<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/NCT02977871</url>
  </required_header>
  <id_info>
    <org_study_id>1828</org_study_id>
    <nct_id>NCT02977871</nct_id>
  </id_info>
  <brief_title>Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women</brief_title>
  <official_title>A Randomized Trial Comparing Bladder Flap Versus Omission of Flap During Cesarean Section of Primiparous Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kanuni Sultan Suleyman Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kanuni Sultan Suleyman Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cesarean section is the most common surgical procedure performed on women. Over the years&#xD;
      minor variations of each surgical step have been introduced, and cesarean sections are not&#xD;
      standardized and many different techniques are employed during surgery. Creation of a bladder&#xD;
      flap has been an integral surgical step of the cesarean section for many years. The role of&#xD;
      the bladder flap and its usefulness in cesarean section is not known well. Further, in some&#xD;
      cases the bladder flap is omitted during cesarean section. The aim of the current study is to&#xD;
      compare operating time and postoperative urinary symptoms in cesarean sections using either&#xD;
      bladder flap or omission of flap.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cesarean section is the most common surgical procedure performed on women. The main aspects&#xD;
      of the surgical approach to low-transverse cesarean delivery have not changed much since1926.&#xD;
      Over the years minor variations of each surgical step have been introduced, and cesarean&#xD;
      sections are not standardized and many different techniques are employed during surgery.&#xD;
      Creation of a bladder flap has been an integral surgical step of the cesarean section for&#xD;
      many years. The evidence on the role of the bladder flap and its usefulness in cesarean&#xD;
      section is very limited. In emergent cesarean sections where rapid delivery is the main goal,&#xD;
      the bladder flap is usually omitted. Literature about the usefulness of a bladder flap is&#xD;
      limited and more randomized studies are needed. Most of the study outcomes were focusing&#xD;
      operating time however, the investigator in the current study additional focused on&#xD;
      postoperative urinary symptoms and dynamics. The aim of the current study is to compare&#xD;
      operating time and postoperative urinary symptoms in cesarean sections using either bladder&#xD;
      flap or omission of flap.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Total operation time</measure>
    <time_frame>1 hour</time_frame>
    <description>Total operation time from skin incision to the end of operation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>1 hour</time_frame>
    <description>Estimated blood loss during surgery will be measured in terms of mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bladder injury</measure>
    <time_frame>up to 48 hour</time_frame>
    <description>Bladder injury during cesarean section will be assessed by the number and percentage of patients who had injury</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary retention</measure>
    <time_frame>up to 48 hour</time_frame>
    <description>Postoperative urinary retention will be measured by number and percentage of patients who develop this complication</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Cesarean Section</condition>
  <arm_group>
    <arm_group_label>No Bladder Flap group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine uterine incision performed during cesarean section without incision and dissection of the bladder peritoneum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bladder Flap group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bladder flap</intervention_name>
    <description>Performing uterine incision and cesarean section with a bladder flap.</description>
    <arm_group_label>Bladder Flap group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primiparous women &gt;37 weeks without high-risk pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  presence of microbiologically confirmed urinary tract infection before delivery, twin&#xD;
             pregnancies, cervical dilatation at admission ≥4 cm, estimated fetal weight&gt;4000 gr,&#xD;
             history of previous abdominal surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Berna Aslan Cetin, MD,ObGyn</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kanuni Sultan Suleyman Training and Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kanuni Sultan Suleyman Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Pelosi MA 2nd, Pelosi MA 3rd. Risk factors for bladder injury during cesarean delivery. Obstet Gynecol. 2005 Apr;105(4):900; author reply 901. doi: 10.1097/01.AOG.0000158756.29999.0a. No abstract available.</citation>
    <PMID>15802429</PMID>
  </results_reference>
  <results_reference>
    <citation>Wood RM, Simon H, Oz AU. Pelosi-type vs. traditional cesarean delivery. A prospective comparison. J Reprod Med. 1999 Sep;44(9):788-95.</citation>
    <PMID>10509303</PMID>
  </results_reference>
  <results_reference>
    <citation>Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.</citation>
    <PMID>16260200</PMID>
  </results_reference>
  <results_reference>
    <citation>Mahajan NN. Justifying formation of bladder flap at cesarean section? Arch Gynecol Obstet. 2009 Jun;279(6):853-5. doi: 10.1007/s00404-008-0838-6. Epub 2008 Nov 19.</citation>
    <PMID>19018545</PMID>
  </results_reference>
  <results_reference>
    <citation>O'Neill HA, Egan G, Walsh CA, Cotter AM, Walsh SR. Omission of the bladder flap at caesarean section reduces delivery time without increased morbidity: a meta-analysis of randomised controlled trials. Eur J Obstet Gynecol Reprod Biol. 2014 Mar;174:20-6. doi: 10.1016/j.ejogrb.2013.12.020. Epub 2013 Dec 22.</citation>
    <PMID>24411951</PMID>
  </results_reference>
  <results_reference>
    <citation>Tuuli MG, Odibo AO, Fogertey P, Roehl K, Stamilio D, Macones GA. Utility of the bladder flap at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Apr;119(4):815-21. doi: 10.1097/AOG.0b013e31824c0e12.</citation>
    <PMID>22395144</PMID>
  </results_reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kanuni Sultan Suleyman Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Berna Aslan Cetin</investigator_full_name>
    <investigator_title>Attending Physician, ObGyn</investigator_title>
  </responsible_party>
  <keyword>Cesarean section</keyword>
  <keyword>operating time</keyword>
  <keyword>bladder</keyword>
  <keyword>urinary retention</keyword>
  <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/NCT02977871
org study id: 1828
nct id: NCT02977871
lead sponsor: 
has dmc: No
Cesarean section is the most common surgical procedure performed on women. Over the years
      minor variations of each surgical step have been introduced, and cesarean sections are not
      standardized and many different techniques are employed during surgery. Creation of a bladder
      flap has been an integral surgical step of the cesarean section for many years. The role of
      the bladder flap and its usefulness in cesarean section is not known well. Further, in some
      cases the bladder flap is omitted during cesarean section. The aim of the current study is to
      compare operating time and postoperative urinary symptoms in cesarean sections using either
      bladder flap or omission of flap.
