<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/NCT02984917</url>
  </required_header>
  <id_info>
    <org_study_id>FourthAHChinaMU_002</org_study_id>
    <nct_id>NCT02984917</nct_id>
  </id_info>
  <brief_title>Anterior Transversalis Fascia Approach Versus Preperitoneal Space Approach for Inguinal Hernia Repair in Residents</brief_title>
  <official_title>Anterior Transversalis Fascia Approach Versus Preperitoneal Space Approach for Inguinal Hernia Repair in Residents in Northern China: a Prospective, Multi-center, Randomized, Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Fourth Affiliated Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Fourth Affiliated Hospital of China Medical 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>
      To investigate the advantages and disadvantages of the anterior transversalis fascia approach&#xD;
      versus the preperitoneal approach for inguinal hernia repair in residents from northern China&#xD;
      regarding common postoperative complications (including acute and chronic pain, wound&#xD;
      infection, rates of wound infection, hematoma, seroma, and hernia recurrence) and severe&#xD;
      postoperative complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      History and current related studies Inguinal hernia is a common surgical disease that&#xD;
      manifests as protrusion of abdominal cavity contents through the inguinal canal because of an&#xD;
      abdominal wall defect. It is more common in males than in females, with an overall incidence&#xD;
      of 5-10%. Methods for surgical repair of abdominal wall defects in the inguinal region are&#xD;
      classified as either 'tension'repairs or 'tension-free' repairs. Herniorrhaphy through repair&#xD;
      of the posterior wall of the inguinal canal was first described by Bassini in 1887, and is&#xD;
      regarded as a classic surgical method.&#xD;
&#xD;
      As understanding of the anatomic location and pathophysical characteristics of inguinal&#xD;
      hernia developed, the American surgeon Lichtenstein proposed a new concept of tension-free&#xD;
      herniorrhaphy. This technique was quickly adopted worldwide because of its advantages&#xD;
      including minimal invasion, technical ease, effectiveness, low complication rate, low&#xD;
      recurrence rate, and allowance of resumption of unrestricted physical activity. The most&#xD;
      common technique is open tension-free herniorrhaphy.&#xD;
&#xD;
      Many surgical repair methods involving patches (of varying types and materials) are available&#xD;
      for inguinal hernia repair.&#xD;
&#xD;
      Tension-free herniorrhaphy methods include anterior transversalis fascia repair,&#xD;
      preperitoneal repair, abdominal cavity patch repair and combined repair approaches.&#xD;
      Lichtenstein herniorrhaphy is the representative technique of anterior transversalis fascia&#xD;
      repair. Preperitoneal repair techniques include transabdominal preperitoneal, total&#xD;
      extraperitoneal, and Kugel repair techniques. The combined repair approaches refer to&#xD;
      tension-free herniorrhaphy using a modified Kugel patch and the Ultrapro hernia system.&#xD;
&#xD;
      There are few reports on the effects of different inguinal hernia repair approaches on&#xD;
      postoperative complications, particularly regarding severe postoperative complications, in&#xD;
      patients in northern China. The incidence of severe complications after inguinal hernia&#xD;
      repair is relatively low, but this surgery can lead to physical impairment or organ&#xD;
      dysfunction that greatly decreases patient quality of life and places a heavy burden on the&#xD;
      patient's family and society. At present, there is a scarcity of clinical evidence from&#xD;
      large-sample, randomized, controlled trials investigating the effectiveness of inguinal&#xD;
      hernia repair via the anterior transversalis fascia approach versus the preperitoneal&#xD;
      approach.&#xD;
&#xD;
      Adverse events and serious adverse events (SAE) According to the study protocol and clinical&#xD;
      judgment, AE/SAE occurring after herniorrhaphy will be reported to the Department of General&#xD;
      Surgery, the Fourth Affiliated Hospital of China Medical University.&#xD;
&#xD;
      AE refer to any adverse medical events occurring after herniorrhaphy in patients or clinical&#xD;
      subjects. SAE refer to any adverse postoperative medical events involving one or more of the&#xD;
      following criteria:&#xD;
&#xD;
      Death, irrespective of the cause Life-threatening event Severe or permanent disability or&#xD;
      organ dysfunction Hemorrhage Malformation, birth defect Hospitalization or extended hospital&#xD;
