<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/NCT04437784</url>
  </required_header>
  <id_info>
    <org_study_id>302765</org_study_id>
    <nct_id>NCT04437784</nct_id>
  </id_info>
  <brief_title>Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia</brief_title>
  <official_title>Laparoscopic Versus Open Mesh Repair of Bilateral Primary Inguinal Hernia; 3 Armed Randomized Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Alexandria 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>
      The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The&#xD;
      aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of&#xD;
      bilateral primary inguinal hernia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This prospective study included 180 patients with bilateral primary inguinal hernia;&#xD;
      randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by&#xD;
      laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II&#xD;
      treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral&#xD;
      Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative&#xD;
      complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2014</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Double (Participant, Investigator)</masking>
    <masking_description>Sealed opaque envelopes containing computer generated random numbers</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time</measure>
    <time_frame>From skin incision until incision closure at the end of surgery</time_frame>
    <description>Operative time (in minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain after 24 hours</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain after 7 days</measure>
    <time_frame>7 days after surgery</time_frame>
    <description>Pain intensity was assessed 7 days after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Early postoperative complications</measure>
    <time_frame>Within 30 days after the surgery</time_frame>
    <description>All complication related to surgery developed within 30 days after the surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Chronic Groin pain</measure>
    <time_frame>After 3 months postoperatively</time_frame>
    <description>Groin pain lasting for more than 3 months after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 years hernia recurrence rate</measure>
    <time_frame>within 3 years after surgery</time_frame>
    <description>Unilateral or bilateral - residual or recurrent hernia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient's satisfaction score</measure>
    <time_frame>within 3 years after surgery</time_frame>
    <description>Patient satisfaction was assessed using 1 to 10 scale where: 9-10 means very satisfied, 7-8: satisfied, 6-7: neutral, 4-5: dissatisfied, &lt;4: very dissatisfied</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Bilateral Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open Pre-Peritoneal Repair ( Open PP group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilateral Lichtenstein repair (LICHT group)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Trans-Abdominal Pre-Peritoneal</intervention_name>
    <description>Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers</description>
    <arm_group_label>Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open pre-peritoneal repair</intervention_name>
    <description>Open pre-peritoneal single mesh repair with suture fixation</description>
    <arm_group_label>Open Pre-Peritoneal Repair ( Open PP group)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral Lichtenstein repair</intervention_name>
    <description>Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation</description>
    <arm_group_label>Bilateral Lichtenstein repair (LICHT group)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with painless uncomplicated primary bilateral inguinal hernias&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Immune compromised patients&#xD;
&#xD;
          -  Coagulopathy&#xD;
&#xD;
          -  Chronic liver or renal disease&#xD;
&#xD;
          -  High-risk patients unfit for major surgery (ASA III or IV),&#xD;
&#xD;
          -  Massive scrotal hernias, Recurrent or Complicated hernias&#xD;
&#xD;
          -  Groin pain due to any other pathology&#xD;
&#xD;
          -  Previous infra-umbilical surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed Elmessiry, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor of Surgery</affiliation>
  </overall_official>
  <reference>
    <citation>Sarli L, Iusco DR, Sansebastiano G, Costi R. Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach. Surg Laparosc Endosc Percutan Tech. 2001 Aug;11(4):262-7. doi: 10.1097/00129689-200108000-00007.</citation>
    <PMID>11525372</PMID>
  </reference>
  <reference>
    <citation>Feliu X, Claveria R, Besora P, Camps J, Fernandez-Sallent E, Vinas X, Abad JM. Bilateral inguinal hernia repair: laparoscopic or open approach? Hernia. 2011 Feb;15(1):15-8. doi: 10.1007/s10029-010-0736-2. Epub 2010 Oct 21.</citation>
    <PMID>20960019</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 16, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>June 17, 2020</last_update_submitted>
  <last_update_submitted_qc>June 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alexandria University</investigator_affiliation>
    <investigator_full_name>Mohamed El Messiry</investigator_full_name>
    <investigator_title>Assistant professor of Surgery</investigator_title>
  </responsible_party>
  <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>
  <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/NCT04437784
org study id: 302765
nct id: NCT04437784
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The best approach for simultaneous repair of bilateral inguinal hernia is controversial. The
      aim of this study is to compare the outcomes after laparoscopic versus open mesh repair of
      bilateral primary inguinal hernia
This prospective study included 180 patients with bilateral primary inguinal hernia;
      randomized by sealed envelopes into 3 groups; each includes 60 patients. Group I treated by
      laparoscopic trans-abdominal pre-peritoneal (TAPP) repair using 2 separate meshes, Group II
      treated by open pre-peritoneal (PP) single mesh repair, while Group III treated by bilateral
      Lichtenstein repair. The 3 groups were compared regarding: operative time, postoperative
      complications, postoperative pain, 3 years-recurrence rate and patient's satisfaction.

