xD;
          -  Patients who can not be reached by phone&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CLAUDIA LOPEZ, Gynecologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>CLINICA DEL PRADO</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Claudia Lopez</name>
      <address>
        <city>Medellin</city>
        <state>Antioquia</state>
        <country>Colombia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <results_reference>
    <citation>Cohen SL, Einarsson JI. Total and supracervical hysterectomy. Obstet Gynecol Clin North Am. 2011 Dec;38(4):651-61. doi: 10.1016/j.ogc.2011.09.002.</citation>
    <PMID>22134014</PMID>
  </results_reference>
  <results_reference>
    <citation>Hur HC, Donnellan N, Mansuria S, Barber RE, Guido R, Lee T. Vaginal cuff dehiscence after different modes of hysterectomy. Obstet Gynecol. 2011 Oct;118(4):794-801. doi: 10.1097/AOG.0b013e31822f1c92.</citation>
    <PMID>21934442</PMID>
  </results_reference>
  <results_reference>
    <citation>Ceccaroni M, Berretta R, Malzoni M, Scioscia M, Roviglione G, Spagnolo E, Rolla M, Farina A, Malzoni C, De Iaco P, Minelli L, Bovicelli L. Vaginal cuff dehiscence after hysterectomy: a multicenter retrospective study. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):308-13. doi: 10.1016/j.ejogrb.2011.05.013. Epub 2011 Jul 1.</citation>
    <PMID>21723030</PMID>
  </results_reference>
  <results_reference>
    <citation>Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566.</citation>
    <PMID>21333192</PMID>
  </results_reference>
  <results_reference>
    <citation>Hwang JH, Lee JK, Lee NW, Lee KW. Vaginal cuff closure: a comparison between the vaginal route and laparoscopic suture in patients undergoing total laparoscopic hysterectomy. Gynecol Obstet Invest. 2011;71(3):163-9. doi: 10.1159/000316052. Epub 2010 Dec 14.</citation>
    <PMID>21160140</PMID>
  </results_reference>
  <results_reference>
    <citation>Jeung IC, Baek JM, Park EK, Lee HN, Kim CJ, Park TC, Lee YS. A prospective comparison of vaginal stump suturing techniques during total laparoscopic hysterectomy. Arch Gynecol Obstet. 2010 Dec;282(6):631-8. doi: 10.1007/s00404-009-1300-0. Epub 2009 Nov 27.</citation>
    <PMID>19943055</PMID>
  </results_reference>
  <results_reference>
    <citation>Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002.</citation>
    <PMID>21354068</PMID>
  </results_reference>
  <results_reference>
    <citation>Uccella S, Ghezzi F, Mariani A, Cromi A, Bogani G, Serati M, Bolis P. Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature. Am J Obstet Gynecol. 2011 Aug;205(2):119.e1-12. doi: 10.1016/j.ajog.2011.03.024. Epub 2011 Mar 22.</citation>
    <PMID>21620360</PMID>
  </results_reference>
  <results_reference>
    <citation>Ramirez PT, Klemer DP. Vaginal evisceration after hysterectomy: a literature review. Obstet Gynecol Surv. 2002 Jul;57(7):462-7. doi: 10.1097/00006254-200207000-00023.</citation>
    <PMID>12172223</PMID>
  </results_reference>
  <results_reference>
    <citation>Iaco PD, Ceccaroni M, Alboni C, Roset B, Sansovini M, D'Alessandro L, Pignotti E, Aloysio DD. Transvaginal evisceration after hysterectomy: is vaginal cuff closure associated with a reduced risk? Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):134-8. doi: 10.1016/j.ejogrb.2005.08.009. Epub 2005 Sep 8.</citation>
    <PMID>16154253</PMID>
  </results_reference>
  <results_reference>
    <citation>Croak AJ, Gebhart JB, Klingele CJ, Schroeder G, Lee RA, Podratz KC. Characteristics of patients with vaginal rupture and evisceration. Obstet Gynecol. 2004 Mar;103(3):572-6. doi: 10.1097/01.AOG.0000115507.26155.45.</citation>
    <PMID>14990423</PMID>
  </results_reference>
  <results_reference>
    <citation>Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol. 2009 Nov;114(5):1041-1048. doi: 10.1097/AOG.0b013e3181b9d222.</citation>
    <PMID>20168105</PMID>
  </results_reference>
  <results_reference>
    <citation>Cronin B, Sung VW, Matteson KA. Vaginal cuff dehiscence: risk factors and management. Am J Obstet Gynecol. 2012 Apr;206(4):284-8. doi: 10.1016/j.ajog.2011.08.026. Epub 2011 Aug 27.</citation>
