<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/NCT03254056</url>
  </required_header>
  <id_info>
    <org_study_id>ZTB1</org_study_id>
    <nct_id>NCT03254056</nct_id>
  </id_info>
  <brief_title>Fascial Closure Techniques Post-Operative Pain Laparoscopy</brief_title>
  <official_title>The Effects of Fascial Closure Techniques on Post-Operative Pain in Gynecologic Laparoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zekai Tahir Burak Women's Health Research and Education Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zekai Tahir Burak Women's Health Research and Education Hospital</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>
      This study compares post-operative incisional pain on post-operative days 1 and 7 who will&#xD;
      undergo gynecologic laparoscopic operations. Half of participants will undergo conventional&#xD;
      fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl&#xD;
      Storz, Belgium).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy.&#xD;
      The patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who&#xD;
      undergo laparotomy. This point is also one of the advantages of the laparoscopic surgery. The&#xD;
      fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an&#xD;
      important issue. Incisional hernias may occur after laparoscopic surgery. The surgeons prefer&#xD;
      the techniques in fascial closure which is more safe and cause less pain. In current study,&#xD;
      investigators aim to compare the post-operative incisional pain in two different techniques&#xD;
      in gynecologic laparoscopic surgery; conventional versus by 'Berci Fascial Closure'.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 3, 2017</start_date>
  <completion_date type="Actual">June 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 2018</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>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative incisional pain</measure>
    <time_frame>24 hours after fascial closure closure</time_frame>
    <description>Visual Analog Scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Post-operative incisional pain</measure>
    <time_frame>7 days after fascial closure closure</time_frame>
    <description>Visual Analog Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time for fascial closure</measure>
    <time_frame>Intraoperative</time_frame>
    <description>Minutes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Post-operative Pain</condition>
  <condition>Fascial Closure</condition>
  <arm_group>
    <arm_group_label>Conventional Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The edges of the fascia will be hold by the surgical instruments. The fascial defect will be repaired by using devices which are generated for laparotomy operations.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Berci Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional technique</intervention_name>
    <description>Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.</description>
    <arm_group_label>Conventional Technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Berci technique</intervention_name>
    <description>Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.</description>
    <arm_group_label>Berci Technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-65 years&#xD;
&#xD;
          2. Ability to understand the inform consent&#xD;
&#xD;
          3. No conversion from laparoscopy to laparotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No-ability to understand the inform consent&#xD;
&#xD;
          2. Conversion to laparotomy from laparoscopy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yaprak Üstün, Prof</last_name>
    <role>Study Chair</role>
    <affiliation>University of Health Sciences, Zekai Tahir Burak Women's Health Health Research and Practice Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zekai Tahir Burak Women Health Education and Research Hospital</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Lyapis A, Ulrich A, LaMonica R, Kuo CL, Kaye L, Luciano D. Does the Difference in Fascial Closure Technique Affect Postoperative Pain? J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1190-1194. doi: 10.1016/j.jmig.2017.07.020. Epub 2017 Jul 27.</citation>
    <PMID>28757438</PMID>
  </results_reference>
  <results_reference>
    <citation>Williams CP, Rosen MJ, Jin J, McGee MF, Schomisch SJ, Ponsky J. Objective analysis of the accuracy and efficacy of a novel fascial closure device. Surg Innov. 2008 Dec;15(4):307-11. doi: 10.1177/1553350608327168.</citation>
    <PMID>19036733</PMID>
  </results_reference>
  <results_reference>
    <citation>Elashry OM, Nakada SY, Wolf JS Jr, Figenshau RS, McDougall EM, Clayman RV. Comparative clinical study of port-closure techniques following laparoscopic surgery. J Am Coll Surg. 1996 Oct;183(4):335-44.</citation>
    <PMID>8843262</PMID>
  </results_reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>June 25, 2018</last_update_submitted>
  <last_update_submitted_qc>June 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zekai Tahir Burak Women's Health Research and Education Hospital</investigator_affiliation>
    <investigator_full_name>Hasan Onur Topçu</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>fascial closure device</keyword>
  <keyword>laparoscopic surgery</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03254056
org study id: ZTB1
nct id: NCT03254056
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study compares post-operative incisional pain on post-operative days 1 and 7 who will
      undergo gynecologic laparoscopic operations. Half of participants will undergo conventional
      fascial closure, while the other will undergo fascial closure by Berci Fascial Closure (Karl
      Storz, Belgium).
Studies have demonstrated that laparoscopic surgery has numerous advantages over laparotomy.
      The patients who undergo laparoscopic surgery acquired fewer doses of analgesics than who
      undergo laparotomy. This point is also one of the advantages of the laparoscopic surgery. The
      fascia closure in fascial defects larger than 10 mm diameters in laparoscopic surgery is an
      important issue. Incisional hernias may occur after laparoscopic surgery. The surgeons prefer
      the techniques in fascial closure which is more safe and cause less pain. In current study,
      investigators aim to compare the post-operative incisional pain in two different techniques
      in gynecologic laparoscopic surgery; conventional versus by 'Berci Fascial Closure'.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Post-operative incisional pain
time frame: 24 hours after fascial closure closure
description: Visual Analog Scale
measure: Post-operative incisional pain
time frame: 7 days after fascial closure closure
description: Visual Analog Scale
measure: Time for fascial closure
time frame: Intraoperative
description: Minutes
arm group label: Conventional Technique
arm group type: Active Comparator
description: The edges of the fascia will be hold by the surgical instruments. The fascial defect will be repaired by using devices which are generated for laparotomy operations.
arm group label: Berci Technique
arm group type: Active Comparator
description: This instrument facilitates full thickness abdominal wall closure under the view of laparoscopic optic.
intervention type: Procedure
intervention name: Conventional technique
description: Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.
arm group label: Conventional Technique
intervention type: Procedure
intervention name: Berci technique
description: Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.
arm group label: Berci Technique
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yaprak Üstün, Prof
role: Study Chair
affiliation: University of Health Sciences, Zekai Tahir Burak Women's Health Health Research and Practice Center
facility: 
country: Turkey
citation: Lyapis A, Ulrich A, LaMonica R, Kuo CL, Kaye L, Luciano D. Does the Difference in Fascial Closure Technique Affect Postoperative Pain? J Minim Invasive Gynecol. 2017 Nov-Dec;24(7):1190-1194. doi: 10.1016/j.jmig.2017.07.020. Epub 2017 Jul 27.
PMID: 28757438
citation: Williams CP, Rosen MJ, Jin J, McGee MF, Schomisch SJ, Ponsky J. Objective analysis of the accuracy and efficacy of a novel fascial closure device. Surg Innov. 2008 Dec;15(4):307-11. doi: 10.1177/1553350608327168.
PMID: 19036733
citation: Elashry OM, Nakada SY, Wolf JS Jr, Figenshau RS, McDougall EM, Clayman RV. Comparative clinical study of port-closure techniques following laparoscopic surgery. J Am Coll Surg. 1996 Oct;183(4):335-44.
PMID: 8843262
responsible party type: Principal Investigator
investigator affiliation: Zekai Tahir Burak Women's Health Research and Education Hospital
investigator full name: Hasan Onur Topçu
investigator title: Associate Professor
mesh term: Pain, Postoperative
sharing ipd: No