<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/NCT04434066</url>
  </required_header>
  <id_info>
    <org_study_id>STU-2019-1402</org_study_id>
    <nct_id>NCT04434066</nct_id>
  </id_info>
  <brief_title>Outcomes on Abdominal Versus Vaginal Morcellation At Time of Hysterectomy</brief_title>
  <official_title>A Comparison of Perioperative and Patient-Centered Outcomes With Abdominal Versus Vaginal Morcellation: A Randomized-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of the study is to investigate differences in perioperative and postoperative&#xD;
      outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in&#xD;
      participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the proposed study is to investigate differences in intraoperative and&#xD;
      postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained&#xD;
      morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized&#xD;
      surgical trial.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. To evaluate differences in total operating time between subjects undergoing AM compared&#xD;
           to VM.&#xD;
&#xD;
        2. To evaluate differences in morcellation time between AM and VM.&#xD;
&#xD;
        3. To evaluate differences in the amount of total narcotic use during hospital admission&#xD;
           between AM and VM through morphine milligram equivalents (MME).&#xD;
&#xD;
        4. To evaluate differences in the patient's subjective pain assessment via Visual Analogue&#xD;
           Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM&#xD;
           and VM groups.&#xD;
&#xD;
        5. To evaluate differences in the patient's pain medication usage as reported by the&#xD;
           patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM&#xD;
           groups.&#xD;
&#xD;
        6. To evaluate differences in body image survey (BIS) scores at enrollment and 6-week&#xD;
           postoperative visit between the AM group compared to VM group.&#xD;
&#xD;
        7. To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week&#xD;
           postoperative visit between the AM group compared to VM group.&#xD;
&#xD;
        8. To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at&#xD;
           24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 8, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2023</completion_date>
  <primary_completion_date type="Actual">July 19, 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>Mean difference in total operating room time</measure>
    <time_frame>intraoperative</time_frame>
    <description>Total operating room time is defined as skin incision to skin closure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively</measure>
    <time_frame>through study completion up to 6-weeks post-operatively</time_frame>
    <description>Body Image Scale will be collected at baseline, and 6-weeks post-operatively. Body Image Scale will be scored from 10 to 40 points maximum, with higher scores referring to being &quot;very dissatisfied&quot; with overall body image</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively</measure>
    <time_frame>through study completion up to 6-weeks post-operatively</time_frame>
    <description>Pain Visual Analogue Scale will be collected at baseline, and 6-weeks post-operatively. VAS scale will be measured from 0 to 10mm, with higher scores referring to more pain experienced</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively</measure>
    <time_frame>through study completion up to 6-weeks post-operatively</time_frame>
    <description>Quality of Recovery will be collected at baseline, 24-hours, and 2-weeks post-operatively. Quality of Recovery will be scored from 10 to 100, with higher scores referring to better quality of recovery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively</measure>
    <time_frame>through study completion up to 6-weeks post-operatively</time_frame>
    <description>Quality of Life Scores will be collected at baseline, and 6-weeks post-operatively. The Quality of Life Score will be scored from 11 to 44, with higher scores referring to better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morcellation Time</measure>
    <time_frame>intraoperative</time_frame>
    <description>Defined as specimen bag introduction to specimen bag removal</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Post-Operative Complications</measure>
    <time_frame>through study completion up to 6-weeks post-operatively</time_frame>
    <description>Post-operative complications will be collected including: readmission to the hospital or emergency room, number of visits seen in the clinic, diagnoses of infection, bleeding, blood transfusions, surgery-related injuries, reoperations, and overall mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation</measure>
    <time_frame>after surgery to 2-weeks post-operatively</time_frame>
    <description>The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Abnormal Uterine Bleeding</condition>
  <condition>Uterine Bleeding</condition>
  <condition>Fibroid Uterus</condition>
  <condition>Surgery</condition>
  <arm_group>
    <arm_group_label>Abdominal Morcellation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Abdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Vaginal Morcellation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Total Laparoscopic Hysterectomy</intervention_name>
    <description>Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy</description>
    <arm_group_label>Abdominal Morcellation</arm_group_label>