Cesarean section is the most common surgical procedure performed on women. The main aspects
      of the surgical approach to low-transverse cesarean delivery have not changed much since1926.
      Over the years minor variations of each surgical step have been introduced, and cesarean
      sections are not standardized and many different techniques are employed during surgery.
      Creation of a bladder flap has been an integral surgical step of the cesarean section for
      many years. The evidence on the role of the bladder flap and its usefulness in cesarean
      section is very limited. In emergent cesarean sections where rapid delivery is the main goal,
      the bladder flap is usually omitted. Literature about the usefulness of a bladder flap is
      limited and more randomized studies are needed. Most of the study outcomes were focusing
      operating time however, the investigator in the current study additional focused on
      postoperative urinary symptoms and dynamics. The aim of the current study is to compare
      operating time and postoperative urinary symptoms in cesarean sections using either bladder
      flap or omission of flap.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total operation time
time frame: 1 hour
description: Total operation time from skin incision to the end of operation
measure: Estimated blood loss
time frame: 1 hour
description: Estimated blood loss during surgery will be measured in terms of mL
measure: Bladder injury
time frame: up to 48 hour
description: Bladder injury during cesarean section will be assessed by the number and percentage of patients who had injury
measure: Urinary retention
time frame: up to 48 hour
description: Postoperative urinary retention will be measured by number and percentage of patients who develop this complication
arm group label: No Bladder Flap group
arm group type: No Intervention
description: Routine uterine incision performed during cesarean section without incision and dissection of the bladder peritoneum.
arm group label: Bladder Flap group
arm group type: Active Comparator
description: Routine uterine incision performed during cesarean section with an incision and a dissection of a bladder flap.
intervention type: Procedure
intervention name: Bladder flap
description: Performing uterine incision and cesarean section with a bladder flap.
arm group label: Bladder Flap group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Berna Aslan Cetin, MD,ObGyn
role: Principal Investigator
affiliation: Kanuni Sultan Suleyman Training and Research Hospital
facility: 
country: Turkey
citation: Pelosi MA 2nd, Pelosi MA 3rd. Risk factors for bladder injury during cesarean delivery. Obstet Gynecol. 2005 Apr;105(4):900; author reply 901. doi: 10.1097/01.AOG.0000158756.29999.0a. No abstract available.
PMID: 15802429
citation: Wood RM, Simon H, Oz AU. Pelosi-type vs. traditional cesarean delivery. A prospective comparison. J Reprod Med. 1999 Sep;44(9):788-95.
PMID: 10509303
citation: Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for cesarean delivery. Am J Obstet Gynecol. 2005 Nov;193(5):1607-17. doi: 10.1016/j.ajog.2005.03.063.
PMID: 16260200
citation: Mahajan NN. Justifying formation of bladder flap at cesarean section? Arch Gynecol Obstet. 2009 Jun;279(6):853-5. doi: 10.1007/s00404-008-0838-6. Epub 2008 Nov 19.
PMID: 19018545
citation: O'Neill HA, Egan G, Walsh CA, Cotter AM, Walsh SR. Omission of the bladder flap at caesarean section reduces delivery time without increased morbidity: a meta-analysis of randomised controlled trials. Eur J Obstet Gynecol Reprod Biol. 2014 Mar;174:20-6. doi: 10.1016/j.ejogrb.2013.12.020. Epub 2013 Dec 22.
PMID: 24411951
citation: Tuuli MG, Odibo AO, Fogertey P, Roehl K, Stamilio D, Macones GA. Utility of the bladder flap at cesarean delivery: a randomized controlled trial. Obstet Gynecol. 2012 Apr;119(4):815-21. doi: 10.1097/AOG.0b013e31824c0e12.
PMID: 22395144
responsible party type: Principal Investigator
investigator affiliation: Kanuni Sultan Suleyman Training and Research Hospital
investigator full name: Berna Aslan Cetin
investigator title: Attending Physician, ObGyn
sharing ipd: No