xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06037304</url>
    </required_header>
    <id_info>
      <org_study_id>QoL</org_study_id>
      <nct_id>NCT06037304</nct_id>
    </id_info>
    <brief_title>Quality of Life After Shouldice Repair</brief_title>
    <acronym>QoL</acronym>
    <official_title>Quality of Life After Shouldice Repair</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Shouldice Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Shouldice Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This research project aims to assess the quality of life (QOL) and pain/discomfort&#xD;
        experienced by patients who have undergone primary inguinal hernia repair at Shouldice&#xD;
        Hospital. Historically, postoperative mortality and symptom improvement have been the main&#xD;
        outcomes assessed after hernia surgery, neglecting the patient experience. As QOL gains&#xD;
        significance in hernia patient care, this study focuses on evaluating patient QOL before and&#xD;
        after surgery, contributing to a better understanding of hernia surgery outcomes.&#xD;
  &#xD;
        Study Objectives:&#xD;
  &#xD;
        Determine preoperative quality of life. Determine patient-reported quality of life at 1 week&#xD;
        after surgery. Determine patient-reported quality of life at 1 month after surgery. Determine&#xD;
        patient-reported quality of life at 6 months after surgery. Evaluate changes in quality of&#xD;
        life from the preoperative time to 6 months after surgery.&#xD;
  &#xD;
        Hypotheses/Research Questions:&#xD;
  &#xD;
        Does quality of life change after hernia surgery? What is the quality of life before and&#xD;
        after primary unilateral inguinal hernia repair? Does hernia repair improve patient quality&#xD;
        of life?&#xD;
  &#xD;
        Study Design:&#xD;
  &#xD;
        This is a prospective cohort pilot study involving primary unilateral inguinal hernia&#xD;
        patients who received Shouldice repair at Shouldice Hospital. It includes chart reviews&#xD;
        (medical histories and operative notes) and surveys at preoperative, 1-week, 1-month, and&#xD;
        6-month postoperative time points. Surveys are conducted using the EQ5D3L tool to measure&#xD;
        health-related quality of life.&#xD;
  &#xD;
        Study Population:&#xD;
  &#xD;
        The study population includes male and female patients aged 16-90, of all nationalities and&#xD;
        races, capable of English communication, in good general health, who had primary unilateral&#xD;
        inguinal hernia repair at Shouldice Hospital. Exclusions encompass patients who had mesh&#xD;
        repair, non-inguinal hernias, concurrent hernias, bilateral hernia repair, or emergency&#xD;
        surgeries.&#xD;
  &#xD;
        Data Collection:&#xD;
  &#xD;
        Data is collected from patient survey responses, medical records, and charts. Surveys are&#xD;
        administered via email at specific time points. A deferred consent process is used, and&#xD;
        participants are informed about their rights and the ability to withdraw. Data is&#xD;
        deidentified for privacy.&#xD;
  &#xD;
        Duration of Study:&#xD;
  &#xD;
        The study is expected to take 14 months, with a 3-month recruitment phase, a 6-month&#xD;
        follow-up period, and 5 months for data analysis and write-up. The estimated participation&#xD;
        time for each participant is 13 minutes, and no reminders are sent.&#xD;
  &#xD;
        Risks and Benefits:&#xD;
  &#xD;
        There are no known risks to participants, and no direct benefits are provided. Personal data&#xD;
        is protected, and participation is voluntary.&#xD;
  &#xD;
        This study aims to contribute valuable insights into the quality of life of hernia surgery&#xD;
        patients, particularly those who have undergone open tissue hernia repair at Shouldice&#xD;
        Hospital.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The proposed project is a pilot study designed in a prospective cohort manner, on primary&#xD;
        unilateral inguinal hernia patients who had a Shouldice repair at the Shouldice Hospital. It&#xD;
        includes prospective chart review (medical histories and operative notes) and a qualitative&#xD;
        component (surveys). Patients will be emailed 5-7 days before surgery, with information&#xD;
        inviting them to participate or read more about this research project, and a link to a full&#xD;
        consent form. If patients consent they will be taken directly to the first (preoperative)&#xD;
        survey and the same methodology will be used again at 1 week, 1 month, and 6 months after&#xD;
        surgery. Contact is made by email using the hospital's current survey site: Simple Survey.&#xD;
  &#xD;
        The survey is made up of the EQ5D3L, which is a standardized measurement of QOL (health&#xD;
        related). The EQ5D3L contains two parts, one that measures health status through rating 5&#xD;
        questions in terms of having no, some or extreme problems with mobility, self-care, usual&#xD;
        activities, pain/discomfort, and anxiety/depression.&#xD;
  &#xD;
        The second part contains a visual analogue scale called EQVAS where participants rate their&#xD;
        overall health from 0- worst imaginable to 100- best imaginable. The choice to use the EQ5D3L&#xD;
        was made because it is a commonly used tool, has shown comparable results to other validated&#xD;
        surveys like the CCS [6], and the EQ5D3L is a single short way to measure QOL. Although many&#xD;
        studies use multiple surveys to assess QOL, for simplicity sake, and to reduce time burden on&#xD;
        patients as well as prevent any reduced response rate just the EQ5D3L will be used.&#xD;
  &#xD;
        The study population will focus on male and female patients aged 16-90 years of age, standard&#xD;
        age of patients accepted for surgery at Shouldice Hospital, who had a Shouldice repair of a&#xD;
