<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT201102085783N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-05-10</date_registration>
      <primary_sponsor>Baqiyatallah University of Medical Sciences,</primary_sponsor>
      <public_title>Comparison of "Read-Rives" and ''Lichtenstein'' repair for treatment of unilateral inguinal hernia.</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of "Read-Rives" and ''Lichtenstein'' repair for treatment of unilateral inguinal hernia.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2002-04-04</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>126</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/6277</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other.</study_design>
      <phase>0 (exploratory trials)</phase>
      <hc_freetext>inguinal hernia.</hc_freetext>
      <i_freetext>Intervention 1: Rives procedures were done through the longitudinal opening in the transversalis fascia in the inguinal floor, at the first, the prepritoneal space was dissected and the spermatic cord was parietalized, after that, a 10×15cm of mesh was implanted in front of the peritoneum, and the mesh was held in place with 2/0 nylon sutures to pubic tubercle, cooper ligament, and psoas muscle. Finally the fascia was closed over the mesh. Intervention 2: In the Lichtenstein repair for large direct hernias the sac was reduced into the prepritoneal space with purse string over it. We preferred using of a 10×15cm polypropylene (proline) mesh prosthesis for all the patients. In the Lichtenstein repair, the mesh was placed over the transversalis fascia and secured with 2/0 nylon sutures to pubic tubercle, inguinal ligament, and anterior rectus sheet.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Jamal Akhavan Moghaddam</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mollasadra Ave, Vanak Square,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8803 3539</telephone>
        <email>dr-akhavan@yahoo.com</email>
        <affiliation>Dept. of Surgery, Baqiyatallah University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Shaban Mehrvarz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Mollasadra Ave, Vanak Square,</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1435915371</zip>
        <telephone>+98 21 8803 3539</telephone>
        <email>mehrvarz@bmsu.ac.ir</email>
        <affiliation>Baqiyatallah University of Medical Sciences,</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Presence of type III and IV (Nyhus classification) &#13;
Exclusion criteria: Morbidly obese patients, presence of incarcerated or strangulated hernias</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>K40.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Unilateral or unspecified inguinal hernia, without obstruction or gangrene</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Rives procedures were done through the longitudinal opening in the transversalis fascia in the inguinal floor, at the first, the prepritoneal space was dissected and the spermatic cord was parietalized, after that, a 10×15cm of mesh was implanted in front of the peritoneum, and the mesh was held in place with 2/0 nylon sutures to pubic tubercle, cooper ligament, and psoas muscle. Finally the fascia was closed over the mesh.</i_keyword>
      <i_keyword>In the Lichtenstein repair for large direct hernias the sac was reduced into the prepritoneal space with purse string over it. We preferred using of a 10×15cm polypropylene (proline) mesh prosthesis for all the patients. In the Lichtenstein repair, the mesh was placed over the transversalis fascia and secured with 2/0 nylon sutures to pubic tubercle, inguinal ligament, and anterior rectus sheet.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Early post-operative complications (i.e. infection, hematoma, unusual pain),. Timepoint: weekly. Method of measurement: visit and telephone.</prim_outcome>
      <prim_outcome>Post op pain. Timepoint: first potoprative day. Method of measurement: Visual Analog Scale(VAS).</prim_outcome>
      <prim_outcome>Return to normal activity. Timepoint: weekly. Method of measurement: Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Recurrence Rate. Timepoint: weekiy. Method of measurement: visit.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Baqiyatallah University of Medical Sciences,</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2004-04-26</approval_date>
        <contact_name>Baqiyatallah University of Medical Sciences</contact_name>
        <contact_address>Mollasadra Ave, Vanak Square, Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
