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/NCT05966285</url>
    </required_header>
    <id_info>
      <org_study_id>Huadong Hospital to FDU</org_study_id>
      <nct_id>NCT05966285</nct_id>
    </id_info>
    <brief_title>Suture Repair vs Mesh Repair in the Treatment of Incarcerated Groin Hernia in Elderly Populations</brief_title>
    <official_title>Suture Repair vs Mesh Repair in the Treatment of Incarcerated Groin Hernia in Elderly Populations: a Retrospective, Single-center Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Purpose:&#xD;
  &#xD;
        Tension-free hernia repair is the gold standard for groin hernia repair. However, there is no&#xD;
        consensus on the optimal surgical treatment for incarcerated groin hernia in elderly&#xD;
        populations, The aim of this study was to compare the clinical efficacy of mesh repair and&#xD;
        suture repair in the treatment of incarcerated groin hernia in elderly patients.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to&#xD;
        June 2022 will be included. Patient demographic data and short-term and long-term&#xD;
        postoperative outcomes will be retrospectively analyzed.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study includes consecutive patients ≥65 years diagnosed with IGH who underwent emergency&#xD;
        surgical repair at our center between January 2015 and June 2022. The study is conducted in&#xD;
        compliance with the ethical standards laid down in the 1964 Declaration of Helsinki and its&#xD;
        subsequent amendments.&#xD;
  &#xD;
        Only true emergencies were included in the study, involving IGH patients who underwent urgent&#xD;
        surgical repair within six hours of an emergency admission or patients who underwent&#xD;
        emergency surgery due to sudden exacerbation while awaiting elective repair surgery during&#xD;
        hospitalization. Various techniques were performed to repair IGH during the surgical&#xD;
        procedure. In cases where there was no ischemic necrosis of the hernia contents, the hernia&#xD;
        content was simply reduced, followed by high ligation of the hernia sac at the inner ring of&#xD;
        the groin. Subsequently, mesh repair was conducted using a synthetic and biological mesh in&#xD;
        the Lichtenstein or open preperitoneal techniques, while suture repair was utilized in the&#xD;
        Bassini, Ferguson, or Halsted operation. For femoral hernias, McVay repair was used in suture&#xD;
        repair while open preperitoneal techniques was used for mesh repair. In cases of IGH&#xD;
        accompanied by intestinal necrosis, the initial procedure involved resection of the necrotic&#xD;
        bowel followed by in vitro anastomosis through a groin incision. Subsequently, high ligation&#xD;
        of the hernia sac was carried out, and the choice between mesh or tissue repair was left to&#xD;
        the discretion of the surgeon. The choice of surgical techniques was based on the surgeons'&#xD;
        experience and the overall condition of the patient. Based on the surgical method used, the&#xD;
        researchers were categorized into two groups: suture repair and mesh repair groups.&#xD;
  &#xD;
        After hospital discharge, the patient was scheduled for regular outpatient visits for at&#xD;
        least 1 year of follow-up, physical Examination and patient's subjective perceptions were&#xD;
        used to determine the presence of recurrence or other long-term complications. The end of the&#xD;
        follow-up was June 2023. Recorded death, recurrence, or loss to follow-up were considered to&#xD;
        be the endpoint.&#xD;
  &#xD;
        Investigators collected data on the following three aspects: (1) patients' demographic&#xD;
        information, including age, sex, American Society of Anesthesiologists (ASA) grade, previous&#xD;
        abdominal operation, previous surgical repair of groin hernia, history of acute&#xD;
        incarceration, comorbidities, and time from incarceration to surgery; (2) surgical details,&#xD;
        such as the type of groin hernia, preoperative antibiotic use, nighttime surgery (the start&#xD;
        time of surgery was from 5 p.m. to before 8 a.m. the next day), hernia contents, bowel&#xD;
        resection, hernia sac size, area of the hernia ring, prosthetic material used, open or&#xD;
        laparoscopic surgery, type of anesthesia (general anesthesia or spinal anesthesia), placement&#xD;
        of the drainage; and (3) clinical outcomes, which included postoperative recurrence as a&#xD;
        long-term outcome, and the surgery related death, surgical site infection (SSI) within 30&#xD;
        days, length of hospital stay, ICU admission, and overall wound complications as short-term&#xD;
        outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 20, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Recurrence</measure>
      <time_frame>at least one year</time_frame>
      <description>Recurrence is determined by physical examination or the patient's subjective perceptions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>length of hospital stay</measure>
      <time_frame>up to 3 months</time_frame>
      <description>The number of days from hospitalization to discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of ICU stay</measure>
      <time_frame>up to 3 months</time_frame>
      <description>The number of days in ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>surgery-related death</measure>
      <time_frame>within 30 days after surgery</time_frame>
      <description>Deaths occurring during the first hospital stay</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>surgical site infection</measure>
      <time_frame>within 30 days after surgery</time_frame>
      <description>would infection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>overall complications</measure>
      <time_frame>at least 1 months</time_frame>
      <description>combination of Outcome 1 to 6</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">70</enrollment>
    <condition>Incarcerated Groin Hernia</condition>
    <arm_group>
      <arm_group_label>suture group</arm_group_label>
      <description>Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>mesh repair</arm_group_label>
      <description>Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>suture repair</intervention_name>
      <description>Suture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique.</description>
      <arm_group_label>suture group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>mesh repair</intervention_name>
      <description>Mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques.</description>
      <arm_group_label>mesh repair</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients ≥65 years diagnosed with incarcerated groin hernia (IGH) who underwent emergency&#xD;
          surgical repair.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients diagnosed with incarcerated groin hernia (IGH).&#xD;
  &#xD;
            2. Aged ≥65 years&#xD;
  &#xD;
            3. Received emergency surgical repair (mesh or suture repair) at our center between&#xD;
               January 2015 and June 2022.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  IGH patients did not undergo either mesh repair or suture repair.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Hekai Shi, M.D.</last_name>
      <phone>+86 18580290227</phone>
      <email>22211280026@m.fudan.edu.cn</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Zhijun Bao</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <keyword>Incarcerated groin hernia</keyword>
    <keyword>Emergency</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hernia</mesh_term>
      <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/NCT05966285
  org study id: Huadong Hospital to FDU
  nct id: NCT05966285
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Purpose:
  
