<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/NCT03812731</url>
  </required_header>
  <id_info>
    <org_study_id>EC/01/19/1478</org_study_id>
    <nct_id>NCT03812731</nct_id>
  </id_info>
  <brief_title>Incidence of Urethrocutaneous Fistula With and Without Caudal Epidural Block</brief_title>
  <official_title>Incidence of Urethrocutaneous Fistula Following Distal Hypospadias Repair With and Without Caudal Epidural Block - A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sir Ganga Ram Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sir Ganga Ram Hospital</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>
      The study is designed to explore any association between the caudal epidural block(CEB) given&#xD;
      for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in&#xD;
      children undergoing distal hypospadias repair .We also intend to study the duration of penile&#xD;
      engorgement due to CEB causing penile oedema which may subsequently play a role in fistula&#xD;
      formation. The pilot study will recruit children under 8 years of age diagnosed with distal&#xD;
      hypospadias scheduled to undergo Tubularised Incised Plate Urethroplasty, operated by a&#xD;
      single paediatric surgeon. General anaesthesia will be induced with sevoflurane in oxygen&#xD;
      nitrous oxide mixture supplemented by fentanyl citrate and atracurium besylate in all&#xD;
      children. LMA Pro SealTMof appropriate size will be inserted. Children in group I will then&#xD;
      be given caudal epidural block (CEB) as per our practice protocol. Children in group II will&#xD;
      be given additional intravenous fentanyl citrate. All children will be followed&#xD;
      postoperatively till 3 months to evaluate incidence of urethtocutaneous fistula. The&#xD;
      prospective study attempts to eliminate previously reported confounding factors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CEB is routinely used along with general anaesthesia for inguinal and genital surgeries. It&#xD;
      provides intraoperative and postoperative analgesia, is safe, simple and has success rate of&#xD;
      more than 90% in children.It decreases the requirement of inhalational anaesthetics and&#xD;
      narcotics, decreases stress hormone release and facilitates early recovery. Hypospadias is&#xD;
      the most common congenital anomaly of penis, incidence being 1 in 300 live births.&#xD;
      Hypospadias repair is a technical procedure that can be associated with significant&#xD;
      complications such as meatal stenosis, stricture, glans dehiscence and flap necrosis&#xD;
      Urethrocutaneous fisula formation is the most common complication after primary repair with&#xD;
      an incidence of upto 20%. There have been controversies regarding the association of CEB with&#xD;
      urethrocutaneous fistula. Some studies have reported a high incidence of postoperative&#xD;
      urethrocutaneous fistula in children who received CEB while others have not confirmed any&#xD;
      such relationship. Association between urethrocutaneous fistula and site of urethral opening,&#xD;
      age of patient, duration of surgery, surgeon's expertise, use of subcutaneous epinephrine and&#xD;
      use of preoperative testosterone has been found. Penile engorgement, post inflammatory&#xD;
      response and tissue oedema may be contributory factors for development of fistula. However&#xD;
      any association between CEB and fistula formation is not clear. All studies, except one, are&#xD;
      retrospective, limited by small sample size and presence of various confounding factors. The&#xD;
      present study is aimed to explore any association between CEB and urethrocutaneous fistula.&#xD;
      The study will be conducted in children with distal hypospadias only; they will be operated&#xD;
      by a single surgeon, without the use of subcutaneous epinephrine, so that any association, if&#xD;
      at all between CEB and urethrocutaneous fistula becomes evident.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 22, 2019</start_date>
  <completion_date type="Actual">November 28, 2019</completion_date>
  <primary_completion_date type="Actual">November 28, 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>
    <intervention_model_description>30 male patients aged 1-8 years, ASA physical status I/II, and undergoing distal hypospadias repair will be randomly allocated to one of the following two groups:&#xD;
GROUP I- (Caudal group, n= 15) Children will receive general anesthesia (GA) and analgesia will be maintained with caudal epidural block (CEB) with 0.2% ropivacaine:1 ml/kg.&#xD;
GROUP II- (Non-caudal group, n= 15) Children will receive general anaesthesia (GA) and analgesia will be maintained with intravenous fentanyl citrate 1mcg/kg/hr.&#xD;
roup-1 [CLADS Group, n=60]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS. Group-2 [Desflurane Group, n=60]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The attending anaesthesiologist will not be blinded to the technique utilised to administer GA. An independent assessor blinded to the technique of GA will follow up the patients to determine the incidence of uretherocutaneous fistula</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of urethrocutaneous fistula</measure>
    <time_frame>From one day after surgery(0-hours, baseline) till 3-months post surgery</time_frame>
    <description>Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Penile Engorgement</measure>
    <time_frame>After induction of anaesthesia (0-hours, baseline) till end of surgery</time_frame>
    <description>Length of penis from pubic bone to glans tip and mid shaft circumference i.e. girth around the widest part of the penile shaft will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in intra-operative heart rate (beats per minute)</measure>
    <time_frame>From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively</time_frame>
    <description>Comparison of intra-operative heart rate between both the arms will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)</measure>
