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/NCT06039800</url>
    </required_header>
    <id_info>
      <org_study_id>ShouldiceH</org_study_id>
      <nct_id>NCT06039800</nct_id>
    </id_info>
    <brief_title>Patient-reported Outcomes for Patients Undergoing Surgery at Shouldice Hospital.</brief_title>
    <acronym>PROM project</acronym>
    <official_title>Patient Reported Outcome Measures (PROMS): Follow up of Shouldice Hospital Patients</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>
        Background:&#xD;
  &#xD;
        Previous publications have highlighted limited data on patient outcomes and experiences at&#xD;
        Shouldice Hospital. Existing studies from Europe reported outcomes following Shouldice repair&#xD;
        but lacked recent data. The current project seeks to optimize patient care and knowledge&#xD;
        through systematic follow-up.&#xD;
  &#xD;
        Study Objectives:&#xD;
  &#xD;
        Establish a patient-reported outcome measure follow-up program. Evaluate postoperative&#xD;
        complication rates. Determine important outcomes to patients. Establish and monitor patient&#xD;
        satisfaction with decision-making and hernia repair.&#xD;
  &#xD;
        Hypotheses/Research Questions:&#xD;
  &#xD;
        Several research questions related to patient motivations, outcomes, knowledge, and&#xD;
        satisfaction are posed for investigation.&#xD;
  &#xD;
        Potential Risks and Benefits:&#xD;
  &#xD;
        No anticipated risks to participants. Participants won't directly benefit but contribute to&#xD;
        improving patient care and knowledge.&#xD;
  &#xD;
        Study Design:&#xD;
  &#xD;
        The study employs a prospective follow-up approach. Surveys are sent at specific intervals&#xD;
        (30-40 days, 1-year, 3-years, and 5-years) via email.&#xD;
  &#xD;
        Consent forms are included in the email, allowing participants to choose their level of&#xD;
        involvement. Data is collected from survey responses, patient charts, and operative notes.&#xD;
  &#xD;
        Study Population:&#xD;
  &#xD;
        All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible.&#xD;
  &#xD;
        Exclusion criteria:&#xD;
  &#xD;
        Lack of an email address. The required sample size is unknown, and this study serves as a&#xD;
        pilot.&#xD;
  &#xD;
        Data Collection:&#xD;
  &#xD;
        Data is collected from surveys, patient charts, and operative notes. Consent is obtained&#xD;
        through deferred consent (initial contact via email, with consent forms provided).&#xD;
  &#xD;
        Safeguards are in place to protect personal health information.&#xD;
  &#xD;
        Duration of Study:&#xD;
  &#xD;
        Estimated to take 5-6 years. Recruitment/enrollment: 6-12 months. Follow-up: 5 years from the&#xD;
        last enrolled participant. Data analysis and write-up: 5 months.&#xD;
  &#xD;
        Overlap with Other Projects:&#xD;
  &#xD;
        Concerns about overlap with other studies are addressed, and concurrent participation is&#xD;
        allowed. Participants can withdraw at any time.&#xD;
  &#xD;
        In summary, this research project aims to gather comprehensive data on hernia surgery&#xD;
        outcomes, patient experiences, and satisfaction at Shouldice Hospital through a systematic&#xD;
        follow-up approach, contributing to the improvement of patient care and knowledge in this&#xD;
        field.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Increasing awareness, research, and publications on patient reported outcomes, patient&#xD;
        knowledge, and what matters to patients are being done. There is limited data available in&#xD;
        these areas at Shouldice Hospital, leaving potential gaps in knowledge and areas of&#xD;
        improvement unidentified. Large scale follow-up on the Shouldice Hospital's postoperative&#xD;
        complications.&#xD;
  &#xD;
        There are two publications within the last 18 years from Europe reporting outcomes following&#xD;
        Shouldice repair with a larger number of enrolled individuals. These publications included&#xD;
        3,888 Shouldice repairs. Bittner et al. (2005) published a Meta-analysis analyzing the&#xD;
        postoperative outcome following TAPP/TEP (n=1,830) and Shouldice repair (n=1,773). The&#xD;
        authors revealed an infection rate of 0.9%, a hematoma rate of 6.4% (higher than in the&#xD;
        laparoscopic group) and a seroma rate of 1.2%. The recurrence rate was 2%. Moreover, a 5.4%&#xD;
        rate of chronic pain and a 30-days period until return to work were published. These rates&#xD;
        were higher in comparison to endoscopic hernia repair (Bittner et al, 2005). In addition, a&#xD;
        German matched-pair registry analysis among 2,115 cases of Shouldice repair took place in&#xD;
        2018. The authors published, that for a selected group of patients (average age: 40 years, a&#xD;
        large proportion of women of 30%, a mean BMI value of 24 kg/m2 and a proportion of defect&#xD;
        sizes up to 3 cm of over 85%) the Shouldice repair can be used for primary unilateral&#xD;
        inguinal hernia repair while achieving an outcome comparable to that of Lichtenstein, TEP and&#xD;
        TAPP operations (Kockerling et al, 2018). Malik et al. (2016) provided information on the&#xD;
        recurrence rate (age-standardized recurrence risk of 1.15%; n=65,148) of patients who were&#xD;
        operated on in the Shouldice repair at the Shouldice hospital. But in terms of SSI, SSO and&#xD;
        postoperative outcome in general no current information from our Shouldice hospital has been&#xD;
        revealed within the last two decades (Malik et al, 2016).&#xD;
  &#xD;
        In order to further optimize, evaluate, and increase knowledge of the Shouldice repair&#xD;
        systematic follow-up of patients who were operated on at the Shouldice Hospital should be&#xD;
        updated. The current project aims to perform a systematic follow-up of patients for the&#xD;
        purpose of supporting the ongoing improvement of patient care and knowledge. This study will&#xD;
        act as a pilot for refining our long term follow up, focused on patient and surgical&#xD;
        outcomes.&#xD;
  &#xD;
        Study Objectives:&#xD;
