<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/NCT02249637</url>
  </required_header>
  <id_info>
    <org_study_id>SLMC_2014(SLIU1)</org_study_id>
    <nct_id>NCT02249637</nct_id>
  </id_info>
  <brief_title>A Novel Technique of Circumcision Incision Orchidopexy</brief_title>
  <official_title>A Novel Technique of Circumcision Incision Orchidopexy for Palpable Low Inguinal Cryptorchidism: A Preliminary Report</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Luke's Medical Center, Philippines</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Luke's Medical Center, Philippines</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Given that both circumcision and orchidopexy are commonly done in a single setting, the&#xD;
      investigators adopted the technique of orchidopexy via circumcision incision, particularly&#xD;
      for palpable low inguinal cryptorchidism. In this paper, the investigators aim to present a&#xD;
      novel technique and discuss our preliminary outcome of such procedure compared to the&#xD;
      traditional inguinal-scrotal double incision technique. Specifically, the investigators aimed&#xD;
      to determine the differences in operative time, testicular size changes, peri-operative&#xD;
      complications, pain score and parent's satisfaction of both novel technique and conventional&#xD;
      orchidopexy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cryptorchidism is the most common disorder of the male endocrine gland in children.. 1&#xD;
      According to the latest guideline by European Association of Urology in the Pediatric Urology&#xD;
      for the treatment of cryptorchidism, both inguinal and scrotal approaches orchidopexy are&#xD;
      accepted standard treatment options. 2 In the local setting, circumcision is another common&#xD;
      surgical procedure among the children, particularly under the same instance of anesthesia for&#xD;
      other procedure. Not only due to religious and sociocultural reasons, male circumcision has&#xD;
      been recently considered having a protective effect against acquisition of various sexually&#xD;
      transmitted infections (STIs). 3 This benefit is one of many that have led to many&#xD;
      affirmative evidence-based policy statements by medical bodies in support of the procedure.&#xD;
&#xD;
      Given that both procedures are commonly done in a single setting, we adopted the technique of&#xD;
      orchidopexy via circumcision incision, particularly for palpable low inguinal cryptorchidism.&#xD;
      In this paper, we aim to present a novel technique and discuss our preliminary outcome of&#xD;
      such procedure compared to the traditional inguinal-scrotal double incision technique.&#xD;
      Specifically, we aimed to determine the differences in operative time, testicular size&#xD;
      changes, peri-operative complications, pain score and parent's satisfaction of both novel&#xD;
      technique and conventional orchidopexy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Complication rate occurence related to the procedure</measure>
    <time_frame>3 months- 5 years</time_frame>
    <description>Perioperative complications such as incidents of persistence of procesus vaginalis, testicular atrophy, hematoma, surgical site wound infection as well as the post-operative outcome such as testicular size changes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual analogue scale (VAS) pain score post-operation</measure>
    <time_frame>post-operative 24-48 hour</time_frame>
    <description>Average pain score post operation as described by the patient using visual analogue scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent's satisfaction score for the procedure post-operation</measure>
    <time_frame>1 week post operative follow up</time_frame>
    <description>Parent's satisfaction score measured as 1-5 scale, with 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 being satisfied, 5 being very satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative time consumed by the procedure</measure>
    <time_frame>Operative time</time_frame>
    <description>Time from incision to incision closure end</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Cryptorchidism</condition>
  <condition>Undescended Testis</condition>
  <arm_group>
    <arm_group_label>Inguinal Orchidopexy</arm_group_label>
    <description>Patients with diagnosed palpable low inguinal cryptorchidism underwent inguinal approach as originally described by Schuller and Bevan.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Novel Technique (Circumcision incision)</arm_group_label>
    <description>Patients with diagnosed palpable low inguinal cryptorchidism underwent novel technique- circumcision incision orchidopexy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Novel technique Circumcision Incision Orchidopexy</intervention_name>
    <description>The novel technique starts with retraction of the prepucial skin off the glans penis and double incision circumcision done with mucosal sparing, then degloving of the penis on the side of the undescended testis. Dissection via Dartos' layer into the inguinal area until the palpable testicle was identified and extracted with mobilization of the spermatic cord. Hernia sac was then separated and suture ligated as high as the area of internal ring opening. Spematic cord lengthening was done until adequate length achieved for fixation into the inferior aspect of the scrotum. Then development of the Dartos' pouch via the circumcision site was done. A double or single suture testicular fixation using Vicryl 3-0 simple interrupted sutures on the everted Dartos' pouch inner surface was done. Subsequent placement of the testicle into the Dartos' pouch was done as the inner surface was inverted. The last step was the completion of the circumcision closure using Chromic 4-0 interrupted sutures.</description>
    <arm_group_label>Novel Technique (Circumcision incision)</arm_group_label>
    <other_name>Chua's Procedure</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children diagnosed with palpable cryptorchidism with pre-operative inguino-scrotal&#xD;
        ultrasound to confirm the location of the testis on the low inguinal canal and its&#xD;
        viability. Recruited from September 2013- September 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children diagnosed with palpable cryptorchidism with pre-operative inguino-scrotal&#xD;
             ultrasound to confirm the location of the testis on the low inguinal canal and its&#xD;
             viability.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Excluded were non-palpable testis, with prior orchidopexy, circumcised, with other&#xD;
             concomitant genital anomalies.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>3 Months</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Institute of Urology</name>
      <address>
        <city>Quezon City</city>
        <state>NCR</state>
        <country>Philippines</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Philippines</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <last_update_submitted>April 5, 2015</last_update_submitted>
  <last_update_submitted_qc>April 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 7, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Luke's Medical Center, Philippines</investigator_affiliation>
    <investigator_full_name>Michael E. Chua</investigator_full_name>
    <investigator_title>Urology Staff</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cryptorchidism</mesh_term>
  </condition_browse>
  <!-- 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/NCT02249637
org study id: SLMC_2014(SLIU1)
nct id: NCT02249637
lead sponsor: 
collaborator: 
has dmc: Yes
Given that both circumcision and orchidopexy are commonly done in a single setting, the
      investigators adopted the technique of orchidopexy via circumcision incision, particularly
      for palpable low inguinal cryptorchidism. In this paper, the investigators aim to present a
      novel technique and discuss our preliminary outcome of such procedure compared to the
      traditional inguinal-scrotal double incision technique. Specifically, the investigators aimed
      to determine the differences in operative time, testicular size changes, peri-operative
      complications, pain score and parent's satisfaction of both novel technique and conventional
      orchidopexy.