      stay Re-admission to hospital Recurrence (symptomatic) of inguinal hernia&#xD;
&#xD;
      Statistical analysis Descriptive statistics will be used to analyze the data. For measurement&#xD;
      data, the number of patients (number of missing patients), mean, median, standard deviation,&#xD;
      first quartile, third quartile, and maximum and minimum will be described, and 95% confidence&#xD;
      intervals will be calculated. For counted data, the frequency and relative numbers will be&#xD;
      described, and 95% confidence intervals will be calculated. According to whether the&#xD;
      differences between scores before and after treatments are normally distributed, the paired&#xD;
      t-test or Wilcoxon signed rank test will be used for comparison of measurement data in the&#xD;
      same group. The chi-squared test or Fisher's exact test will be used for analysis of counted&#xD;
      data, and the Wilcoxon signed rank test will be used for analysis of ranked data. The&#xD;
      last-observation-carried-forward imputation method will be used when the effects-related&#xD;
      visit data at the last visit are missing.&#xD;
&#xD;
      Full analysis set According to the intention-to-treat principle, patients who receive at&#xD;
      least one treatment according to study protocol and undergo at least one evaluation regarding&#xD;
      curative effects after baseline evaluation will be included in the full analysis set.&#xD;
&#xD;
      Curative effects analysis Full analysis set analysis of curative effects will be performed.&#xD;
      The proportions of patients with no complications, patients with common complications, and&#xD;
      patients with severe complications within postoperative 3 weeks will be analyzed using&#xD;
      descriptive statistics. The chi-squared test or Fisher's exact test will be used for&#xD;
      comparison of differences between groups. If statistical differences exist between groups,&#xD;
      the Bonferroni method will be used to adjust the α value, and pairwise comparisons will be&#xD;
      made.&#xD;
&#xD;
      If the change in VAS pain score after treatment meets the normality and homogeneity of&#xD;
      variance, analysis of variance will be performed. If the statistical analysis of variance&#xD;
      results are significant, in-depth statistical analysis will be performed, and the Bonferroni&#xD;
      method will be used for pairwise comparisons. Otherwise, the Kruskal-Wallis test will be&#xD;
      performed. If the statistical results of the Kruskal-Wallis test are significant, in-depth&#xD;
      statistical analysis will be performed, and the independent Wilcoxon signed rank test will be&#xD;
      performed. The Bonferroni method will be used to adjust P values for pairwise comparisons.&#xD;
&#xD;
      Safety evaluation Safety analysis and analysis of the incidence of postoperative&#xD;
      complications will be performed using descriptive statistics. The chi-squared test or&#xD;
      Fisher's exact test will be performed for comparisons between groups. If significant&#xD;
      differences exist, the Bonferroni method will be used to adjust the α value, and in-depth&#xD;
      pairwise comparisons will be made between groups. Vital signs and laboratory outcomes will be&#xD;
      analyzed using descriptive statistics. The paired t-test or Wilcoxon signed rank test will be&#xD;
      used to analyze the differences between values before and after surgery. Imaging data and&#xD;
      electrocardiograms will be analyzed using cross tabulations.&#xD;
&#xD;
      Economic analysis Cost-utility analysis will be used for economic evaluation, and sensitivity&#xD;
      analysis of cost and utility will be performed.&#xD;
&#xD;
      Interim analysis When an adequate number of patients are enrolled and followed-up, interim&#xD;
      analysis will be performed. When data are included for the full analysis set and recorded in&#xD;
      the database, the first interim analysis during the management period will be performed to&#xD;
      check whether the core data collected are suitable for preliminary significant data analysis.&#xD;
      According to research progression, subsequent interim analysis of all data included in the&#xD;
      database will then be designated. After acquiring approval from the Department of General&#xD;
      Surgery and Scientific Construction Committee, the Fourth Affiliated Hospital of China&#xD;
      Medical University, the data collected in the Department of General Surgery, the Fourth&#xD;
      Affiliated Hospital of China Medical University are likely to be analyzed together with the&#xD;