  &#xD;
          1. Establish a patient reported outcome measure follow up program at Shouldice Hospital&#xD;
  &#xD;
          2. Evaluate the postoperative complication rate (pain, infection, recurrence, and other&#xD;
             complications)&#xD;
  &#xD;
          3. Determine the reasoning and important outcomes to patients who undergo hernia repair at&#xD;
             Shouldice Hospital.&#xD;
  &#xD;
          4. Establish and monitor patient satisfaction with decision making and hernia repair.&#xD;
  &#xD;
        Hypothesis/Research Questions:&#xD;
  &#xD;
          1. What were the most common reasons for patients to undergo hernia repair?&#xD;
  &#xD;
          2. What was the most reported important outcome to patients after hernia surgery?&#xD;
  &#xD;
          3. Did patients feel they had adequate knowledge and feel a part of the decision-making&#xD;
             process?&#xD;
  &#xD;
          4. How satisfied and confident were patients with their Shouldice hernia repair at 1-year&#xD;
             after surgery?&#xD;
  &#xD;
          5. Was there any improvement in quality of life due to hernia repair noted at 1-year after&#xD;
             surgery?&#xD;
  &#xD;
          6. What is the infection rate, pain incidence, and hernia recurrence rate at 30-days after&#xD;
             hernia repair at Shouldice Hospital?&#xD;
  &#xD;
          7. What is the pain incidence and hernia recurrence rate at 1-, 3-, and 5-years after&#xD;
             hernia repair at Shouldice Hospital?&#xD;
  &#xD;
          8. Is there a difference in pain experienced after surgery by patients based off the hernia&#xD;
             they had repaired?&#xD;
  &#xD;
          9. Does infection rate differ depending on hernia and/or hernia repair?&#xD;
  &#xD;
         10. Does infection rate differ for those given or not given antibiotics prior to or during&#xD;
             surgery?&#xD;
  &#xD;
        Potential Risks and Benefits:&#xD;
  &#xD;
        There are no known or anticipated risks to participants as individuals or as part of an&#xD;
        identifiable group. This includes no physical, psychological, or emotional, social, and/or&#xD;
        data security breach risks. The use of information will remove any personal identifiers&#xD;
        before data analysis. There are no direct benefits to the participants from their involvement&#xD;
        in the project and these include no education about research methods or useful knowledge&#xD;
        about self.&#xD;
  &#xD;
        Study Design:&#xD;
  &#xD;
        The current study is a prospective follow up of patients who had an operation for a hernia at&#xD;
        the Shouldice Hospital. The study design includes using an automated report generated for&#xD;
        follow up which will allow for participant identification and provide necessary information&#xD;
        to send the consent forms and follow up to patients, as well as responses from follow up&#xD;
        surveys by email, and manual review of charts and operative notes. All patients that had&#xD;
        surgery at Shouldice Hospital are included unless they did not have an email address. The&#xD;
        reason for this exclusion is due to the electronic and internet-based nature of the project.&#xD;
        Patients will be emailed 30-40 days after surgery, as well as 1-year, 3-years, and 5-years&#xD;
        after surgery using the Hospital's current survey site: Simple Survey. Each email will have a&#xD;
        link to a consent form, which will provide potential participants with the choice to be taken&#xD;
        directly to the survey if they have consented, decline to participate, or be provided with&#xD;
        information to contact a research team member. Patients that do not respond after the&#xD;
        30-40-day postoperative survey will be contacted by phone; this is to ensure comprehensive&#xD;
        data collection regarding infection at 30-40 days after surgery. Patients that respond yes to&#xD;
        infection questions at the 30-40-day postoperative survey will additionally be asked if we&#xD;
        can contact them via telephone to follow up on their potential infection.&#xD;
  &#xD;
        The survey is designed to capture the results of important questions and aims about this&#xD;
        study. The 30-40 day and 1-year postoperative survey includes a postoperative recovery,&#xD;
        preoperative decisions and hernia repair, and final questions and comments section. The 3-&#xD;
        and 5-year postoperative surveys have the postoperative recovery and final questions and&#xD;
        comments sections. The postoperative recovery portion includes questions regarding pain and&#xD;
        swelling (30-40 day/1-year/3-year/5-year survey) from HerniaMed (Stechemesser et al, 2012),&#xD;
        questions regarding infection, fluid formation, and hematoma pertaining to grade of surgical&#xD;
        site infection and surgical site occurrence (30-40 day survey), and additional questions&#xD;
        regarding hernia relapse (30-40 day/1-year/3-year/5-year survey) and wound complication&#xD;
        (30-40 day survey). Another part of the survey pertains to preoperative decisions and hernia&#xD;
        repair. The 30-40-day postoperative survey enquires about the reasons for surgery, which was&#xD;
        used for our purposes of analyzing the reason for having surgery but tailored from Smith et&#xD;
        al (2022). This paper by Smith et al (2022) found five superordinate themes when studying&#xD;
        what matters to abdominal wall hernia patients, which included body image, mental health,&#xD;
        symptoms, interpersonal relationships, and employment. After these questions, patients are&#xD;
        asked what the most important outcome was to them after surgery. This question is asked on&#xD;
        the 30-40-day postoperative survey and may hold some hindsight bias, but we felt it was&#xD;
        important that our ongoing research include these types of questions as patient's responses&#xD;
        may differ from the current documented reasons for surgery and important outcomes. Additional&#xD;
        questions on the 30-40-day postoperative survey was asked on the knowledge patients had&#xD;
        regarding hernia surgery and recovery and how patients felt about being a part of the&#xD;
