<?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>IRCT20221111056465N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-20</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of aesthetic results of different types of umbilical reconstruction methods in abdominal operations: Mercedes incision versus inverted V incision</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the aesthetic results of different types of umbilical cord reconstruction methods in abdominal operations: Mercedes incision versus inverted V incision in patients referred to Hazrat Fatemeh Hospital for umbilical cord reconstruction</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-19</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68538</url>
      <study_type>observational</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method is used in randomization. An envelope contains 60 pieces of paper on which groups A and B are written, and there are 30 pieces of each group in the envelope. Group A is assigned to the Mercedes surgery method and group B is assigned to the inverted V surgery method. Before performing the surgery, the surgeon takes out a paper from the envelope for each patient and the surgical method is selected based on the type of group, Blinding description: Before the operation, after choosing the type of operation, the surgeon and the researcher are aware of the type of operation, but after the surgery and subsequent examinations and data reporting, other residents of the center are used for examination, who are assigned a code for each type of operation. It is possible that only the researcher is aware of it.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Patients referred for abdominoplasty and breast reconstruction with abdominal flap.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In this group, the Mercedes surgical method is used, where a marking with methylene blue on the two lateral and upper wings between 0.5 and 1.0 cm from the central point is determined, and they form the "Y" suggested in this technique. At this point, the skin is cut above the Y mark. To prevent umbilical stenosis, two "cuts" are removed from the side flaps of the Y to allow the umbilical suture to fit better. Intervention 2: Control group: In this group, we use the inverted V surgery method, where the arms of the incision are approximately 1.5 to 2 cm and are separated by a distance of approximately 1.5 to 2.5 cm at the base. An inverted V-shaped skin flap is raised at a predetermined, palpated umbilical point.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
The written informed consent form will be provided to the participants after the procedure and will be included in the thesis. We have also published it in the Pajuheshyar system
The data of the study also includes the results of the variables, including the level of satisfaction with the form of not causing complications

When:
The consent form will be placed in the attachments section after the thesis is printed. Also, the data of the participants is included in the thesis

To whom:
All people who have access to the full text of the thesis

Conditions:
It can be modeled in similar studies

Where to obtain:
Email to the general supervisor of the thesis
Dr. Vahab Rezaee
vahab_rezaee@yahoo.com

How to obtain:
After sending the email to the general supervisor, the thesis can be received within 1 week

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Vahab Rezaee</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Seyed Jamalodin Asadabadi st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8871 7272</telephone>
        <email>vahab_rezaee@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reza Vaghardoost</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Seyed Jamalodin Asadabadi st.</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1433933111</zip>
        <telephone>+98 21 8871 7272</telephone>
        <email>rezavaghar@yahoo.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>People over 18 years old
A candidate for Abdominoplasty or Breast Reconstruction Surgery
Female</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Performing navel cosmetic surgery in the past</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z42.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Encounter for breast reconstruction following mastectomy</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: In this group, the Mercedes surgical method is used, where a marking with methylene blue on the two lateral and upper wings between 0.5 and 1.0 cm from the central point is determined, and they form the "Y" suggested in this technique. At this point, the skin is cut above the Y mark. To prevent umbilical stenosis, two "cuts" are removed from the side flaps of the Y to allow the umbilical suture to fit better</i_keyword>
      <i_keyword>Control group: In this group, we use the inverted V surgery method, where the arms of the incision are approximately 1.5 to 2 cm and are separated by a distance of approximately 1.5 to 2.5 cm at the base. An inverted V-shaped skin flap is raised at a predetermined, palpated umbilical point</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Aesthetics evaluation. Timepoint: Three months after surgery. Method of measurement: Observation and direct question from the patient.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Umbilical necrosis. Timepoint: Three months after surgery. Method of measurement: Direct observation.</sec_outcome>
      <sec_outcome>Mbilical stenosis. Timepoint: Three months after surgery. Method of measurement: Direct observation.</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>Hazrate Fatemeh Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-02-08</approval_date>
        <contact_name>Ethics Committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Seyed JamalodinAsadabadi St. Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