    <arm_group_label>Vaginal Morcellation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All benign total laparoscopic hysterectomy and/or robotic-assisted hysterectomy, +/-&#xD;
             unilateral salpingo-oophorectomy or bilateral salpingo-oophorectomy&#xD;
&#xD;
          -  Adnexectomy, cystectomy, tubal procedures at time of hysterectomy&#xD;
&#xD;
          -  Age &gt;18 years old&#xD;
&#xD;
          -  Uterus &gt;12 weeks, or &gt;250 grams (based on imaging), or requiring morcellation based on&#xD;
             clinical judgment at time of pre-operative enrollment&#xD;
&#xD;
          -  English and Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-malignant conditions (i.e. endometrial intraepithelial neoplasia, high-grade&#xD;
             cervical intraepithelial neoplasia), known gynecologic malignancy, and any&#xD;
             contraindications to abdominal or vaginal morcellation&#xD;
&#xD;
          -  Planned concurrent procedures (i.e. hernia repair, bowel resections, anti-incontinence&#xD;
             procedures, prolapse repair, and mastectomy)&#xD;
&#xD;
          -  Appendectomy for endometriosis is not excluded&#xD;
&#xD;
          -  No chronic pain disorders requiring medical management (endometriosis can be included)&#xD;
&#xD;
          -  Planned abdominal hysterectomy or vaginal hysterectomy candidates&#xD;
&#xD;
          -  Conversion to laparotomy or inability to complete morcellation&#xD;
&#xD;
          -  Contraindications to laparoscopy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>All females</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kimberly A Kho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)</citation>
  </reference>
  <reference>
    <citation>US Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)</citation>
  </reference>
  <reference>
    <citation>Siedhoff MT, Cohen SL. Tissue Extraction Techniques for Leiomyomas and Uteri During Minimally Invasive Surgery. Obstet Gynecol. 2017 Dec;130(6):1251-1260. doi: 10.1097/AOG.0000000000002334.</citation>
    <PMID>29112659</PMID>
  </reference>
  <reference>
    <citation>Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.</citation>
    <PMID>25162248</PMID>
  </reference>
  <reference>
    <citation>Solima E, Scagnelli G, Austoni V, Natale A, Bertulessi C, Busacca M, Vignali M. Vaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1244-6. doi: 10.1016/j.jmig.2015.07.007. Epub 2015 Jul 20.</citation>
    <PMID>26205578</PMID>
  </reference>
  <reference>
    <citation>Moawad GN, Abi KhalIL ED, Opoku-Anane J, Marfori CQ, Harman AC, Fisher S, Levy M, Robinson JK. Comparison of methods of morcellation: manual versus power. Acta Obstet Gynecol Scand. 2016 Jan;95(1):52-4. doi: 10.1111/aogs.12783. Epub 2015 Oct 19.</citation>
    <PMID>26400045</PMID>
  </reference>
  <reference>
    <citation>Meurs EAIM, Brito LG, Ajao MO, Goggins ER, Vitonis AF, Einarsson JI, Cohen SL. Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy. J Minim Invasive Gynecol. 2017 Jul-Aug;24(5):843-849. doi: 10.1016/j.jmig.2017.04.023. Epub 2017 May 5.</citation>
    <PMID>28483536</PMID>
  </reference>
  <reference>
    <citation>Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.</citation>
    <PMID>26801067</PMID>
  </reference>
  <reference>
    <citation>Frasca C, Degli Esposti E, Arena A, Tuzzato G, Moro E, Martelli V, Seracchioli R. Can In-Bag Manual Morcellation Represent an Alternative to Uncontained Power Morcellation in Laparoscopic Myomectomy? A Randomized Controlled Trial. Gynecol Obstet Invest. 2018;83(1):52-56. doi: 10.1159/000477171. Epub 2017 Jun 7.</citation>
    <PMID>28586771</PMID>
  </reference>
  <reference>
    <citation>Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23.</citation>
    <PMID>22704765</PMID>
  </reference>
  <reference>
    <citation>Cohen SL, Clark NV, Ajao MO, Brown DN, Gargiulo AR, Gu X, Einarsson JI. Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach. J Minim Invasive Gynecol. 2019 May-Jun;26(4):702-708. doi: 10.1016/j.jmig.2018.07.020. Epub 2018 Aug 1.</citation>
    <PMID>30075302</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 12, 2023</last_update_submitted>
  <last_update_submitted_qc>January 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Kimberly Kho</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>hysterectomy</keyword>
  <keyword>abnormal uterine bleeding</keyword>
  <keyword>morcellation</keyword>
  <keyword>abdominal</keyword>
  <keyword>vaginal</keyword>
  <keyword>surgery</keyword>
  <keyword>laparoscopic</keyword>
  <keyword>laparoscopy</keyword>
  <keyword>total hysterectomy</keyword>
  <keyword>pelvic pain</keyword>
  <keyword>endometriosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Uterine Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <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/NCT04434066
org study id: STU-2019-1402
nct id: NCT04434066
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to investigate differences in perioperative and postoperative
      outcomes between the abdominal (AM) versus vaginal (VM) routes of contained morcellation in
      participants undergoing laparoscopic total hysterectomies in a randomized controlled trial.
The purpose of the proposed study is to investigate differences in intraoperative and
      postoperative outcomes between the abdominal (AM) versus vaginal (VM) routes of contained
      morcellation in subjects undergoing laparoscopic total hysterectomies in a randomized
      surgical trial.

