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/NCT06025188</url>
    </required_header>
    <id_info>
      <org_study_id>TJH-DVNPPH</org_study_id>
      <nct_id>NCT06025188</nct_id>
    </id_info>
    <brief_title>Development and Validation of a Nomogram Predicting the Probability of in Hirschsprung Children Following Surgery</brief_title>
    <official_title>Department of Pediatric Surgery, Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Tongji Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Postoperative soiling is a common complication following Hirschsprung disease [HSCR] surgery.&#xD;
        The aim of this study was to develop a nomogram for predicting the probability of&#xD;
        postoperative soiling in patients aged &gt;1 year operated for HSCR. The investigators&#xD;
        retrospectively analyzed HSCR patients with surgical therapy over one year of age from&#xD;
        January 2000 and December 2019 at our department. Eligible patients were randomly categorized&#xD;
        into the training and validation set at a ratio of 7:3. By integrating the least absolute&#xD;
        shrinkage and selection operator [LASSO] and multivariable logistic regression analysis,&#xD;
        crucial variables were determined for establishment of nomogram. And, the performance of&#xD;
        nomogram was evaluated by C-index，area under the receiver operating characteristic curve&#xD;
        [ROC], calibration curves, and decision curve analysis [DCA]. Meanwhile, a validation set was&#xD;
        used to further assess the model.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This retrospective study was conducted on patients diagnosed with HSCR who underwent surgical&#xD;
        treatment at our hospital department from January 2000 to December 2019. This research study&#xD;
        was reviewed and approved by the ethics committee at Hospital, waiving the requirement for&#xD;
        informed consent in alignment with the Declaration of Helsinki. The number of the&#xD;
        institutional reviewboard approval is S108. The diagnosis of HSCR was established through&#xD;
        preoperative examinations, which included barium enema, anorectal manometry, and suction&#xD;
        rectal biopsy. Additionally, postoperative pathological examination was conducted to further&#xD;
        confirm the diagnosis. All operations were performed in accordance with the standard&#xD;
        procedures by experienced surgical groups in our department.&#xD;
  &#xD;
        2.2. Definition of soiling This study refers to the diagnostic criteria for soiling as&#xD;
        described in the published literature . Based on the previously established criteria and&#xD;
        clinical experience, patients who experienced soiling persisting for more than six months&#xD;
        following surgery were ultimately identified for inclusion in this study. In this study,&#xD;
        patients with Down's syndrome, and other established syndromes potentially contributed to&#xD;
        maldevelopment were excluded as previous described . In addition, patients who had their&#xD;
        initial surgery at another institution were excluded from the study, as well as any&#xD;
        participants received staged treatment or had missing data related to soiling.&#xD;
  &#xD;
        In this study, The investigators collected the clinical information about patients from a&#xD;
        thorough review of relevant literatures and clinical judgement. These data included the age&#xD;
        for definitive surgery, sex, weight at operation, premature delivery history, family history,&#xD;
        meconium, duration of constipation, conservative treatment, surgical history, surgical&#xD;
        techniques, length of removed bowel, surgical procedure, and soiling status. The surgical&#xD;
        techniques included laparoscopic-assisted pull-through [LAPT], laparotomy-assisted endorectal&#xD;
        pull-through [LEPT], and transanal endorectal pull-through [TEPT]. Length of removed bowel&#xD;
        included left colectomy, subtotal ectomy, and total colectomy. Surgical procedures were&#xD;
        categorized as Soave, Heart-Shaped, Rebbein, Duhamel, and others. Data with a deletion rate&#xD;
        &gt;= 20% were excluded from the analysis. The trimming method was introduced to address with&#xD;
        abnormal values and a multiple imputation method was employed to interpolate missing data All&#xD;
        patients were randomly assigned into training and validation set in a 7:3 ratio as previous&#xD;
        reported. No significant differences were observed in demographic and clinical&#xD;
        characteristics between the training and validation sets. To determine potential predictive&#xD;
        factors, the training set was subjected to LASSO regression analysis, which effectively&#xD;
        eliminated several irrelevant or multicollinearity independent variables to reduce&#xD;
        high-dimensional data . Then, the multivariable logistic regression analysis was applied to&#xD;
        determine the variables of soiling in patients with HSCR following surgery over one year of&#xD;
        age. Finally, a nomogram was created based on the training set and validated in the&#xD;
        validation set.&#xD;
  &#xD;
        Discrimination and calibration were employed to assess and test the predictive accuracy of&#xD;
        the established model. Harrell's concordance index [C-index] and the receiver operating&#xD;
        characteristic [ROC] curve [AUC] were generated to estimate the discrimination of the&#xD;
        nomogram. A C-index close to 1 indicates a high level of predictive ability of the model.&#xD;
        Additionally, an AUC &gt; 0.80 indicates relatively good discrimination. The calibration of the&#xD;
        nomogram was accompanied with the Hosmer-Lemeshow test were developed to determine the&#xD;
        consistency between the predicted and observed occurrence of soiling. Lastly, DCA was&#xD;
        performed to evaluate clinical practicability of the nomograms. Both discrimination and&#xD;