    <PMID>21974989</PMID>
  </results_reference>
  <results_reference>
    <citation>Uccella S, Ceccaroni M, Cromi A, Malzoni M, Berretta R, De Iaco P, Roviglione G, Bogani G, Minelli L, Ghezzi F. Vaginal cuff dehiscence in a series of 12,398 hysterectomies: effect of different types of colpotomy and vaginal closure. Obstet Gynecol. 2012 Sep;120(3):516-23. doi: 10.1097/AOG.0b013e318264f848.</citation>
    <PMID>22914459</PMID>
  </results_reference>
  <results_reference>
    <citation>Chan WS, Kong KK, Nikam YA, Merkur H. Vaginal vault dehiscence after laparoscopic hysterectomy over a nine-year period at Sydney West Advanced Pelvic Surgery Unit - our experiences and current understanding of vaginal vault dehiscence. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):121-7. doi: 10.1111/j.1479-828X.2012.01411.x. Epub 2012 Feb 15.</citation>
    <PMID>22335453</PMID>
  </results_reference>
  <results_reference>
    <citation>Blikkendaal MD, Twijnstra AR, Pacquee SC, Rhemrev JP, Smeets MJ, de Kroon CD, Jansen FW. Vaginal cuff dehiscence in laparoscopic hysterectomy: influence of various suturing methods of the vaginal vault. Gynecol Surg. 2012 Nov;9(4):393-400. doi: 10.1007/s10397-012-0745-5. Epub 2012 May 3.</citation>
    <PMID>23144640</PMID>
  </results_reference>
  <results_reference>
    <citation>ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.</citation>
    <PMID>20168127</PMID>
  </results_reference>
  <results_reference>
    <citation>Hur HC, Guido RS, Mansuria SM, Hacker MR, Sanfilippo JS, Lee TT. Incidence and patient characteristics of vaginal cuff dehiscence after different modes of hysterectomies. J Minim Invasive Gynecol. 2007 May-Jun;14(3):311-7. doi: 10.1016/j.jmig.2006.11.005.</citation>
    <PMID>17478361</PMID>
  </results_reference>
  <results_reference>
    <citation>Kho RM, Akl MN, Cornella JL, Magtibay PM, Wechter ME, Magrina JF. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Aug;114(2 Pt 1):231-235. doi: 10.1097/AOG.0b013e3181af36e3.</citation>
    <PMID>19622982</PMID>
  </results_reference>
  <results_reference>
    <citation>Villa MT, White LE, Alam M, Yoo SS, Walton RL. Barbed sutures: a review of the literature. Plast Reconstr Surg. 2008 Mar;121(3):102e-108e. doi: 10.1097/01.prs.0000299452.24743.65.</citation>
    <PMID>18317092</PMID>
  </results_reference>
  <results_reference>
    <citation>Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.</citation>
    <PMID>21364859</PMID>
  </results_reference>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>February 23, 2017</last_update_submitted>
  <last_update_submitted_qc>February 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>CES University</investigator_affiliation>
    <investigator_full_name>Claudia López</investigator_full_name>
    <investigator_title>Gynecologist</investigator_title>
  </responsible_party>
  <keyword>Laparoscopy</keyword>
  <keyword>Hysterectomy</keyword>
  <keyword>Suture Techniques</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 4, 2018</submitted>
    <returned>February 19, 2019</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/NCT03038945
org study id: 377
nct id: NCT03038945
lead sponsor: 
has dmc: No
Total laparoscopic hysterectomy is a procedure that is performed each time more often. One of
      the problems described for this procedure has to do with the closure of the vaginal vault,
      increased surgical time when suture laparoscopically, complications such as dehiscence of the
      dome, infections, hematomas and dyspareunia. A prospective study will be conducted to compare
      two different techniques for closure of the vaginal vault.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Cuff closure time
time frame: 20 minutes
description: time spend for vaginal Cuff closure (in minutes)
measure: Intra or postoperative complications
time frame: 10 days
description: Clinical follow-up to complications during the surgery and ten days after, through questions and clinical exam.