        primary unilateral inguinal hernia at Shouldice Hospital, all nationalities and races,&#xD;
        capable of speaking and reading English, in good general health, and there is no geographic&#xD;
        location constraint. As there are no translators nor non-English survey options provided,&#xD;
        participants who cannot complete the survey in English are excluded. Patients will be&#xD;
        excluded if they underwent a mesh repair, a hernia that was not an inguinal type, a&#xD;
        concurrent hernia, bilateral hernia repair, and surgery was deemed an emergency.&#xD;
  &#xD;
        We aim to contact 1000 2400 patients to analyze a total of 400 participants. This is based&#xD;
        off information gathered by the researchers from the first six weeks of recruitment for this&#xD;
        project. this institution from previously done prospective projects. When consent forms were&#xD;
        emailed, there was a response rate of 4530%, with a retention of patients meeting the&#xD;
        criteria and being sent the follow up surveys at 18%. No dropout rate has been&#xD;
        measured/considered as we will gather data for this pilot project to go on with a sample size&#xD;
        calculation in the future. The 400 patients were concluded based off a multicenter study that&#xD;
        used the EQ5D3L and had similar objectives as this present study. The 2018 study looked at&#xD;
        survey responses after Lichtenstein repair with two difference meshes and had sample sizes of&#xD;
        411 and 397. Thus, analyzing 400 patients would allow for a meaningful comparison to open&#xD;
        inguinal hernia repair.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>EQ5D3L one week after surgery</measure>
      <time_frame>one week after surgery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>EQ5D3L one month after surgery</measure>
      <time_frame>one month after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ5D3L six months after surgery</measure>
      <time_frame>ix months after surgery</time_frame>
    </secondary_outcome>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Hernia, Inguinal</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>no intervention</intervention_name>
      <description>no intervention</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This study focuses on patients aged 16-90 years who underwent a primary unilateral inguinal&#xD;
          hernia repair at Shouldice Hospital. The inclusion criteria encompass both male and female&#xD;
          patients of all nationalities and races, capable of communicating in English, in good&#xD;
          general health, and who did not undergo emergency surgery. Patients who had mesh repair,&#xD;
          hernias other than inguinal, concurrent hernias, bilateral hernia repairs, and those who&#xD;
          couldn't complete surveys in English are excluded. The goal is to contact 2,400 patients to&#xD;
          ultimately analyze 400 participants, based on recruitment data. Consent forms yielded a&#xD;
          45-30% response rate, with an 18% follow-up survey retention rate. No dropout rate has been&#xD;
          measured yet. The choice of 400 patients is based on a similar study that analyzed sample&#xD;
          sizes of 411 and 397 in a multicenter study involving Lichtenstein repair with different&#xD;
          meshes for meaningful comparison to open inguinal hernia repair.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          The study population will focus on male and female patients aged 16-90 years of age,&#xD;
          standard age of patients accepted for surgery at Shouldice Hospital, who had a Shouldice&#xD;
          repair of a primary unilateral inguinal hernia at Shouldice Hospital, all nationalities and&#xD;
          races, capable of speaking and reading English, in good general health, and there is no&#xD;
          geographic location constraint. As there are no translators nor non-English survey options&#xD;
          provided, participants who cannot complete the survey in English are excluded.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients will be excluded if they underwent a mesh repair, a hernia that was not an&#xD;
          inguinal type, a concurrent hernia, bilateral hernia repair, and surgery was deemed an&#xD;
          emergency.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>90 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Christoph Paasch, MD</last_name>
      <phone>9058891125</phone>
      <phone_ext>435</phone_ext>
      <email>cpaasch@shouldice.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marguerite Mainprize</last_name>
      <phone>9058891125</phone>
      <phone_ext>297</phone_ext>
      <email>mmainprize@shouldice.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Christoph Paasch</name>
        <address>
          <city>Thornhill</city>
          <state>Ontario</state>
          <zip>L3T 4A3</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christoph Paasch</last_name>
        <phone>9058891125</phone>
        <phone_ext>435</phone_ext>
        <email>cpaasch@shouldice.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Quality of life</keyword>
    <keyword>shouldice repair</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia, Inguinal</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06037304
  org study id: QoL
  nct id: NCT06037304
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This research project aims to assess the quality of life (QOL) and pain/discomfort
        experienced by patients who have undergone primary inguinal hernia repair at Shouldice
        Hospital. Historically, postoperative mortality and symptom improvement have been the main
        outcomes assessed after hernia surgery, neglecting the patient experience. As QOL gains
        significance in hernia patient care, this study focuses on evaluating patient QOL before and
        after surgery, contributing to a better understanding of hernia surgery outcomes.
  
