<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/NCT04430816</url>
  </required_header>
  <id_info>
    <org_study_id>compared chevrel hazem</org_study_id>
    <nct_id>NCT04430816</nct_id>
  </id_info>
  <brief_title>Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty</brief_title>
  <official_title>Management Of Large Incisional Hernia, Double Mesh Modification Of Chevrel's Technique Versus On Lay Mesh Hernioplasty, A Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <has_dmc>No</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>
      comparison between two groups of large midline incisional hernia, the first group managed by&#xD;
      double mesh modification of chevrel's technique the second one managed by conventional onlay&#xD;
      mesh repair&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This comparative study was carried out in general surgery unit, Zagazig university hospitals,&#xD;
      between January 2018 and December 2020, on 43 cases with large incisional hernia,&#xD;
      participants were randomly allocated according to the deemed option of management into two&#xD;
      groups, group A, the modified Chevrel group, 22 participants were treated by double mesh&#xD;
      modification of Chevrel's technique, and group B, the on-lay group, participants treated by&#xD;
      anatomical repair and fixation of non-absorbable mesh in on-lay position.&#xD;
&#xD;
      inclusion criteria&#xD;
&#xD;
        -  &gt; 18 years old suffering large midline incisional hernia. exclusion criteria&#xD;
&#xD;
        -  complicated incisional hernia,&#xD;
&#xD;
        -  advanced cardiac, respiratory, liver and renal diseases&#xD;
&#xD;
        -  patients with abdominal and abdominal wall malignancy&#xD;
&#xD;
        -  ASA III and IV The study condition is the large midline incisional hernia defined as&#xD;
           hernia following mid line incision, its defect is 10 cm or more in any of its diameters.&#xD;
&#xD;
      The main outcome of the study is recurrence of hernia and local complications mainly skin&#xD;
      sloughing, seroma formation and wound infection.&#xD;
&#xD;
      All the study participants signed an informed written consent, the study was approved by our&#xD;
      local ethical committee and institutional review board All the study participants were&#xD;
      subjected to thorough history taking and full systemic and abdominal examination chest X ray,&#xD;
      abdomino-pelvic ultrasound examination, measuring of the defect by ultrasound or abdominal CT&#xD;
      if needed, preoperative routine laboratory tests, fractionated heparin was given when&#xD;
      indicated as a prophylaxis for deep venous thrombosis (BMI &gt;35, previous history of DVT,),&#xD;
      they were given third generation cephalosporins just before the induction of anesthesia.&#xD;
&#xD;
      Procedures :&#xD;
&#xD;
      In participants of the double mesh modification of Chevrel's technique, after excision of the&#xD;
      previous scar, skin and subcutaneous tissue was dissected off the hernia sac, the sac was&#xD;
      then opened, released off intra-abdominal adhesions and resected, the real defect size was&#xD;
      measured, the skin and subcutaneous tissue was dissected off the anterior rectus sheath,&#xD;
      dissection was limited to less than 2 cm lateral to the hernia defect edges.&#xD;
&#xD;
      Then, a bilateral vertical incisions of the anterior rectus sheath was done parallel to the&#xD;
      midline and at maximum 2 cm far from it thus two medial anterior rectus sheath flaps could be&#xD;
      created and dissected off the rectus abdominis muscles on both sides, dissection of both&#xD;
      recti abdominis muscles was continued to be separated off the posterior rectus sheath opening&#xD;
      the retro-rectus space, linea alba was reformed by suturing each of the newly formed medial&#xD;
      anterior rectus sheath flaps to its fellow of the other side, using Vicryl\0 sutures, the&#xD;
      flaps help tension free closure of the defect and formation of a common posterior rectus&#xD;
      sheath,&#xD;
&#xD;
      A prolene mesh was spread in the retro-rectus space, extending between the two lateral ends&#xD;
      of the space and 4 cm beyond the vertical edges of the defect, fixed to the posterior sheath&#xD;
      with prolene sutures .&#xD;
&#xD;
      At the end the anterior rectus sheath was closed with prolene mesh tailored to the space&#xD;
      between lateral flaps of anterior rectus sheath, and sutured to their medial edges with&#xD;
      interrupted non absorbable sutures .&#xD;
&#xD;
      In the group of on-lay mesh repair the old scar was excised, the sac was laid open at its&#xD;
      fundus, adhesolysis was done to free the abdominal viscera from the parietal peritoneum, the&#xD;
      sac was excised, skin and subcutaneous tissue were dissected of the anterior rectus sheath&#xD;
      till the linea semilunaris, taking care to preserve the perforating vessels, anatomical&#xD;
      repair was done by midline closure with prolene 1\0 non absorbable interrupted suture, a&#xD;
      prolene mesh was fixed in on-lay position by prolene 2\0 sutures.&#xD;
&#xD;
      In both groups after proper hemostasis a suction drain was left over the mesh, subcutaneous&#xD;
      tissue was approximated by vicryl 3\0 skin closed by prolene 3\0.in the postoperative period&#xD;
      patients received non-steroid pain killer according to need and third generation&#xD;
