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/NCT06008873</url>
    </required_header>
    <id_info>
      <org_study_id>2023ZSLYEC-260</org_study_id>
      <nct_id>NCT06008873</nct_id>
    </id_info>
    <brief_title>Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study</brief_title>
    <acronym>PIPQoR</acronym>
    <official_title>Association Between Preoperative Insomnia and Postoperative Quality of Recovery in Non-elderly Patients Undergoing Non-emergency Cancer Resection Surgery: A Prospective Observational Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sixth Affiliated Hospital, Sun Yat-sen University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Sixth Affiliated Hospital, Sun Yat-sen University</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>
        Although patients with cancers are prone to insomnia, especially waiting for surgery during&#xD;
        hospitalization, and insomnia promotes acute respiratory infections (ARI) and is not&#xD;
        conducive to the postoperative quality of recovery (QoR), evidence that preoperative insomnia&#xD;
        delays postoperative recovery is still lacking. In this prospective observational study, we&#xD;
        enroll 175 non-elderly subjects with abdominal cancer who will undergo non-emergency cancer&#xD;
        resection surgery. Insomnia Severity Index scale (ISI) is used to assess the insomnia&#xD;
        severity during hospitalization while awaiting surgery. The Quality of Recovery-15 (QoR-15)&#xD;
        is used to evaluate the overall recovery after surgery. Meanwhile, wrist watch and sleep&#xD;
        diary are used to record sleep. The aim of the study is to investigate the association&#xD;
        between preoperative insomnia and postoperative QoR, the association between preoperative&#xD;
        insomnia and postoperative ARI,and to describe preoperative sleep traits.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In the single-center, prospective observational study, ISI is used to investigate the&#xD;
        perceptive sleep during hospitalization waiting for surgery,and QoR-15 is used to investigate&#xD;
        the overall quality of functional recovery at postoperative 1, 3, 7, 14, and 30 days&#xD;
        (POD1/3/7/14/30). At the same time, both of ARI within POD30 and neutrophil to lymphocyte&#xD;
        ratio(NLR) in peripheral blood perioperation are recorded. The study is divided into four&#xD;
        phases: (1) Screening: on the first day of admission, the subjects are screened according to&#xD;
        the inclusion and exclusion criteria, and the basic data are collected, including ISI, QoR-15&#xD;
        and depression/anxiety questionnaires, et al. (2) Enrollment (sleep survey during&#xD;
        hospitalization waiting for surgery) : ISI is performed in the day of surgery to perceive the&#xD;
        severity of insomnia during the whole period of hospitalization waiting for surgery, and&#xD;
        objective and subjective sleep are investigated by wrist watch and sleep diary. (3) Surgical&#xD;
        and anesthesia period: the key medical data related to surgery, anesthesia and nursing&#xD;
        occurred during the operation are recorded. (4) Follow-up: QoR-15 is investigated&#xD;
        POD1/3/7/14/30. Meanwhile, both of ARI and NLR are investigated.&#xD;
  &#xD;
        The planned enrollment is 175 subjects. No randomized or any protocol-driven treatment is&#xD;
        administered to the subjects during the study. The effect size f2 of the independent variable&#xD;
        (ISI scores of hospitalization waiting for surgery) on the dependent variable (QoR-15 on&#xD;
        POD1) is expected to be 0.1. The number of covariates is predicted to be 46, α is set as&#xD;
        two-sided 0.05, and the power is 0.9. The sample size calculated by PASS software is 157&#xD;
        cases. Considering 10% dropout, a sample size of 175 will be required. Data will be presented&#xD;
        as mean±standard deviation, median and number (%). Logistic multivariate, or multivariable&#xD;
        models will be both performed by statisticians.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 15, 2023</start_date>
    <completion_date type="Anticipated">October 2023</completion_date>
    <primary_completion_date type="Anticipated">September 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery</measure>
      <time_frame>on the day before surgery or the day of surgery</time_frame>
      <description>ISI is used to assess insomnia during the time when waiting for surgery in hospital from the day of admission to the day of surgery.&#xD;
  ISI is used to assess how satisfied with sleep patterns and psychological distress or impairments in daytime functioning associated with sleep difficulties.&#xD;
  ISI is filled in by subjects on the day before surgery or the day of surgery. ISI contents 7 items, which item is measured by an 0-4 point rating scale (0=&quot;very satisfaction&quot;; 4=&quot;very dissatisfaction&quot;).&#xD;
  ISI total scores range from 0 to 28, with higher scores indicating higher severity of insomnia.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1</measure>
      <time_frame>on postoperative day 1</time_frame>
      <description>QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.&#xD;