        decision-making process. After reading Rossello Jimenez et al (2022) paper, which was done to&#xD;
        understand patient knowledge of hernia surgery (self-reported), we decided that the other&#xD;
        variables, when trying to understand important patient perspectives for patient reported&#xD;
        outcomes, included if patients had adequate knowledge regarding surgery and recovery as well&#xD;
        as if they felt a part of the decision-making team. The preoperative decisions and hernia&#xD;
        repair section differs on the 1-year postoperative survey. At the 1-year postoperative time&#xD;
        the survey asks patients questions about satisfaction with hernia repair, outcome of hernia&#xD;
        repair, and improvement of quality of life with hernia repair. These questions were adapted&#xD;
        from the hernia quality of life assessment instrument (HERQL) (Huang et al, 2017). The final&#xD;
        part of the surveys allow for further context to patients attitudes towards the Hospital, any&#xD;
        major life events that may affect recovery, and additional space for comments.&#xD;
  &#xD;
        Study Population:&#xD;
  &#xD;
        The population will focus on all patients aged 16-90 years of age, standard age of patients&#xD;
        accepted for surgery at Shouldice Hospital, who had a hernia operation at Shouldice Hospital.&#xD;
        The only exclusion criteria are those without an email address. The reason for this exclusion&#xD;
        is due to the electronic and internet-based nature of the project. As this is the first study&#xD;
        of its kind at Shouldice Hospital the required sample size is unknown, and this study will&#xD;
        act as an initial pilot for systematic follow up focused on patient and surgical outcomes.&#xD;
        However, for the infection rate analysis we know that to compare to the publications on&#xD;
        Shouldice Repair in Europe that were written within the last two decades, which had 3,888&#xD;
        individuals combined (Bittner et al. 2005, n=1773; Köckerling et al. 2018, n=2115), we will&#xD;
        aim to analyze information from 2,000 patients to allow for a meaningful scientific&#xD;
        comparison with current knowledge. Therefore, we aim to contact 4,500 patients in order to&#xD;
        analyze a total of 2,000 patients. This is based off information gathered by this institution&#xD;
        from previously done prospective projects. When initial research contact was emailed, there&#xD;
        was a response rate of 45%. No dropout rate has been measured as we will gather data for this&#xD;
        study to go on with a sample size calculation in the future.&#xD;
  &#xD;
        Data Collection:&#xD;
  &#xD;
        This study will use recorded sources (responses to surveys, patient charts, and operative&#xD;
        notes) to collect information. This will include a research team member manually checking&#xD;
        patient charts and operative notes as well as downloading and inputting survey responses.&#xD;
        Surveys are sent at 30-40 days, 1-year, 3-year, and 5-year postoperative time. Provided in&#xD;
        supplemental material is a list of the data we will be collecting to use in data analysis and&#xD;
        during the explanations of results.&#xD;
  &#xD;
        A study personnel will identify potential study participants through a report that is&#xD;
        generated daily, using the hospital database, which is sent and stored as an excel file on&#xD;
        the hospitals secure network (EDrive). Only research team personnel will have access to these&#xD;
        excel files. The report shows patient Hospital account number, patient first and last name,&#xD;
        discharge date, length of hospital stay, patient email address, as well as patient&#xD;
        information (sex, smoker, height, and weight). The automated report will be used by a study&#xD;
        personnel to upload and send surveys, utilizing SimpleSurvey, at the postoperative times. The&#xD;
        contacting person will not be already known to potential participants when making initial&#xD;
        contact, however, the potential participants will be known to Shouldice Hospital as they will&#xD;
        have had an operation here.&#xD;
  &#xD;
        For the purposes of this research project, composed of simple review of charts and operative&#xD;
        notes as well as follow up for patient reported outcomes, a consent alteration is requested&#xD;
        (deferred consent). As the request for altered consent pertains to TCPS2 3.7A this research&#xD;
        project presents as no more than minimal risk to the participants, an alteration to the&#xD;
        consent requirement is unlikely to adversely affect the welfare of participants, and it may&#xD;
        be impractical (Government of Canada, 2018) to carry out a large scale follow up initiative&#xD;
        without an altered consent process. The altered consent process would compromise of deferred&#xD;
        consent so that initial contact to send consent forms can be achieved. In person consenting&#xD;
        would be impractical as the current hospital procedures for patient intake and during&#xD;
        hospital stay would be onerous to other departments as well as a burden to the small number&#xD;
        of research department staff. In regard to TCPS2 3.7B each postoperative contact email will&#xD;
        immediately notify potential participants of the research project and will have a link to the&#xD;
        consent form to ensure consent is obtained and ongoing. On each of the consent forms&#xD;
        potential participants will have the choice to be taken directly to the survey if they have&#xD;
        consented, decline to take part, or be provided with information to contact a research team&#xD;
        member. Potential participants can take as long as they want to decide about participation,&#xD;
        but the nature of the study focuses on data collection at specific postoperative intervals.&#xD;
        This research is not being done under medical emergencies or involving those with diminished&#xD;
        decision-making capacity (TCPS2 3.8-3.11). In regard to PHIPA, this research project will be&#xD;