      data collected from the other research centers. In accordance with applicable laws and&#xD;
      regulations, the information on the subjects in the study will be kept confidential. The data&#xD;
      for interim analysis will be precisely described in a statistical analysis plan. The interim&#xD;
      analysis results will be submitted to the sponsor and the project manager in the form of a&#xD;
      statistical analysis report, and as slides by the co-sponsors.&#xD;
&#xD;
      Sample size Investigators hypothesized that anterior transversalis fascia repair can reduce&#xD;
      the percentage of patients with postoperative pain by 15% compared with the percentage of&#xD;
      patients with pain before surgery. Taking α = 0.05 and power = 80%, the final effective&#xD;
      sample size of n = 300 was calculated. Assuming a patient loss rate of 20%, investigators&#xD;
      require 360 patients. This study is planned to be performed in more than nine institutes to&#xD;
      investigate the effectiveness of inguinal hernia repair via the anterior transversalis fascia&#xD;
      approach versus the preperitoneal approach in patients in northern China. Investigators plan&#xD;
      to include at least 2,000 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 6, 2017</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>VAS pain score</measure>
    <time_frame>changes of month 1, month 3, month 12, month 24 after operation</time_frame>
    <description>Visual Analogue Scale(VAS) pain score is one of the most commonly used tools for assessing pain.It comprises a 10 cm line with 0 at one end, representing no pain, and 10 at the other end, representing the worst pain imaginable; the patient places a mark on the line to indicate the degree of pain that they are experiencing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative complications</measure>
    <time_frame>changes of month 1, month 3, month 12, month 24 after operation</time_frame>
    <description>Postoperative complications including wound infection, rates of hematoma, seroma, hernia recurrence, intestinal obstruction, intestinal fistula, entocele, mesenteric thrombosis, femoral vein thrombosis, ischemic orchitis, painful ejaculation, varicocele and scrotal edema.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Inguinal Hernia</condition>
  <arm_group>
    <arm_group_label>anterior transversalis fascia approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with inguinal hernia will undergo inguinal hernia repair via the anterior transversalis fascia approach.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>preperitoneal space approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with inguinal hernia will undergo inguinal hernia repair via the preperitoneal space approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Anterior transversalis fascia approach</intervention_name>
    <description>Patients will undergo inguinal hernia repair via the anterior transversalis fascia approach.</description>
    <arm_group_label>anterior transversalis fascia approach</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Preperitoneal space approach</intervention_name>
    <description>Patients will undergo inguinal hernia repair via the preperitoneal space approach.</description>
    <arm_group_label>preperitoneal space approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with primary unilateral inguinal hernia&#xD;
&#xD;
          -  Aged 18-80 years&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) classification I-II&#xD;
&#xD;
          -  Provision of informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe organ dysfunction or inability to tolerate surgery&#xD;
&#xD;
          -  Hernia recurrence&#xD;
&#xD;
          -  Giant hernia (inner size of the hernia &gt; 4 cm)&#xD;
&#xD;
          -  Scrotal hernia&#xD;
&#xD;
          -  Incarcerated inguinal hernia&#xD;
&#xD;
          -  Inability to complete follow-up or questionnaire because of mental disorder or other&#xD;
             reasons&#xD;
&#xD;
          -  History of preperitoneal surgery, such as radical prostatectomy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hangyu Li, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Fourth Affiliated Hospital of China Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hangyu Li, Ph.D</last_name>
    <phone>8618940257002</phone>
    <email>li_hangyu@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>General Hospital of Benxi Steel and Iron (Group) Co., LTD</name>
      <address>
        <city>Benxi</city>
        <state>Liaoning</state>
        <zip>117000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhong-shu Dai, Ph.D</last_name>
      <phone>8613841460709</phone>
      <email>dzs20092009@163.com</email>