        calibration were assessed by bootstrapping with 1000 resamples.&#xD;
  &#xD;
        For parameters with continuous variables, the normal distribution was expressed as mean ±&#xD;
        standard deviation [SD], and the skewed distribution was presented as median [M] and quartile&#xD;
        range [Q25-Q75]. Continuous data between two groups were compared using the independent&#xD;
        t-test. The unequal variance t-test was used to compare data between groups with unequal&#xD;
        variances. In cases of skewed distribution, the Mann-Whitney U test was employed.&#xD;
        Furthermore, categorical data were compared using 2 or Fisher's exact test. Statistical&#xD;
        analysis was performed using R Software v.4.0.2 [The R Project for Statistical Computing,&#xD;
        www.r-project.org] with the &quot;rms&quot; package utilized for logistic regression analysis and&#xD;
        nomogram construction. A two-sided P-value less than 0.05 was considered statistically&#xD;
        significant.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">July 1, 2021</start_date>
    <completion_date type="Actual">August 1, 2022</completion_date>
    <primary_completion_date type="Actual">August 1, 2021</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>Harrell's concordance index (C-index)</measure>
      <time_frame>1 month</time_frame>
      <description>Harrell's concordance index [C-index] was generated to estimate the discrimination of the nomogram A C-index close to 1 indicates a high level of predictive ability of the model.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">600</enrollment>
    <condition>Develop a Nomogram</condition>
    <arm_group>
      <arm_group_label>training set</arm_group_label>
      <description>To determine potential predictive factors, the training set was subjected to LASSO regression analysis, which effectively eliminated several irrelevant or multicollinearity independent variables to reduce high-dimensional data</description>
    </arm_group>
    <arm_group>
      <arm_group_label>validation set</arm_group_label>
      <description>The multivariable logistic regression analysis was applied to determine the variables of soiling in patients with HSCR following surgery over one year of age. Finally, a nomogram was created based on the training set and validated in the validation set.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>training set</intervention_name>
      <description>LASSO regression analysis, Logistic regression analysis, Nomogram</description>
      <arm_group_label>training set</arm_group_label>
      <arm_group_label>validation set</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          This retrospective study was conducted on patients diagnosed with HSCR who underwent&#xD;
          surgical treatment at our hospital department from January 2000 to December 2019.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patients were experienced soiling persisting for more than 6 months following surgery.&#xD;
  &#xD;
          Patients aged &gt;1 year, gender is not limited. The patient must sign an informed consent&#xD;
          form and can actively cooperate with the treatment and follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Patients with other severe deformity. Patients with mental symptoms or other disease.&#xD;
          patients who had their initial surgery at another institution.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>patients aged &gt;1 year operated for HSCR.</gender_description>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tongji hospital affiliated to tongji medical college of huazhong university of science and technology</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>September 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 2, 2023</last_update_submitted>
    <last_update_submitted_qc>September 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tongji Hospital</investigator_affiliation>
      <investigator_full_name>Jiexiong Feng</investigator_full_name>
      <investigator_title>Chief in Department</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06025188
  org study id: TJH-DVNPPH
  nct id: NCT06025188
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Postoperative soiling is a common complication following Hirschsprung disease [HSCR] surgery.
        The aim of this study was to develop a nomogram for predicting the probability of
        postoperative soiling in patients aged >1 year operated for HSCR. The investigators
        retrospectively analyzed HSCR patients with surgical therapy over one year of age from
        January 2000 and December 2019 at our department. Eligible patients were randomly categorized
        into the training and validation set at a ratio of 7:3. By integrating the least absolute
        shrinkage and selection operator [LASSO] and multivariable logistic regression analysis,
        crucial variables were determined for establishment of nomogram. And, the performance of
        nomogram was evaluated by C-index，area under the receiver operating characteristic curve
        [ROC], calibration curves, and decision curve analysis [DCA]. Meanwhile, a validation set was
        used to further assess the model.
  This retrospective study was conducted on patients diagnosed with HSCR who underwent surgical
        treatment at our hospital department from January 2000 to December 2019. This research study
        was reviewed and approved by the ethics committee at Hospital, waiving the requirement for
        informed consent in alignment with the Declaration of Helsinki. The number of the
        institutional reviewboard approval is S108. The diagnosis of HSCR was established through
        preoperative examinations, which included barium enema, anorectal manometry, and suction
        rectal biopsy. Additionally, postoperative pathological examination was conducted to further
        confirm the diagnosis. All operations were performed in accordance with the standard
        procedures by experienced surgical groups in our department.