        submitted to an ethics board and researchers will comply with the outlined compliance in&#xD;
        section 44. In order to ensure potential participants meet the criteria for follow up (have&#xD;
        an email address) and to send a consent form, we require personal information without direct&#xD;
        consent, but will obtain consent prior to the collection of all additional information which&#xD;
        was not provided in the automated report. Potential participants will be informed about the&#xD;
        opportunity to withdraw at any time. By doing so potential participants can refuse to&#xD;
        participate or request additional contact/information by research personnel. Steps are taken&#xD;
        to safeguard personal health information by password protection and safe storage.&#xD;
  &#xD;
        Overlap with other projects is a concern as we aim to have multiple studies running. However,&#xD;
        there will be additional populations under review in this project (all hernia types and&#xD;
        recurrences) and this project is specifically aimed to pilot a systemic follow up program.&#xD;
        Standard follow up procedures and concurrent research participation can be routine practices.&#xD;
        Participants will be able to withdraw from participation at any time as well as decline to&#xD;
        participate.&#xD;
  &#xD;
        Duration of Study:&#xD;
  &#xD;
        The study is estimated to take 5-6 years from the beginning of data collection until&#xD;
        finishing the write up of results. Recruitment/enrollment will take 6-12 months, follow up&#xD;
        will take 5 years from last enrolled participant, and data analysis and study write up will&#xD;
        take 5 months. The time it takes for publication is not taken into consideration. Duration of&#xD;
        participant participation is dependent on which and how many follow up surveys are completed.&#xD;
        It is estimated to take 5 minutes for consent form review (multiplied by 4 consent forms),&#xD;
        3-5 minutes for the 30-40 day postoperative survey, 3 minutes for the 1-year postoperative&#xD;
        survey, and 4 minutes for 3- and 5-year postoperative surveys (2 minutes each). The surveys&#xD;
        are sent to patients 30-40 days, 1-year, 3-years, and 5-years after surgery. There will only&#xD;
        be a follow up phone call reminder for those who don't complete and respond yes to being&#xD;
        contacted in regard to the infection questions at the 30-40 day postoperative survey.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 2028</completion_date>
    <primary_completion_date type="Anticipated">August 2028</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>Recurrence after hernia repair</measure>
      <time_frame>Recurrence after hernia repair after one year</time_frame>
      <description>Recurrence after hernia repair</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Recurrence after hernia repair</measure>
      <time_frame>Recurrence after hernia repair after three years</time_frame>
      <description>Recurrence after hernia repair</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence after hernia repair</measure>
      <time_frame>Recurrence after hernia repair after five years</time_frame>
      <description>Recurrence after hernia repair</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recurrence after hernia repair</measure>
      <time_frame>Recurrence after hernia repair after 30 days</time_frame>
      <description>Recurrence after hernia repair</description>
    </secondary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Hernia</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>No intervention</intervention_name>
      <description>No intervention</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The study will include all patients aged 16-90 who underwent hernia surgery at Shouldice&#xD;
          Hospital, with the only exclusion being those without an email address. This exclusion is&#xD;
          due to the electronic nature of the project. Since this is the first study of its kind at&#xD;
          Shouldice Hospital, the required sample size is unknown, and this project serves as a pilot&#xD;
          for systematic follow-up on patient and surgical outcomes.&#xD;
  &#xD;
          For the specific analysis of infection rates, the study aims to gather data from 2,000&#xD;
          patients. To achieve this, the researchers plan to contact 4,500 patients, based on&#xD;
          information from previous projects. Initial research contact yielded a 45% response rate,&#xD;
          and no dropout rate has been measured yet, as data collection for this study will inform&#xD;
          future sample size calculations.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are&#xD;
               eligible.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Lack of an email address.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Christoph Paasch, MD</last_name>
      <phone>6476542790</phone>
      <email>cpaasch@shouldice.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Marguerite Mainprize, MSc</last_name>
      <phone>4169316244</phone>
      <email>mmainprize@shouldice.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shouldice Hospital</name>
        <address>
          <city>Thornhill</city>
          <state>Ontario</state>
          <zip>L3T 4A3,</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marguerite Mainprize, MSc</last_name>
        <phone>905-889-1125 ext. 1297</phone>
        <email>mmainprize@shouldice.com</email>
      </contact>
      <contact_backup>
        <last_name>Fernando Netto Spencer, PhD</last_name>
        <phone>905-889-1125 ext. 1297</phone>
        <email>fspencernetto@shouldice.com</email>
      </contact_backup>
      <investigator>
        <last_name>Christoph Paasch, PD Dr.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marguerite Mainprize, MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fernando Netto Spencer, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>hernia</keyword>
    <keyword>groin hernia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia</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/NCT06039800
  org study id: ShouldiceH
  nct id: NCT06039800
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Background:
  