    </contact>
    <investigator>
      <last_name>Zhong-shu Dai, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Dalian Medical University</name>
      <address>
        <city>Dalian</city>
        <state>Liaoning</state>
        <zip>116011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>De-wei An, Ph.D</last_name>
      <phone>8613704262820</phone>
      <email>anweide@sina.com</email>
    </contact>
    <investigator>
      <last_name>De-wei An, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Dandong City</name>
      <address>
        <city>Dandong</city>
        <state>Liaoning</state>
        <zip>118000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yao-qiang Wu, Ph.D</last_name>
      <phone>8613704959939</phone>
      <email>wuyaoqiang@sina.com</email>
    </contact>
    <investigator>
      <last_name>Yao-qiang Wu, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Jinzhou Medical University</name>
      <address>
        <city>Jinzhou</city>
        <state>Liaoning</state>
        <zip>121001</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shi-feng Qiao, Ph.D</last_name>
      <phone>8618004969133</phone>
      <email>shifengqiao2013@163.com</email>
    </contact>
    <investigator>
      <last_name>Shi-feng Qiao, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The 202nd Hospital of PLA</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fu-rong Wang, Ph.D</last_name>
      <phone>8613352457285</phone>
      <email>furong_jiyu@126.com</email>
    </contact>
    <investigator>
      <last_name>Fu-rong Wang, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fengtian Hospital of Shenyang Medical College</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110024</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shao-jun Zhang, Ph.D</last_name>
      <phone>8613909888012</phone>
      <email>shaojunzhang@163.com</email>
    </contact>
    <investigator>
      <last_name>Shao-jun Zhang, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>General Hospital of Shenyang Military Region</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110031</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hui-yong Jiang, Ph.D</last_name>
      <phone>8613352457673</phone>
      <email>huiyongj@126.com</email>
    </contact>
    <investigator>
      <last_name>Hui-yong Jiang, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Fourth Affiliated Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hang-yu Li, Ph.D</last_name>
      <phone>8618940257002</phone>
      <email>li_hangyu@126.com</email>
    </contact>
    <investigator>
      <last_name>Hang-yu Li, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Shengjing Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>117004</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fu-quan Yang, Ph.D</last_name>
      <phone>8618940251755</phone>
      <email>yangfq@sj-hospital.org</email>
    </contact>
    <investigator>
      <last_name>Fu-quan Yang, Ph.D</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>June 14, 2017</last_update_submitted>
  <last_update_submitted_qc>June 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Fourth Affiliated Hospital of China Medical University</investigator_affiliation>
    <investigator_full_name>Hangyu Li</investigator_full_name>
    <investigator_title>Chief Physician</investigator_title>
  </responsible_party>
  <keyword>anterior transversalis fascia repair; preperitoneal repair</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>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT02984917
org study id: FourthAHChinaMU_002
nct id: NCT02984917
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To investigate the advantages and disadvantages of the anterior transversalis fascia approach
      versus the preperitoneal approach for inguinal hernia repair in residents from northern China
      regarding common postoperative complications (including acute and chronic pain, wound
      infection, rates of wound infection, hematoma, seroma, and hernia recurrence) and severe
      postoperative complications.
History and current related studies Inguinal hernia is a common surgical disease that
      manifests as protrusion of abdominal cavity contents through the inguinal canal because of an
      abdominal wall defect. It is more common in males than in females, with an overall incidence
      of 5-10%. Methods for surgical repair of abdominal wall defects in the inguinal region are
      classified as either 'tension'repairs or 'tension-free' repairs. Herniorrhaphy through repair
      of the posterior wall of the inguinal canal was first described by Bassini in 1887, and is
      regarded as a classic surgical method.

