xml: <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/NCT06024109</url>
    </required_header>
    <id_info>
      <org_study_id>AAG-O-H-2001</org_study_id>
      <nct_id>NCT06024109</nct_id>
    </id_info>
    <brief_title>Observational Study on the Performance of SYMMCORA® vs. V-Loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy</brief_title>
    <acronym>BARHYSTER</acronym>
    <official_title>Prospective, International, Randomized, Multicentric, Controlled Study on the Performance of SYMMCORA® Mid-term Unidirectional Barbed Suture Versus V-loc® Suture Material in Patients Undergoing Laparoscopic Total Hysterectomy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aesculap AG</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>B.Braun Surgical SA</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Aesculap AG</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 aim of this study is to show the superiority of the new unidirectional barbed suture&#xD;
        (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to&#xD;
        perform the vaginal cuff closure during gynecologic surgeries without an increase in the&#xD;
        complication rate.&#xD;
  &#xD;
        Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®,&#xD;
        unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study&#xD;
        will be performed in routine clinical setting, the only difference will be the randomization&#xD;
        into two different suture groups. Both suture materials which will be applied to approximate&#xD;
        the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be&#xD;
        applied in their intended use. Neither additional invasive measures nor additional burden in&#xD;
        regard to the patient will be performed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Suturing time to close the vaginal cuff</measure>
      <time_frame>intraoperatively</time_frame>
      <description>Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of patients with early complications</measure>
      <time_frame>at discharge (up to 10 days after surgery)</time_frame>
      <description>Documented early complications include Hemoglobin drop and Fever more than 38°C within 48 hours</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with complications over the study period</measure>
      <time_frame>at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively</time_frame>
      <description>Documented complications include Vaginal cuff infection, Vaginal cuff dehiscence (Defined as a visually confirmed partial or complete opening of the vaginal stump with or without visceral organ herniation), Vaginal cuff granulation formation, Pelvic Abscess Formation, Hematoma, Vaginal spotting (defined as bloody vaginal discharge that did not require extraordinary procedures or medication and disappeared spontaneously. (Days of postoperative bleeding, Number of pads / tampons used), Vaginal bleeding (Defined as postoperative vaginal stump bleeding that required additional stump suture to stop bleeding. (Days of postoperative bleeding, number of pads / tampons used), Urinary tract infection, Bladder injury, Ureter injury, Bowel obstruction, Ileus, Cystitis and Pelvic Adhesions.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of patients with device deficiencies over the study period</measure>
      <time_frame>intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively</time_frame>
      <description>Documented device deficiencies include Suture rupture, Knots in the thread, Connection between needle and thread not intact and Disconnection of the anchor from the thread</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction (VAS 0-100) over time</measure>
      <time_frame>at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively</time_frame>
      <description>The patient's self assessment of her satisfaction with the surgery. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states &quot;0&quot; at one end representing &quot;low&quot; and &quot;100&quot; at the opposite end representing &quot;high&quot;. The value is measured in [mm] with a ruler and documented in whole numbers.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progress of Female Sexual Function Index (FSFI) compared to baseline</measure>
      <time_frame>Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively</time_frame>
      <description>The Female Sexual Function Index (FSFI) is a 19-item, self-report measure of female sexual function that provides scores on overall levels of sexual function as well as the primary components of sexual function in women, including sexual desire, arousal, orgasm, pain, and satisfaction. The 19 items of the FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. (0 points in some cases for items that are not applicable). To score the measure, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal and lubrication; 0.4 for orgasm, satisfaction and pain) in order to place all domain totals on a more comparable scale, and then subsequently summed to derive a total FSFI score. The domain scores range from 1.2 - 6, the overall score ranges from 7.2 - 36.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall operation time</measure>
      <time_frame>intraoperatively</time_frame>
      <description>From the first cut to the end of the surgery</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost of treatment</measure>
      <time_frame>at discharge (approximately 10 days after surgery)</time_frame>
      <description>Calculation using the length of hospitalization (days until discharge), suturing time, suture costs and needed transfusions)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of postoperative hospital stay</measure>
      <time_frame>at discharge (approximately 10 days after surgery)</time_frame>