        Previous publications have highlighted limited data on patient outcomes and experiences at
        Shouldice Hospital. Existing studies from Europe reported outcomes following Shouldice repair
        but lacked recent data. The current project seeks to optimize patient care and knowledge
        through systematic follow-up.
  
        Study Objectives:
  
        Establish a patient-reported outcome measure follow-up program. Evaluate postoperative
        complication rates. Determine important outcomes to patients. Establish and monitor patient
        satisfaction with decision-making and hernia repair.
  
        Hypotheses/Research Questions:
  
        Several research questions related to patient motivations, outcomes, knowledge, and
        satisfaction are posed for investigation.
  
        Potential Risks and Benefits:
  
        No anticipated risks to participants. Participants won't directly benefit but contribute to
        improving patient care and knowledge.
  
        Study Design:
  
        The study employs a prospective follow-up approach. Surveys are sent at specific intervals
        (30-40 days, 1-year, 3-years, and 5-years) via email.
  
        Consent forms are included in the email, allowing participants to choose their level of
        involvement. Data is collected from survey responses, patient charts, and operative notes.
  
        Study Population:
  
        All patients aged 16-90 who underwent hernia surgery at Shouldice Hospital are eligible.
  
        Exclusion criteria:
  
        Lack of an email address. The required sample size is unknown, and this study serves as a
        pilot.
  
        Data Collection:
  
        Data is collected from surveys, patient charts, and operative notes. Consent is obtained
        through deferred consent (initial contact via email, with consent forms provided).
  
        Safeguards are in place to protect personal health information.
  
        Duration of Study:
  
        Estimated to take 5-6 years. Recruitment/enrollment: 6-12 months. Follow-up: 5 years from the
        last enrolled participant. Data analysis and write-up: 5 months.
  