      As understanding of the anatomic location and pathophysical characteristics of inguinal
      hernia developed, the American surgeon Lichtenstein proposed a new concept of tension-free
      herniorrhaphy. This technique was quickly adopted worldwide because of its advantages
      including minimal invasion, technical ease, effectiveness, low complication rate, low
      recurrence rate, and allowance of resumption of unrestricted physical activity. The most
      common technique is open tension-free herniorrhaphy.

      Many surgical repair methods involving patches (of varying types and materials) are available
      for inguinal hernia repair.

      Tension-free herniorrhaphy methods include anterior transversalis fascia repair,
      preperitoneal repair, abdominal cavity patch repair and combined repair approaches.
      Lichtenstein herniorrhaphy is the representative technique of anterior transversalis fascia
      repair. Preperitoneal repair techniques include transabdominal preperitoneal, total
      extraperitoneal, and Kugel repair techniques. The combined repair approaches refer to
      tension-free herniorrhaphy using a modified Kugel patch and the Ultrapro hernia system.

      There are few reports on the effects of different inguinal hernia repair approaches on
      postoperative complications, particularly regarding severe postoperative complications, in
      patients in northern China. The incidence of severe complications after inguinal hernia
      repair is relatively low, but this surgery can lead to physical impairment or organ
      dysfunction that greatly decreases patient quality of life and places a heavy burden on the
      patient's family and society. At present, there is a scarcity of clinical evidence from
      large-sample, randomized, controlled trials investigating the effectiveness of inguinal
      hernia repair via the anterior transversalis fascia approach versus the preperitoneal
      approach.

      Adverse events and serious adverse events (SAE) According to the study protocol and clinical
      judgment, AE/SAE occurring after herniorrhaphy will be reported to the Department of General
      Surgery, the Fourth Affiliated Hospital of China Medical University.

      AE refer to any adverse medical events occurring after herniorrhaphy in patients or clinical
      subjects. SAE refer to any adverse postoperative medical events involving one or more of the
      following criteria:

      Death, irrespective of the cause Life-threatening event Severe or permanent disability or
      organ dysfunction Hemorrhage Malformation, birth defect Hospitalization or extended hospital
      stay Re-admission to hospital Recurrence (symptomatic) of inguinal hernia

      Statistical analysis Descriptive statistics will be used to analyze the data. For measurement
      data, the number of patients (number of missing patients), mean, median, standard deviation,
      first quartile, third quartile, and maximum and minimum will be described, and 95% confidence
      intervals will be calculated. For counted data, the frequency and relative numbers will be
      described, and 95% confidence intervals will be calculated. According to whether the
      differences between scores before and after treatments are normally distributed, the paired
      t-test or Wilcoxon signed rank test will be used for comparison of measurement data in the
      same group. The chi-squared test or Fisher's exact test will be used for analysis of counted
      data, and the Wilcoxon signed rank test will be used for analysis of ranked data. The
      last-observation-carried-forward imputation method will be used when the effects-related
      visit data at the last visit are missing.

      Full analysis set According to the intention-to-treat principle, patients who receive at
      least one treatment according to study protocol and undergo at least one evaluation regarding
      curative effects after baseline evaluation will be included in the full analysis set.

      Curative effects analysis Full analysis set analysis of curative effects will be performed.
      The proportions of patients with no complications, patients with common complications, and
      patients with severe complications within postoperative 3 weeks will be analyzed using
      descriptive statistics. The chi-squared test or Fisher's exact test will be used for
      comparison of differences between groups. If statistical differences exist between groups,
      the Bonferroni method will be used to adjust the α value, and pairwise comparisons will be
      made.

      If the change in VAS pain score after treatment meets the normality and homogeneity of
      variance, analysis of variance will be performed. If the statistical analysis of variance
      results are significant, in-depth statistical analysis will be performed, and the Bonferroni
      method will be used for pairwise comparisons. Otherwise, the Kruskal-Wallis test will be
      performed. If the statistical results of the Kruskal-Wallis test are significant, in-depth
      statistical analysis will be performed, and the independent Wilcoxon signed rank test will be
      performed. The Bonferroni method will be used to adjust P values for pairwise comparisons.