        Study Objectives:
  
        Determine preoperative quality of life. Determine patient-reported quality of life at 1 week
        after surgery. Determine patient-reported quality of life at 1 month after surgery. Determine
        patient-reported quality of life at 6 months after surgery. Evaluate changes in quality of
        life from the preoperative time to 6 months after surgery.
  
        Hypotheses/Research Questions:
  
        Does quality of life change after hernia surgery? What is the quality of life before and
        after primary unilateral inguinal hernia repair? Does hernia repair improve patient quality
        of life?
  
        Study Design:
  
        This is a prospective cohort pilot study involving primary unilateral inguinal hernia
        patients who received Shouldice repair at Shouldice Hospital. It includes chart reviews
        (medical histories and operative notes) and surveys at preoperative, 1-week, 1-month, and
        6-month postoperative time points. Surveys are conducted using the EQ5D3L tool to measure
        health-related quality of life.
  
        Study Population:
  
        The study population includes male and female patients aged 16-90, of all nationalities and
        races, capable of English communication, in good general health, who had primary unilateral
        inguinal hernia repair at Shouldice Hospital. Exclusions encompass patients who had mesh
        repair, non-inguinal hernias, concurrent hernias, bilateral hernia repair, or emergency
        surgeries.
  
        Data Collection:
  
        Data is collected from patient survey responses, medical records, and charts. Surveys are
        administered via email at specific time points. A deferred consent process is used, and
        participants are informed about their rights and the ability to withdraw. Data is
        deidentified for privacy.
  
        Duration of Study:
  
        The study is expected to take 14 months, with a 3-month recruitment phase, a 6-month
        follow-up period, and 5 months for data analysis and write-up. The estimated participation
        time for each participant is 13 minutes, and no reminders are sent.
  