      <description>calculated by subtracting the surgery date from the date of discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progress of Patient's abdominal pain (VAS 0-100) compared to baseline</measure>
      <time_frame>preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively</time_frame>
      <description>The patient's self assessment of her abdominal pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states &quot;0&quot; at one end representing &quot;no pain&quot; and &quot;100&quot; at the opposite end representing &quot;heavy pain&quot;. The value is measured in [mm] with a ruler and documented in whole numbers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progress of Patient's pelvic pain (VAS 0-100) compared to baseline</measure>
      <time_frame>preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively</time_frame>
      <description>The patient's self assessment of her pelvic pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states &quot;0&quot; at one end representing &quot;no pain&quot; and &quot;100&quot; at the opposite end representing &quot;heavy pain&quot;. The value is measured in [mm] with a ruler and documented in whole numbers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progress of Patient's lumbar pain (VAS 0-100) compared to baseline</measure>
      <time_frame>preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively</time_frame>
      <description>The patient's self assessment of her lumbar pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states &quot;0&quot; at one end representing &quot;no pain&quot; and &quot;100&quot; at the opposite end representing &quot;heavy pain&quot;. The value is measured in [mm] with a ruler and documented in whole numbers</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progress of General Health Status compared to baseline</measure>
      <time_frame>preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively</time_frame>
      <description>The patient's self assessment of her general health status. Health status is based on assessment of the patient to the question, &quot;Would you say your health in general is...:&quot; The options are excellent / very good / good / fair / poor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient assessment of postoperative Dyspareunia</measure>
      <time_frame>at both follow-up visits (6-8 weeks postoperatively and 6 months postoperatively)</time_frame>
      <description>Dyspareunia is defined by genital pain that can be experienced before, during, or after intercourse. The patient answers with yes or no.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the handling of the barbed suture (SYMMCORA®)</measure>
      <time_frame>intraoperatively</time_frame>
      <description>Assessment of the handling of the unidirectional barbed suture (SYMMCORA®) intra-operatively including eleven different dimensions (pliability, Pass-through, traumaticity, anchoring capacity, safety of closure, locking system size, locking system deployment, locking system unbarbed area, locking system safety of closure, atraumaticity, wound closure approximation) and an overall impression with 5 evaluations levels (excellent, very good, good, satisfied, poor).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture</measure>
      <time_frame>intraoperatively</time_frame>
      <description>Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture regarding degree of difficulties and the ease of handling. (Likert Scale: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of the handling of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc)</measure>
      <time_frame>intraoperatively</time_frame>
      <description>Assessment of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc®) regarding smoothness, suppleness, traumaticity of the thread, the handling, the opening of the package and the overall opinion (Likert Scale: worse, equal, better).</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">132</enrollment>
    <condition>Abnormal Uterine Bleeding</condition>
    <condition>Endometriosis</condition>
    <condition>Uterine Prolapse</condition>
    <condition>Uterine Cancer</condition>
    <condition>Ovarian Cancer</condition>
    <condition>Fallopian Tube Cancer</condition>
    <condition>Cervical Cancer</condition>
    <condition>Endometrial Cancer</condition>
    <arm_group>
      <arm_group_label>SYMMCORA®</arm_group_label>
      <description>Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>V-Loc®</arm_group_label>
      <description>Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Closure of the Vaginal Cuff after Total Hysterectomy</intervention_name>
      <description>Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).</description>
      <arm_group_label>SYMMCORA®</arm_group_label>
      <arm_group_label>V-Loc®</arm_group_label>
      <other_name>Suturing</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Female patients undergoing an elective, laparoscopic total hysterectomy&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Females undergoing an elective, laparoscopic total hysterectomy&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Written informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency surgery&#xD;
  &#xD;
            -  Open surgery&#xD;
  &#xD;
            -  Patients undergone immunosuppressive drug treatment within the prior 6 months&#xD;
  &#xD;
            -  Patients with hypersensitivity or allergy to the suture material.&#xD;
  &#xD;
            -  Participation in another clinical study&#xD;
  &#xD;
            -  Non-compliance of patient&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Amadeus Hornemann, Prof. Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Klinikum Sachsenhausen der DGD</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Petra Baumann</last_name>
      <phone>+49746195</phone>
      <phone_ext>1646</phone_ext>