      Safety evaluation Safety analysis and analysis of the incidence of postoperative
      complications will be performed using descriptive statistics. The chi-squared test or
      Fisher's exact test will be performed for comparisons between groups. If significant
      differences exist, the Bonferroni method will be used to adjust the α value, and in-depth
      pairwise comparisons will be made between groups. Vital signs and laboratory outcomes will be
      analyzed using descriptive statistics. The paired t-test or Wilcoxon signed rank test will be
      used to analyze the differences between values before and after surgery. Imaging data and
      electrocardiograms will be analyzed using cross tabulations.

      Economic analysis Cost-utility analysis will be used for economic evaluation, and sensitivity
      analysis of cost and utility will be performed.

      Interim analysis When an adequate number of patients are enrolled and followed-up, interim
      analysis will be performed. When data are included for the full analysis set and recorded in
      the database, the first interim analysis during the management period will be performed to
      check whether the core data collected are suitable for preliminary significant data analysis.
      According to research progression, subsequent interim analysis of all data included in the
      database will then be designated. After acquiring approval from the Department of General
      Surgery and Scientific Construction Committee, the Fourth Affiliated Hospital of China
      Medical University, the data collected in the Department of General Surgery, the Fourth
      Affiliated Hospital of China Medical University are likely to be analyzed together with the
      data collected from the other research centers. In accordance with applicable laws and
      regulations, the information on the subjects in the study will be kept confidential. The data
      for interim analysis will be precisely described in a statistical analysis plan. The interim
      analysis results will be submitted to the sponsor and the project manager in the form of a
      statistical analysis report, and as slides by the co-sponsors.

      Sample size Investigators hypothesized that anterior transversalis fascia repair can reduce
      the percentage of patients with postoperative pain by 15% compared with the percentage of
      patients with pain before surgery. Taking α = 0.05 and power = 80%, the final effective
      sample size of n = 300 was calculated. Assuming a patient loss rate of 20%, investigators
      require 360 patients. This study is planned to be performed in more than nine institutes to
      investigate the effectiveness of inguinal hernia repair via the anterior transversalis fascia
      approach versus the preperitoneal approach in patients in northern China. Investigators plan
      to include at least 2,000 patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: VAS pain score
time frame: changes of month 1, month 3, month 12, month 24 after operation
description: Visual Analogue Scale(VAS) pain score is one of the most commonly used tools for assessing pain.It comprises a 10 cm line with 0 at one end, representing no pain, and 10 at the other end, representing the worst pain imaginable; the patient places a mark on the line to indicate the degree of pain that they are experiencing.
measure: Postoperative complications
time frame: changes of month 1, month 3, month 12, month 24 after operation
description: Postoperative complications including wound infection, rates of hematoma, seroma, hernia recurrence, intestinal obstruction, intestinal fistula, entocele, mesenteric thrombosis, femoral vein thrombosis, ischemic orchitis, painful ejaculation, varicocele and scrotal edema.
arm group label: anterior transversalis fascia approach
arm group type: Experimental
description: Patients with inguinal hernia will undergo inguinal hernia repair via the anterior transversalis fascia approach.
arm group label: preperitoneal space approach
arm group type: Experimental
description: Patients with inguinal hernia will undergo inguinal hernia repair via the preperitoneal space approach.
intervention type: Procedure
intervention name: Anterior transversalis fascia approach
description: Patients will undergo inguinal hernia repair via the anterior transversalis fascia approach.
arm group label: anterior transversalis fascia approach
intervention type: Procedure
intervention name: Preperitoneal space approach
description: Patients will undergo inguinal hernia repair via the preperitoneal space approach.
arm group label: preperitoneal space approach
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hangyu Li, Ph.D
role: Principal Investigator
affiliation: The Fourth Affiliated Hospital of China Medical University
last name: Hangyu Li, Ph.D
phone: 8618940257002
email: li_hangyu@126.com
facility: 
status: Recruiting
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status: Recruiting
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country: China
responsible party type: Principal Investigator
investigator affiliation: The Fourth Affiliated Hospital of China Medical University
investigator full name: Hangyu Li
investigator title: Chief Physician
mesh term: Hernia
mesh term: Hernia, Inguinal
sharing ipd: Undecided