<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/NCT03291678</url>
  </required_header>
  <id_info>
    <org_study_id>ASSUIT HOSPITAL UNIVERSITY</org_study_id>
    <nct_id>NCT03291678</nct_id>
  </id_info>
  <brief_title>Impact of Percutaneous Laparoscopic Assisted Internal Ring Ligation During Lap Orchiopexy</brief_title>
  <official_title>Randomized Control Study for Patient With Abdominal Undescended Testis Using New Technique</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmed Hamdy Rateb</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut 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>
      Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing&#xD;
      incidence of congenital hernia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cryptorchidism is the most common genitourinary anomaly in male children. Its incidence can&#xD;
      reach 3% in full term neonates, rising to 30% in premature boys . The treatment of the crypt&#xD;
      orchid testicle is justified by the increased risk of infertility and malignancy, as well as&#xD;
      an associated inguinal hernia and the risk of trauma to the ectopic testicle against the&#xD;
      pubis. Furthermore, the psychological stigma of a missing testis for the patient, as well as&#xD;
      the parents' anxiety is also factors that justify this type of treatment .&#xD;
&#xD;
      About 20% of crypt orchid testicles are non palpable. The treatment of non-descended&#xD;
      testicles is mandatory due to the increased risk of infertility, present in up to 40% of the&#xD;
      patients, as compared to 6% of control groups, including malignancy, which reaches 20 times&#xD;
      that of normal adults .&#xD;
&#xD;
      The treatment of the crypt orchid testis before 2 years of age is recommended, treatment is&#xD;
      necessary not only for the risk of malignancy, but also for the satisfaction and improvement&#xD;
      in the quality of the patient's life and parents´ concern for their children's health.&#xD;
&#xD;
      In relation to diagnosis, despite a sensitivity of 70-90% in the diagnosis of inguinal&#xD;
      testes, ultrasonography is not useful in intra-abdominal cases . Although presenting a better&#xD;
      quality, both computed tomography and nuclear magnetic resonance lack sufficient sensitivity&#xD;
      and specificity to be considered as gold standard diagnostic tools . More recently, the&#xD;
      magnetic angioresonance was introduced with sensibility of 96% and specificity of 100%, but&#xD;
      it is still a new method, with high costs, also requiring general anesthesia in children .&#xD;
&#xD;
      In relation to the treatment, the use of gonadotrophin for un descended testes presents a&#xD;
      success rate of definitive descent to the scrotum of 21 to 56%, with better results in&#xD;
      bilateral cases . Surgical treatment via an inguinal incision is the main treatment option&#xD;
      for palpable testicles, but can also be employed for the evaluation and treatment of&#xD;
      non-palpable testis. In this situation, however, surgical exploration can often require large&#xD;
      incisions and extensive dissections, especially in bilateral cases. This can be avoided using&#xD;
      laparoscopic evaluation, with a sensitivity and specificity reaching more than 90%&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 25, 2017</start_date>
  <completion_date type="Anticipated">September 6, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 5, 2018</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>one group which is control group will not subjected to internal ring ligation and another group will subjected to closure of the internal ring</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>decrease incidence of congenital hernia which associated with undescended testis</measure>
    <time_frame>one year</time_frame>
    <description>patient follow up will be after 15 days and then after two months by examination of the operation site ,stitches , and hernial orifices to be sure of absence of congenital hernia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary outcome measure postoperative complication</measure>
    <time_frame>one week post operative</time_frame>
    <description>close observation of the patient depending on follow up the wound daily ,occurence of edema by observation, good feeding of the patient by mother</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Congenital Disorders</condition>
  <arm_group>
    <arm_group_label>new laparoscopic orchiopexy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring</description>
  </arm_group>
  <arm_group>
    <arm_group_label>classic laparoscopic orchoipexy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>new laparoscopic orchiopexy</intervention_name>
    <description>closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous</description>
    <arm_group_label>new laparoscopic orchiopexy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>classic laparoscopic orchiopexy</intervention_name>
    <description>delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal</description>
    <arm_group_label>classic laparoscopic orchoipexy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA&#xD;
&#xD;
               1. Age above six months&#xD;
&#xD;
               2. SEX must be male&#xD;
&#xD;
               3. Surgical approach is closure of internal ring via percutaneous technique after&#xD;
                  delivery of undescended testis&#xD;
&#xD;
          -  EXCLUSION CRITERIA&#xD;
&#xD;
               1. Age less than 3 months&#xD;
&#xD;
               2. Patients with palpable undescended testis&#xD;
&#xD;
               3. Any associated major congenital anomalies like cardiac anomalies&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>2 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>gamal abdel hamid ahmed, prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>prof of general surgery assuit university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahmed mohammed soliaman, dr</last_name>
    <phone>0201091672661</phone>
    <email>ahmed.ali15@med.au.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>mohamed abdelkader osman, prof</last_name>
    <phone>0201090266780</phone>
    <email>osman@med.aun.edu.eg</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>September 24, 2017</last_update_submitted>
  <last_update_submitted_qc>September 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ahmed Hamdy Rateb</investigator_full_name>
    <investigator_title>resident physician of general surgery assuit university</investigator_title>
  </responsible_party>
  <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/NCT03291678
org study id: ASSUIT HOSPITAL UNIVERSITY
nct id: NCT03291678
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Impact of percutaneous internal ring ligation during laparoscopic orchiopexy in decreasing
      incidence of congenital hernia
Cryptorchidism is the most common genitourinary anomaly in male children. Its incidence can
      reach 3% in full term neonates, rising to 30% in premature boys . The treatment of the crypt
      orchid testicle is justified by the increased risk of infertility and malignancy, as well as
      an associated inguinal hernia and the risk of trauma to the ectopic testicle against the
      pubis. Furthermore, the psychological stigma of a missing testis for the patient, as well as
      the parents' anxiety is also factors that justify this type of treatment .