      cephalosporin intravenous injection, wounds were observed after 24 hours for assessment of&#xD;
      any local wound complications specially skin flap ischemia, after discharge patients were&#xD;
      followed up in the outpatients clinic by the attending surgeon, follow up data including&#xD;
      (wound complications as sloughing of skin flap, drainage amount and duration, corset feeling,&#xD;
      parasthesia of abdominal wall and corset feeling) was collected in each visit, two months&#xD;
      after operation an abdominal wall ultrasound examination was done for detection of early&#xD;
      recurrence, a clinic visits or phone contact was done every 6 months till the end of the&#xD;
      study.&#xD;
&#xD;
      Continues data was presented in mean and standard deviation, statistically analyzed using t&#xD;
      test, z test, in SPSS program 22&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>two groups of patients with incisional hernia group A underwent double mesh modification of chevrel's technique, group B underwent onlay mesh hernioplasty</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>the participants don't know the procedure they will undergo</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of skin flap ischemia</measure>
    <time_frame>24 hours postoperative</time_frame>
    <description>impaired capillary filling of wound skin flaps , measured by clinical examination (capillary filling time &gt; 2 seconds)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of seroma formation</measure>
    <time_frame>24 hours after drain removal</time_frame>
    <description>presence of more than 20 ml serous fluid collected around the mesh prosthesis measured by superficial probe ultrasound</description>
  </primary_outcome>
  <primary_outcome>
    <measure>incidence of hernia recurrence</measure>
    <time_frame>in the first 2 years post operative</time_frame>
    <description>presence of hernia defect of any size in the midline or near it detected by ultrasound or coputerized tomography scan of the anterior abdominal wall</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>difference between operative time of both groups</measure>
    <time_frame>1 day</time_frame>
    <description>the time between the start point of the operative procedure and the end of the operative procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Hernia Incisional Ventral</condition>
  <arm_group>
    <arm_group_label>modified chevrel technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>22 participant with large midline incisional hernia underwent repair by double mesh modification of chevrel's technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ON LAY mesh hernioplasty</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>21 participant with large midline incisional hernia underwent repair by online mesh hernioplasty</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>double mesh modification of chevrel's technique</intervention_name>
    <description>repair of midline incisional hernia by double mesh modification of chevrel's technique</description>
    <arm_group_label>modified chevrel technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>on lay mesh hernioplasty</intervention_name>
    <description>repair of midline incisional hernia by online mesh hernioplasty</description>
    <arm_group_label>ON LAY mesh hernioplasty</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • above 18 years old suffering large midline incisional hernia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  complicated incisional hernia,&#xD;
&#xD;
          -  advanced cardiac, respiratory, liver and renal diseases&#xD;
&#xD;
          -  patients with abdominal and abdominal wall malignancy&#xD;
&#xD;
          -  ASA III and IV&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>hazem nour, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>zag university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zagazig Faculty of Medicine</name>
      <address>
        <city>Zagazig</city>
        <state>Sharqya</state>
        <zip>44519</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 11, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 11, 2020</last_update_submitted>
  <last_update_submitted_qc>June 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Hazem Nour Abdellatif</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>midline incisional hernia chevrel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Incisional Hernia</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/NCT04430816
org study id: compared chevrel hazem
nct id: NCT04430816
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
comparison between two groups of large midline incisional hernia, the first group managed by
      double mesh modification of chevrel's technique the second one managed by conventional onlay
      mesh repair
This comparative study was carried out in general surgery unit, Zagazig university hospitals,
      between January 2018 and December 2020, on 43 cases with large incisional hernia,
      participants were randomly allocated according to the deemed option of management into two
      groups, group A, the modified Chevrel group, 22 participants were treated by double mesh
      modification of Chevrel's technique, and group B, the on-lay group, participants treated by
      anatomical repair and fixation of non-absorbable mesh in on-lay position.

