<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/NCT03763916</url>
  </required_header>
  <id_info>
    <org_study_id>44</org_study_id>
    <nct_id>NCT03763916</nct_id>
  </id_info>
  <brief_title>Intraoperative Ureteric Dissection vs Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta</brief_title>
  <official_title>Comparative Study Between Intraoperative Ureteric Dissection and Preoperative Ureteric Stenting in Women With Abnormally Invasive Placenta</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      80 Egyptian pregnant female patients will be enrolled in our prospective study. All&#xD;
      candidates will have the diagnosis of placenta percreta [confirmed by 2D and 3D ultrasound&#xD;
      and Doppler by senior sonographer]. All candidates will be scheduled for cesarean&#xD;
      hysterectomy; patients will be randomized into two groups, first group will include 40&#xD;
      patients who will undergo cesarean hysterectomy with intraoperative ureteric dissection, and&#xD;
      the second group will include the other 40 patients who will undergo cesarean hysterectomy&#xD;
      with preoperative ureteric stenting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      80 pregnant females with the diagnosis of Abnormally invasive placenta [AIP] will be involved&#xD;
      in our study [ after proper sample size calculation]. The diagnosis Of AIP will be confirmed&#xD;
      by 2D and 3D ultrasound as well as power Doppler evaluation [machine]. Sonographic evaluation&#xD;
      will be done and confirmed by senior sonographer in our ACCRETA team.&#xD;
&#xD;
      Patients will be randomized into two groups using closed envelopes after taking written&#xD;
      consents; group 1 with intraoperative ureteric dissection and group 2 with preoperative&#xD;
      ureteric stenting.&#xD;
&#xD;
      In group 1 cesarean hysterectomy is performed with intra operative ureteric dissection;&#xD;
      midline abdominal incision extending supraumbilical, incision of the SC tissue, dissection&#xD;
      and splitting of the recti, classic midline incision of the uterus [above the site of&#xD;
      placental insertion], delivery of the fetus in presence of a well trained neonatology team,&#xD;
      avoid traction of the placenta, quick closure of the uterus [in presence of the placenta] in&#xD;
      one layer, clamping and cutting the round ligament, clamping and cutting the ovarian ligament&#xD;
      with ovarian preservation, careful dissection and clamping of the broad ligament&#xD;
      varicosities, careful dissection of the post leaflet of the broad ligament until ureter is&#xD;
      reached, careful dissection and exposure of both ureter and proper identification of the&#xD;
      iliac vessels so as to facilitate the ligation of anterior division of internal iliac artery&#xD;
      if needed and to avoid any major vascular injury, if unfortunately severe bleeding occurs and&#xD;
      rapid surgical intervention is needed. Following ureteric dissection is performed lateral&#xD;
      dissection of the uterus is completed from the pelvic side wall, followed by very CAREFUL&#xD;
      BLADDER DISSECTION. Finally clamping of the uterine vessels is done below the level of the&#xD;
      placenta with or without complete removal of the cervix. Closure of the uterine stump is&#xD;
      performed followed by CAREFUL HEMOSTASIS then closure of the abdomen is performed after&#xD;
      leaving two wide bore drains.&#xD;
&#xD;
      In group2; preoperative insertion of ureteric catheters is performed by the urologist in our&#xD;
      team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy,&#xD;
      cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche]&#xD;
      are inserted followed by the insertion of Foley's urethral catheter. Ureteral catheters are&#xD;
      fixed to the Foley's catheter. the ureteric catheters are scheduled for removal immediately&#xD;
      postoperative. The patient is then placed in the supine position and sterilization of the&#xD;
      abdominal wall is performed and cesarean hysterectomy is performed similarly as in the first&#xD;
      group but without ureteric dissection.&#xD;
&#xD;
      The two groups will be carefully studied as regards to incidence of ureteric and bladder&#xD;
      injuries, amount of blood loss [measured by weighing towels pre and postoperative; the&#xD;
      difference represents the intraoperative blood loss] and the intraoperative timing.&#xD;
      Statistical comparison between the rate of complications in each groups will be done.&#xD;
      Patients' data will be analyzed statistically using SAS program (SAS, 1996).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ureteric injuryoccurance of any type of ureteric injuries including partial , complete transection or inclusion in a ligature</measure>
    <time_frame>during the operation</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Placenta Accreta</condition>
  <arm_group>
    <arm_group_label>Intra operative ureteric dissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>midline abdominal incision extending supraumbilical, incision of the SC tissue, dissection and splitting of the recti, classic midline incision of the uterus [above the site of placental insertion], delivery of the fetus , avoid traction of the placenta, quick closure of the uterus [in presence of the placenta] in one layer, clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preoperative ureteric stenting</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ureteric dissection</intervention_name>
    <description>clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels</description>
    <arm_group_label>Intra operative ureteric dissection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preoperative ureteric stenting</intervention_name>
    <description>preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter</description>
    <arm_group_label>Preoperative ureteric stenting</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cesarean hysterectomy</intervention_name>
    <description>lateral dissection of the uterus is completed from the pelvic side wall, followed by very CAREFUL BLADDER DISSECTION. Finally clamping of the uterine vessels is done below the level of the placenta with or without complete removal of the cervix. Closure of the uterine stump is performed followed by CAREFUL HEMOSTASIS then closure of the abdomen is performed after leaving two wide bore drains</description>
    <arm_group_label>Intra operative ureteric dissection</arm_group_label>
    <arm_group_label>Preoperative ureteric stenting</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parity; multiparas&#xD;
&#xD;
          -  Advanced gestational age more than 36 weeks&#xD;
&#xD;
          -  Repeated cesarean sections&#xD;
&#xD;
          -  Placenta previa&#xD;
&#xD;
          -  Abnormally invasive placenta diagnosed and confirmed by senior sonographer&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Morbidly obese patient [BMI over 35] Severly anaemic; patients[ Hb less than 8gmLdl]&#xD;
             Elderly females [age over 40]&#xD;
&#xD;
          -  Inability to insert ureteric stent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Professor</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed Maged, MD</last_name>
    <phone>+201005227404</phone>
    <email>prof.ahmedmaged@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ahmed Alsawaf, MD</last_name>
    <phone>+201223380269</phone>
    <email>hsawaf40@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>December 3, 2018</last_update_submitted>
  <last_update_submitted_qc>December 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Placenta Accreta</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03763916
org study id: 44
nct id: NCT03763916
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
80 Egyptian pregnant female patients will be enrolled in our prospective study. All
      candidates will have the diagnosis of placenta percreta [confirmed by 2D and 3D ultrasound
      and Doppler by senior sonographer]. All candidates will be scheduled for cesarean
      hysterectomy; patients will be randomized into two groups, first group will include 40
      patients who will undergo cesarean hysterectomy with intraoperative ureteric dissection, and
      the second group will include the other 40 patients who will undergo cesarean hysterectomy
      with preoperative ureteric stenting.
80 pregnant females with the diagnosis of Abnormally invasive placenta [AIP] will be involved
      in our study [ after proper sample size calculation]. The diagnosis Of AIP will be confirmed
      by 2D and 3D ultrasound as well as power Doppler evaluation [machine]. Sonographic evaluation
      will be done and confirmed by senior sonographer in our ACCRETA team.

