<?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>IRCT138805012220N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2009-11-01</date_registration>
      <primary_sponsor>Vice-Chancellor for Research,Shahid Beheshti University of Medical Science</primary_sponsor>
      <public_title>Infection rate after cholecystectomy</public_title>
      <acronym>IRAC</acronym>
      <scientific_title>Infections after laparoscopic and open cholecystectomy; Ceftriaxone versus placebo; a randomized clinical trial</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2006-08-11</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>130</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1841</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: After explanation of surgical methods and study protocol we divided the patients into two groups by a table of random numbers. Group A undergone open cholecystectomy (OC) and group B undergone Laparoscopic Cholecystectomy (LC). Lab tests (CBC/diff, AST, ALT, serum billirubin, ALK-Ph) were checked for all patients before surgery. All surgeries were performed with the same surgery team who were expert in both methods. In each group patients randomly divided into two subgroups: first group received 1 gram Ceftriaxone during induction of anesthesia and the second group received 10 ml of isotonic sodium chlorides solution as placebo.drugs are injected by Anesthesiologist  and neither the  surgery team,who follow the patients,nor the patient know about the type of drug recieved . None of the patients received extra dosage of antibiotics (AB) during/after surgery. We compare patients according to demographic features, body weight ASA score, frequency of empyema, hydrops of gall bladder, cholecystitis, gall stones /polyps at time of admission, mean time of surgery and hospital stay, complications of surgery and infection rate, in each surgery method and compare the role of prophylactic antibiotic in reducing infection rate.</study_design>
      <phase>3</phase>
      <hc_freetext>Condition 1: symptomatic gallstones. Condition 2: polyps of gallbladder.</hc_freetext>
      <i_freetext>Intervention 1: single dose of ceftriaxone, 1 gr. during induction of anesthesia. Intervention 2: single dose of normal saline ,10 cc during induction of anesthesia. Intervention 3: laparoscopic cholecystectomy. Intervention 4: open cholecystectomy.</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>Mohamad Reza Sobhiyeh</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Surgery, Shohada e Tajrish Hospital,Tajrish Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21227180009</telephone>
        <email>mreza_sobhiyeh@yahoo.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mohamad Mozafar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Department of Surgery, Shohada e Tajrish Hospital,Tajrish Square</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1989934148</zip>
        <telephone>+98 21227180009</telephone>
        <email>mozafar@sbmu.ac.ir</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria: 1-aged 20-80, 2- cholelithiasis with acute/chronic cholecystitis [based on three of the following signs; abdominal pain in the upper right quadrant, Murphy’s sign, leucocytosis &gt; 10000/mm³, rectal temperature &gt; 38 °C or &lt; 36.5 °C plus, cholecystolithiasis (stones/sludge) or sonographic signs of cholecystitis (thickening and triple layer formation of the gall bladder wall) or polyps of gallbladder], 3- admitted in Shohada-e-Tajrish Hospital, Tehran, Iran for cholecystectomy between 2006 and 2008.&#13;
Exclusion criteria: 1- Pregnant women, 2-patients with jaundice at the time of diagnosis, 3- coagulopathy, 4-coledocholithiasis, 5- portal hypertension, 6- diabetes mellitus, 7- immunosuppressive disorders, 8-previous biliary surgery, 9- biliary pancreatitis, 10- history of antibiotic consumption within one week before surgery, 11-allergic reaction/anaphylaxis to penicillin or cephalosporins, 12- any acute emergency interventions, 13- any contraindications for LC (previous history of abdominal surgery), 14 -conversion from LC to OC, 15- do not agree with conditions of study.</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>80 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>k80</hc_code>
      <hc_code>k82</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Cholelithiasis</hc_keyword>
      <hc_keyword>Other diseases of gallbladder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Prevention</i_code>
      <i_code>Placebo</i_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>single dose of ceftriaxone, 1 gr. during induction of anesthesia</i_keyword>
      <i_keyword>single dose of normal saline ,10 cc during induction of anesthesia</i_keyword>
      <i_keyword>laparoscopic cholecystectomy</i_keyword>
      <i_keyword>open cholecystectomy</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Complications of surgery method. Timepoint: during and one weak after surgery. Method of measurement: history and physical exam.</prim_outcome>
      <prim_outcome>Spillage of bile/gallstone. Timepoint: during surgery. Method of measurement: observation.</prim_outcome>
      <prim_outcome>Need for Subhepatic drain. Timepoint: within one weak after surgery. Method of measurement: cc of secretion.</prim_outcome>
      <prim_outcome>Mean operation time. Timepoint: period between begining and end of surgery. Method of measurement: minute.</prim_outcome>
      <prim_outcome>Bile culture results. Timepoint: one week after surgery. Method of measurement: culture results ,colony formation.</prim_outcome>
      <prim_outcome>Surgical site infection. Timepoint: within one weak after surgery. Method of measurement: history,physical exam.</prim_outcome>
      <prim_outcome>Hospital Stay. Timepoint: period between admition for surgery and discharge. Method of measurement: days.</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,Shahid Beheshti University of Medical Science</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2007-06-04</approval_date>
        <contact_name>Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>Shahid Beheshti University of Medical Sciences, Shahid Beheshti Blv. Daneshjoo Sqr. Velenjac Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