      .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: Sealed opaque envelopes containing computer generated random numbers
measure: Operative time
time frame: From skin incision until incision closure at the end of surgery
description: Operative time (in minutes)
measure: Postoperative pain after 24 hours
time frame: 24 hours after surgery
description: Pain intensity was assessed 24 hours after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
measure: Postoperative pain after 7 days
time frame: 7 days after surgery
description: Pain intensity was assessed 7 days after surgery using the pain visual analogue scale (VAS) with values ranging from 1 (no pain) to 10 (worst possible pain)
measure: Early postoperative complications
time frame: Within 30 days after the surgery
description: All complication related to surgery developed within 30 days after the surgery
measure: Chronic Groin pain
time frame: After 3 months postoperatively
description: Groin pain lasting for more than 3 months after surgery
measure: 3 years hernia recurrence rate
time frame: within 3 years after surgery
description: Unilateral or bilateral - residual or recurrent hernia
measure: Patient's satisfaction score
time frame: within 3 years after surgery
description: Patient satisfaction was assessed using 1 to 10 scale where: 9-10 means very satisfied, 7-8: satisfied, 6-7: neutral, 4-5: dissatisfied, <4: very dissatisfied
arm group label: Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))
arm group type: Active Comparator
description: Both hernias were treated by laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
arm group label: Open Pre-Peritoneal Repair ( Open PP group)
arm group type: Active Comparator
description: Both hernias were treated by open pre-peritoneal single mesh repair with suture fixation
arm group label: Bilateral Lichtenstein repair (LICHT group)
arm group type: Active Comparator
description: treated by bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation
intervention type: Procedure
intervention name: Laparoscopic Trans-Abdominal Pre-Peritoneal
description: Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
arm group label: Laparoscopic Trans-Abdominal Pre-Peritoneal (Lap TAPP group))
intervention type: Procedure
intervention name: Open pre-peritoneal repair
description: Open pre-peritoneal single mesh repair with suture fixation
arm group label: Open Pre-Peritoneal Repair ( Open PP group)
intervention type: Procedure
intervention name: Bilateral Lichtenstein repair
description: Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation
arm group label: Bilateral Lichtenstein repair (LICHT group)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mohamed Elmessiry, MD, PhD
role: Principal Investigator
affiliation: Assistant Professor of Surgery
citation: Sarli L, Iusco DR, Sansebastiano G, Costi R. Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach. Surg Laparosc Endosc Percutan Tech. 2001 Aug;11(4):262-7. doi: 10.1097/00129689-200108000-00007.
PMID: 11525372
citation: Feliu X, Claveria R, Besora P, Camps J, Fernandez-Sallent E, Vinas X, Abad JM. Bilateral inguinal hernia repair: laparoscopic or open approach? Hernia. 2011 Feb;15(1):15-8. doi: 10.1007/s10029-010-0736-2. Epub 2010 Oct 21.
PMID: 20960019
responsible party type: Principal Investigator
investigator affiliation: Alexandria University
investigator full name: Mohamed El Messiry
investigator title: Assistant professor of Surgery
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: No