<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/NCT04467359</url>
  </required_header>
  <id_info>
    <org_study_id>2018180520</org_study_id>
    <nct_id>NCT04467359</nct_id>
  </id_info>
  <brief_title>Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy</brief_title>
  <official_title>Application of Rapid Rehabilitation Nursing in Perioperative Rehabilitation of Knee Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to apply the concept of rapid rehabilitation nursing in the&#xD;
      perioperative period of knee arthroscopy, to make up for the gap in this field, to provide&#xD;
      reference basis for the general colleagues, promote the development of perioperative rapid&#xD;
      rehabilitation nursing of knee arthroscopy, accelerate the rehabilitation of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study aims to apply rapid rehabilitation nursing concept to the arthroscopic&#xD;
      perioperative nursing, used to make up for the blank in this field, provides the reference&#xD;
      for the overwhelming majority of peer, prompt the arthroscopic perioperative rehabilitation&#xD;
      nursing development, accelerate the patient rehabilitation in January 2020 - December 2020 in&#xD;
      Beijing a third rate sports medicine hospital be in hospital, to line the arthroscopic&#xD;
      surgery patients as the research object, adopt the method of prospective, randomized,&#xD;
      controlled in 220 patients. Inclusion criteria: &lt; 60 age 18 years old, patients with informed&#xD;
      consent and voluntary participation in arthroscopic anterior cruciate ligament reconstruction&#xD;
      under external anesthesia were excluded from this study: patients with mental system diseases&#xD;
      or communication disorders; Patients with metabolic diseases such as diabetes; Patients who&#xD;
      could not quit smoking and drinking alcohol before surgery as required; Patients with&#xD;
      gastrointestinal tract disease research object were randomly divided into experimental group&#xD;
      and control group, control group given conventional perioperative nursing, the experimental&#xD;
      group to implement rapid rehabilitation program, the specific implementation process, see&#xD;
      table 1 and table 2, compare two groups of preoperative postoperative self-care ability score&#xD;
      (Barthel index) 、 the degree of postoperative pain numerical rating scale (NRS 0-10 score)&#xD;
      、the degree of comfort (Likert 1-5 rating score) and rehabilitation completion -Range of&#xD;
      motion(ROM) score difference; The safety index was the occurrence of postoperative&#xD;
      complications such as nausea, vomiting, dizziness, headache and urinary retention, and the&#xD;
      occurrence of postoperative complications such as hypothermia after lower extremity deep&#xD;
      venous thrombosis (preoperative and postoperative comparison of erythrocyte sedimentation&#xD;
      rate(ESR)、C-reactive protein（CRP） and procalcitonin indexes in blood routine&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">March 31, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</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>
    <intervention_model_description>The subjects were randomly divided into the experimental group and the control group. The control group received conventional rehabilitation nursing during the perioperative period, while the experimental group received ERAS intervention. The differences between the two groups in postoperative pain degree (NRS0-10) comfort level (Likert 1-5) and rehabilitation completion Range of motion(ROM) score were compared. The safety index was the occurrence of postoperative complications such as nausea, vomiting, dizziness, headache and urinary retention, and the occurrence of postoperative complications such as hypothermia after lower extremity deep venous thrombosis (preoperative and postoperative comparison of ESR CRP and procalcitonin indexes in blood routine)</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-care ability score</measure>
    <time_frame>1 day before operation</time_frame>
    <description>Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor &gt;. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Self-care ability score</measure>
    <time_frame>Postoperative 1 day</time_frame>
    <description>Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor &gt;. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of postoperative pain</measure>
    <time_frame>Postoperative 1 day</time_frame>
    <description>Numerical Rating Scale(NRS )score:0 means no pain, 10 means the most severe pain imaginable, and the higher the score, the more severe the pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comfort level</measure>
    <time_frame>Postoperative 1 day</time_frame>
    <description>Likert 1-5 score:0 means very uncomfortable, 10 means very comfortable, and the higher the score, the higher the comfort</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehabilitation Completion</measure>
    <time_frame>2 weeks after discharged</time_frame>
    <description>Range of motion(ROM):Use a square to measure the Angle of motion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehabilitation Completion</measure>
    <time_frame>4 weeks after discharged</time_frame>
    <description>Range of motion(ROM):Use a square to measure the Angle of motion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehabilitation Completion</measure>
    <time_frame>8 weeks after discharged</time_frame>
    <description>Range of motion(ROM):Use a square to measure the Angle of motion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rehabilitation Completion</measure>
    <time_frame>12 weeks after discharged</time_frame>
    <description>Range of motion(ROM):Use a square to measure the Angle of motion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse reaction</measure>
    <time_frame>postoperative 1 day</time_frame>
    <description>Postoperative nausea, vomiting, dizziness, headache, urinary retention and other non-reaction occurred</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">172</enrollment>
  <condition>Knee Arthroscopy</condition>
  <arm_group>