Cryptorchidism is the most common disorder of the male endocrine gland in children.. 1
      According to the latest guideline by European Association of Urology in the Pediatric Urology
      for the treatment of cryptorchidism, both inguinal and scrotal approaches orchidopexy are
      accepted standard treatment options. 2 In the local setting, circumcision is another common
      surgical procedure among the children, particularly under the same instance of anesthesia for
      other procedure. Not only due to religious and sociocultural reasons, male circumcision has
      been recently considered having a protective effect against acquisition of various sexually
      transmitted infections (STIs). 3 This benefit is one of many that have led to many
      affirmative evidence-based policy statements by medical bodies in support of the procedure.

      Given that both procedures are commonly done in a single setting, we adopted the technique of
      orchidopexy via circumcision incision, particularly for palpable low inguinal cryptorchidism.
      In this paper, we aim to present a novel technique and discuss our preliminary outcome of
      such procedure compared to the traditional inguinal-scrotal double incision technique.
      Specifically, we aimed to determine the differences in operative time, testicular size
      changes, peri-operative complications, pain score and parent's satisfaction of both novel
      technique and conventional orchidopexy.
observational model: Case-Control
time perspective: Retrospective
measure: Complication rate occurence related to the procedure
time frame: 3 months- 5 years
description: Perioperative complications such as incidents of persistence of procesus vaginalis, testicular atrophy, hematoma, surgical site wound infection as well as the post-operative outcome such as testicular size changes
measure: Visual analogue scale (VAS) pain score post-operation
time frame: post-operative 24-48 hour
description: Average pain score post operation as described by the patient using visual analogue scale
measure: Parent's satisfaction score for the procedure post-operation
time frame: 1 week post operative follow up
description: Parent's satisfaction score measured as 1-5 scale, with 1 being very unsatisfied, 2 being unsatisfied, 3 being neutral, 4 being satisfied, 5 being very satisfied
measure: Operative time consumed by the procedure
time frame: Operative time
description: Time from incision to incision closure end
arm group label: Inguinal Orchidopexy
description: Patients with diagnosed palpable low inguinal cryptorchidism underwent inguinal approach as originally described by Schuller and Bevan.
arm group label: Novel Technique (Circumcision incision)
description: Patients with diagnosed palpable low inguinal cryptorchidism underwent novel technique- circumcision incision orchidopexy.
intervention type: Procedure
intervention name: Novel technique Circumcision Incision Orchidopexy
description: The novel technique starts with retraction of the prepucial skin off the glans penis and double incision circumcision done with mucosal sparing, then degloving of the penis on the side of the undescended testis. Dissection via Dartos' layer into the inguinal area until the palpable testicle was identified and extracted with mobilization of the spermatic cord. Hernia sac was then separated and suture ligated as high as the area of internal ring opening. Spematic cord lengthening was done until adequate length achieved for fixation into the inferior aspect of the scrotum. Then development of the Dartos' pouch via the circumcision site was done. A double or single suture testicular fixation using Vicryl 3-0 simple interrupted sutures on the everted Dartos' pouch inner surface was done. Subsequent placement of the testicle into the Dartos' pouch was done as the inner surface was inverted. The last step was the completion of the circumcision closure using Chromic 4-0 interrupted sutures.
arm group label: Novel Technique (Circumcision incision)
other name: Chua's Procedure
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 3 Months
maximum age: 10 Years
healthy volunteers: No
facility: 
country: Philippines
responsible party type: Principal Investigator
investigator affiliation: St. Luke's Medical Center, Philippines
investigator full name: Michael E. Chua
investigator title: Urology Staff
mesh term: Cryptorchidism