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= &quot;none of the time&quot; to 10=&quot;all of the time&quot;; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sleep-onset latency(min)(resulting from CSD): Distribution frequency of different degrees of sleep latency during the time when waiting for surgery in hospital from the day of admission to the day of surgery</measure>
      <time_frame>Everyday when waiting for surgery in hospital from the day of admission to the day of surgery</time_frame>
      <description>A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday when waiting for surgery in hospital from the day of admission to the day of surgery.&#xD;
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Numbers of awakenings(resulting from CSD): Distribution of Numbers of awakenings during the time when waiting for surgery in hospital from the day of admission to the day of surgery</measure>
      <time_frame>Everyday when waiting for surgery in hospital from the day of admission to the day of surgery</time_frame>
      <description>A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.&#xD;
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total duration of sleep in night(min)(resulting from CSD): Distribution of total duration of sleep in night during the time when waiting for surgery in hospital from the day of admission to the day of surgery</measure>
      <time_frame>Everyday when waiting for surgery in hospital from the day of admission to the day of surgery</time_frame>
      <description>A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.&#xD;
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sleep influencing factors(resulting from CSD): Distribution of factors that could influence sleep in night when waiting for surgery in hospital from the day of admission to the day of surgery</measure>
      <time_frame>Everyday when waiting for surgery in hospital from the day of admission to the day of surgery</time_frame>
      <description>A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.&#xD;
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 3</measure>
      <time_frame>on postoperative day 3</time_frame>
      <description>QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.&#xD;
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= &quot;none of the time&quot; to 10=&quot;all of the time&quot;; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 7</measure>
      <time_frame>on postoperative day 7</time_frame>
      <description>QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.&#xD;
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= &quot;none of the time&quot; to 10=&quot;all of the time&quot;; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 14</measure>
      <time_frame>on postoperative day 14</time_frame>
      <description>QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.&#xD;
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= &quot;none of the time&quot; to 10=&quot;all of the time&quot;; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 30</measure>
      <time_frame>on postoperative day 30</time_frame>
      <description>QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.&#xD;
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0=&quot;none of the time&quot; to 10=&quot;all of the time&quot;; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence rate of Acute Respiratory Tract Infection (ARTI) within postoperative day 30</measure>
      <time_frame>within postoperative day 30</time_frame>
      <description>Acute Respiratory Tract Infection (ARTI): including acute upper respiratory infection and acute lower respiratory infection, according to patients self-reporting.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1</measure>
      <time_frame>on postoperative day 1</time_frame>
      <description>Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1 resulting from blood routine examination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3</measure>
      <time_frame>on postoperative day 3</time_frame>
      <description>Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3 from blood routine examination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7</measure>
      <time_frame>on postoperative day 7</time_frame>
      <description>Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7 from blood routine examination</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">175</enrollment>
    <condition>Sleep Disorder</condition>
    <arm_group>
      <arm_group_label>One group only</arm_group_label>
      <description>No intervention.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Referred to the Eligibility Criteria for details.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1.Voluntarily execute informed consent;&#xD;
  &#xD;
            -  2.Effective linguistic communication and collaboration;&#xD;
  &#xD;
            -  3.No history of mental disorders;&#xD;
  &#xD;
            -  4.Age of 18-64 years old, male or female;&#xD;
  &#xD;
            -  5.BMI 18-30kg/m2;&#xD;
  &#xD;
            -  6.American Society of anesthesiology (ASA) grade 1-2, New York Heart Association(NYHA)&#xD;
               grade Ⅰ or Ⅱ;&#xD;
  &#xD;
            -  7.Initial diagnosis of abdominal cancers and the diagnosis has been disclosed to&#xD;
               subjects;&#xD;
  &#xD;
            -  8.Non-emergency cancer resection surgery is planned;&#xD;
  &#xD;