      Objectives:

        1. To evaluate differences in total operating time between subjects undergoing AM compared
           to VM.

        2. To evaluate differences in morcellation time between AM and VM.

        3. To evaluate differences in the amount of total narcotic use during hospital admission
           between AM and VM through morphine milligram equivalents (MME).

        4. To evaluate differences in the patient's subjective pain assessment via Visual Analogue
           Scale (VAS) before surgery, at 2-weeks, and at 6 week post-operative visits in both AM
           and VM groups.

        5. To evaluate differences in the patient's pain medication usage as reported by the
           patient verbally at 24-hours post-operatively and 2-weeks post surgery between AM and VM
           groups.

        6. To evaluate differences in body image survey (BIS) scores at enrollment and 6-week
           postoperative visit between the AM group compared to VM group.

        7. To evaluate differences in overall Quality of Life (QoL) scores at enrollment and 6-week
           postoperative visit between the AM group compared to VM group.

        8. To evaluate differences in Quality of Recovery (QoR) scores at enrollment and at
           24-hours post-operatively, and then 2-weeks post surgery between AM and VM group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Mean difference in total operating room time
time frame: intraoperative
description: Total operating room time is defined as skin incision to skin closure
measure: Mean difference from baseline in Body Image Scale Score to 6-weeks post-operatively
time frame: through study completion up to 6-weeks post-operatively
description: Body Image Scale will be collected at baseline, and 6-weeks post-operatively. Body Image Scale will be scored from 10 to 40 points maximum, with higher scores referring to being "very dissatisfied" with overall body image
measure: Mean difference from baseline in Pain Visual Analogue Scale to 6-weeks post-operatively
time frame: through study completion up to 6-weeks post-operatively
description: Pain Visual Analogue Scale will be collected at baseline, and 6-weeks post-operatively. VAS scale will be measured from 0 to 10mm, with higher scores referring to more pain experienced
measure: Mean difference from baseline in Quality of Recovery Score to 2-weeks post-operatively
time frame: through study completion up to 6-weeks post-operatively
description: Quality of Recovery will be collected at baseline, 24-hours, and 2-weeks post-operatively. Quality of Recovery will be scored from 10 to 100, with higher scores referring to better quality of recovery
measure: Mean difference from baseline in Quality of Life Score to 6-weeks post-operatively
time frame: through study completion up to 6-weeks post-operatively
description: Quality of Life Scores will be collected at baseline, and 6-weeks post-operatively. The Quality of Life Score will be scored from 11 to 44, with higher scores referring to better quality of life
measure: Morcellation Time
time frame: intraoperative
description: Defined as specimen bag introduction to specimen bag removal
measure: Rates of Post-Operative Complications
time frame: through study completion up to 6-weeks post-operatively
description: Post-operative complications will be collected including: readmission to the hospital or emergency room, number of visits seen in the clinic, diagnoses of infection, bleeding, blood transfusions, surgery-related injuries, reoperations, and overall mortality
measure: Mean difference in the dosages of morphine milligram equivalent (MME) for post-operative pain between abdominal and vaginal morcellation
time frame: after surgery to 2-weeks post-operatively
description: The type and dosages of various narcotics will be recorded between both groups following surgery until 2-weeks post-operatively
arm group label: Abdominal Morcellation
arm group type: Experimental
