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/NCT06032637</url>
    </required_header>
    <id_info>
      <org_study_id>Obstet1222</org_study_id>
      <nct_id>NCT06032637</nct_id>
    </id_info>
    <brief_title>Best Incision in Cesarean Section of Obese Women</brief_title>
    <official_title>Difference Between Pfannenstiel Incision and Higher Transverse Supra Umbilical Incision, During Elective Cesarean Section in Morbidly Obese Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar 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>
        The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher&#xD;
        transverse supra umbilical incision techniques during elective cesarean section in morbidly&#xD;
        obese patients. The main questions it aims to answer are:&#xD;
  &#xD;
        Is there a difference in operative time between the two incision techniques? Is there a&#xD;
        difference in estimated blood loss between the two techniques? Is there a difference in&#xD;
        post-operative pain scores between the two techniques? Is there a difference in wound&#xD;
        complication rates between the two techniques? Participants will be randomly assigned to&#xD;
        receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during&#xD;
        their scheduled cesarean delivery.&#xD;
  &#xD;
        Researchers will compare the Pfannenstiel incision group to the higher transverse supra&#xD;
        umbilical incision group to see if there are differences in operative time, blood loss,&#xD;
        post-operative pain, and wound complications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled&#xD;
        for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined&#xD;
        as pre-pregnancy body mass index ≥40 kg/m2.&#xD;
  &#xD;
        Patients will be randomly allocated to one of two groups (30 patients per group):&#xD;
  &#xD;
        Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision&#xD;
        2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus&#xD;
        sheath in the same line as the skin incision, blunt digital separation of the rectus muscles,&#xD;
        and transverse uterine incision in the lower segment.&#xD;
  &#xD;
        Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision&#xD;
        halfway between the umbilicus and xiphoid process, followed by transverse incision of the&#xD;
        anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and&#xD;
        transverse uterine incision in the lower segment.&#xD;
  &#xD;
        The primary outcome measures will be operative time, estimated blood loss, post-operative&#xD;
        pain scores, and wound complication rates. Secondary outcomes will include length of hospital&#xD;
        stay, patient satisfaction scores, and cosmetic results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2023</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>Rate of surgical site wound infection</measure>
      <time_frame>4 weeks after the surgery.</time_frame>
      <description>Surgical site infections will be assessed at the cesarean incision site and tracked for 4 weeks postoperatively. Wound infection will be defined as purulent drainage from the incision, positive culture, and/or at least two of the following signs or symptoms: pain or tenderness, localized swelling, redness, or heat. The 4-week timeframe starts on the day of surgery (day 0) and ends 28 days postoperatively. Wound infections occurring up to 4 weeks after surgery will be captured and recorded as the primary outcome measure. Wound assessments will be performed daily during the hospital stay, at the post-op visit around 2 weeks, and at the 4-week follow-up visit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Operative time</measure>
      <time_frame>during the surgery</time_frame>
      <description>Operative time will be defined as the time from skin incision to complete wound closure. It will be recorded in minutes by a study investigator observing each procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Hospital length of stay</measure>
      <time_frame>From day of surgery to discharge, up to 8 weeks.</time_frame>
      <description>Hospital length of stay will be defined as the number of days from surgery until discharge from the hospital.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Estimated blood loss</measure>
      <time_frame>during the procedure</time_frame>
      <description>Estimated blood loss will be assessed by the anesthesiologist and surgeon at the end of the procedure, based on the amount of blood in the suction canister and blood-soaked sponges/lap pads.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Postoperative pain</measure>
      <time_frame>From end of surgery through 4 weeks postoperatively</time_frame>
      <description>Postoperative pain will be assessed using a visual analog scale (VAS) of 0-10, with 0 being no pain and 10 being worst possible pain. Patients will rate their pain level at set intervals after surgery - immediately after recovery room discharge, daily while inpatient, and at 2 weeks and 4 weeks postop during follow-up visits.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Morbid Obesity</condition>
    <condition>Cesarean Section Complications</condition>
    <arm_group>
      <arm_group_label>Pfannenstiel incision</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients randomized to the Pfannenstiel incision arm will undergo a transverse skin incision 2-3cm above the symphysis pubis. Subcutaneous tissue will be dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the inferior epigastric arteries. Rectus muscles will be separated manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Supra-Umbilical</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients randomized to the supra-umbilical transverse incision arm will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. Subcutaneous tissue will be bluntly dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. Rectus muscles will be split manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pfannenstiel incision</intervention_name>