            -  9.The planned anesthesia is general anesthesia with endotracheal intubation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1.Obstructive apnea syndrome, narcolepsy, restless leg/periodic limb movement&#xD;
               disorder, sleepwalking disorder, nightmare disorder;&#xD;
  &#xD;
            -  2.Not suitable to participate in the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>64 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jin sanqing, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>the Sixth Affiliated Hospital, Sun Yat-sen University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jin sanqing, MD</last_name>
      <phone>0086-13719366863</phone>
      <email>jinsq@mail.sysu.edu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zhou Yan, MD</last_name>
      <phone>0086-13632404420</phone>
      <email>zhouyan8@mail3.sysu.edu.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>the Sixth Affiliated Hospital, Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510655</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>SanQing Jin, MD</last_name>
        <phone>0086-13719366863</phone>
        <email>sanqingjin@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Sixth Affiliated Hospital, Sun Yat-sen University</investigator_affiliation>
      <investigator_full_name>SanQing Jin</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </responsible_party>
    <keyword>Insomnia</keyword>
    <keyword>Perioperative Medicine</keyword>
    <keyword>cancer</keyword>
    <keyword>surgery</keyword>
    <keyword>Quality of Recovery</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance Disorders</mesh_term>
      <mesh_term>Sleep Wake Disorders</mesh_term>
    </condition_browse>
    <!-- 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/NCT06008873
  org study id: 2023ZSLYEC-260
  nct id: NCT06008873
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Although patients with cancers are prone to insomnia, especially waiting for surgery during
        hospitalization, and insomnia promotes acute respiratory infections (ARI) and is not
        conducive to the postoperative quality of recovery (QoR), evidence that preoperative insomnia
        delays postoperative recovery is still lacking. In this prospective observational study, we
        enroll 175 non-elderly subjects with abdominal cancer who will undergo non-emergency cancer
        resection surgery. Insomnia Severity Index scale (ISI) is used to assess the insomnia
        severity during hospitalization while awaiting surgery. The Quality of Recovery-15 (QoR-15)
        is used to evaluate the overall recovery after surgery. Meanwhile, wrist watch and sleep
        diary are used to record sleep. The aim of the study is to investigate the association
        between preoperative insomnia and postoperative QoR, the association between preoperative
        insomnia and postoperative ARI,and to describe preoperative sleep traits.
  In the single-center, prospective observational study, ISI is used to investigate the
        perceptive sleep during hospitalization waiting for surgery,and QoR-15 is used to investigate
        the overall quality of functional recovery at postoperative 1, 3, 7, 14, and 30 days
        (POD1/3/7/14/30). At the same time, both of ARI within POD30 and neutrophil to lymphocyte
        ratio(NLR) in peripheral blood perioperation are recorded. The study is divided into four
        phases: (1) Screening: on the first day of admission, the subjects are screened according to
        the inclusion and exclusion criteria, and the basic data are collected, including ISI, QoR-15
        and depression/anxiety questionnaires, et al. (2) Enrollment (sleep survey during
        hospitalization waiting for surgery) : ISI is performed in the day of surgery to perceive the
        severity of insomnia during the whole period of hospitalization waiting for surgery, and
        objective and subjective sleep are investigated by wrist watch and sleep diary. (3) Surgical
        and anesthesia period: the key medical data related to surgery, anesthesia and nursing
        occurred during the operation are recorded. (4) Follow-up: QoR-15 is investigated
        POD1/3/7/14/30. Meanwhile, both of ARI and NLR are investigated.
  
        The planned enrollment is 175 subjects. No randomized or any protocol-driven treatment is
        administered to the subjects during the study. The effect size f2 of the independent variable
        (ISI scores of hospitalization waiting for surgery) on the dependent variable (QoR-15 on
        POD1) is expected to be 0.1. The number of covariates is predicted to be 46, α is set as
        two-sided 0.05, and the power is 0.9. The sample size calculated by PASS software is 157
        cases. Considering 10% dropout, a sample size of 175 will be required. Data will be presented
        as mean±standard deviation, median and number (%). Logistic multivariate, or multivariable
        models will be both performed by statisticians.
  observational model: Cohort
  time perspective: Prospective
  measure: Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery
  time frame: on the day before surgery or the day of surgery
  description: ISI is used to assess insomnia during the time when waiting for surgery in hospital from the day of admission to the day of surgery.
