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/NCT05969067</url>
    </required_header>
    <id_info>
      <org_study_id>23-0124</org_study_id>
      <nct_id>NCT05969067</nct_id>
    </id_info>
    <brief_title>Retroperitoneal Tunneling Versus Dissection Technique During Sacrocolpopexy</brief_title>
    <official_title>Comparing Retroperitoneal Tunneling Versus Dissection Technique During Robotic Assisted Sacrocolpopexy for Pelvic Organ Prolapse</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Medical Branch, Galveston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas Medical Branch, Galveston</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 purpose of this study is to compare operative time, patient reported outcomes, surgical&#xD;
        complications, and surgical outcomes between the tunneling versus dissection technique during&#xD;
        robotic assisted sacrocolpopexy (RA SCP).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached&#xD;
        to participate. Using the study protocol inclusion and exclusion criteria, patient's&#xD;
        eligibility will be determined. All eligible subjects will provide the written informed&#xD;
        consent before any research data is collected. All screening assessments will be completed at&#xD;
        a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then&#xD;
        undergo randomization to tunneling versus dissection technique during RA SCP with the total&#xD;
        sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary&#xD;
        incontinence are permitted and will be based upon the operating surgeons' standard clinical&#xD;
        practice and best clinical judgement. Subsequently, the subject will have postoperative&#xD;
        follow up at 2 weeks, 6 weeks and 3 months&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">May 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2025</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Operative Time (minutes)</measure>
      <time_frame>Intraoperative time</time_frame>
      <description>Operating time for dissection technique: includes dissection and suturing time. The dissection time starts when the robotic instruments are used to extend the retroperitoneal incision (created during the presacral space dissection) and ends when the extension reaches the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum at the presacral space and ends when the suture is cut after the presacral space, retroperitoneal space and the peritoneum covering the mesh are completely re-approximated.&#xD;
  Operating time for tunneling technique: includes tunneling and suturing time. The tunneling time starts when the robotic instruments are used to undermine the peritoneum and ends when the tunnel is completely created, reaching the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum to close the presacral space and ends when the suture is cut after the peritoneum covering the mesh is completely re-approximated.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>POP-Q exam</measure>
      <time_frame>Baseline, 6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>The POP-Q is staged by using the 9 measurements. The stage can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pelvic Floor Distress Inventory PFDI-20</measure>
      <time_frame>Baseline, 6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pelvic Floor Impact Questionnaire PFIQ-7</measure>
      <time_frame>Baseline, 6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12</measure>
      <time_frame>Baseline, 6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>The total score of the PISQ-12 questionnaire ranges from 0 to 48. The higher the score is, the better the quality of sexual life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Global Impression of Improvement PGI-I</measure>
      <time_frame>Baseline, 6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>Report the patient's response using the response scale from 1-7</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Decision Regret Scale (DRS)</measure>
      <time_frame>6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>A five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Higher scores are worse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with Decision Scale (SDS)</measure>
      <time_frame>6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>Scoring consists of taking the mean of the 6 items (range 1 to 5)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Clavien-Dindo classification for operative complication</measure>
      <time_frame>2 weeks, 6 weeks postoperatively and 12 weeks postoperatively</time_frame>
      <description>The system is used to grade adverse events related to surgical procedures from 1 to 5. Higher grade indicates worse adverse event</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Pelvic Organ Prolapse</condition>
    <arm_group>
      <arm_group_label>Dissection Technique</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The peritoneum is incised superficially and opened longitudinally from the sacral promontory, downward to the posterior cul-de-sac and the posterior vaginal wall to create retroperitoneal space for the SCP mesh.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Tunneling Technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>A retroperitoneal tunnel is created by undermining the peritoneum with the robotic scissors and/or needle driver which is placed in the peritoneal opening over the sacral promontory. The tunnel is created just medial to the right uterosacral ligament and toward the posterior vaginal wall by using forward pressure and a sweeping motion to create a space within the retroperitoneum</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Tunneling Technique during RA SCP</intervention_name>
      <description>As described in the intervention arm above</description>
      <arm_group_label>Tunneling Technique</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dissection Technique during RA SCP</intervention_name>
      <description>As described in the intervention arm above</description>
      <arm_group_label>Dissection Technique</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Females at least 18 years of age at the time of consent.&#xD;
  &#xD;
            2. Able to understand and read English&#xD;
  &#xD;
