<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/NCT02239185</url>
  </required_header>
  <id_info>
    <org_study_id>CTP-2014</org_study_id>
    <secondary_id>RAFIK-2014</secondary_id>
    <nct_id>NCT02239185</nct_id>
  </id_info>
  <brief_title>Laparoscopic Inguinal Hernia Repair in Infancy and Childhood</brief_title>
  <acronym>LIHR-2014</acronym>
  <official_title>Laparoscopic Inguinal Hernia Repair in Infancy and Childhood; a Prospective Controlled Randomized Study of Two Different Technique</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study The aim of this study is to test the hypothesis that during laparoscopic&#xD;
      hernia repair, disconnection of the hernial sac along with suture ligation of the neck is&#xD;
      better than transperitoneal purse string suture around the hernial sac at the neck leaving&#xD;
      the sac in continuity. Also to compare the two different laparoscopic techniques as regards&#xD;
      operative time, recurrence rate, hydrocele formation, and other possible complications as&#xD;
      bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic&#xD;
      results.&#xD;
&#xD;
      ..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ethical Consideration:&#xD;
&#xD;
      The protocol will be discussed and approved for clinical study by the Ethical Research&#xD;
      Committee of our University. The procedures and the aim of the study are clearly explained to&#xD;
      the patient and the family. A written informed consent is obtained before enrollment of the&#xD;
      patients into the study. The family refusal to give consent for laparoscopic hernia repair by&#xD;
      either technique does not deprive the patient from getting surgical care by open herniotomy&#xD;
&#xD;
      • In the 2 groups, after induction of general endotracheal tube anesthesia, the patient is&#xD;
      positioned supine in Trendelenburg's position. Insertion of the main umbilical port [5-mm] by&#xD;
      open technique will be done for 5-mm 30° telescope, then pneumoperitoneum will be created to&#xD;
      a pressure of 8-12 mmHg.&#xD;
&#xD;
      Laparoscopy will be used for initial visualization of the pelvis and internal inguinal rings&#xD;
      on both sides. In group I, the laparoscopic hernia repair will be done according to a&#xD;
      technique described by Scheir Two 3-mm trocars are inserted under laparoscopic guidance at&#xD;
      the level of umbilicus in mid-clavicular line on either side as working ports unilateral&#xD;
      hernia, on the side of hernia can be little higher and opposite side little lower, for better&#xD;
      triangulation. In infants and small babies, the working ports are placed little higher than&#xD;
      the level of umbilicus.&#xD;
&#xD;
      Non absorbable 3-0 Prolene suture is used in all patients after its shortening to 8cm.length.&#xD;
&#xD;
      Group I, laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 -&#xD;
      0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well&#xD;
      visualized and protected during the suture. In all cases, hydro dissection can be done by&#xD;
      injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders&#xD;
      are used for intracorporeal insertion of purse string suture around the opened IIR with&#xD;
      intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular&#xD;
      tissue lateral to the spermatic cord. The procedure is modified in children with a dilated&#xD;
      internal ring. Ligature of the hernia sac at internal inguinal ring (IIR) is inadequate in&#xD;
      such cases. Here, laparoscopic narrowing of IIR by few interrupted sutures will be done.&#xD;
&#xD;
      Group II, circumferential incision on the peritoneum at IIR will be started to separate&#xD;
      hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and&#xD;
      then the peritoneum posterior to the internal ring will be divided and then the anterior&#xD;
      disconnection will be carried out. Saline can be injected to separate the peritoneum from&#xD;
      cord structures (hydro dissection). Care is taken not to damage the vas and vessels by&#xD;
      handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0&#xD;
      prolene on round body needle. Closure: In both groups, supra-umbilical incision will be&#xD;
      closed with polyglycolic acid 3-0 suture. Three mm trocar sites will be approximated with the&#xD;
      steri-strips.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Recurrence</measure>
    <time_frame>At 3 and 6 months post operatively</time_frame>