      inclusion criteria

        -  > 18 years old suffering large midline incisional hernia. exclusion criteria

        -  complicated incisional hernia,

        -  advanced cardiac, respiratory, liver and renal diseases

        -  patients with abdominal and abdominal wall malignancy

        -  ASA III and IV The study condition is the large midline incisional hernia defined as
           hernia following mid line incision, its defect is 10 cm or more in any of its diameters.

      The main outcome of the study is recurrence of hernia and local complications mainly skin
      sloughing, seroma formation and wound infection.

      All the study participants signed an informed written consent, the study was approved by our
      local ethical committee and institutional review board All the study participants were
      subjected to thorough history taking and full systemic and abdominal examination chest X ray,
      abdomino-pelvic ultrasound examination, measuring of the defect by ultrasound or abdominal CT
      if needed, preoperative routine laboratory tests, fractionated heparin was given when
      indicated as a prophylaxis for deep venous thrombosis (BMI >35, previous history of DVT,),
      they were given third generation cephalosporins just before the induction of anesthesia.

      Procedures :

      In participants of the double mesh modification of Chevrel's technique, after excision of the
      previous scar, skin and subcutaneous tissue was dissected off the hernia sac, the sac was
      then opened, released off intra-abdominal adhesions and resected, the real defect size was
      measured, the skin and subcutaneous tissue was dissected off the anterior rectus sheath,
      dissection was limited to less than 2 cm lateral to the hernia defect edges.

      Then, a bilateral vertical incisions of the anterior rectus sheath was done parallel to the
      midline and at maximum 2 cm far from it thus two medial anterior rectus sheath flaps could be
      created and dissected off the rectus abdominis muscles on both sides, dissection of both
      recti abdominis muscles was continued to be separated off the posterior rectus sheath opening
      the retro-rectus space, linea alba was reformed by suturing each of the newly formed medial
      anterior rectus sheath flaps to its fellow of the other side, using Vicryl\0 sutures, the
      flaps help tension free closure of the defect and formation of a common posterior rectus
      sheath,

      A prolene mesh was spread in the retro-rectus space, extending between the two lateral ends
      of the space and 4 cm beyond the vertical edges of the defect, fixed to the posterior sheath
      with prolene sutures .

      At the end the anterior rectus sheath was closed with prolene mesh tailored to the space
      between lateral flaps of anterior rectus sheath, and sutured to their medial edges with
      interrupted non absorbable sutures .

      In the group of on-lay mesh repair the old scar was excised, the sac was laid open at its
      fundus, adhesolysis was done to free the abdominal viscera from the parietal peritoneum, the
      sac was excised, skin and subcutaneous tissue were dissected of the anterior rectus sheath
      till the linea semilunaris, taking care to preserve the perforating vessels, anatomical
      repair was done by midline closure with prolene 1\0 non absorbable interrupted suture, a
      prolene mesh was fixed in on-lay position by prolene 2\0 sutures.

      In both groups after proper hemostasis a suction drain was left over the mesh, subcutaneous
      tissue was approximated by vicryl 3\0 skin closed by prolene 3\0.in the postoperative period
      patients received non-steroid pain killer according to need and third generation
      cephalosporin intravenous injection, wounds were observed after 24 hours for assessment of
      any local wound complications specially skin flap ischemia, after discharge patients were
      followed up in the outpatients clinic by the attending surgeon, follow up data including
      (wound complications as sloughing of skin flap, drainage amount and duration, corset feeling,
      parasthesia of abdominal wall and corset feeling) was collected in each visit, two months
      after operation an abdominal wall ultrasound examination was done for detection of early
      recurrence, a clinic visits or phone contact was done every 6 months till the end of the
      study.

      Continues data was presented in mean and standard deviation, statistically analyzed using t
      test, z test, in SPSS program 22
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: two groups of patients with incisional hernia group A underwent double mesh modification of chevrel's technique, group B underwent onlay mesh hernioplasty
primary purpose: Treatment
masking: Single (Participant)
masking description: the participants don't know the procedure they will undergo
measure: incidence of skin flap ischemia
time frame: 24 hours postoperative
description: impaired capillary filling of wound skin flaps , measured by clinical examination (capillary filling time > 2 seconds)
measure: incidence of seroma formation
time frame: 24 hours after drain removal
description: presence of more than 20 ml serous fluid collected around the mesh prosthesis measured by superficial probe ultrasound
measure: incidence of hernia recurrence
time frame: in the first 2 years post operative
description: presence of hernia defect of any size in the midline or near it detected by ultrasound or coputerized tomography scan of the anterior abdominal wall
measure: difference between operative time of both groups
time frame: 1 day
description: the time between the start point of the operative procedure and the end of the operative procedure
arm group label: modified chevrel technique
arm group type: Active Comparator
description: 22 participant with large midline incisional hernia underwent repair by double mesh modification of chevrel's technique
arm group label: ON LAY mesh hernioplasty
arm group type: Active Comparator
description: 21 participant with large midline incisional hernia underwent repair by online mesh hernioplasty
intervention type: Procedure
intervention name: double mesh modification of chevrel's technique
description: repair of midline incisional hernia by double mesh modification of chevrel's technique
arm group label: modified chevrel technique
intervention type: Procedure
intervention name: on lay mesh hernioplasty
description: repair of midline incisional hernia by online mesh hernioplasty
arm group label: ON LAY mesh hernioplasty
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: hazem nour, MD
role: Principal Investigator
affiliation: zag university
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Hazem Nour Abdellatif
investigator title: Assistant professor
mesh term: Hernia
mesh term: Incisional Hernia
sharing ipd: No