        Risks and Benefits:
  
        There are no known risks to participants, and no direct benefits are provided. Personal data
        is protected, and participation is voluntary.
  
        This study aims to contribute valuable insights into the quality of life of hernia surgery
        patients, particularly those who have undergone open tissue hernia repair at Shouldice
        Hospital.
  The proposed project is a pilot study designed in a prospective cohort manner, on primary
        unilateral inguinal hernia patients who had a Shouldice repair at the Shouldice Hospital. It
        includes prospective chart review (medical histories and operative notes) and a qualitative
        component (surveys). Patients will be emailed 5-7 days before surgery, with information
        inviting them to participate or read more about this research project, and a link to a full
        consent form. If patients consent they will be taken directly to the first (preoperative)
        survey and the same methodology will be used again at 1 week, 1 month, and 6 months after
        surgery. Contact is made by email using the hospital's current survey site: Simple Survey.
  
        The survey is made up of the EQ5D3L, which is a standardized measurement of QOL (health
        related). The EQ5D3L contains two parts, one that measures health status through rating 5
        questions in terms of having no, some or extreme problems with mobility, self-care, usual
        activities, pain/discomfort, and anxiety/depression.
  
        The second part contains a visual analogue scale called EQVAS where participants rate their
        overall health from 0- worst imaginable to 100- best imaginable. The choice to use the EQ5D3L
        was made because it is a commonly used tool, has shown comparable results to other validated
        surveys like the CCS [6], and the EQ5D3L is a single short way to measure QOL. Although many
        studies use multiple surveys to assess QOL, for simplicity sake, and to reduce time burden on
        patients as well as prevent any reduced response rate just the EQ5D3L will be used.
  
        The study population will focus on male and female patients aged 16-90 years of age, standard
        age of patients accepted for surgery at Shouldice Hospital, who had a Shouldice repair of a
        primary unilateral inguinal hernia at Shouldice Hospital, all nationalities and races,
        capable of speaking and reading English, in good general health, and there is no geographic
        location constraint. As there are no translators nor non-English survey options provided,
        participants who cannot complete the survey in English are excluded. Patients will be
        excluded if they underwent a mesh repair, a hernia that was not an inguinal type, a
        concurrent hernia, bilateral hernia repair, and surgery was deemed an emergency.
  
        We aim to contact 1000 2400 patients to analyze a total of 400 participants. This is based
        off information gathered by the researchers from the first six weeks of recruitment for this
        project. this institution from previously done prospective projects. When consent forms were
        emailed, there was a response rate of 4530%, with a retention of patients meeting the
        criteria and being sent the follow up surveys at 18%. No dropout rate has been
        measured/considered as we will gather data for this pilot project to go on with a sample size
        calculation in the future. The 400 patients were concluded based off a multicenter study that
        used the EQ5D3L and had similar objectives as this present study. The 2018 study looked at
        survey responses after Lichtenstein repair with two difference meshes and had sample sizes of
        411 and 397. Thus, analyzing 400 patients would allow for a meaningful comparison to open
        inguinal hernia repair.
  observational model: Other
  time perspective: Prospective
  measure: EQ5D3L one week after surgery
  time frame: one week after surgery
  measure: EQ5D3L one month after surgery
  time frame: one month after surgery
  measure: EQ5D3L six months after surgery
  time frame: ix months after surgery
  intervention type: Other
  intervention name: no intervention
  description: no intervention
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 90 Years
  healthy volunteers: No
  last name: Christoph Paasch, MD
  phone: 9058891125
  phone ext: 435
  email: cpaasch@shouldice.com
  last name: Marguerite Mainprize
  phone: 9058891125
  phone ext: 297
  email: mmainprize@shouldice.com
  facility: 
  status: Recruiting
  contact: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Hernia, Inguinal
  sharing ipd: No