  ISI is used to assess how satisfied with sleep patterns and psychological distress or impairments in daytime functioning associated with sleep difficulties.
  ISI is filled in by subjects on the day before surgery or the day of surgery. ISI contents 7 items, which item is measured by an 0-4 point rating scale (0="very satisfaction"; 4="very dissatisfaction").
  ISI total scores range from 0 to 28, with higher scores indicating higher severity of insomnia.
  measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1
  time frame: on postoperative day 1
  description: QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
  measure: Sleep-onset latency(min)(resulting from CSD): Distribution frequency of different degrees of sleep latency during the time when waiting for surgery in hospital from the day of admission to the day of surgery
  time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
  description: A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday when waiting for surgery in hospital from the day of admission to the day of surgery.
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
  measure: Numbers of awakenings(resulting from CSD): Distribution of Numbers of awakenings during the time when waiting for surgery in hospital from the day of admission to the day of surgery
  time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
  description: A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
  measure: Total duration of sleep in night(min)(resulting from CSD): Distribution of total duration of sleep in night during the time when waiting for surgery in hospital from the day of admission to the day of surgery
  time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
  description: A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
  measure: Sleep influencing factors(resulting from CSD): Distribution of factors that could influence sleep in night when waiting for surgery in hospital from the day of admission to the day of surgery
  time frame: Everyday when waiting for surgery in hospital from the day of admission to the day of surgery
  description: A Consensus Sleep Diary (CSD) is used to asses subjective sleep quantity everyday waiting for surgery in hospital from the day of admission to the day of surgery.
  The CSD items assess sleep-onset latency (time taken to fall asleep), the number of awakenings, and the total duration of sleep. Subjects also allow to record factors that could influence sleep, including use of sleep medication.
  measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 3
  time frame: on postoperative day 3
  description: QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
  measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 7
  time frame: on postoperative day 7
  description: QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
  measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 14
  time frame: on postoperative day 14
  description: QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0= "none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
  measure: Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 30
  time frame: on postoperative day 30
  description: QoR-15 is a patient-reported measure, and is used to assess global recovery quality after surgery physiologically and psychologically.
  QoR-15 is filled on postoperative day 1. QoR-15 contents 15 items, which item is constructed by an 11-point numerical rating scale (for positive items, 0="none of the time" to 10="all of the time"; for negative items the scoring was reversed). The total scores are ranging from 0(extremely poor QoR) to 150 (excellent QoR).
  measure: Incidence rate of Acute Respiratory Tract Infection (ARTI) within postoperative day 30
  time frame: within postoperative day 30
  description: Acute Respiratory Tract Infection (ARTI): including acute upper respiratory infection and acute lower respiratory infection, according to patients self-reporting.
  measure: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1
  time frame: on postoperative day 1
  description: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 1 resulting from blood routine examination
  measure: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3
  time frame: on postoperative day 3
  description: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 3 from blood routine examination
  measure: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7
  time frame: on postoperative day 7
  description: Peripheral blood neutrophil/lymphocyte ratio on postoperative day 7 from blood routine examination
  arm group label: One group only
  description: No intervention.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 64 Years
  healthy volunteers: No
  last name: Jin sanqing, MD
  role: Principal Investigator
  affiliation: the Sixth Affiliated Hospital, Sun Yat-sen University
  last name: Jin sanqing, MD
  phone: 0086-13719366863
  email: jinsq@mail.sysu.edu.cn
  last name: Zhou Yan, MD
  phone: 0086-13632404420
  email: zhouyan8@mail3.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Sixth Affiliated Hospital, Sun Yat-sen University
  investigator full name: SanQing Jin
  investigator title: professor
  mesh term: Sleep Initiation and Maintenance Disorders
  mesh term: Sleep Wake Disorders