      <email>petra.baumann@aesculap.de</email>
    </overall_contact>
    <location>
      <facility>
        <name>Klinikum Sachsenhausen der DGD</name>
        <address>
          <city>Frankfurt/Main</city>
          <state>Hessen</state>
          <zip>60594</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Amadeus Hornemann, Prof. Dr.</last_name>
      </contact>
      <investigator>
        <last_name>Amadeus Hornemann, Prof. Dr.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Hospital Sant Joan de Déu de Manresa</name>
        <address>
          <city>Manresa</city>
          <state>Barcelona</state>
          <zip>08243</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Lourdes Hinojosa Garcia, Dra.</last_name>
      </contact>
      <investigator>
        <last_name>Lourdes Hinojosa Garcia, Dra.</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Arantxa Monteils Llabenia, Dra.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Barbed Suture</keyword>
    <keyword>Hysterectomy</keyword>
    <keyword>Laparoscopy</keyword>
    <keyword>Minimal Invasive</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial Neoplasms</mesh_term>
      <mesh_term>Fallopian Tube Neoplasms</mesh_term>
      <mesh_term>Uterine Neoplasms</mesh_term>
      <mesh_term>Endometriosis</mesh_term>
      <mesh_term>Uterine Hemorrhage</mesh_term>
      <mesh_term>Uterine Prolapse</mesh_term>
      <mesh_term>Prolapse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024109
  org study id: AAG-O-H-2001
  nct id: NCT06024109
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study is to show the superiority of the new unidirectional barbed suture
        (SYMMCORA® mid-term, unidirectional) to conventional suture material in terms of time to
        perform the vaginal cuff closure during gynecologic surgeries without an increase in the
        complication rate.
  
        Secondly, the superiority of SYMMCORA®, mid-term unidirectional compared to the V-Loc®,
        unidirectional will be assessed regarding the mean time to close the vaginal cuff. The study
        will be performed in routine clinical setting, the only difference will be the randomization
        into two different suture groups. Both suture materials which will be applied to approximate
        the vaginal cuff are approved and carrying the CE-marks. Additionally, both sutures will be
        applied in their intended use. Neither additional invasive measures nor additional burden in
        regard to the patient will be performed.
  observational model: Case-Control
  time perspective: Prospective
  measure: Suturing time to close the vaginal cuff
  time frame: intraoperatively
  description: Measured in Minutes. Time to perform the vaginal cuff closure after laparoscopic total hysterectomy using a stop watch. Time starts when the needle passes the first time the tissue and ends after completion of the wound closure (cut of the needle from the thread).
  measure: Number of patients with early complications
  time frame: at discharge (up to 10 days after surgery)
  description: Documented early complications include Hemoglobin drop and Fever more than 38°C within 48 hours
  measure: Number of patients with complications over the study period
  time frame: at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
  description: Documented complications include Vaginal cuff infection, Vaginal cuff dehiscence (Defined as a visually confirmed partial or complete opening of the vaginal stump with or without visceral organ herniation), Vaginal cuff granulation formation, Pelvic Abscess Formation, Hematoma, Vaginal spotting (defined as bloody vaginal discharge that did not require extraordinary procedures or medication and disappeared spontaneously. (Days of postoperative bleeding, Number of pads / tampons used), Vaginal bleeding (Defined as postoperative vaginal stump bleeding that required additional stump suture to stop bleeding. (Days of postoperative bleeding, number of pads / tampons used), Urinary tract infection, Bladder injury, Ureter injury, Bowel obstruction, Ileus, Cystitis and Pelvic Adhesions.
  measure: Number of patients with device deficiencies over the study period
  time frame: intraoperatively, at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
  description: Documented device deficiencies include Suture rupture, Knots in the thread, Connection between needle and thread not intact and Disconnection of the anchor from the thread
  measure: Patient satisfaction (VAS 0-100) over time
  time frame: at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
  description: The patient's self assessment of her satisfaction with the surgery. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "low" and "100" at the opposite end representing "high". The value is measured in [mm] with a ruler and documented in whole numbers.
  measure: Progress of Female Sexual Function Index (FSFI) compared to baseline
  time frame: Preoperatively (baseline), at follow-up visits 6-8 weeks postoperatively and 6 months postoperatively
  description: The Female Sexual Function Index (FSFI) is a 19-item, self-report measure of female sexual function that provides scores on overall levels of sexual function as well as the primary components of sexual function in women, including sexual desire, arousal, orgasm, pain, and satisfaction. The 19 items of the FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning on the respective item. (0 points in some cases for items that are not applicable). To score the measure, the sum of each domain score is first multiplied by a domain factor ratio (0.6 for desire; 0.3 for arousal and lubrication; 0.4 for orgasm, satisfaction and pain) in order to place all domain totals on a more comparable scale, and then subsequently summed to derive a total FSFI score. The domain scores range from 1.2 - 6, the overall score ranges from 7.2 - 36.