      <description>Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.</description>
      <arm_group_label>Pfannenstiel incision</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Supra-umbilical transverse incision</intervention_name>
      <description>Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision 3-4cm above the umbilicus, extending laterally to the semilunar lines, without panniculus retraction. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. The rectus sheath will be incised transversely using electrocautery for hemostasis, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually along the midline using blunt dissection. The peritoneum will be transversely incised and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.</description>
      <arm_group_label>Supra-Umbilical</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Female patients aged between 20 and 40 years.&#xD;
  &#xD;
            -  Singleton pregnancy.&#xD;
  &#xD;
            -  Gestational age ≥ 37 weeks.&#xD;
  &#xD;
            -  Scheduled for elective cesarean delivery.&#xD;
  &#xD;
            -  Morbid obesity, defined as pre-pregnancy body mass index (BMI) ≥ 40 kg/m2.&#xD;
  &#xD;
            -  Willing and able to provide informed consent.&#xD;
  &#xD;
            -  Able to adhere to study procedures and follow-up schedule.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency cesarean delivery.&#xD;
  &#xD;
            -  Multiple gestation (twins, triplets, etc)&#xD;
  &#xD;
            -  Placenta previa or vasa previa.&#xD;
  &#xD;
            -  History of more than 1 previous cesarean delivery.&#xD;
  &#xD;
            -  HIV, hepatitis B/C infection.&#xD;
  &#xD;
            -  Current anticoagulation therapy.&#xD;
  &#xD;
            -  Immune-compromised conditions.&#xD;
  &#xD;
            -  Premature rupture of membranes.&#xD;
  &#xD;
            -  Pre-existing skin conditions affecting the abdomen.&#xD;
  &#xD;
            -  Inability to provide informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>This study will enroll only female participants, as the surgical procedures being compared are specific to cesarean delivery. Only pregnant patients who are scheduled to undergo elective cesarean section will be included. This study is restricted to women only given the gender-specific nature of pregnancy and childbirth. Patients must be female sex at birth with intact uteri in order to be eligible. Transgender male patients and individuals with no female reproductive organs will be excluded. Enrollment is limited to cisgender women only.</gender_description>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Muhamed A Alhagrasy, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Al-Azhar University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Muhamed Alhagrasy, M.D.</last_name>
      <phone>01017313413</phone>
      <email>MuhamedAhmed.216@azhar.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Al-Hussein University Hospital</name>
        <address>
          <city>Cairo</city>
          <zip>11633</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Muhamed A Alhagrasy, M.D.</last_name>
        <phone>00201017313413</phone>
        <email>MuhamedAhmed.216@azhar.edu.eg</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 9, 2023</last_update_submitted>
    <last_update_submitted_qc>September 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy</investigator_full_name>
      <investigator_title>lecturer and consultant at Obstetrics and Gynecology Department.</investigator_title>
    </responsible_party>
    <keyword>elective cesarean section</keyword>
    <keyword>morbid obesity</keyword>
    <keyword>Pfannenstiel incision</keyword>
    <keyword>Transverse supra-umbilical incision</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity, Morbid</mesh_term>
      <mesh_term>Surgical Wound</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>The study involves a vulnerable population of pregnant women and collecting sensitive health information. Sharing individual participant data could risk participant privacy and confidentiality even if de-identified.&#xD;
  The sample size is small at only 60 participants. individual participant data from such a small sample has a higher risk of re-identification.&#xD;
  The research team intends to use the individual participant data for additional analyses and future studies. Sharing individual participant data may lead to misuse, misinterpretation, or compromised validity if not properly analyzed.&#xD;
  Logistical barriers make preparing and curating a database for individual participant data sharing highly resource and time intensive for the research team.</ipd_description>
    </patient_data>
    <!-- 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/NCT06032637
  org study id: Obstet1222
  nct id: NCT06032637
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this comparative clinical trial is to compare Pfannenstiel incision and higher
        transverse supra umbilical incision techniques during elective cesarean section in morbidly
        obese patients. The main questions it aims to answer are:
  
        Is there a difference in operative time between the two incision techniques? Is there a
        difference in estimated blood loss between the two techniques? Is there a difference in
        post-operative pain scores between the two techniques? Is there a difference in wound
        complication rates between the two techniques? Participants will be randomly assigned to
        receive either a Pfannenstiel incision or a higher transverse supra umbilical incision during
        their scheduled cesarean delivery.