        Overlap with Other Projects:
  
        Concerns about overlap with other studies are addressed, and concurrent participation is
        allowed. Participants can withdraw at any time.
  
        In summary, this research project aims to gather comprehensive data on hernia surgery
        outcomes, patient experiences, and satisfaction at Shouldice Hospital through a systematic
        follow-up approach, contributing to the improvement of patient care and knowledge in this
        field.
  Increasing awareness, research, and publications on patient reported outcomes, patient
        knowledge, and what matters to patients are being done. There is limited data available in
        these areas at Shouldice Hospital, leaving potential gaps in knowledge and areas of
        improvement unidentified. Large scale follow-up on the Shouldice Hospital's postoperative
        complications.
  
        There are two publications within the last 18 years from Europe reporting outcomes following
        Shouldice repair with a larger number of enrolled individuals. These publications included
        3,888 Shouldice repairs. Bittner et al. (2005) published a Meta-analysis analyzing the
        postoperative outcome following TAPP/TEP (n=1,830) and Shouldice repair (n=1,773). The
        authors revealed an infection rate of 0.9%, a hematoma rate of 6.4% (higher than in the
        laparoscopic group) and a seroma rate of 1.2%. The recurrence rate was 2%. Moreover, a 5.4%
        rate of chronic pain and a 30-days period until return to work were published. These rates
        were higher in comparison to endoscopic hernia repair (Bittner et al, 2005). In addition, a
        German matched-pair registry analysis among 2,115 cases of Shouldice repair took place in
        2018. The authors published, that for a selected group of patients (average age: 40 years, a
        large proportion of women of 30%, a mean BMI value of 24 kg/m2 and a proportion of defect
        sizes up to 3 cm of over 85%) the Shouldice repair can be used for primary unilateral
        inguinal hernia repair while achieving an outcome comparable to that of Lichtenstein, TEP and
        TAPP operations (Kockerling et al, 2018). Malik et al. (2016) provided information on the
        recurrence rate (age-standardized recurrence risk of 1.15%; n=65,148) of patients who were
        operated on in the Shouldice repair at the Shouldice hospital. But in terms of SSI, SSO and
        postoperative outcome in general no current information from our Shouldice hospital has been
        revealed within the last two decades (Malik et al, 2016).
  
        In order to further optimize, evaluate, and increase knowledge of the Shouldice repair
        systematic follow-up of patients who were operated on at the Shouldice Hospital should be
        updated. The current project aims to perform a systematic follow-up of patients for the
        purpose of supporting the ongoing improvement of patient care and knowledge. This study will
        act as a pilot for refining our long term follow up, focused on patient and surgical
        outcomes.
  
        Study Objectives:
  
          1. Establish a patient reported outcome measure follow up program at Shouldice Hospital
  
          2. Evaluate the postoperative complication rate (pain, infection, recurrence, and other
             complications)
  
          3. Determine the reasoning and important outcomes to patients who undergo hernia repair at
             Shouldice Hospital.
  
          4. Establish and monitor patient satisfaction with decision making and hernia repair.
  
        Hypothesis/Research Questions:
  
          1. What were the most common reasons for patients to undergo hernia repair?
  
          2. What was the most reported important outcome to patients after hernia surgery?
  
          3. Did patients feel they had adequate knowledge and feel a part of the decision-making
             process?
  
          4. How satisfied and confident were patients with their Shouldice hernia repair at 1-year
             after surgery?
  
          5. Was there any improvement in quality of life due to hernia repair noted at 1-year after
             surgery?
  
          6. What is the infection rate, pain incidence, and hernia recurrence rate at 30-days after
             hernia repair at Shouldice Hospital?
  
          7. What is the pain incidence and hernia recurrence rate at 1-, 3-, and 5-years after
             hernia repair at Shouldice Hospital?
  
          8. Is there a difference in pain experienced after surgery by patients based off the hernia
             they had repaired?
  
          9. Does infection rate differ depending on hernia and/or hernia repair?
  
         10. Does infection rate differ for those given or not given antibiotics prior to or during
             surgery?
  
        Potential Risks and Benefits:
  
        There are no known or anticipated risks to participants as individuals or as part of an
        identifiable group. This includes no physical, psychological, or emotional, social, and/or
        data security breach risks. The use of information will remove any personal identifiers
        before data analysis. There are no direct benefits to the participants from their involvement
        in the project and these include no education about research methods or useful knowledge
        about self.
  