  measure: Overall operation time
  time frame: intraoperatively
  description: From the first cut to the end of the surgery
  measure: Cost of treatment
  time frame: at discharge (approximately 10 days after surgery)
  description: Calculation using the length of hospitalization (days until discharge), suturing time, suture costs and needed transfusions)
  measure: Length of postoperative hospital stay
  time frame: at discharge (approximately 10 days after surgery)
  description: calculated by subtracting the surgery date from the date of discharge
  measure: Progress of Patient's abdominal pain (VAS 0-100) compared to baseline
  time frame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
  description: The patient's self assessment of her abdominal pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in [mm] with a ruler and documented in whole numbers
  measure: Progress of Patient's pelvic pain (VAS 0-100) compared to baseline
  time frame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
  description: The patient's self assessment of her pelvic pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in [mm] with a ruler and documented in whole numbers
  measure: Progress of Patient's lumbar pain (VAS 0-100) compared to baseline
  time frame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
  description: The patient's self assessment of her lumbar pain. This parameter will be noted using the Visual Analogue Scale (VAS), represented by a line 10 cm of length, which states "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain". The value is measured in [mm] with a ruler and documented in whole numbers
  measure: Progress of General Health Status compared to baseline
  time frame: preoperatively (baseline) and at discharge (up to 10 days after surgery), 6-8 weeks postoperatively, 6 months postoperatively
  description: The patient's self assessment of her general health status. Health status is based on assessment of the patient to the question, "Would you say your health in general is...:" The options are excellent / very good / good / fair / poor
  measure: Patient assessment of postoperative Dyspareunia
  time frame: at both follow-up visits (6-8 weeks postoperatively and 6 months postoperatively)
  description: Dyspareunia is defined by genital pain that can be experienced before, during, or after intercourse. The patient answers with yes or no.
  measure: Assessment of the handling of the barbed suture (SYMMCORA®)
  time frame: intraoperatively
  description: Assessment of the handling of the unidirectional barbed suture (SYMMCORA®) intra-operatively including eleven different dimensions (pliability, Pass-through, traumaticity, anchoring capacity, safety of closure, locking system size, locking system deployment, locking system unbarbed area, locking system safety of closure, atraumaticity, wound closure approximation) and an overall impression with 5 evaluations levels (excellent, very good, good, satisfied, poor).
  measure: Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture
  time frame: intraoperatively
  description: Assessment of the handling of the barbed suture (SYMMCORA®) compared to conventional suture regarding degree of difficulties and the ease of handling. (Likert Scale: strongly agree, agree, neither agree nor disagree, disagree, strongly disagree).
  measure: Assessment of the handling of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc)
  time frame: intraoperatively
  description: Assessment of the barbed suture (SYMMCORA®) compared to barbed suture (V-Loc®) regarding smoothness, suppleness, traumaticity of the thread, the handling, the opening of the package and the overall opinion (Likert Scale: worse, equal, better).
  arm group label: SYMMCORA®
  description: Barbed suture SYMMCORA® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
  arm group label: V-Loc®
  description: Barbed suture V-Loc® used for the vaginal cuff closure in female patients undergoing total laparoscopic hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
  intervention type: Device
  intervention name: Closure of the Vaginal Cuff after Total Hysterectomy
  description: Closure of the vaginal cuff in patients undergoing laparoscopic total hysterectomy. The product under investigation and the comparator suture material will be used in routine clinical practice and according to the Instructions for Use (IfU).
  arm group label: SYMMCORA®
  arm group label: V-Loc®
  other name: Suturing
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Amadeus Hornemann, Prof. Dr.
  role: Principal Investigator
  affiliation: Klinikum Sachsenhausen der DGD
  last name: Petra Baumann
  phone: +49746195
  phone ext: 1646
  email: petra.baumann@aesculap.de
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  investigator: 
  country: Germany
  country: Spain
  responsible party type: Sponsor
  mesh term: Endometrial Neoplasms
  mesh term: Fallopian Tube Neoplasms
  mesh term: Uterine Neoplasms
  mesh term: Endometriosis
  mesh term: Uterine Hemorrhage
  mesh term: Uterine Prolapse
  mesh term: Prolapse
  sharing ipd: No