<?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>IRCT20240503061640N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-09-28</date_registration>
      <primary_sponsor>Nishter medical University</primary_sponsor>
      <public_title>Comparison ofBiliary Leakage between Laparoscopic Versus Open  Surgery of Liver Hydatid Cyst: A Randomized Controlled Trial</public_title>
      <acronym></acronym>
      <scientific_title>Comparison ofBiliary Leakage between Laparoscopic Versus Open  Surgery of Liver Hydatid Cyst: A Randomized Controlled Trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-06-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>84</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/78719</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization was done using the Random Allocation Software 2.0. Patients were allocated to either group using computer generated sets of random allocation to group A or B. The group allocation was done in advance, and sealed in consecutively numbered opaque envelopes, Blinding description: Statistician was blinded in the study analysis i.e single blinded RCT.</study_design>
      <phase>2</phase>
      <hc_freetext>Echinococcosis, Hydatid disease.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group-A: open surgery was done for Hydatid disease. Intervention 2: Intervention group- B: laparoscopic surgery for Hydatid disease.</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:
Comparison ofBiliary Leakage between Laparoscopic Versus Open  Surgery of Liver Hydatid Cyst: A Randomized Controlled Trial

When:
In December 2025

To whom:
Only available for people working in academic institute

Conditions:
Khurram.niaz@hotmail.com

Where to obtain:
Khurram.niaz@hotmail.com

How to obtain:
Through email ID

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Khurram Niaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh zayed medical college</address>
        <city>Rahim yar khan</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>+92 321 6801550</telephone>
        <email>Khurram.niaz@hotmail.com</email>
        <affiliation>Sheikh Zayed Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Khurram Niaz</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Sheikh zayed medical college</address>
        <city>Rahim Yar Khan</city>
        <country1>Pakistan</country1>
        <zip>64200</zip>
        <telephone>+92 321 6801550</telephone>
        <email>Khurram.niaz@hotmail.com</email>
        <affiliation>Sheikh zayed medical college</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Gender; both male and female patients.
Age range; 18-60 years.
Patients with liver hydatid cyst with size ≥3 cm (as per operational definition)</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Severely anemic patients (Hb levels less than 8 g/dl)
. Patients with recurrent disease, cysts in  liver segment 1 and 7, concomitant cyst in other organs, cysto-biliary communication and patients with ruptured cyst (confirmed from patient record file and any suspected communication will be confirmed on CT)
Chronic liver disease (confirmed from patient record file).
Alcoholic abuse (patient’s history, alcohol consumption for &gt; 1 year)
Pregnant ladies</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>B67.0</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Echinococcus granulosus infection of liver</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-A: open surgery was done for Hydatid disease</i_keyword>
      <i_keyword>Intervention group- B: laparoscopic surgery for Hydatid disease</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Biliary leakage. Timepoint: 72 hours post-surgery and on follow-up visits at 1, 2, and 4 weeks post-surgery. Method of measurement: Clinical examination, ultrasonography.</prim_outcome>
      <prim_outcome>Pain. Timepoint: 72 hours post-surgery and on follow-up visits at 1, 2, and 4 weeks post-surgery. Method of measurement: History.</prim_outcome>
      <prim_outcome>Recurrence. Timepoint: 72 hours post-surgery and on follow-up visits at 1, 2, and 4 weeks post-surgery. Method of measurement: Clinical examination, ultrasonography.</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>Nishter medical University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-17</approval_date>
        <contact_name>IRB nishter medical University</contact_name>
        <contact_address>Nishtar Medical University, Nishtar Rd, Gillani Colony, Multan, Punjab 66000 Multan Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