    <description>All Patients will be subjected to post operative clinical examination and scrotal U/S for assessment of the recurrence. Recurrence is identified by visual of a bulg at the site of hernia on crying and the presence of defect more than 4 mm. In diameter</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Operative time</measure>
    <time_frame>intra operative time is measured from skin incision to skin closure</time_frame>
    <description>The operative time will be measured by minutes in both group. The operative time is measured from skin incision to skin closure. It does not enclude induction and recovery of anesthesia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative hydrocele formation</measure>
    <time_frame>at 1 and 3 months post operatively</time_frame>
    <description>Post operative hydrocele formation is evaluated by clinical and U/S examination. It is measured by milliter of fluids in the tunica vaginalis around the testis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Congenital Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Hernial sac ligation in continuity</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>laparoscopic closure of hernia sac in continuity using 3 - 0 non-absorbable purse-string suture. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hernial sac disconnection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>circumferential incision on the peritoneum at internal inguinal ring (IIR) with separation of hernia sac from the peritoneum. The proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hernial sac ligation in continuity</intervention_name>
    <description>Laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring.</description>
    <arm_group_label>Hernial sac ligation in continuity</arm_group_label>
    <other_name>Purse string suture around IIR leaving the sac in continuity</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Hernial sac disconnection</intervention_name>
    <description>Circumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.</description>
    <arm_group_label>Hernial sac disconnection</arm_group_label>
    <other_name>Laparoscopic disconnection of the hernial sac at IIR</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Bilateral congenital inguinal hernia (CIH), recurrent cases, unilateral cases with&#xD;
        questionable other side, parental request and cases with CIH associated with umbilical&#xD;
        hernia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Hernia of canal of Nuck in females, Inguinal hernia with undescended testis, Parental&#xD;
        refusal, Contraindications for laparoscopy as lower major abdominal surgery&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>3 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rafik MI Shalaby, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Al-Azhar University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rafik Shalaby</name>
      <address>
        <city>Cairo</city>
        <zip>11884</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Shalaby R, Ibrahem R, Shahin M, Yehya A, Abdalrazek M, Alsayaad I, Shouker MA. Laparoscopic Hernia Repair versus Open Herniotomy in Children: A Controlled Randomized Study. Minim Invasive Surg. 2012;2012:484135. doi: 10.1155/2012/484135. Epub 2012 Dec 27.</citation>
    <PMID>23326656</PMID>
  </reference>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>February 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>January 17, 2020</last_update_submitted>
  <last_update_submitted_qc>January 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Al-Azhar University</investigator_affiliation>
    <investigator_full_name>Rafik Shalaby</investigator_full_name>
    <investigator_title>professor</investigator_title>
  </responsible_party>
  <keyword>Laparoscopy</keyword>
  <keyword>purse string</keyword>
  <keyword>hernial sac</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Inguinal</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/NCT02239185
org study id: CTP-2014
secondary id: RAFIK-2014
nct id: NCT02239185
lead sponsor: 
has dmc: No
Aim of the study The aim of this study is to test the hypothesis that during laparoscopic
      hernia repair, disconnection of the hernial sac along with suture ligation of the neck is
      better than transperitoneal purse string suture around the hernial sac at the neck leaving
      the sac in continuity. Also to compare the two different laparoscopic techniques as regards
      operative time, recurrence rate, hydrocele formation, and other possible complications as
      bleeding, hematoma, injury of the vas and testicular atrophy and post-operative cosmetic
      results.