description: Abdominal morcellation will occur following completion of the hysterectomy. Route of incision will be either suprapubic or umbilical incision - based on surgeon preferences. All steps and instruments have been standardized for abdominal morcellation.
arm group label: Vaginal Morcellation
arm group type: Experimental
description: Vaginal morcellation will occur following completion of the hysterectomy. All steps and instruments have been standardized for vaginal morcellation.
intervention type: Procedure
intervention name: Total Laparoscopic Hysterectomy
description: Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy
arm group label: Abdominal Morcellation
arm group label: Vaginal Morcellation
criteria: 
gender: Female
gender based: Yes
gender description: All females
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kimberly A Kho, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
citation: US Food and Drug Administration. Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
citation: US Food and Drug Administration. Updated Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy. US FDA, Silver Spring, MD; 2014 (FDA Safety Communication)
citation: Siedhoff MT, Cohen SL. Tissue Extraction Techniques for Leiomyomas and Uteri During Minimally Invasive Surgery. Obstet Gynecol. 2017 Dec;130(6):1251-1260. doi: 10.1097/AOG.0000000000002334.
PMID: 29112659
citation: Cohen SL, Einarsson JI, Wang KC, Brown D, Boruta D, Scheib SA, Fader AN, Shibley T. Contained power morcellation within an insufflated isolation bag. Obstet Gynecol. 2014 Sep;124(3):491-497. doi: 10.1097/AOG.0000000000000421.
PMID: 25162248
citation: Solima E, Scagnelli G, Austoni V, Natale A, Bertulessi C, Busacca M, Vignali M. Vaginal Uterine Morcellation Within a Specimen Containment System: A Study of Bag Integrity. J Minim Invasive Gynecol. 2015 Nov-Dec;22(7):1244-6. doi: 10.1016/j.jmig.2015.07.007. Epub 2015 Jul 20.
PMID: 26205578
citation: Moawad GN, Abi KhalIL ED, Opoku-Anane J, Marfori CQ, Harman AC, Fisher S, Levy M, Robinson JK. Comparison of methods of morcellation: manual versus power. Acta Obstet Gynecol Scand. 2016 Jan;95(1):52-4. doi: 10.1111/aogs.12783. Epub 2015 Oct 19.
PMID: 26400045
citation: Meurs EAIM, Brito LG, Ajao MO, Goggins ER, Vitonis AF, Einarsson JI, Cohen SL. Comparison of Morcellation Techniques at the Time of Laparoscopic Hysterectomy and Myomectomy. J Minim Invasive Gynecol. 2017 Jul-Aug;24(5):843-849. doi: 10.1016/j.jmig.2017.04.023. Epub 2017 May 5.
PMID: 28483536
citation: Venturella R, Rocca ML, Lico D, La Ferrera N, Cirillo R, Gizzo S, Morelli M, Zupi E, Zullo F. In-bag manual versus uncontained power morcellation for laparoscopic myomectomy: randomized controlled trial. Fertil Steril. 2016 May;105(5):1369-1376. doi: 10.1016/j.fertnstert.2015.12.133. Epub 2016 Jan 19.
PMID: 26801067
citation: Frasca C, Degli Esposti E, Arena A, Tuzzato G, Moro E, Martelli V, Seracchioli R. Can In-Bag Manual Morcellation Represent an Alternative to Uncontained Power Morcellation in Laparoscopic Myomectomy? A Randomized Controlled Trial. Gynecol Obstet Invest. 2018;83(1):52-56. doi: 10.1159/000477171. Epub 2017 Jun 7.
PMID: 28586771
citation: Ghezzi F, Cromi A, Uccella S, Bogani G, Serati M, Bolis P. Transumbilical versus transvaginal retrieval of surgical specimens at laparoscopy: a randomized trial. Am J Obstet Gynecol. 2012 Aug;207(2):112.e1-6. doi: 10.1016/j.ajog.2012.05.016. Epub 2012 May 23.
PMID: 22704765
citation: Cohen SL, Clark NV, Ajao MO, Brown DN, Gargiulo AR, Gu X, Einarsson JI. Prospective Evaluation of Manual Morcellation Techniques: Minilaparotomy versus Vaginal Approach. J Minim Invasive Gynecol. 2019 May-Jun;26(4):702-708. doi: 10.1016/j.jmig.2018.07.020. Epub 2018 Aug 1.
PMID: 30075302
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Kimberly Kho
investigator title: Associate Professor
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Uterine Hemorrhage
mesh term: Hemorrhage
sharing ipd: No