            3. Able and willing to provide written informed consent&#xD;
  &#xD;
            4. Able to comply with the follow-up study protocol, per clinician judgment&#xD;
  &#xD;
            5. Symptomatic POP (bulge or pressure) evidenced with vaginal prolapse with POP-Q&#xD;
               measurement consistent with Stage II-IV.&#xD;
  &#xD;
            6. RA SCP as desired surgical approach to correct apical prolapse&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Females who are pregnant, or intend to become pregnant during the study&#xD;
  &#xD;
            2. Texas Department of Criminal Justice prisoners&#xD;
  &#xD;
            3. A known history of sensitivity to propylene mesh&#xD;
  &#xD;
            4. Prior prolapse repair surgery using mesh (abdominal, vaginal or rectal)&#xD;
  &#xD;
            5. Active or chronic systemic infection including any pelvic infection, abscess&#xD;
  &#xD;
            6. Has had history of primary pelvic organ cancer (uterine, ovarian, endometrial,&#xD;
               cervical, bladder) or any cancer that is metastatic to the pelvis&#xD;
  &#xD;
            7. Prior or current pelvic radiation, or chemotherapy.&#xD;
  &#xD;
            8. Not a candidate for general anesthesia&#xD;
  &#xD;
            9. History of systemic connective tissue or musculoskeletal disorders (scleroderma, SLE,&#xD;
               Marfan's syndrome, Ehlers Danlos, polymyositis, Lambert Eaton syndrome etc)&#xD;
  &#xD;
           10. History of neurologic condition affecting bladder function (multiple sclerosis, spinal&#xD;
               cord injury, stroke with neurologic deficit)&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gokhan Kilic, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>UTMB</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Trieu H Do, MD</last_name>
      <phone>8326327965</phone>
      <email>trhdo@utmb.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Tayseer Ishag, MD</last_name>
      <phone>8326327965</phone>
      <email>tgishag@utmb.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Texas Medical Branch Galveston</name>
        <address>
          <city>Galveston</city>
          <state>Texas</state>
          <zip>77554</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Trieu H Do, MD</last_name>
        <phone>832-632-7965</phone>
        <email>trhdo@utmb.edu</email>
      </contact>
      <contact_backup>
        <last_name>Tayseer Ishag, MD</last_name>
        <phone>8326327965</phone>
        <email>tgishag@utmb.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Gokhan Kilic, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.</citation>
      <PMID>24807341</PMID>
    </reference>
    <reference>
      <citation>Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.</citation>
      <PMID>20966694</PMID>
    </reference>
    <reference>
      <citation>Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD012376. doi: 10.1002/14651858.CD012376.</citation>
      <PMID>27696355</PMID>
    </reference>
    <reference>
      <citation>Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.</citation>
      <PMID>21979458</PMID>
    </reference>
    <reference>
      <citation>Erekson EA, Yip SO, Ciarleglio MM, Fried TR. Postoperative complications after gynecologic surgery. Obstet Gynecol. 2011 Oct;118(4):785-93. doi: 10.1097/AOG.0b013e31822dac5d.</citation>
      <PMID>21934441</PMID>
    </reference>
    <reference>
      <citation>Kim EK, Applebaum JC, Kravitz ES, Hinkle SN, Koelper NC, Andy UU, Harvie HS. &quot;Every minute counts&quot;: association between operative time and post-operative complications for patients undergoing minimally invasive sacrocolpopexy. Int Urogynecol J. 2023 Jan;34(1):263-270. doi: 10.1007/s00192-022-05412-1. Epub 2022 Nov 23.</citation>
      <PMID>36418567</PMID>
    </reference>
    <reference>
      <citation>Hoshino K, Yoshimura K, Nishimura K, Hachisuga T. How to reduce the operative time of laparoscopic sacrocolpopexy? Gynecol Minim Invasive Ther. 2017 Jan-Mar;6(1):17-19. doi: 10.1016/j.gmit.2016.05.005. Epub 2016 Jul 5.</citation>
      <PMID>30254863</PMID>
    </reference>
    <reference>
      <citation>Guan X, Ma Y, Gisseman J, Kleithermes C, Liu J. Robotic Single-Site Sacrocolpopexy Using Barbed Suture Anchoring and Peritoneal Tunneling Technique: Tips and Tricks. J Minim Invasive Gynecol. 2017 Jan 1;24(1):12-13. doi: 10.1016/j.jmig.2016.06.012. Epub 2016 Jun 23.</citation>
      <PMID>27344033</PMID>
    </reference>
    <reference>
      <citation>Liu J, Bardawil E, Zurawin RK, Wu J, Fu H, Orejuela F, Guan X. Robotic Single-Site Sacrocolpopexy with Retroperitoneal Tunneling. JSLS. 2018 Jul-Sep;22(3):e2018.00009. doi: 10.4293/JSLS.2018.00009.</citation>
      <PMID>30356342</PMID>
    </reference>
    <reference>
      <citation>Pushkar DY, Kasyan GR, Popov AA. Robotic sacrocolpopexy in pelvic organ prolapse: a review of current literature. Curr Opin Urol. 2021 Nov 1;31(6):531-536. doi: 10.1097/MOU.0000000000000932.</citation>
      <PMID>34506336</PMID>
    </reference>
    <reference>
      <citation>Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.</citation>
      <PMID>31589864</PMID>
    </reference>
    <reference>
      <citation>Halder GE, White AB, Brown HW, Caldwell L, Wright ML, Giles DL, Heisler CA, Bilagi D, Rogers RG. A telehealth intervention to increase patient preparedness for surgery: a randomized trial. Int Urogynecol J. 2022 Jan;33(1):85-93. doi: 10.1007/s00192-021-04831-w. Epub 2021 May 24.</citation>
      <PMID>34028575</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Pelvic organ prolapse</keyword>
    <keyword>Sacrocolpopexy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prolapse</mesh_term>
      <mesh_term>Pelvic Organ Prolapse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>There is no plan to share IPD with other researchers</ipd_description>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 13, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT05969067/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05969067
  org study id: 23-0124
  nct id: NCT05969067
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare operative time, patient reported outcomes, surgical
        complications, and surgical outcomes between the tunneling versus dissection technique during
        robotic assisted sacrocolpopexy (RA SCP).