      About 20% of crypt orchid testicles are non palpable. The treatment of non-descended
      testicles is mandatory due to the increased risk of infertility, present in up to 40% of the
      patients, as compared to 6% of control groups, including malignancy, which reaches 20 times
      that of normal adults .

      The treatment of the crypt orchid testis before 2 years of age is recommended, treatment is
      necessary not only for the risk of malignancy, but also for the satisfaction and improvement
      in the quality of the patient's life and parents´ concern for their children's health.

      In relation to diagnosis, despite a sensitivity of 70-90% in the diagnosis of inguinal
      testes, ultrasonography is not useful in intra-abdominal cases . Although presenting a better
      quality, both computed tomography and nuclear magnetic resonance lack sufficient sensitivity
      and specificity to be considered as gold standard diagnostic tools . More recently, the
      magnetic angioresonance was introduced with sensibility of 96% and specificity of 100%, but
      it is still a new method, with high costs, also requiring general anesthesia in children .

      In relation to the treatment, the use of gonadotrophin for un descended testes presents a
      success rate of definitive descent to the scrotum of 21 to 56%, with better results in
      bilateral cases . Surgical treatment via an inguinal incision is the main treatment option
      for palpable testicles, but can also be employed for the evaluation and treatment of
      non-palpable testis. In this situation, however, surgical exploration can often require large
      incisions and extensive dissections, especially in bilateral cases. This can be avoided using
      laparoscopic evaluation, with a sensitivity and specificity reaching more than 90%
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: one group which is control group will not subjected to internal ring ligation and another group will subjected to closure of the internal ring
primary purpose: Treatment
masking: None (Open Label)
measure: decrease incidence of congenital hernia which associated with undescended testis
time frame: one year
description: patient follow up will be after 15 days and then after two months by examination of the operation site ,stitches , and hernial orifices to be sure of absence of congenital hernia
measure: The secondary outcome measure postoperative complication
time frame: one week post operative
description: close observation of the patient depending on follow up the wound daily ,occurence of edema by observation, good feeding of the patient by mother
arm group label: new laparoscopic orchiopexy
arm group type: Experimental
description: this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum with closure of internal ring
arm group label: classic laparoscopic orchoipexy
arm group type: Active Comparator
description: this group will subjected to classic laparoscopic orchiopexy by delivery of abdominal undescended testis to subdartos pouch of scrotum
intervention type: Procedure
intervention name: new laparoscopic orchiopexy
description: closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
arm group label: new laparoscopic orchiopexy
intervention type: Procedure
intervention name: classic laparoscopic orchiopexy
description: delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal
arm group label: classic laparoscopic orchoipexy
criteria: 
gender: Male
minimum age: 6 Months
maximum age: 2 Years
healthy volunteers: No
last name: gamal abdel hamid ahmed, prof
role: Principal Investigator
affiliation: prof of general surgery assuit university
last name: Ahmed mohammed soliaman, dr
phone: 0201091672661
email: ahmed.ali15@med.au.edu.eg
last name: mohamed abdelkader osman, prof
phone: 0201090266780
email: osman@med.aun.edu.eg
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Ahmed Hamdy Rateb
investigator title: resident physician of general surgery assuit university
sharing ipd: Undecided