        Tension-free hernia repair is the gold standard for groin hernia repair. However, there is no
        consensus on the optimal surgical treatment for incarcerated groin hernia in elderly
        populations, The aim of this study was to compare the clinical efficacy of mesh repair and
        suture repair in the treatment of incarcerated groin hernia in elderly patients.
  
        Methods:
  
        Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to
        June 2022 will be included. Patient demographic data and short-term and long-term
        postoperative outcomes will be retrospectively analyzed.
  This study includes consecutive patients ≥65 years diagnosed with IGH who underwent emergency
        surgical repair at our center between January 2015 and June 2022. The study is conducted in
        compliance with the ethical standards laid down in the 1964 Declaration of Helsinki and its
        subsequent amendments.
  
        Only true emergencies were included in the study, involving IGH patients who underwent urgent
        surgical repair within six hours of an emergency admission or patients who underwent
        emergency surgery due to sudden exacerbation while awaiting elective repair surgery during
        hospitalization. Various techniques were performed to repair IGH during the surgical
        procedure. In cases where there was no ischemic necrosis of the hernia contents, the hernia
        content was simply reduced, followed by high ligation of the hernia sac at the inner ring of
        the groin. Subsequently, mesh repair was conducted using a synthetic and biological mesh in
        the Lichtenstein or open preperitoneal techniques, while suture repair was utilized in the
        Bassini, Ferguson, or Halsted operation. For femoral hernias, McVay repair was used in suture
        repair while open preperitoneal techniques was used for mesh repair. In cases of IGH
        accompanied by intestinal necrosis, the initial procedure involved resection of the necrotic
        bowel followed by in vitro anastomosis through a groin incision. Subsequently, high ligation
        of the hernia sac was carried out, and the choice between mesh or tissue repair was left to
        the discretion of the surgeon. The choice of surgical techniques was based on the surgeons'
        experience and the overall condition of the patient. Based on the surgical method used, the
        researchers were categorized into two groups: suture repair and mesh repair groups.
  
        After hospital discharge, the patient was scheduled for regular outpatient visits for at
        least 1 year of follow-up, physical Examination and patient's subjective perceptions were
        used to determine the presence of recurrence or other long-term complications. The end of the
        follow-up was June 2023. Recorded death, recurrence, or loss to follow-up were considered to
        be the endpoint.
  
        Investigators collected data on the following three aspects: (1) patients' demographic
        information, including age, sex, American Society of Anesthesiologists (ASA) grade, previous
        abdominal operation, previous surgical repair of groin hernia, history of acute
        incarceration, comorbidities, and time from incarceration to surgery; (2) surgical details,
        such as the type of groin hernia, preoperative antibiotic use, nighttime surgery (the start
        time of surgery was from 5 p.m. to before 8 a.m. the next day), hernia contents, bowel
        resection, hernia sac size, area of the hernia ring, prosthetic material used, open or
        laparoscopic surgery, type of anesthesia (general anesthesia or spinal anesthesia), placement
        of the drainage; and (3) clinical outcomes, which included postoperative recurrence as a
        long-term outcome, and the surgery related death, surgical site infection (SSI) within 30
        days, length of hospital stay, ICU admission, and overall wound complications as short-term
        outcomes.
  observational model: Cohort
  time perspective: Retrospective
  measure: Recurrence
  time frame: at least one year
  description: Recurrence is determined by physical examination or the patient's subjective perceptions
  measure: length of hospital stay
  time frame: up to 3 months
  description: The number of days from hospitalization to discharge
  measure: length of ICU stay
  time frame: up to 3 months
  description: The number of days in ICU
  measure: surgery-related death
  time frame: within 30 days after surgery
  description: Deaths occurring during the first hospital stay
  measure: surgical site infection
  time frame: within 30 days after surgery
  description: would infection
  measure: overall complications
  time frame: at least 1 months
  description: combination of Outcome 1 to 6
  arm group label: suture group
  description: Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.
  arm group label: mesh repair
  description: Patients ≥65 years who underwent urgent surgical groin hernia repair from January 2015 to June 2022 were included.
  intervention type: Other
  intervention name: suture repair
  description: Suture repair was used to reinforce the abdominal wall, including Bassini, Ferguson, McVay, or Halsted technique.
  arm group label: suture group
  intervention type: Other
  intervention name: mesh repair
  description: Mesh repair was conducted using a synthetic and biological mesh in the Lichtenstein or open preperitoneal techniques.
  arm group label: mesh repair
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hekai Shi, M.D.
  phone: +86 18580290227
  email: 22211280026@m.fudan.edu.cn
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Zhijun Bao
  investigator title: Director
  mesh term: Hernia
  mesh term: Hernia, Inguinal
  sharing ipd: No