measure: Dyspareunia
time frame: 12 weeks
description: the visual scale was used to analyze the dyspareunia
arm group label: 2/0 barbed suture
arm group type: Experimental
description: Use barbed suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
arm group label: Vicryl suture
arm group type: Active Comparator
description: Use VICRYL suture for the closure of the vaginal vault in patients with total Laparoscopic hysterectomy caused by a benign gynecologist pathology
intervention type: Other
intervention name: 2/0 barbed suture
description: Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology
arm group label: 2/0 barbed suture
intervention type: Other
intervention name: 0/0 Vicryl suture
description: Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology
arm group label: Vicryl suture
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: CLAUDIA LOPEZ, Gynecologist
role: Principal Investigator
affiliation: CLINICA DEL PRADO
facility: 
country: Colombia
citation: Cohen SL, Einarsson JI. Total and supracervical hysterectomy. Obstet Gynecol Clin North Am. 2011 Dec;38(4):651-61. doi: 10.1016/j.ogc.2011.09.002.
PMID: 22134014
citation: Hur HC, Donnellan N, Mansuria S, Barber RE, Guido R, Lee T. Vaginal cuff dehiscence after different modes of hysterectomy. Obstet Gynecol. 2011 Oct;118(4):794-801. doi: 10.1097/AOG.0b013e31822f1c92.
PMID: 21934442
citation: Ceccaroni M, Berretta R, Malzoni M, Scioscia M, Roviglione G, Spagnolo E, Rolla M, Farina A, Malzoni C, De Iaco P, Minelli L, Bovicelli L. Vaginal cuff dehiscence after hysterectomy: a multicenter retrospective study. Eur J Obstet Gynecol Reprod Biol. 2011 Oct;158(2):308-13. doi: 10.1016/j.ejogrb.2011.05.013. Epub 2011 Jul 1.
PMID: 21723030
citation: Einarsson JI, Vellinga TT, Twijnstra AR, Chavan NR, Suzuki Y, Greenberg JA. Bidirectional barbed suture: an evaluation of safety and clinical outcomes. JSLS. 2010 Jul-Sep;14(3):381-5. doi: 10.4293/108680810X12924466007566.
PMID: 21333192
citation: Hwang JH, Lee JK, Lee NW, Lee KW. Vaginal cuff closure: a comparison between the vaginal route and laparoscopic suture in patients undergoing total laparoscopic hysterectomy. Gynecol Obstet Invest. 2011;71(3):163-9. doi: 10.1159/000316052. Epub 2010 Dec 14.
PMID: 21160140
citation: Jeung IC, Baek JM, Park EK, Lee HN, Kim CJ, Park TC, Lee YS. A prospective comparison of vaginal stump suturing techniques during total laparoscopic hysterectomy. Arch Gynecol Obstet. 2010 Dec;282(6):631-8. doi: 10.1007/s00404-009-1300-0. Epub 2009 Nov 27.
PMID: 19943055
citation: Siedhoff MT, Yunker AC, Steege JF. Decreased incidence of vaginal cuff dehiscence after laparoscopic closure with bidirectional barbed suture. J Minim Invasive Gynecol. 2011 Mar-Apr;18(2):218-23. doi: 10.1016/j.jmig.2011.01.002.
PMID: 21354068
citation: Uccella S, Ghezzi F, Mariani A, Cromi A, Bogani G, Serati M, Bolis P. Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature. Am J Obstet Gynecol. 2011 Aug;205(2):119.e1-12. doi: 10.1016/j.ajog.2011.03.024. Epub 2011 Mar 22.
PMID: 21620360
citation: Ramirez PT, Klemer DP. Vaginal evisceration after hysterectomy: a literature review. Obstet Gynecol Surv. 2002 Jul;57(7):462-7. doi: 10.1097/00006254-200207000-00023.