    <time_frame>rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively</time_frame>
    <description>Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative analgesia requirement</measure>
    <time_frame>From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively</time_frame>
    <description>Additional fentanyl citrate 0.5-mcg/kg will be administered intravenously if the Face, Legs, Activity, Cry, Consolability scale (FLACC scale) score is &gt; 3 and total amount administered will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of complications</measure>
    <time_frame>From end of anaesthesia (0-hours, baseline) till 3-months postoperatively</time_frame>
    <description>Complications of surgery such as infection, bleeding , hematoma, glans dehiscence, skin or flap necrosis will be noted</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Distal Hypospadias</condition>
  <arm_group>
    <arm_group_label>Caudal Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2 mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.&#xD;
Children in will then receive CEB with 0.2 % ropivacaine 1-ml/kg for maintaining analgesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non- Caudal Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2-mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.&#xD;
Children in will then receive fentanyl citrate 1-mcg/kg/hr for maintaining analgesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg</description>
    <arm_group_label>Caudal Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl Citrate</intervention_name>
    <description>Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered</description>
    <arm_group_label>Non- Caudal Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male children l&#xD;
&#xD;
          2. 1 to 8 years of age&#xD;
&#xD;
          3. ASA physical status I and II&#xD;
&#xD;
          4. Distal hypospadias -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Simultaneously undergoing any other procedure&#xD;
&#xD;
          2. Local infection in sacral region&#xD;
&#xD;
          3. Bleeding diathesis&#xD;
&#xD;
          4. Preoperative testosterone stimulation&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Only male patients with distal hypospadias will be included</gender_description>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deepali Shukla, DA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sir Ganga Ram Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Archna Koul, MS, MCH</last_name>
    <role>Study Director</role>
    <affiliation>Sir Ganga Ram Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 19, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sir Ganga Ram Hospital</investigator_affiliation>
    <investigator_full_name>Dr Nitin Sethi</investigator_full_name>
    <investigator_title>Associate Professor &amp; Consultant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypospadias</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_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/NCT03812731
org study id: EC/01/19/1478
nct id: NCT03812731
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study is designed to explore any association between the caudal epidural block(CEB) given
      for perioperative analgesia and the occurrence of urethrocutaneous fistula postoperatively in
      children undergoing distal hypospadias repair .We also intend to study the duration of penile
      engorgement due to CEB causing penile oedema which may subsequently play a role in fistula
      formation. The pilot study will recruit children under 8 years of age diagnosed with distal
      hypospadias scheduled to undergo Tubularised Incised Plate Urethroplasty, operated by a
      single paediatric surgeon. General anaesthesia will be induced with sevoflurane in oxygen
      nitrous oxide mixture supplemented by fentanyl citrate and atracurium besylate in all
      children. LMA Pro SealTMof appropriate size will be inserted. Children in group I will then
      be given caudal epidural block (CEB) as per our practice protocol. Children in group II will
      be given additional intravenous fentanyl citrate. All children will be followed
      postoperatively till 3 months to evaluate incidence of urethtocutaneous fistula. The
      prospective study attempts to eliminate previously reported confounding factors.
CEB is routinely used along with general anaesthesia for inguinal and genital surgeries. It
      provides intraoperative and postoperative analgesia, is safe, simple and has success rate of
      more than 90% in children.It decreases the requirement of inhalational anaesthetics and
      narcotics, decreases stress hormone release and facilitates early recovery. Hypospadias is
      the most common congenital anomaly of penis, incidence being 1 in 300 live births.
      Hypospadias repair is a technical procedure that can be associated with significant
      complications such as meatal stenosis, stricture, glans dehiscence and flap necrosis
      Urethrocutaneous fisula formation is the most common complication after primary repair with
      an incidence of upto 20%. There have been controversies regarding the association of CEB with
      urethrocutaneous fistula. Some studies have reported a high incidence of postoperative
      urethrocutaneous fistula in children who received CEB while others have not confirmed any
      such relationship. Association between urethrocutaneous fistula and site of urethral opening,
      age of patient, duration of surgery, surgeon's expertise, use of subcutaneous epinephrine and
      use of preoperative testosterone has been found. Penile engorgement, post inflammatory
      response and tissue oedema may be contributory factors for development of fistula. However
      any association between CEB and fistula formation is not clear. All studies, except one, are
      retrospective, limited by small sample size and presence of various confounding factors. The
      present study is aimed to explore any association between CEB and urethrocutaneous fistula.