  Women with symptomatic, stage II to IV POP who plan RA SCP at UTMB Health will be approached
        to participate. Using the study protocol inclusion and exclusion criteria, patient's
        eligibility will be determined. All eligible subjects will provide the written informed
        consent before any research data is collected. All screening assessments will be completed at
        a preoperative, in-person, clinic visit, and within 60 days of surgery. The subject will then
        undergo randomization to tunneling versus dissection technique during RA SCP with the total
        sample size of 40 female subjects (20 per group). Concomitant procedures for POP or urinary
        incontinence are permitted and will be based upon the operating surgeons' standard clinical
        practice and best clinical judgement. Subsequently, the subject will have postoperative
        follow up at 2 weeks, 6 weeks and 3 months
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: Operative Time (minutes)
  time frame: Intraoperative time
  description: Operating time for dissection technique: includes dissection and suturing time. The dissection time starts when the robotic instruments are used to extend the retroperitoneal incision (created during the presacral space dissection) and ends when the extension reaches the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum at the presacral space and ends when the suture is cut after the presacral space, retroperitoneal space and the peritoneum covering the mesh are completely re-approximated.
  Operating time for tunneling technique: includes tunneling and suturing time. The tunneling time starts when the robotic instruments are used to undermine the peritoneum and ends when the tunnel is completely created, reaching the posterior vaginal wall. The suturing time starts when the needle enters the peritoneum to close the presacral space and ends when the suture is cut after the peritoneum covering the mesh is completely re-approximated.
  measure: POP-Q exam
  time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
  description: The POP-Q is staged by using the 9 measurements. The stage can range from good support (no organ descent) reported as a POP-Q stage 0 or I to a POP-Q score of IV (complete procidentia or vault eversion)
  measure: Pelvic Floor Distress Inventory PFDI-20
  time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
  description: The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
  measure: Pelvic Floor Impact Questionnaire PFIQ-7
  time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
  description: The questionnaire is scored from 0-300. Higher scores indicate being worse (more distressing)
  measure: Pelvic Organ Prolapse/ Urinary Incontinence Sexual Questionnaire PISQ-12
  time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
  description: The total score of the PISQ-12 questionnaire ranges from 0 to 48. The higher the score is, the better the quality of sexual life.
  measure: Patient Global Impression of Improvement PGI-I
  time frame: Baseline, 6 weeks postoperatively and 12 weeks postoperatively
  description: Report the patient's response using the response scale from 1-7
  measure: Decision Regret Scale (DRS)
  time frame: 6 weeks postoperatively and 12 weeks postoperatively
  description: A five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree). Higher scores are worse.
  measure: Satisfaction with Decision Scale (SDS)
  time frame: 6 weeks postoperatively and 12 weeks postoperatively
  description: Scoring consists of taking the mean of the 6 items (range 1 to 5)
  measure: Clavien-Dindo classification for operative complication
  time frame: 2 weeks, 6 weeks postoperatively and 12 weeks postoperatively
  description: The system is used to grade adverse events related to surgical procedures from 1 to 5. Higher grade indicates worse adverse event
  arm group label: Dissection Technique
  arm group type: Placebo Comparator
  description: The peritoneum is incised superficially and opened longitudinally from the sacral promontory, downward to the posterior cul-de-sac and the posterior vaginal wall to create retroperitoneal space for the SCP mesh.
