<?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>IRCT20191123045476N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-05-21</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>Comparative study between enhanced and conventional recovery on postoperative outcomes in women candidates for laparoscopic surgery.</public_title>
      <acronym></acronym>
      <scientific_title>Comparative study between enhanced and conventional recovery on postoperative outcomes in women candidates for laparoscopic surgery.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-10-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>160</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/43924</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the patients will be randomly assigned to one of two groups by a computer-generated random table block of size 4, Blinding description: In this study, the principal investigator and data analyser will be kept blind to the assigning groups of the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Laparoscopic gynecological surgery.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group will be 80 patients who were candidates laparoscopic for gynecological surgery. Perioperatively, this group will be managed according to Enhanced Recovery After Surgery (ERAS) protocols. The basic principles of ERAS include attention to the following: preoperative counseling and nutritional strategies, including avoidance of prolonged perioperative fasting, perioperative considerations, including a focus on regional anesthetic and nonopiod analgesic approaches, fluid balance, and maintenance of norothermia, and promotion of postoperative recovery strategies, including early mobilization and appropriate thromboprophylaxia. Intervention 2: Control group will be 80 patients who were candidates laparoscopic for gynecological surgery. Perioperatively, this group will be managed according to conventional hospital management protocols.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is there is no information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Iran University of Medical Sciences</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6650 9283</telephone>
        <email>s.rokhgireh@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Samaneh Rokhgireh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Rasoul-e-Akram Hospital, Mazar-i-Mansouri St., Sattarkhan Street</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1445613131</zip>
        <telephone>+98 21 6650 9283</telephone>
        <email>s.rokhgireh@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Not being anemia
Not being infected
Do not suffer from underlying disease (heart, lung, gastrointestinal, thyroid, nervous, mental, etc.).
BMI&lt;25.5</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Conversion from laparoscopic surgery to laparotomy
The unwillingness of women to continue the study.
More interventions (blood transfusions,.....)
Occurrence of unpredictable complications during surgery</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>Z53.31</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Laparoscopic surgical procedure converted to open procedure</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 will be 80 patients who were candidates laparoscopic for gynecological surgery. Perioperatively, this group will be managed according to Enhanced Recovery After Surgery (ERAS) protocols. The basic principles of ERAS include attention to the following: preoperative counseling and nutritional strategies, including avoidance of prolonged perioperative fasting, perioperative considerations, including a focus on regional anesthetic and nonopiod analgesic approaches, fluid balance, and maintenance of norothermia, and promotion of postoperative recovery strategies, including early mobilization and appropriate thromboprophylaxia.</i_keyword>
      <i_keyword>Control group will be 80 patients who were candidates laparoscopic for gynecological surgery. Perioperatively, this group will be managed according to conventional hospital management protocols.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pain score. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Need for analgesia. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Fever. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Nausea and vomiting. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Diarrhea. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Postoperative infection,. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Length of hospital stay. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Hemoglobin changes. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Bleeding volume. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
      <prim_outcome>Resumption of bowel activity. Timepoint: After surgery. Method of measurement: Questionnaire and medical records.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Postoperative infection. Timepoint: 2 weeks after surgery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Return to normal activity. Timepoint: 2 weeks after surgery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Return to work. Timepoint: 2 weeks after surgery. Method of measurement: Questionnaire.</sec_outcome>
      <sec_outcome>Hospital readmission. Timepoint: 2 weeks after surgery. Method of measurement: Questionnaire.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-10-13</approval_date>
        <contact_name>Ethics committee of Iran University of Medical Sciences</contact_name>
        <contact_address>Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