    <arm_group_label>The experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ERAS intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sports medicine rehabilitation nursing group</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ERAS</intervention_name>
    <description>Optimize physical conditions; Fasting solid diet 6h before surgery, fasting clear fluid 2 h before surgery; If there is no chief complaint of dizziness, nausea or other discomfort after the operation, warm water (no more than 100ml) can be immediately drunk. Pain management; Encourage patients to engage in early activities under the premise of effective pain control; If no dural puncture and other complications occur, the patient has no chief complaints of headache, dizziness, nausea and other discomfort, and there is no need to lie supine, the comfortable position such as semi-supine lateral supine position can be taken immediately (avoid 90-degree upright position for patients with hip joint); Prevention of thrombosis; Prevention and treatment of nausea and vomiting; Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the operation.</description>
    <arm_group_label>The experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Perioperative routine rehabilitation nursing</intervention_name>
    <description>Fasting and water deprivation at 12 o 'clock on the first day before surgery; Fasting water 6-8 hours after surgery; Lie flat on your pillow for 6 hours; Get out of bed activity 1 day after operation</description>
    <arm_group_label>The control group</arm_group_label>
    <arm_group_label>The experimental group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Arthroscopic anterior cruciate ligament reconstruction was performed under epidural&#xD;
             anesthesia&#xD;
&#xD;
          -  The patients consented and volunteered to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with mental disorders or communication disorders&#xD;
&#xD;
          -  Patients with metabolic diseases such as diabetes&#xD;
&#xD;
          -  Patients who could not quit smoking and drinking alcohol before surgery as required&#xD;
&#xD;
          -  Patients with gastrointestinal disorders&#xD;
&#xD;
          -  Patients who are not under epidural anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Wang</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Third Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Universitu 3rd Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>October 9, 2022</last_update_submitted>
  <last_update_submitted_qc>October 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Nursing</keyword>
  <keyword>Enhanced Recovery After Surgery（ERAS）</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04467359
org study id: 2018180520
nct id: NCT04467359
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to apply the concept of rapid rehabilitation nursing in the
      perioperative period of knee arthroscopy, to make up for the gap in this field, to provide
      reference basis for the general colleagues, promote the development of perioperative rapid
      rehabilitation nursing of knee arthroscopy, accelerate the rehabilitation of patients.
This study aims to apply rapid rehabilitation nursing concept to the arthroscopic
      perioperative nursing, used to make up for the blank in this field, provides the reference
      for the overwhelming majority of peer, prompt the arthroscopic perioperative rehabilitation
      nursing development, accelerate the patient rehabilitation in January 2020 - December 2020 in
      Beijing a third rate sports medicine hospital be in hospital, to line the arthroscopic
      surgery patients as the research object, adopt the method of prospective, randomized,
      controlled in 220 patients. Inclusion criteria: < 60 age 18 years old, patients with informed
      consent and voluntary participation in arthroscopic anterior cruciate ligament reconstruction
      under external anesthesia were excluded from this study: patients with mental system diseases
      or communication disorders; Patients with metabolic diseases such as diabetes; Patients who
      could not quit smoking and drinking alcohol before surgery as required; Patients with
      gastrointestinal tract disease research object were randomly divided into experimental group
      and control group, control group given conventional perioperative nursing, the experimental
      group to implement rapid rehabilitation program, the specific implementation process, see
      table 1 and table 2, compare two groups of preoperative postoperative self-care ability score
      (Barthel index) 、 the degree of postoperative pain numerical rating scale (NRS 0-10 score)
      、the degree of comfort (Likert 1-5 rating score) and rehabilitation completion -Range of
      motion(ROM) score difference; The safety index was the occurrence of postoperative
      complications such as nausea, vomiting, dizziness, headache and urinary retention, and the
      occurrence of postoperative complications such as hypothermia after lower extremity deep
      venous thrombosis (preoperative and postoperative comparison of erythrocyte sedimentation
      rate(ESR)、C-reactive protein（CRP） and procalcitonin indexes in blood routine
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The subjects were randomly divided into the experimental group and the control group. The control group received conventional rehabilitation nursing during the perioperative period, while the experimental group received ERAS intervention. The differences between the two groups in postoperative pain degree (NRS0-10) comfort level (Likert 1-5) and rehabilitation completion Range of motion(ROM) score were compared. The safety index was the occurrence of postoperative complications such as nausea, vomiting, dizziness, headache and urinary retention, and the occurrence of postoperative complications such as hypothermia after lower extremity deep venous thrombosis (preoperative and postoperative comparison of ESR CRP and procalcitonin indexes in blood routine)
primary purpose: Other
masking: None (Open Label)
measure: Self-care ability score
time frame: 1 day before operation
description: Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor >. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.
