<?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>IRCT201104121946N8</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2011-09-13</date_registration>
      <primary_sponsor>Vice Chancellor for research-Guilan University of Medical Sciences</primary_sponsor>
      <public_title>An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy</public_title>
      <acronym></acronym>
      <scientific_title>An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2011-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>66</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/1530</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>2</phase>
      <hc_freetext>Postprocedural disorders of genitourinary system, not elsewhere classified.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Oral Methylnaltrexone tablet (25mg); two hours before operation. After operation, bowel sounds in 12,13,….23,24 hours were listened every hour for one minute in right lower quaderant of abdomen and other  measurements were checked. Intervention 2: Control group: Placebo oral tablet (25mg); two hours before operation. After operation, bowel sounds in 12,13,….23,24 hours were listened every hour for one minute in right lower quaderant of abdomen and other  measurements were checked.</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>Dr. Mandana Mansur Ghanaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Reproductive Health research center-Alzahra hospital-Namjo street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 13 1322 5624</telephone>
        <email>m_m_ghanaie@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mandana Mansur Ghanaie</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Reproductive Health research center-Alzahra hospital-Namjo street</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 911 131 3242</telephone>
        <email>m_m_ghanaie@yahoo.com</email>
        <affiliation>Guilan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Inclusion criteria:1) women who were 35-55 years old (with ASA class I&amp;II) .2) without history of susceptible diseases for post-operative nausea and vomiting  for example peptic ulcer, gastritis and uses of chemotherapy's drugs. 3) Lack of history about chronic constipation , IBS and IBD. 4) Without history of drug reaction to Naltrexone , another drugs, foods and seasonal allergies or asthma. 5) Lack of kidney's diseases.6) lack of  liver's diseases especially hepatitis. 7) lack of addiction to opioids (Tramadol, Morphine, Percocet) and alcohol.8) lack of using psychological drugs/pain reliefer with Codeine or Propoxyphene/ Clonidine/ Disulfiram/ Laxative/ Immunosuppress drugs/ thyroglobulin for diagnose Hashimoto's thyroiditis or hypothyroidism.9) Without history for laparatomy twice or more than. 10) lack of lung's diseases. 11) Without history of organ's transplantation.  Exclusion criteria: 1) duration of operation more than two hours.2) existence of another operation accompanied by hysterectomy.3) incidence of oparation's or anesthesia's side-effects.4) hypertension.</inclusion_criteria>
      <agemin>35 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N99</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Postprocedural disorder of genitourinary system, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Oral Methylnaltrexone tablet (25mg); two hours before operation. After operation, bowel sounds in 12,13,….23,24 hours were listened every hour for one minute in right lower quaderant of abdomen and other  measurements were checked.</i_keyword>
      <i_keyword>Control group: Placebo oral tablet (25mg); two hours before operation. After operation, bowel sounds in 12,13,….23,24 hours were listened every hour for one minute in right lower quaderant of abdomen and other  measurements were checked.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>An assessment about impression of oral Methylnaltrexone on time of beginning of the bowel sounds after abdominal hysterectomy. Timepoint: 12 hours after operation, every hour. Method of measurement: Patient visits, listening to bowel sounds.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Assessment of median time of beginning of the bowel sounds. Timepoint: Assessment of median time of beginning of the bowel sounds in first group (patients that received oral Methylnaltrexone). Method of measurement: Patient visits, listening to bowel sounds.</sec_outcome>
      <sec_outcome>Determination of frequency of urinary retention. Timepoint: After fully discharge. Method of measurement: Assessment about patient's ability  to urinating.</sec_outcome>
      <sec_outcome>Determination of frequency of constipation. Timepoint: after surgery. Method of measurement: Patient visits, question about defecation.</sec_outcome>
      <sec_outcome>Determination of frequency of vomiting. Timepoint: after surgery. Method of measurement: Patient visits, question about vomiting.</sec_outcome>
      <sec_outcome>Determination of frequency of itching. Timepoint: after surgery. Method of measurement: Patient visits, question on base of itching score.</sec_outcome>
      <sec_outcome>Determination of frequency of ileus. Timepoint: 12 hours after operation, every hour. Method of measurement: Patient visits, listening to bowel sounds.</sec_outcome>
      <sec_outcome>Determination of frequency of side-effects (abdominal pain, bloating ,nausea ,hyperthermia, vertigo ,hypotension). Timepoint: after surgery. Method of measurement: Patient visit and examine.</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-Guilan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2011-05-28</approval_date>
        <contact_name>Vice chancellor for research-Guilan University of Medical Sciences</contact_name>
        <contact_address>Vice chancellor for research-opposite of Azodi Studium-Namjo street Rasht  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
