<?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>IRCT20250105064277N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-04-22</date_registration>
      <primary_sponsor>Shahre-kord University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of two solutions used during hydatid cyst surgery to prevent disease recurrence</public_title>
      <acronym>-</acronym>
      <scientific_title>Comparison of chlorhexidine gluconate 0.04% with hypertonic saline as a scolcidal agent during liver hydatid surgery and the recurrence of hydatid cyst</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-04-30</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/88448</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This randomized clinical trial employs balanced block randomization with an allocation ratio of 1:1 to assign eligible patients into two intervention groups. Block randomization is used to ensure balanced group sizes throughout the recruitment period. Variable block sizes (e.g., 4 and 6) are generated randomly to prevent predictability of treatment allocation. The exact block sizes are not disclosed to the research team to minimize selection bias, Blinding description: A double-blind design is implemented in this study. Blinding is maintained as follows:
	1.	Participants:
Patients are unaware of which scolicidal solution is used during surgery. Both solutions are presented in identical, unlabeled packages.
	2.	Surgeons and Clinical Staff:
The operating surgeon and clinical team performing patient care are blinded to group allocation. Intervention packages are prepared by an independent supervisor and identified only by coded 1 and 2 labels.
	3.	Data Collectors and Outcome Assessors:
Data collection, form completion, and outcome evaluation (including CT scan assessment for recurrence) are performed by investigators who remain blinded to treatment allocation.
	4.	Data Analysts:
Statistical analyses are conducted using coded group labels (Group 1 and Group 2), without revealing the actual intervention identity.
	5.	Study Supervisor:
Only the study supervisor has access to the allocation code and does not participate in patient recruitment, treatment, data collection, or data analysis.

Thus, blinding is preserved from patient enrollment through intervention delivery, outcome assessment, and statistical analysis.</study_design>
      <phase>3</phase>
      <hc_freetext>Hepatic hydatid cyst; Liver echinococcosis; Hydatid cyst surgery; Scolicidal agent; Chlorhexidine gluconate; Hypertonic saline; Hydatid cyst recurrence.</hc_freetext>
      <i_freetext>Intervention 1: Group 1: Hypertonic saline group Group 2: Chlorhexidine gluconate at a concentration of 0.04% as a scoliosis agent during liver hydatid cyst surgery; topical application within the surgical field and cystic cavity according to standard open surgical technique; once during surgery. Intervention 2: Intervention group: Hypertonic saline as a scolicidal agent during hepatic hydatid cyst surgery; topical application in the operative field and cyst cavity; single use during surgery.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is Due to the single-center design, limited sample size, and to ensure confidentiality of patient information, there is no plan to share individual participant data outside the research team.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Rasoul Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Kashani Hospital,Parastar Street,</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816758915</zip>
        <telephone>+98 38 3226 4841</telephone>
        <email>rahimi.r@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Rasoul Rahimi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Ayatollah Kashani Hospital,Parastar Street,</address>
        <city>Shahrekord</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8816758915</zip>
        <telephone>+98 38 3226 4841</telephone>
        <email>rahimi.r@skums.ac.ir</email>
        <affiliation>Shahre-kord University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients with hepatic hydatid cysts with an indication for surgery
Willingness to participate in the study and provision of informed consent
Age between 18 and 65 years
No contraindication to surgery</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>65 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients with severe concomitant systemic diseases
History of hypersensitivity to chlorhexidine gluconate
Patients with recurrent hydatid cysts
Patients undergoing reoperation for hydatid cyst
Lack of cooperation or refusal to participate in the study
Use of albendazole prior to surgery</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>Group 1: Hypertonic saline group Group 2: Chlorhexidine gluconate at a concentration of 0.04% as a scoliosis agent during liver hydatid cyst surgery; topical application within the surgical field and cystic cavity according to standard open surgical technique; once during surgery.</i_keyword>
      <i_keyword>Intervention group: Hypertonic saline as a scolicidal agent during hepatic hydatid cyst surgery; topical application in the operative field and cyst cavity; single use during surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Proportion of patients with recurrent hepatic hydatid cyst detected by CT scan within 6 months after surgery. Timepoint: 6-month postoperative follow-up. Method of measurement: Computed Tomography imaging of the liver for detection of hydatid cyst recurrence.</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>Shahre-kord University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2025-09-17</approval_date>
        <contact_name>Ethics Committee, Shahrekord University of Medical Sciences</contact_name>
        <contact_address>University Headquarters, Kashani Boulevard Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