      The study will be conducted in children with distal hypospadias only; they will be operated
      by a single surgeon, without the use of subcutaneous epinephrine, so that any association, if
      at all between CEB and urethrocutaneous fistula becomes evident.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 30 male patients aged 1-8 years, ASA physical status I/II, and undergoing distal hypospadias repair will be randomly allocated to one of the following two groups:
GROUP I- (Caudal group, n= 15) Children will receive general anesthesia (GA) and analgesia will be maintained with caudal epidural block (CEB) with 0.2% ropivacaine:1 ml/kg.
GROUP II- (Non-caudal group, n= 15) Children will receive general anaesthesia (GA) and analgesia will be maintained with intravenous fentanyl citrate 1mcg/kg/hr.
roup-1 [CLADS Group, n=60]: Anaesthesia will be induced and maintained with propofol administered using the BIS feedback-based automated CLADS. Group-2 [Desflurane Group, n=60]: Anaesthesia will be induced with propofol CLADS and will be maintained intraoperatively by Desflurane titrated to BIS monitoring.
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
masking description: The attending anaesthesiologist will not be blinded to the technique utilised to administer GA. An independent assessor blinded to the technique of GA will follow up the patients to determine the incidence of uretherocutaneous fistula
measure: Incidence of urethrocutaneous fistula
time frame: From one day after surgery(0-hours, baseline) till 3-months post surgery
description: Patients undergoing distal hypospadias repair will be followed up for occurrence of uretherocutaneous fistula
measure: Penile Engorgement
time frame: After induction of anaesthesia (0-hours, baseline) till end of surgery
description: Length of penis from pubic bone to glans tip and mid shaft circumference i.e. girth around the widest part of the penile shaft will be calculated
measure: Changes in intra-operative heart rate (beats per minute)
time frame: From beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
description: Comparison of intra-operative heart rate between both the arms will be done
measure: Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)
time frame: rom beginning of anesthesia (0-hours, baseline) till 2-hours intraoperatively
description: Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done
measure: Postoperative analgesia requirement
time frame: From end of anaesthesia (0-hours, baseline) till 24-hours postoperatively
description: Additional fentanyl citrate 0.5-mcg/kg will be administered intravenously if the Face, Legs, Activity, Cry, Consolability scale (FLACC scale) score is > 3 and total amount administered will be recorded
measure: Incidence of complications
time frame: From end of anaesthesia (0-hours, baseline) till 3-months postoperatively
description: Complications of surgery such as infection, bleeding , hematoma, glans dehiscence, skin or flap necrosis will be noted
arm group label: Caudal Group
arm group type: Active Comparator
description: Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2 mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.
Children in will then receive CEB with 0.2 % ropivacaine 1-ml/kg for maintaining analgesia
arm group label: Non- Caudal Group
arm group type: Active Comparator
description: Children will receive oral midazolam 0.25 mg/kg thirty minutes before induction. Inhalational induction will be carried with incremental concentration of sevoflurane upto 8% in 50% oxygen and nitrous oxide mixture. As soon as the child will be asleep, ASA standard monitors (SPO2, HR, ECG and NIBP) will be attached. Intravenous access with age appropriate IV cannula will be secured. Injection fentanyl citrate 2-mcg/ kg followed by injection atracurium 0.5 mg/kg will be administered. Appropriate size LMA Pro SealTM will be inserted and pressure controlled ventilation will be instituted.
Children in will then receive fentanyl citrate 1-mcg/kg/hr for maintaining analgesia
intervention type: Drug
intervention name: Ropivacaine
description: Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg
arm group label: Caudal Group
intervention type: Drug
intervention name: Fentanyl Citrate
description: Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered
arm group label: Non- Caudal Group
criteria: 
gender: Male
gender based: Yes
gender description: Only male patients with distal hypospadias will be included
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: No
last name: Deepali Shukla, DA
role: Principal Investigator
affiliation: Sir Ganga Ram Hospital
last name: Archna Koul, MS, MCH
role: Study Director
affiliation: Sir Ganga Ram Hospital
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: Sir Ganga Ram Hospital
investigator full name: Dr Nitin Sethi
investigator title: Associate Professor & Consultant
mesh term: Hypospadias
mesh term: Fistula
mesh term: Fentanyl
mesh term: Ropivacaine
sharing ipd: No