        Study Design:
  
        The current study is a prospective follow up of patients who had an operation for a hernia at
        the Shouldice Hospital. The study design includes using an automated report generated for
        follow up which will allow for participant identification and provide necessary information
        to send the consent forms and follow up to patients, as well as responses from follow up
        surveys by email, and manual review of charts and operative notes. All patients that had
        surgery at Shouldice Hospital are included unless they did not have an email address. The
        reason for this exclusion is due to the electronic and internet-based nature of the project.
        Patients will be emailed 30-40 days after surgery, as well as 1-year, 3-years, and 5-years
        after surgery using the Hospital's current survey site: Simple Survey. Each email will have a
        link to a consent form, which will provide potential participants with the choice to be taken
        directly to the survey if they have consented, decline to participate, or be provided with
        information to contact a research team member. Patients that do not respond after the
        30-40-day postoperative survey will be contacted by phone; this is to ensure comprehensive
        data collection regarding infection at 30-40 days after surgery. Patients that respond yes to
        infection questions at the 30-40-day postoperative survey will additionally be asked if we
        can contact them via telephone to follow up on their potential infection.
  
        The survey is designed to capture the results of important questions and aims about this
        study. The 30-40 day and 1-year postoperative survey includes a postoperative recovery,
        preoperative decisions and hernia repair, and final questions and comments section. The 3-
        and 5-year postoperative surveys have the postoperative recovery and final questions and
        comments sections. The postoperative recovery portion includes questions regarding pain and
        swelling (30-40 day/1-year/3-year/5-year survey) from HerniaMed (Stechemesser et al, 2012),
        questions regarding infection, fluid formation, and hematoma pertaining to grade of surgical
        site infection and surgical site occurrence (30-40 day survey), and additional questions
        regarding hernia relapse (30-40 day/1-year/3-year/5-year survey) and wound complication
        (30-40 day survey). Another part of the survey pertains to preoperative decisions and hernia
        repair. The 30-40-day postoperative survey enquires about the reasons for surgery, which was
        used for our purposes of analyzing the reason for having surgery but tailored from Smith et
        al (2022). This paper by Smith et al (2022) found five superordinate themes when studying
        what matters to abdominal wall hernia patients, which included body image, mental health,
        symptoms, interpersonal relationships, and employment. After these questions, patients are
        asked what the most important outcome was to them after surgery. This question is asked on
        the 30-40-day postoperative survey and may hold some hindsight bias, but we felt it was
        important that our ongoing research include these types of questions as patient's responses
        may differ from the current documented reasons for surgery and important outcomes. Additional
        questions on the 30-40-day postoperative survey was asked on the knowledge patients had
        regarding hernia surgery and recovery and how patients felt about being a part of the
        decision-making process. After reading Rossello Jimenez et al (2022) paper, which was done to
        understand patient knowledge of hernia surgery (self-reported), we decided that the other
        variables, when trying to understand important patient perspectives for patient reported
        outcomes, included if patients had adequate knowledge regarding surgery and recovery as well
        as if they felt a part of the decision-making team. The preoperative decisions and hernia
        repair section differs on the 1-year postoperative survey. At the 1-year postoperative time
        the survey asks patients questions about satisfaction with hernia repair, outcome of hernia
        repair, and improvement of quality of life with hernia repair. These questions were adapted
        from the hernia quality of life assessment instrument (HERQL) (Huang et al, 2017). The final
        part of the surveys allow for further context to patients attitudes towards the Hospital, any
        major life events that may affect recovery, and additional space for comments.
  
        Study Population:
  
        The population will focus on all patients aged 16-90 years of age, standard age of patients
        accepted for surgery at Shouldice Hospital, who had a hernia operation at Shouldice Hospital.
        The only exclusion criteria are those without an email address. The reason for this exclusion
        is due to the electronic and internet-based nature of the project. As this is the first study
        of its kind at Shouldice Hospital the required sample size is unknown, and this study will
        act as an initial pilot for systematic follow up focused on patient and surgical outcomes.
        However, for the infection rate analysis we know that to compare to the publications on
        Shouldice Repair in Europe that were written within the last two decades, which had 3,888
        individuals combined (Bittner et al. 2005, n=1773; Köckerling et al. 2018, n=2115), we will
        aim to analyze information from 2,000 patients to allow for a meaningful scientific
        comparison with current knowledge. Therefore, we aim to contact 4,500 patients in order to
        analyze a total of 2,000 patients. This is based off information gathered by this institution
        from previously done prospective projects. When initial research contact was emailed, there
        was a response rate of 45%. No dropout rate has been measured as we will gather data for this
        study to go on with a sample size calculation in the future.
  
        Data Collection:
  
        This study will use recorded sources (responses to surveys, patient charts, and operative
        notes) to collect information. This will include a research team member manually checking
        patient charts and operative notes as well as downloading and inputting survey responses.
        Surveys are sent at 30-40 days, 1-year, 3-year, and 5-year postoperative time. Provided in
        supplemental material is a list of the data we will be collecting to use in data analysis and
        during the explanations of results.
  