  
        Researchers will compare the Pfannenstiel incision group to the higher transverse supra
        umbilical incision group to see if there are differences in operative time, blood loss,
        post-operative pain, and wound complications.
  This randomized controlled trial will enroll 60 morbidly obese pregnant patients scheduled
        for elective cesarean delivery at gestational age ≥37 weeks. Morbid obesity will be defined
        as pre-pregnancy body mass index ≥40 kg/m2.
  
        Patients will be randomly allocated to one of two groups (30 patients per group):
  
        Group 1 (Pfannenstiel group): Patients will undergo a transverse infraumbilical skin incision
        2-3 cm above the symphysis pubis, followed by transverse incision of the anterior rectus
        sheath in the same line as the skin incision, blunt digital separation of the rectus muscles,
        and transverse uterine incision in the lower segment.
  
        Group 2 (Supra-umbilical transverse group): Patients will undergo a transverse skin incision
        halfway between the umbilicus and xiphoid process, followed by transverse incision of the
        anterior rectus sheath in the same line, blunt digital separation of the rectus muscles, and
        transverse uterine incision in the lower segment.
  
        The primary outcome measures will be operative time, estimated blood loss, post-operative
        pain scores, and wound complication rates. Secondary outcomes will include length of hospital
        stay, patient satisfaction scores, and cosmetic results.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Rate of surgical site wound infection
  time frame: 4 weeks after the surgery.
  description: Surgical site infections will be assessed at the cesarean incision site and tracked for 4 weeks postoperatively. Wound infection will be defined as purulent drainage from the incision, positive culture, and/or at least two of the following signs or symptoms: pain or tenderness, localized swelling, redness, or heat. The 4-week timeframe starts on the day of surgery (day 0) and ends 28 days postoperatively. Wound infections occurring up to 4 weeks after surgery will be captured and recorded as the primary outcome measure. Wound assessments will be performed daily during the hospital stay, at the post-op visit around 2 weeks, and at the 4-week follow-up visit.
  measure: Operative time
  time frame: during the surgery
  description: Operative time will be defined as the time from skin incision to complete wound closure. It will be recorded in minutes by a study investigator observing each procedure.
  measure: Hospital length of stay
  time frame: From day of surgery to discharge, up to 8 weeks.
  description: Hospital length of stay will be defined as the number of days from surgery until discharge from the hospital.
  measure: Estimated blood loss
  time frame: during the procedure
  description: Estimated blood loss will be assessed by the anesthesiologist and surgeon at the end of the procedure, based on the amount of blood in the suction canister and blood-soaked sponges/lap pads.
