<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/NCT04483986</url>
  </required_header>
  <id_info>
    <org_study_id>Rectus-reapproximation</org_study_id>
    <nct_id>NCT04483986</nct_id>
  </id_info>
  <brief_title>Does Rectus Re-approximation Cause Adhesion After Cesarean Section?</brief_title>
  <official_title>The Evaluation of Rectus Re-approximation in Terms of Adhesion After Cesarean Section by Elastography.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Giresun University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Giresun University</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>
      Rectus re-approximation and periton closure are not the obligatory steps during cesarean&#xD;
      section. These steps are due to surgeon's preference. However, there is lack of knowledge&#xD;
      about the relation of rectus muscle re-approximation and adhesion formation. We are going to&#xD;
      study the rectus muscle stiffness by share-wave elastosonography.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">September 25, 2021</completion_date>
  <primary_completion_date type="Anticipated">August 25, 2021</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>
    <masking_description>Radiologist is blind.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rectus muscle stiffness</measure>
    <time_frame>3 months after cesarean section</time_frame>
    <description>Share wave elastosonography is going to perform to six different points of rectus muscle. Each points will be 2 cm right or left side of linea alba line in horizontal axis. Two points are on cesarean section incision, next two points 2 cm below the incision and other next two points 2 cm above the incision in vertical axis. Rectus muscle stiffness will show the adhesion formation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operation time</measure>
    <time_frame>During operation</time_frame>
    <description>Operation time in minutes is going to be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>3 months after cesarean section</time_frame>
    <description>VAS scale is going to be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative bowel function</measure>
    <time_frame>3 months after cesarean section</time_frame>
    <description>It is going to be evaluated by self developed questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative bladder function</measure>
    <time_frame>3 months after cesarean section</time_frame>
    <description>It is going to be evaluated by self developed questionnaire.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Obstetric Complication</condition>
  <condition>Muscle Injury</condition>
  <arm_group>
    <arm_group_label>Study group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This arm is going to include the patients who are performed rectus reapproximation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This arm is going to include the patients who are not performed rectus reapproximation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Rectus muscle re-approximation</intervention_name>
    <description>Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.</description>
    <arm_group_label>Study group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Wound infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sebnem Alanya Tosun</name>
      <address>
        <city>Giresun</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 4, 2021</last_update_submitted>
  <last_update_submitted_qc>August 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Giresun University</investigator_affiliation>
    <investigator_full_name>Sebnem Alanya Tosun</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>elastography</keyword>
  <keyword>rectus muscle re-approximation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tissue Adhesions</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/NCT04483986
org study id: Rectus-reapproximation
nct id: NCT04483986
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rectus re-approximation and periton closure are not the obligatory steps during cesarean
      section. These steps are due to surgeon's preference. However, there is lack of knowledge
      about the relation of rectus muscle re-approximation and adhesion formation. We are going to
      study the rectus muscle stiffness by share-wave elastosonography.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
masking description: Radiologist is blind.
measure: Rectus muscle stiffness
time frame: 3 months after cesarean section
description: Share wave elastosonography is going to perform to six different points of rectus muscle. Each points will be 2 cm right or left side of linea alba line in horizontal axis. Two points are on cesarean section incision, next two points 2 cm below the incision and other next two points 2 cm above the incision in vertical axis. Rectus muscle stiffness will show the adhesion formation.
measure: Operation time
time frame: During operation
description: Operation time in minutes is going to be recorded
measure: Postoperative pain
time frame: 3 months after cesarean section
description: VAS scale is going to be used.
measure: Postoperative bowel function
time frame: 3 months after cesarean section
description: It is going to be evaluated by self developed questionnaire.
measure: Postoperative bladder function
time frame: 3 months after cesarean section
description: It is going to be evaluated by self developed questionnaire.
arm group label: Study group
arm group type: Active Comparator
description: This arm is going to include the patients who are performed rectus reapproximation.
arm group label: Control group
arm group type: No Intervention
description: This arm is going to include the patients who are not performed rectus reapproximation.
intervention type: Procedure
intervention name: Rectus muscle re-approximation
description: Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.
arm group label: Study group
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Giresun University
investigator full name: Sebnem Alanya Tosun
investigator title: Assistant Professor
mesh term: Tissue Adhesions
sharing ipd: No