<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/NCT02998658</url>
  </required_header>
  <id_info>
    <org_study_id>Barbed/vaginal cuff</org_study_id>
    <nct_id>NCT02998658</nct_id>
  </id_info>
  <brief_title>Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy</brief_title>
  <official_title>Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to estimate whether the use of the barbed suture facilitates&#xD;
      laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vaginal cuff suturing is a significant step during hysterectomy with regard to operating time&#xD;
      and a critical passage for the risk of vaginal cuff dehiscence. Vaginal cuff dehiscence is a&#xD;
      severe adverse event and occurs more frequently after total laparoscopic hysterectomy&#xD;
      (0.3-3.1 %) compared to abdominal and vaginal hysterectomy&#xD;
&#xD;
      Barbed suture is a new type of sutures introduced to facilitate laparoscopic suturing.When&#xD;
      compared with conventional smooth suture, barbed suture has external barbs that anchor the&#xD;
      suture to the tissues and prevent the retrograde movement of suture thread during suturing.&#xD;
      Consequently, laparoscopic suturing can be performed easily without the need for suture&#xD;
      locking, without applying traction on suture thread by the assistant and without tying knots&#xD;
      at both ends of the suture line In gynecology, barbed sutures have been used in minimally&#xD;
      invasive ,myomectomy hysterectomy, ovarian cystectomy and sacrocolpopexy. There is a growing&#xD;
      body of evidence that the use of barbed sutures in these procedures facilitates laparoscopic&#xD;
      suturing and significantly reduces suturing time, total operating time and intraoperative&#xD;
      blood loss To date only two small randomized controlled trials compared the effectiveness of&#xD;
      the bidirectional knotless barbed suture versus standard suture in the repair of vaginal cuff&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">February 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Phase 2</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>Suturing time of vaginal cuff</measure>
    <time_frame>During hysterectomy operation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>During hysterectomy operation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">54</enrollment>
  <condition>Hysterectomy</condition>
  <arm_group>
    <arm_group_label>Vaginal cuff closure using barbed sutures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vaginal cuff is closed with barbed sutures</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaginal cuff closure using conventional sutures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vaginal cuff is closed with conventional sutures</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vaginal cuff closure using barbed sutures</intervention_name>
    <description>Vaginal cuff will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA )</description>
    <arm_group_label>Vaginal cuff closure using barbed sutures</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vaginal cuff closure using conventional sutures</intervention_name>
    <description>Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .</description>
    <arm_group_label>Vaginal cuff closure using conventional sutures</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure&#xD;
             symptoms)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Genital malignancy&#xD;
&#xD;
          -  Uterine size more than 16 weeks&#xD;
&#xD;
          -  Coagulation defects or concurrent anticoagulant therapy&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Compromised cardiopulmonary status&#xD;
&#xD;
          -  Contraindications for general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Usama M Fouda, Prof.</last_name>
    <role>Study Director</role>
    <affiliation>Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khaled A Elsetohy,, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Usama M Fouda, Prof.</last_name>
    <email>umfrfouda@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Khaled A Elsetohy,, Prof.</last_name>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cairo university</name>
      <address>
        <city>Caene</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Usama M. Fouda, Prof.</last_name>
      <email>umfrfouda@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Einarsson JI, Cohen SL, Gobern JM, Sandberg EM, Hill-Lydecker CI, Wang K, Brown DN. Barbed versus standard suture: a randomized trial for laparoscopic vaginal cuff closure. J Minim Invasive Gynecol. 2013 Jul-Aug;20(4):492-8. doi: 10.1016/j.jmig.2013.02.015. Epub 2013 May 14.</citation>
    <PMID>23680517</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 19, 2016</last_update_submitted>
  <last_update_submitted_qc>December 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Usama M Fouda</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Laparoscopy</keyword>
  <keyword>Barbed sutures</keyword>
  <keyword>Hysterectomy</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02998658
org study id: Barbed/vaginal cuff
nct id: NCT02998658
lead sponsor: 
has dmc: Yes
The aim of this study is to estimate whether the use of the barbed suture facilitates
      laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.
Vaginal cuff suturing is a significant step during hysterectomy with regard to operating time
      and a critical passage for the risk of vaginal cuff dehiscence. Vaginal cuff dehiscence is a
      severe adverse event and occurs more frequently after total laparoscopic hysterectomy
      (0.3-3.1 %) compared to abdominal and vaginal hysterectomy

      Barbed suture is a new type of sutures introduced to facilitate laparoscopic suturing.When
      compared with conventional smooth suture, barbed suture has external barbs that anchor the
      suture to the tissues and prevent the retrograde movement of suture thread during suturing.
      Consequently, laparoscopic suturing can be performed easily without the need for suture
      locking, without applying traction on suture thread by the assistant and without tying knots
      at both ends of the suture line In gynecology, barbed sutures have been used in minimally
      invasive ,myomectomy hysterectomy, ovarian cystectomy and sacrocolpopexy. There is a growing
      body of evidence that the use of barbed sutures in these procedures facilitates laparoscopic
      suturing and significantly reduces suturing time, total operating time and intraoperative
      blood loss To date only two small randomized controlled trials compared the effectiveness of
      the bidirectional knotless barbed suture versus standard suture in the repair of vaginal cuff
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Suturing time of vaginal cuff
time frame: During hysterectomy operation
measure: Operative time
time frame: During hysterectomy operation
arm group label: Vaginal cuff closure using barbed sutures
arm group type: Experimental
description: Vaginal cuff is closed with barbed sutures
arm group label: Vaginal cuff closure using conventional sutures
arm group type: Active Comparator
description: Vaginal cuff is closed with conventional sutures
intervention type: Device
intervention name: Vaginal cuff closure using barbed sutures
description: Vaginal cuff will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA )
arm group label: Vaginal cuff closure using barbed sutures
intervention type: Device
intervention name: Vaginal cuff closure using conventional sutures
description: Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .
arm group label: Vaginal cuff closure using conventional sutures
criteria: 
gender: Female
minimum age: 30 Years
maximum age: 70 Years
healthy volunteers: No
last name: Usama M Fouda, Prof.
role: Study Director
affiliation: Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
last name: Khaled A Elsetohy,, Prof.
role: Principal Investigator
affiliation: Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department
last name: Usama M Fouda, Prof.
email: umfrfouda@yahoo.com
last name: Khaled A Elsetohy,, Prof.
facility: 
contact: 
country: Egypt
citation: Einarsson JI, Cohen SL, Gobern JM, Sandberg EM, Hill-Lydecker CI, Wang K, Brown DN. Barbed versus standard suture: a randomized trial for laparoscopic vaginal cuff closure. J Minim Invasive Gynecol. 2013 Jul-Aug;20(4):492-8. doi: 10.1016/j.jmig.2013.02.015. Epub 2013 May 14.
PMID: 23680517
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Usama M Fouda
investigator title: Prof.
sharing ipd: No