  measure: Postoperative pain
  time frame: From end of surgery through 4 weeks postoperatively
  description: Postoperative pain will be assessed using a visual analog scale (VAS) of 0-10, with 0 being no pain and 10 being worst possible pain. Patients will rate their pain level at set intervals after surgery - immediately after recovery room discharge, daily while inpatient, and at 2 weeks and 4 weeks postop during follow-up visits.
  arm group label: Pfannenstiel incision
  arm group type: Active Comparator
  description: Patients randomized to the Pfannenstiel incision arm will undergo a transverse skin incision 2-3cm above the symphysis pubis. Subcutaneous tissue will be dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the inferior epigastric arteries. Rectus muscles will be separated manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly.
  arm group label: Supra-Umbilical
  arm group type: Experimental
  description: Patients randomized to the supra-umbilical transverse incision arm will undergo a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. Subcutaneous tissue will be bluntly dissected until anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. Rectus muscles will be split manually along midline using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally with uterine traction to deliver fetus. The visceral peritoneum will not be closed. Rectus muscles will not be re-approximated. Subcutaneous tissue will not be irrigated. Subcutaneous tissue will be closed if over 2cm depth. Skin will be closed with non-absorbable suture subcuticularly.
  intervention type: Procedure
  intervention name: Pfannenstiel incision
  description: Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision halfway between the umbilicus and xiphoid process, extending laterally to the semilunar lines. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. A transverse incision will be made through the rectus sheath in line with the skin incision, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually using blunt dissection. The peritoneum will be incised transversely and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.
  arm group label: Pfannenstiel incision
  intervention type: Procedure
  intervention name: Supra-umbilical transverse incision
  description: Patients randomized to the supra-umbilical transverse incision arm will receive a transverse skin incision 3-4cm above the umbilicus, extending laterally to the semilunar lines, without panniculus retraction. The subcutaneous tissue will be bluntly dissected until the anterior rectus sheath is exposed. The rectus sheath will be incised transversely using electrocautery for hemostasis, avoiding injury to the superior epigastric vessels. The rectus muscles will be split manually along the midline using blunt dissection. The peritoneum will be transversely incised and the hysterotomy extended laterally to deliver the fetus. The visceral peritoneum will not be closed. The rectus muscles will not be re-approximated. The subcutaneous tissue will not be irrigated but closed if over 2cm depth. The skin will be closed with non-absorbable suture subcuticularly.
  arm group label: Supra-Umbilical
  criteria: 
  gender: Female
  gender based: Yes
  gender description: This study will enroll only female participants, as the surgical procedures being compared are specific to cesarean delivery. Only pregnant patients who are scheduled to undergo elective cesarean section will be included. This study is restricted to women only given the gender-specific nature of pregnancy and childbirth. Patients must be female sex at birth with intact uteri in order to be eligible. Transgender male patients and individuals with no female reproductive organs will be excluded. Enrollment is limited to cisgender women only.
  minimum age: 20 Years
  maximum age: 40 Years
  healthy volunteers: No
  last name: Muhamed A Alhagrasy, M.D.
  role: Principal Investigator
  affiliation: Al-Azhar University
  last name: Muhamed Alhagrasy, M.D.
  phone: 01017313413
  email: MuhamedAhmed.216@azhar.edu.eg
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: Muhamed Ahmed Abdelmoaty Muhamed Alhagrasy
  investigator title: lecturer and consultant at Obstetrics and Gynecology Department.
  mesh term: Obesity, Morbid
  mesh term: Surgical Wound
  sharing ipd: No
  ipd description: The study involves a vulnerable population of pregnant women and collecting sensitive health information. Sharing individual participant data could risk participant privacy and confidentiality even if de-identified.
  The sample size is small at only 60 participants. individual participant data from such a small sample has a higher risk of re-identification.
  The research team intends to use the individual participant data for additional analyses and future studies. Sharing individual participant data may lead to misuse, misinterpretation, or compromised validity if not properly analyzed.
  Logistical barriers make preparing and curating a database for individual participant data sharing highly resource and time intensive for the research team.