<?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>IRCT20240415061496N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-06-08</date_registration>
      <primary_sponsor>Ammar Medical Complex, Lahore</primary_sponsor>
      <public_title>Effectiveness Of Nutritional Counselling Among Post-Op Sleeve Gastrectomy Patients In Terms Of Quality Of Life</public_title>
      <acronym>rct</acronym>
      <scientific_title>Effectiveness Of Nutritional Counselling Among Post-Op Sleeve Gastrectomy Patients In Terms Of Quality Of Life.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-06-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>145</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77163</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Other design features: interventional, Randomization description: This study will be based on  six-month randomized control trial conducted in the General Surgery Department at Ammar Medical Complex Lahore with 145 eligible participants who were randomly divided into two groups. will be selected through lottery methord.</study_design>
      <phase>1</phase>
      <hc_freetext>sleeve gastrectomy patients.</hc_freetext>
      <i_freetext>Intervention group: While the other group in the trial did not receive any nutritional counselling, one group in the study received nutritional counselling for six months after 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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Effectiveness of nutritional counselling among post-op Mini-gastric Bypass patients in terms of Quality of life

When:
after 6 months

To whom:
to the research invesigator

Conditions:
Data will be gathered using the meticulously created clinical proforma, which were then entered into, evaluated, and analyzed using the SPSS programmer version 22. Means and standard deviations were used to describe quantitative data.

Where to obtain:
dramnaamarbutt@gmail.com

How to obtain:
application

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>dr amna amar butt</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>110,A,C-2, johar town lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54782</zip>
        <telephone>+92 335 4614376</telephone>
        <email>dramnaamarbutt@gmail.com</email>
        <affiliation>Ammar Medical Complex, Lahore</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>dr maaz ul hassan</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>110,A,C-2, johar town lahore</address>
        <city>lahore</city>
        <country1>Pakistan</country1>
        <zip>54782</zip>
        <telephone>+92 335 4614376</telephone>
        <email>amaramarbutt123@gmail.com</email>
        <affiliation>Ammar Medical Complex, Lahore</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>The study's inclusion criteria included male and female patients aged between 18 to 60 years who have undergone bariatric surgery within 6 months, with no prior bariatric surgery, fractures or limb issues, and no coexisting diseases that affect limb function. This criteria helped in reducing confounding variables</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients under the age of 18 or older than 60, those with a history of bariatric surgery that lasted longer than six months, those with limb fractures, pregnant women with a history of bariatric surgery, those taking antidepressants, and those who refused to adhere to the study's protocol were all excluded from the study. These requirements helped to accurately represent the study's target group and to reduce any potential confounding variables that might have had a detrimental impact on the study's findings</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>E90*</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Nutritional and metabolic disorders in diseases classified elsewhere</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: While the other group in the trial did not receive any nutritional counselling, one group in the study received nutritional counselling for six months after surgery</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Any difference in results between the groups has the potential to enhance current practice and patient life significantly. The purpose of this study is to contribute to the literature by comparing nutritional counselling. In nutritional counselling group, better results with the sleeve gastrectomy will encourage the demand of this minimally invasive counselling. Timepoint: 4 months. Method of measurement: questionnaire.</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>educational research</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2024-06-03</approval_date>
        <contact_name>ethical committee of Ammar Medical Complex, Lahore</contact_name>
        <contact_address>G8MV+X55 Ammar Medical Complex:, Jail Rd, Gulberg V, Lahore, Punjab lahore punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