        A study personnel will identify potential study participants through a report that is
        generated daily, using the hospital database, which is sent and stored as an excel file on
        the hospitals secure network (EDrive). Only research team personnel will have access to these
        excel files. The report shows patient Hospital account number, patient first and last name,
        discharge date, length of hospital stay, patient email address, as well as patient
        information (sex, smoker, height, and weight). The automated report will be used by a study
        personnel to upload and send surveys, utilizing SimpleSurvey, at the postoperative times. The
        contacting person will not be already known to potential participants when making initial
        contact, however, the potential participants will be known to Shouldice Hospital as they will
        have had an operation here.
  
        For the purposes of this research project, composed of simple review of charts and operative
        notes as well as follow up for patient reported outcomes, a consent alteration is requested
        (deferred consent). As the request for altered consent pertains to TCPS2 3.7A this research
        project presents as no more than minimal risk to the participants, an alteration to the
        consent requirement is unlikely to adversely affect the welfare of participants, and it may
        be impractical (Government of Canada, 2018) to carry out a large scale follow up initiative
        without an altered consent process. The altered consent process would compromise of deferred
        consent so that initial contact to send consent forms can be achieved. In person consenting
        would be impractical as the current hospital procedures for patient intake and during
        hospital stay would be onerous to other departments as well as a burden to the small number
        of research department staff. In regard to TCPS2 3.7B each postoperative contact email will
        immediately notify potential participants of the research project and will have a link to the
        consent form to ensure consent is obtained and ongoing. On each of the consent forms
        potential participants will have the choice to be taken directly to the survey if they have
        consented, decline to take part, or be provided with information to contact a research team
        member. Potential participants can take as long as they want to decide about participation,
        but the nature of the study focuses on data collection at specific postoperative intervals.
        This research is not being done under medical emergencies or involving those with diminished
        decision-making capacity (TCPS2 3.8-3.11). In regard to PHIPA, this research project will be
        submitted to an ethics board and researchers will comply with the outlined compliance in
        section 44. In order to ensure potential participants meet the criteria for follow up (have
        an email address) and to send a consent form, we require personal information without direct
        consent, but will obtain consent prior to the collection of all additional information which
        was not provided in the automated report. Potential participants will be informed about the
        opportunity to withdraw at any time. By doing so potential participants can refuse to
        participate or request additional contact/information by research personnel. Steps are taken
        to safeguard personal health information by password protection and safe storage.
  
        Overlap with other projects is a concern as we aim to have multiple studies running. However,
        there will be additional populations under review in this project (all hernia types and
        recurrences) and this project is specifically aimed to pilot a systemic follow up program.
        Standard follow up procedures and concurrent research participation can be routine practices.
        Participants will be able to withdraw from participation at any time as well as decline to
        participate.
  
        Duration of Study:
  
        The study is estimated to take 5-6 years from the beginning of data collection until
        finishing the write up of results. Recruitment/enrollment will take 6-12 months, follow up
        will take 5 years from last enrolled participant, and data analysis and study write up will
        take 5 months. The time it takes for publication is not taken into consideration. Duration of
        participant participation is dependent on which and how many follow up surveys are completed.
        It is estimated to take 5 minutes for consent form review (multiplied by 4 consent forms),
        3-5 minutes for the 30-40 day postoperative survey, 3 minutes for the 1-year postoperative
        survey, and 4 minutes for 3- and 5-year postoperative surveys (2 minutes each). The surveys
        are sent to patients 30-40 days, 1-year, 3-years, and 5-years after surgery. There will only
        be a follow up phone call reminder for those who don't complete and respond yes to being
        contacted in regard to the infection questions at the 30-40 day postoperative survey.
  observational model: Other
  time perspective: Prospective
  measure: Recurrence after hernia repair
  time frame: Recurrence after hernia repair after one year
  description: Recurrence after hernia repair
  measure: Recurrence after hernia repair
  time frame: Recurrence after hernia repair after three years
  description: Recurrence after hernia repair
  measure: Recurrence after hernia repair
  time frame: Recurrence after hernia repair after five years
  description: Recurrence after hernia repair
  measure: Recurrence after hernia repair
  time frame: Recurrence after hernia repair after 30 days
  description: Recurrence after hernia repair
  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: N/A
  healthy volunteers: No
  last name: Christoph Paasch, MD
  phone: 6476542790
  email: cpaasch@shouldice.com
  last name: Marguerite Mainprize, MSc
  phone: 4169316244
  email: mmainprize@shouldice.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Sponsor
  mesh term: Hernia
  sharing ipd: No