  
        2.2. Definition of soiling This study refers to the diagnostic criteria for soiling as
        described in the published literature . Based on the previously established criteria and
        clinical experience, patients who experienced soiling persisting for more than six months
        following surgery were ultimately identified for inclusion in this study. In this study,
        patients with Down's syndrome, and other established syndromes potentially contributed to
        maldevelopment were excluded as previous described . In addition, patients who had their
        initial surgery at another institution were excluded from the study, as well as any
        participants received staged treatment or had missing data related to soiling.
  
        In this study, The investigators collected the clinical information about patients from a
        thorough review of relevant literatures and clinical judgement. These data included the age
        for definitive surgery, sex, weight at operation, premature delivery history, family history,
        meconium, duration of constipation, conservative treatment, surgical history, surgical
        techniques, length of removed bowel, surgical procedure, and soiling status. The surgical
        techniques included laparoscopic-assisted pull-through [LAPT], laparotomy-assisted endorectal
        pull-through [LEPT], and transanal endorectal pull-through [TEPT]. Length of removed bowel
        included left colectomy, subtotal ectomy, and total colectomy. Surgical procedures were
        categorized as Soave, Heart-Shaped, Rebbein, Duhamel, and others. Data with a deletion rate
        >= 20% were excluded from the analysis. The trimming method was introduced to address with
        abnormal values and a multiple imputation method was employed to interpolate missing data All
        patients were randomly assigned into training and validation set in a 7:3 ratio as previous
        reported. No significant differences were observed in demographic and clinical
        characteristics between the training and validation sets. To determine potential predictive
        factors, the training set was subjected to LASSO regression analysis, which effectively
        eliminated several irrelevant or multicollinearity independent variables to reduce
        high-dimensional data . Then, the multivariable logistic regression analysis was applied to
        determine the variables of soiling in patients with HSCR following surgery over one year of
        age. Finally, a nomogram was created based on the training set and validated in the
        validation set.
  
        Discrimination and calibration were employed to assess and test the predictive accuracy of
        the established model. Harrell's concordance index [C-index] and the receiver operating
        characteristic [ROC] curve [AUC] were generated to estimate the discrimination of the
        nomogram. A C-index close to 1 indicates a high level of predictive ability of the model.
        Additionally, an AUC > 0.80 indicates relatively good discrimination. The calibration of the
        nomogram was accompanied with the Hosmer-Lemeshow test were developed to determine the
        consistency between the predicted and observed occurrence of soiling. Lastly, DCA was
        performed to evaluate clinical practicability of the nomograms. Both discrimination and
        calibration were assessed by bootstrapping with 1000 resamples.
  
        For parameters with continuous variables, the normal distribution was expressed as mean ±
        standard deviation [SD], and the skewed distribution was presented as median [M] and quartile
        range [Q25-Q75]. Continuous data between two groups were compared using the independent
        t-test. The unequal variance t-test was used to compare data between groups with unequal
        variances. In cases of skewed distribution, the Mann-Whitney U test was employed.
        Furthermore, categorical data were compared using 2 or Fisher's exact test. Statistical
        analysis was performed using R Software v.4.0.2 [The R Project for Statistical Computing,
        www.r-project.org] with the "rms" package utilized for logistic regression analysis and
        nomogram construction. A two-sided P-value less than 0.05 was considered statistically
        significant.
  observational model: Cohort
  time perspective: Retrospective
  measure: Harrell's concordance index (C-index)
  time frame: 1 month
  description: Harrell's concordance index [C-index] was generated to estimate the discrimination of the nomogram A C-index close to 1 indicates a high level of predictive ability of the model.
  arm group label: training set
  description: To determine potential predictive factors, the training set was subjected to LASSO regression analysis, which effectively eliminated several irrelevant or multicollinearity independent variables to reduce high-dimensional data
  arm group label: validation set
  description: The multivariable logistic regression analysis was applied to determine the variables of soiling in patients with HSCR following surgery over one year of age. Finally, a nomogram was created based on the training set and validated in the validation set.
  intervention type: Other
  intervention name: training set
  description: LASSO regression analysis, Logistic regression analysis, Nomogram
  arm group label: training set
  arm group label: validation set
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  gender based: Yes
  gender description: patients aged >1 year operated for HSCR.
  minimum age: 1 Year
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tongji Hospital
  investigator full name: Jiexiong Feng
  investigator title: Chief in Department
  sharing ipd: Undecided