measure: Self-care ability score
time frame: Postoperative 1 day
description: Barthel Index:Barthel index is scored from 0 to 100. A score of 100 indicates that the patient has a good function in basic daily activities. He/she does not need help from others. He/she is able to control urine and urine, eat, dress, transfer to bed and chair, bathe, walk for at least one block, and can go up and down stairs. A score of 0 indicates poor functioning, lack of independence, and need help with all aspects of daily life. According to the score of Barthel index, the ability of daily activities was divided into three levels: good, medium and poor >. 60 was classified as good. 60 to 41 is medium. Have moderate dysfunction and need great help to complete daily activities; ≤40 is classified as poor, with severe dysfunction, most daily activities cannot be completed or need to be attended to by others.
measure: Degree of postoperative pain
time frame: Postoperative 1 day
description: Numerical Rating Scale(NRS )score:0 means no pain, 10 means the most severe pain imaginable, and the higher the score, the more severe the pain
measure: Comfort level
time frame: Postoperative 1 day
description: Likert 1-5 score:0 means very uncomfortable, 10 means very comfortable, and the higher the score, the higher the comfort
measure: Rehabilitation Completion
time frame: 2 weeks after discharged
description: Range of motion(ROM):Use a square to measure the Angle of motion
measure: Rehabilitation Completion
time frame: 4 weeks after discharged
description: Range of motion(ROM):Use a square to measure the Angle of motion
measure: Rehabilitation Completion
time frame: 8 weeks after discharged
description: Range of motion(ROM):Use a square to measure the Angle of motion
measure: Rehabilitation Completion
time frame: 12 weeks after discharged
description: Range of motion(ROM):Use a square to measure the Angle of motion
measure: adverse reaction
time frame: postoperative 1 day
description: Postoperative nausea, vomiting, dizziness, headache, urinary retention and other non-reaction occurred
arm group label: The experimental group
arm group type: Experimental
description: ERAS intervention group
arm group label: The control group
arm group type: Placebo Comparator
description: Sports medicine rehabilitation nursing group
intervention type: Other
intervention name: ERAS
description: Optimize physical conditions; Fasting solid diet 6h before surgery, fasting clear fluid 2 h before surgery; If there is no chief complaint of dizziness, nausea or other discomfort after the operation, warm water (no more than 100ml) can be immediately drunk. Pain management; Encourage patients to engage in early activities under the premise of effective pain control; If no dural puncture and other complications occur, the patient has no chief complaints of headache, dizziness, nausea and other discomfort, and there is no need to lie supine, the comfortable position such as semi-supine lateral supine position can be taken immediately (avoid 90-degree upright position for patients with hip joint); Prevention of thrombosis; Prevention and treatment of nausea and vomiting; Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the operation.
arm group label: The experimental group
intervention type: Other
intervention name: Perioperative routine rehabilitation nursing
description: Fasting and water deprivation at 12 o 'clock on the first day before surgery; Fasting water 6-8 hours after surgery; Lie flat on your pillow for 6 hours; Get out of bed activity 1 day after operation
arm group label: The control group
arm group label: The experimental group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Xin Wang
role: Principal Investigator
affiliation: Peking University Third Hospital
facility: 
country: China
responsible party type: Sponsor
sharing ipd: No