PMID: 12172223
citation: Iaco PD, Ceccaroni M, Alboni C, Roset B, Sansovini M, D'Alessandro L, Pignotti E, Aloysio DD. Transvaginal evisceration after hysterectomy: is vaginal cuff closure associated with a reduced risk? Eur J Obstet Gynecol Reprod Biol. 2006 Mar 1;125(1):134-8. doi: 10.1016/j.ejogrb.2005.08.009. Epub 2005 Sep 8.
PMID: 16154253
citation: Croak AJ, Gebhart JB, Klingele CJ, Schroeder G, Lee RA, Podratz KC. Characteristics of patients with vaginal rupture and evisceration. Obstet Gynecol. 2004 Mar;103(3):572-6. doi: 10.1097/01.AOG.0000115507.26155.45.
PMID: 14990423
citation: Jacoby VL, Autry A, Jacobson G, Domush R, Nakagawa S, Jacoby A. Nationwide use of laparoscopic hysterectomy compared with abdominal and vaginal approaches. Obstet Gynecol. 2009 Nov;114(5):1041-1048. doi: 10.1097/AOG.0b013e3181b9d222.
PMID: 20168105
citation: Cronin B, Sung VW, Matteson KA. Vaginal cuff dehiscence: risk factors and management. Am J Obstet Gynecol. 2012 Apr;206(4):284-8. doi: 10.1016/j.ajog.2011.08.026. Epub 2011 Aug 27.
PMID: 21974989
citation: Uccella S, Ceccaroni M, Cromi A, Malzoni M, Berretta R, De Iaco P, Roviglione G, Bogani G, Minelli L, Ghezzi F. Vaginal cuff dehiscence in a series of 12,398 hysterectomies: effect of different types of colpotomy and vaginal closure. Obstet Gynecol. 2012 Sep;120(3):516-23. doi: 10.1097/AOG.0b013e318264f848.
PMID: 22914459
citation: Chan WS, Kong KK, Nikam YA, Merkur H. Vaginal vault dehiscence after laparoscopic hysterectomy over a nine-year period at Sydney West Advanced Pelvic Surgery Unit - our experiences and current understanding of vaginal vault dehiscence. Aust N Z J Obstet Gynaecol. 2012 Apr;52(2):121-7. doi: 10.1111/j.1479-828X.2012.01411.x. Epub 2012 Feb 15.
PMID: 22335453
citation: Blikkendaal MD, Twijnstra AR, Pacquee SC, Rhemrev JP, Smeets MJ, de Kroon CD, Jansen FW. Vaginal cuff dehiscence in laparoscopic hysterectomy: influence of various suturing methods of the vaginal vault. Gynecol Surg. 2012 Nov;9(4):393-400. doi: 10.1007/s10397-012-0745-5. Epub 2012 May 3.
PMID: 23144640
citation: ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.
PMID: 20168127
citation: Hur HC, Guido RS, Mansuria SM, Hacker MR, Sanfilippo JS, Lee TT. Incidence and patient characteristics of vaginal cuff dehiscence after different modes of hysterectomies. J Minim Invasive Gynecol. 2007 May-Jun;14(3):311-7. doi: 10.1016/j.jmig.2006.11.005.
PMID: 17478361
citation: Kho RM, Akl MN, Cornella JL, Magtibay PM, Wechter ME, Magrina JF. Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009 Aug;114(2 Pt 1):231-235. doi: 10.1097/AOG.0b013e3181af36e3.
PMID: 19622982
citation: Villa MT, White LE, Alam M, Yoo SS, Walton RL. Barbed sutures: a review of the literature. Plast Reconstr Surg. 2008 Mar;121(3):102e-108e. doi: 10.1097/01.prs.0000299452.24743.65.
PMID: 18317092
citation: Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010 Summer;3(3):82-91.
PMID: 21364859
responsible party type: Principal Investigator
investigator affiliation: CES University
investigator full name: Claudia López
investigator title: Gynecologist
sharing ipd: No
submitted: October 4, 2018
returned: February 19, 2019