  arm group label: Tunneling Technique
  arm group type: Experimental
  description: A retroperitoneal tunnel is created by undermining the peritoneum with the robotic scissors and/or needle driver which is placed in the peritoneal opening over the sacral promontory. The tunnel is created just medial to the right uterosacral ligament and toward the posterior vaginal wall by using forward pressure and a sweeping motion to create a space within the retroperitoneum
  intervention type: Procedure
  intervention name: Tunneling Technique during RA SCP
  description: As described in the intervention arm above
  arm group label: Tunneling Technique
  intervention type: Procedure
  intervention name: Dissection Technique during RA SCP
  description: As described in the intervention arm above
  arm group label: Dissection Technique
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gokhan Kilic, MD
  role: Principal Investigator
  affiliation: UTMB
  last name: Trieu H Do, MD
  phone: 8326327965
  email: trhdo@utmb.edu
  last name: Tayseer Ishag, MD
  phone: 8326327965
  email: tgishag@utmb.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  citation: Wu JM, Matthews CA, Conover MM, Pate V, Jonsson Funk M. Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery. Obstet Gynecol. 2014 Jun;123(6):1201-1206. doi: 10.1097/AOG.0000000000000286.
  PMID: 24807341
  citation: Smith FJ, Holman CD, Moorin RE, Tsokos N. Lifetime risk of undergoing surgery for pelvic organ prolapse. Obstet Gynecol. 2010 Nov;116(5):1096-100. doi: 10.1097/AOG.0b013e3181f73729.
  PMID: 20966694
  citation: Maher C, Feiner B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women with apical vaginal prolapse. Cochrane Database Syst Rev. 2016 Oct 1;10(10):CD012376. doi: 10.1002/14651858.CD012376.
  PMID: 27696355
  citation: Paraiso MFR, Jelovsek JE, Frick A, Chen CCG, Barber MD. Laparoscopic compared with robotic sacrocolpopexy for vaginal prolapse: a randomized controlled trial. Obstet Gynecol. 2011 Nov;118(5):1005-1013. doi: 10.1097/AOG.0b013e318231537c.
  PMID: 21979458
  citation: Erekson EA, Yip SO, Ciarleglio MM, Fried TR. Postoperative complications after gynecologic surgery. Obstet Gynecol. 2011 Oct;118(4):785-93. doi: 10.1097/AOG.0b013e31822dac5d.
  PMID: 21934441
  citation: Kim EK, Applebaum JC, Kravitz ES, Hinkle SN, Koelper NC, Andy UU, Harvie HS. "Every minute counts": association between operative time and post-operative complications for patients undergoing minimally invasive sacrocolpopexy. Int Urogynecol J. 2023 Jan;34(1):263-270. doi: 10.1007/s00192-022-05412-1. Epub 2022 Nov 23.
  PMID: 36418567
  citation: Hoshino K, Yoshimura K, Nishimura K, Hachisuga T. How to reduce the operative time of laparoscopic sacrocolpopexy? Gynecol Minim Invasive Ther. 2017 Jan-Mar;6(1):17-19. doi: 10.1016/j.gmit.2016.05.005. Epub 2016 Jul 5.
  PMID: 30254863
  citation: Guan X, Ma Y, Gisseman J, Kleithermes C, Liu J. Robotic Single-Site Sacrocolpopexy Using Barbed Suture Anchoring and Peritoneal Tunneling Technique: Tips and Tricks. J Minim Invasive Gynecol. 2017 Jan 1;24(1):12-13. doi: 10.1016/j.jmig.2016.06.012. Epub 2016 Jun 23.
  PMID: 27344033
  citation: Liu J, Bardawil E, Zurawin RK, Wu J, Fu H, Orejuela F, Guan X. Robotic Single-Site Sacrocolpopexy with Retroperitoneal Tunneling. JSLS. 2018 Jul-Sep;22(3):e2018.00009. doi: 10.4293/JSLS.2018.00009.
  PMID: 30356342
  citation: Pushkar DY, Kasyan GR, Popov AA. Robotic sacrocolpopexy in pelvic organ prolapse: a review of current literature. Curr Opin Urol. 2021 Nov 1;31(6):531-536. doi: 10.1097/MOU.0000000000000932.
  PMID: 34506336
  citation: Matanes E, Boulus S, Lauterbach R, Amit A, Weiner Z, Lowenstein L. Robotic laparoendoscopic single-site compared with robotic multi-port sacrocolpopexy for apical compartment prolapse. Am J Obstet Gynecol. 2020 Apr;222(4):358.e1-358.e11. doi: 10.1016/j.ajog.2019.09.048. Epub 2019 Oct 4.
  PMID: 31589864
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  PMID: 34028575
  responsible party type: Sponsor
  mesh term: Prolapse
  mesh term: Pelvic Organ Prolapse
  sharing ipd: No
  ipd description: There is no plan to share IPD with other researchers
  provided document: 