      Patients will be randomized into two groups using closed envelopes after taking written
      consents; group 1 with intraoperative ureteric dissection and group 2 with preoperative
      ureteric stenting.

      In group 1 cesarean hysterectomy is performed with intra operative ureteric dissection;
      midline abdominal incision extending supraumbilical, incision of the SC tissue, dissection
      and splitting of the recti, classic midline incision of the uterus [above the site of
      placental insertion], delivery of the fetus in presence of a well trained neonatology team,
      avoid traction of the placenta, quick closure of the uterus [in presence of the placenta] in
      one layer, clamping and cutting the round ligament, clamping and cutting the ovarian ligament
      with ovarian preservation, careful dissection and clamping of the broad ligament
      varicosities, careful dissection of the post leaflet of the broad ligament until ureter is
      reached, careful dissection and exposure of both ureter and proper identification of the
      iliac vessels so as to facilitate the ligation of anterior division of internal iliac artery
      if needed and to avoid any major vascular injury, if unfortunately severe bleeding occurs and
      rapid surgical intervention is needed. Following ureteric dissection is performed lateral
      dissection of the uterus is completed from the pelvic side wall, followed by very CAREFUL
      BLADDER DISSECTION. Finally clamping of the uterine vessels is done below the level of the
      placenta with or without complete removal of the cervix. Closure of the uterine stump is
      performed followed by CAREFUL HEMOSTASIS then closure of the abdomen is performed after
      leaving two wide bore drains.

      In group2; preoperative insertion of ureteric catheters is performed by the urologist in our
      team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy,
      cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche]
      are inserted followed by the insertion of Foley's urethral catheter. Ureteral catheters are
      fixed to the Foley's catheter. the ureteric catheters are scheduled for removal immediately
      postoperative. The patient is then placed in the supine position and sterilization of the
      abdominal wall is performed and cesarean hysterectomy is performed similarly as in the first
      group but without ureteric dissection.

      The two groups will be carefully studied as regards to incidence of ureteric and bladder
      injuries, amount of blood loss [measured by weighing towels pre and postoperative; the
      difference represents the intraoperative blood loss] and the intraoperative timing.
      Statistical comparison between the rate of complications in each groups will be done.
      Patients' data will be analyzed statistically using SAS program (SAS, 1996).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: ureteric injuryoccurance of any type of ureteric injuries including partial , complete transection or inclusion in a ligature
time frame: during the operation
arm group label: Intra operative ureteric dissection
arm group type: Active Comparator
description: midline abdominal incision extending supraumbilical, incision of the SC tissue, dissection and splitting of the recti, classic midline incision of the uterus [above the site of placental insertion], delivery of the fetus , avoid traction of the placenta, quick closure of the uterus [in presence of the placenta] in one layer, clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels
arm group label: Preoperative ureteric stenting
arm group type: Active Comparator
description: preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter.
intervention type: Procedure
intervention name: Ureteric dissection
description: clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels
arm group label: Intra operative ureteric dissection
intervention type: Procedure
intervention name: Preoperative ureteric stenting
description: preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter
arm group label: Preoperative ureteric stenting
intervention type: Procedure
intervention name: Cesarean hysterectomy
description: lateral dissection of the uterus is completed from the pelvic side wall, followed by very CAREFUL BLADDER DISSECTION. Finally clamping of the uterine vessels is done below the level of the placenta with or without complete removal of the cervix. Closure of the uterine stump is performed followed by CAREFUL HEMOSTASIS then closure of the abdomen is performed after leaving two wide bore drains
arm group label: Intra operative ureteric dissection
arm group label: Preoperative ureteric stenting
criteria: 
gender: Female
gender based: Yes
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: Professor
last name: Ahmed Maged, MD
phone: +201005227404
email: prof.ahmedmaged@gmail.com
last name: Ahmed Alsawaf, MD
phone: +201223380269
email: hsawaf40@yahoo.com
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Principal investigator
mesh term: Placenta Accreta
sharing ipd: Undecided