<?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>IRCT2017061317756N19</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-06-18</date_registration>
      <primary_sponsor>Vice-Chancellor for Research, Birjand University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of the outcomes of Lichtenstein and Read-Rives surgical procedures in patients with unilateral inguinal hernia</public_title>
      <acronym></acronym>
      <scientific_title>A clinical trial on the outcomes of Read-Rives and Lichtenstein surgical procedures for inguinal hernia in patients with unilateral inguinal hernia</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-03-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>70</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/16259</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>unilateral inguinal hernia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention Group 1 (Lichtenstein Tension-Free Mesh Repair): After primary open incision and dissection of spermatic cord, the hernia sac will be identified and isolated. A 7.5 × 15 cm piece of polypropylene mesh will be placed on posterior wall of inguinal canal. The first medial-most stitch fixes the mesh 2 cm medial to the pubic tubercle, where the anterior rectus sheath inserts into the pubic bone. The same suture is then used as a continuous suture to fix the lower edge of the mesh to the free lower border of inguinal ligament up to a point just lateral to the internal ring. With the mesh kept lax, its upper edge is then fixed to the rectus sheath and the internal oblique aponeurosis with two or three interrupted nonabsorbable sutures. The two tails are then tucked together and fixed to the inguinal ligament just lateral to the internal ring, thus creating a new internal ring made of mesh. Intervention 2: Intervention Group 2 (Read-Rives procedure): Read-Rives procedure is performed through the longitudinal opening in the transversalis fascia in the inguinal floor. At first, the prepritoneal space is dissected and the spermatic cord is parietalized. Afterwards, a 10×15 cm of mesh is implanted in front of the peritoneum, and the mesh is held in place with 2/0 nylon sutures to pubic tubercle, cooper ligament, and psoas muscle. Finally, the fascia is closed over the mesh.</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>Hamed Mashayekhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Birjand University of Medical Sciences, Ghaffari St.,</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3239 5680</telephone>
        <email>hamedmashayekhi4164@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hamed Mashayekhi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Medicine, Birjand University of Medical Sciecnes, Ghaffari St.,</address>
        <city>Birjand</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 56 3239 5680</telephone>
        <email>hamedmashayekhi4164@gmail.com</email>
        <affiliation>Birjand University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: Minimum age of 19 years and above; indications for inguinal hernia surgery; provision of informed consent. &#13;
Exclusion criteria: unwillingness to continue the study; incarcerated hernia; strangulated hernia; sliding hernia; bilateral hernia.</inclusion_criteria>
      <agemin>19 years</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>Intervention Group 1 (Lichtenstein Tension-Free Mesh Repair): After primary open incision and dissection of spermatic cord, the hernia sac will be identified and isolated. A 7.5 × 15 cm piece of polypropylene mesh will be placed on posterior wall of inguinal canal. The first medial-most stitch fixes the mesh 2 cm medial to the pubic tubercle, where the anterior rectus sheath inserts into the pubic bone. The same suture is then used as a continuous suture to fix the lower edge of the mesh to the free lower border of inguinal ligament up to a point just lateral to the internal ring. With the mesh kept lax, its upper edge is then fixed to the rectus sheath and the internal oblique aponeurosis with two or three interrupted nonabsorbable sutures. The two tails are then tucked together and fixed to the inguinal ligament just lateral to the internal ring, thus creating a new internal ring made of mesh.</i_keyword>
      <i_keyword>Intervention Group 2 (Read-Rives procedure): Read-Rives procedure is performed through the longitudinal opening in the transversalis fascia in the inguinal floor. At first, the prepritoneal space is dissected and the spermatic cord is parietalized. Afterwards, a 10×15 cm of mesh is implanted in front of the peritoneum, and the mesh is held in place with 2/0 nylon sutures to pubic tubercle, cooper ligament, and psoas muscle. Finally, the fascia is closed over the mesh.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean operation length. Timepoint: From the beginning to the end of the surgery. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Pain severity. Timepoint: On a daily basis during hospitalization. Method of measurement: Visual Analogue Scale.</prim_outcome>
      <prim_outcome>Length of postoperative hospitalization. Timepoint: From the operation day to discharge. Method of measurement: day.</prim_outcome>
      <prim_outcome>Wound infection frequency. Timepoint: During hospitalization, first and second weeks after operation. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Mesh infection. Timepoint: During hospitalization, first and second weeks after operation. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Hematoma. Timepoint: During hospitalization, first and second weeks after operation. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Seroma. Timepoint: During hospitalization, first and second weeks after operation. Method of measurement: Clinical examination.</prim_outcome>
      <prim_outcome>Infection of operation site. Timepoint: During hospitalization, first and second weeks after operation. Method of measurement: Clinical examination.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Vice-Chancellor for Research, Birjand University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2016-09-17</approval_date>
        <contact_name>Ethics Committee of Birjand University of Medical Sciences</contact_name>
        <contact_address>Vice-chancellery of Research and Technology, Birjand University of Medical Sciences, Ghaffari St., Birjand  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