      ..
Ethical Consideration:

      The protocol will be discussed and approved for clinical study by the Ethical Research
      Committee of our University. The procedures and the aim of the study are clearly explained to
      the patient and the family. A written informed consent is obtained before enrollment of the
      patients into the study. The family refusal to give consent for laparoscopic hernia repair by
      either technique does not deprive the patient from getting surgical care by open herniotomy

      • In the 2 groups, after induction of general endotracheal tube anesthesia, the patient is
      positioned supine in Trendelenburg's position. Insertion of the main umbilical port [5-mm] by
      open technique will be done for 5-mm 30° telescope, then pneumoperitoneum will be created to
      a pressure of 8-12 mmHg.

      Laparoscopy will be used for initial visualization of the pelvis and internal inguinal rings
      on both sides. In group I, the laparoscopic hernia repair will be done according to a
      technique described by Scheir Two 3-mm trocars are inserted under laparoscopic guidance at
      the level of umbilicus in mid-clavicular line on either side as working ports unilateral
      hernia, on the side of hernia can be little higher and opposite side little lower, for better
      triangulation. In infants and small babies, the working ports are placed little higher than
      the level of umbilicus.

      Non absorbable 3-0 Prolene suture is used in all patients after its shortening to 8cm.length.

      Group I, laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 -
      0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well
      visualized and protected during the suture. In all cases, hydro dissection can be done by
      injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders
      are used for intracorporeal insertion of purse string suture around the opened IIR with
      intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular
      tissue lateral to the spermatic cord. The procedure is modified in children with a dilated
      internal ring. Ligature of the hernia sac at internal inguinal ring (IIR) is inadequate in
      such cases. Here, laparoscopic narrowing of IIR by few interrupted sutures will be done.

      Group II, circumferential incision on the peritoneum at IIR will be started to separate
      hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and
      then the peritoneum posterior to the internal ring will be divided and then the anterior
      disconnection will be carried out. Saline can be injected to separate the peritoneum from
      cord structures (hydro dissection). Care is taken not to damage the vas and vessels by
      handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0
      prolene on round body needle. Closure: In both groups, supra-umbilical incision will be
      closed with polyglycolic acid 3-0 suture. Three mm trocar sites will be approximated with the
      steri-strips.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recurrence
time frame: At 3 and 6 months post operatively
description: All Patients will be subjected to post operative clinical examination and scrotal U/S for assessment of the recurrence. Recurrence is identified by visual of a bulg at the site of hernia on crying and the presence of defect more than 4 mm. In diameter
measure: Operative time
time frame: intra operative time is measured from skin incision to skin closure
description: The operative time will be measured by minutes in both group. The operative time is measured from skin incision to skin closure. It does not enclude induction and recovery of anesthesia.
measure: Post operative hydrocele formation
time frame: at 1 and 3 months post operatively
description: Post operative hydrocele formation is evaluated by clinical and U/S examination. It is measured by milliter of fluids in the tunica vaginalis around the testis
arm group label: Hernial sac ligation in continuity
arm group type: Other
description: laparoscopic closure of hernia sac in continuity using 3 - 0 non-absorbable purse-string suture. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying.
arm group label: Hernial sac disconnection
arm group type: Other
description: circumferential incision on the peritoneum at internal inguinal ring (IIR) with separation of hernia sac from the peritoneum. The proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.
intervention type: Procedure
intervention name: Hernial sac ligation in continuity
description: Laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring.
arm group label: Hernial sac ligation in continuity
other name: Purse string suture around IIR leaving the sac in continuity
intervention type: Procedure
intervention name: Hernial sac disconnection
description: Circumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.
arm group label: Hernial sac disconnection
other name: Laparoscopic disconnection of the hernial sac at IIR
criteria: 
gender: Male
minimum age: 6 Months
maximum age: 3 Years
healthy volunteers: No
last name: Rafik MI Shalaby, MD
role: Principal Investigator
affiliation: Al-Azhar University
facility: 
country: Egypt
citation: Shalaby R, Ibrahem R, Shahin M, Yehya A, Abdalrazek M, Alsayaad I, Shouker MA. Laparoscopic Hernia Repair versus Open Herniotomy in Children: A Controlled Randomized Study. Minim Invasive Surg. 2012;2012:484135. doi: 10.1155/2012/484135. Epub 2012 Dec 27.
PMID: 23326656
responsible party type: Principal Investigator
investigator affiliation: Al-Azhar University
investigator full name: Rafik Shalaby
investigator title: professor
mesh term: Hernia
mesh term: Hernia, Inguinal