<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/NCT03269812</url>
  </required_header>
  <id_info>
    <org_study_id>laparoscopy in Hirschsprung</org_study_id>
    <nct_id>NCT03269812</nct_id>
  </id_info>
  <brief_title>Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease</brief_title>
  <official_title>Laparoscopic Assisted Pull-through Versus Other Surgical Procedures for Treatment of Hirschsprung Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence&#xD;
      and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung&#xD;
      disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the&#xD;
      newborn[1,2], The main goal in the treatment of patients with Hirschsprung,s disease is to&#xD;
      resect the aganglionic segment and pull down the Normo-ganglionic bowel[3]. With the&#xD;
      introduction of minimally invasive surgery, classic pull-through techniques were modified and&#xD;
      improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted&#xD;
      pull-through operations in form of reduced pain and improved cosmoses this approach has&#xD;
      gained much popularity[4,5].&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 1, 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Constipation</measure>
    <time_frame>from one to three months after operation</time_frame>
    <description>persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Hirschsprung Disease</condition>
  <arm_group>
    <arm_group_label>laparoscopic operated group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non laparoscopic operated group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>laparoscopic assisted pull-through oeration</intervention_name>
    <description>Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,</description>
    <arm_group_label>laparoscopic operated group</arm_group_label>
    <arm_group_label>non laparoscopic operated group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age from 6months to 3 years.&#xD;
&#xD;
          2. Both sexes.&#xD;
&#xD;
          3. Classic and long segment Hirshsprung.&#xD;
&#xD;
          4. Total a ganglionic colon.&#xD;
&#xD;
          5. Hirshsprung disease with leveling colostomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients &lt;6 months and &gt;3 years.&#xD;
&#xD;
          2. Short and Ultra-short Hirshsprung.&#xD;
&#xD;
          3. Recurrent cases of Hirshsprung.&#xD;
&#xD;
          4. Other contraindication of laparoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>36 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Mohammed Hamada Takrouney</last_name>
    <phone>+201009321033</phone>
    <email>m.takrouney1988@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ibrahim Ali Ibrahim</last_name>
    <phone>+201005801291</phone>
    <email>Dr.ibrahimali@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>Tomuschat C, Zimmer J, Puri P. Laparoscopic-assisted pull-through operation for Hirschsprung's disease: a systematic review and meta-analysis. Pediatr Surg Int. 2016 Aug;32(8):751-7. doi: 10.1007/s00383-016-3910-5. Epub 2016 Jul 1.</citation>
    <PMID>27369964</PMID>
  </reference>
  <reference>
    <citation>Taguchi T, Obata S, Ieiri S. Current status of Hirschsprung's disease: based on a nationwide survey of Japan. Pediatr Surg Int. 2017 Apr;33(4):497-504. doi: 10.1007/s00383-016-4054-3. Epub 2017 Jan 5.</citation>
    <PMID>28058486</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 30, 2017</last_update_submitted>
  <last_update_submitted_qc>August 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Mohammed Hamada Takrouney</investigator_full_name>
    <investigator_title>Principal investigator and Assistant lecturer of pediatric surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hirschsprung Disease</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/NCT03269812
org study id: laparoscopy in Hirschsprung
nct id: NCT03269812
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the outcomes of laparoscopic pull-through concerning constipation, incontinence
      and enterocolitis in comparison of other surgical procedures for treatment of Hirschsprung
      disease.
Hirschsprung,s disease (HD) is a relatively common cause of intestinal obstruction in the
      newborn[1,2], The main goal in the treatment of patients with Hirschsprung,s disease is to
      resect the aganglionic segment and pull down the Normo-ganglionic bowel[3]. With the
      introduction of minimally invasive surgery, classic pull-through techniques were modified and
      improved with laparoscopy, because of the obvious advantages of laparoscopic-assisted
      pull-through operations in form of reduced pain and improved cosmoses this approach has
      gained much popularity[4,5].
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Constipation
time frame: from one to three months after operation
description: persistace of inablilty to pass stool even after operation and treatment,it is physiological parameter and assisted by asking the mothers of patients about the bowel habits.
arm group label: laparoscopic operated group
arm group type: Experimental
description: Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,
arm group label: non laparoscopic operated group
arm group type: Experimental
description: Under general anesthesia ,abdominal exploration ,removal of a ganglionic part by soav ,duhamel procedures and trans-anal pull through procedures.
intervention type: Procedure
intervention name: laparoscopic assisted pull-through oeration
description: Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,
arm group label: laparoscopic operated group
arm group label: non laparoscopic operated group
criteria: 
gender: All
minimum age: 6 Months
maximum age: 36 Months
healthy volunteers: No
last name: Mohammed Hamada Takrouney
phone: +201009321033
email: m.takrouney1988@gmail.com
last name: Ibrahim Ali Ibrahim
phone: +201005801291
email: Dr.ibrahimali@yahoo.com
citation: Tomuschat C, Zimmer J, Puri P. Laparoscopic-assisted pull-through operation for Hirschsprung's disease: a systematic review and meta-analysis. Pediatr Surg Int. 2016 Aug;32(8):751-7. doi: 10.1007/s00383-016-3910-5. Epub 2016 Jul 1.
PMID: 27369964
citation: Taguchi T, Obata S, Ieiri S. Current status of Hirschsprung's disease: based on a nationwide survey of Japan. Pediatr Surg Int. 2017 Apr;33(4):497-504. doi: 10.1007/s00383-016-4054-3. Epub 2017 Jan 5.
PMID: 28058486
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Mohammed Hamada Takrouney
investigator title: Principal investigator and Assistant lecturer of pediatric surgery
mesh term: Hirschsprung Disease