<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/NCT03271749</url>
  </required_header>
  <id_info>
    <org_study_id>70142917.0.0000.0066</org_study_id>
    <nct_id>NCT03271749</nct_id>
  </id_info>
  <brief_title>Protocol for Accelerated Recovery in Patients Undergoing Thoracic Surgical Procedures (PROSM). Study Randomized Comparative Between the Adoption of the Proposed Guidelines and the Traditional Method Currently Used in the Institution</brief_title>
  <acronym>PROSM</acronym>
  <official_title>Protocol for Accelerated Recovery in Patients Undergoing Thoracic Surgical Procedures Adapted to the Conditions of Santa Marcelina - Itaquera Hospital - São Paulo - Brazil (PROSM). Study Randomized Comparative Between the Adoption of the Proposed Guidelines and the Traditional Method Currently Used in the Institution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Igor Renato Louro Bruno de Abreu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Santa Marcelina</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>
      Introduction:&#xD;
&#xD;
      Aiming at reducing costs and optimizing the use of these financial resources, several&#xD;
      postoperative recovery protocols have emerged that aim to reduce the length of hospital stay&#xD;
      by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic&#xD;
      scenario allied to the existing scientific knowledge on the subject , the investigators&#xD;
      developed a protocol that aims to meet this need using resources already available and&#xD;
      offered in brazilian public health system. The investigators called this protocol as Protocol&#xD;
      of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of&#xD;
      accelerated postoperative recovery already used in several European health services.&#xD;
&#xD;
      Goals:&#xD;
&#xD;
        1. To evaluate the impact of PROSM on the length of hospitalization in days and&#xD;
           postoperative pain (visual analog pain scale - VAS) in patients submitted to surgical&#xD;
           procedures performed by the thoracic surgery team of the Hospital Santa Marcelina de&#xD;
           Itaquera.&#xD;
&#xD;
        2. Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment&#xD;
           and hospitalization of these patients.&#xD;
&#xD;
      Materials and methods:&#xD;
&#xD;
      A group of 200 patients with elective pulmonary resections (segmentectomies, lobectomies or&#xD;
      pneumonectomies) to treat neoplastic lung diseases will be selected by the investigators.&#xD;
&#xD;
      The participants will be randomized into two groups (rate of randomization 1/1).&#xD;
&#xD;
      The first group will be submitted to the standard surgical treatment that is currently used&#xD;
      in Santa Marcelina - Itaquera hospital. The second group will be submitted to treatment with&#xD;
      the adoption of the PROSM guidelines, which will be detailed later.&#xD;
&#xD;
      Investigators will evaluate in the two groups: surgical time in minutes, intraoperative&#xD;
      complications: intraoperative bleeding in mililiters, need for transfusion of blood products,&#xD;
      intraoperative clinical complications. Investigators will also evaluate the need for&#xD;
      postoperative recovery in Intensive Care Unit (ICU), medications used to maintain the&#xD;
      anesthetic plane during the procedure (amount of drugs in milligrams), medications used for&#xD;
      postoperative analgesia, length of hospital stay in days, postoperative clinical&#xD;
      complications, need for surgical re-boarding, immediate postoperative pain (VAS),&#xD;
      postoperative pain at the time of discharge and the first outpatient return (VAS), the need&#xD;
      for opioid analgesics at home after discharge.&#xD;
&#xD;
      After the data collection, the investigators will analyze them and make a comparative study&#xD;
      of the costs of surgical treatment and hospitalization between the two groups. This data will&#xD;
      be obtained from the billing department of the Hospital Santa Marcelina de Itaquera.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction:&#xD;
&#xD;
      Patients submitted to surgical procedures for the treatment of thoracic diseases, whether&#xD;
      benign or neoplastic, are exposed to potential complications.&#xD;
&#xD;
      The main complications related to these procedures are primarily lung infections, followed by&#xD;
      thrombotic events, cardiovascular events, and complications due to previous chronic diseases.&#xD;
&#xD;
      Faced with the occurrence of complications, these patients require a longer hospitalization&#xD;
      period, using high cost medications, generating additional unexpected costs.&#xD;
&#xD;
      Aiming at reducing costs and optimizing the use of these financial resources, several&#xD;
      postoperative recovery protocols have emerged that aim to reduce the length of hospital stay&#xD;
      by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic&#xD;
      scenario allied to the existing scientific knowledge on the subject , the investigators&#xD;
      developed a protocol that aims to meet this need using resources already available and&#xD;
      offered in brazilian public health system. The investigators called this protocol as Protocol&#xD;
      of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of&#xD;
      accelerated postoperative recovery already used in several European health services.&#xD;
&#xD;
      Goals:&#xD;
&#xD;
        1. To evaluate the impact of PROSM on the length of hospitalization in days and&#xD;
           postoperative pain (visual analog pain scale - VAS) in patients submitted to surgical&#xD;
           procedures performed by the thoracic surgery team of the Hospital Santa Marcelina de&#xD;
           Itaquera.&#xD;
&#xD;
        2. Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment&#xD;
           and hospitalization of these patients.&#xD;
&#xD;
      Materials and methods:&#xD;
&#xD;
      A group of 200 patients with elective pulmonary resections (segmentectomies, lobectomies or&#xD;
      pneumonectomies) to treat neoplastic lung diseases will be selected by the investigators.&#xD;
&#xD;
      Patients under the age of eighteen years old, unable to read, understand and sign informed&#xD;
      consent, patients with compromised performance status (ECOG greater than 2), patients with a&#xD;
      body mass below 60 kilograms or greater than 120 kilograms , patients with allergy to latex,&#xD;
      patients with a history of allergy to any of the drugs used in anesthesia for PROSM, patients&#xD;
      with renal dysfunction, liver dysfunction and severe cardiac dysfunction (cardiac failure),&#xD;
      will be excluded from this study.&#xD;
&#xD;
      The participants will be randomized into two groups (rate of randomization 1/1). The first&#xD;
      group will be submitted to the standard surgical treatment that is currently used in Santa&#xD;
      Marcelina - Itaquera hospital. The second group will be submitted to treatment with the&#xD;
      adoption of the PROSM guidelines, which will be detailed later.&#xD;
&#xD;
      Investigators will evaluate in the two groups: surgical time in minutes, intraoperative&#xD;
      complications: intraoperative bleeding in mililiters, need for transfusion of blood products,&#xD;
      intraoperative clinical complications. Investigators will also evaluate the need for&#xD;
      postoperative recovery in Intensive Care Unit (ICU), medications used to maintain the&#xD;
      anesthetic plane during the procedure (amount of drugs in milligrams), medications used for&#xD;
      postoperative analgesia, length of hospital stay in days, postoperative clinical&#xD;
      complications, need for surgical re-boarding, immediate postoperative pain (VAS),&#xD;
      postoperative pain at the time of discharge and the first outpatient return (VAS), the need&#xD;
      for opioid analgesics at home after discharge. The follow-up time of these patients for the&#xD;
      purpose of collecting data for this study will be started with their agreement to participate&#xD;
      in the project and with the signing of the free and informed consent term and will extend&#xD;
      until the third postoperative return. After this period, the participants will be followed&#xD;
      for assistance purposes only.&#xD;
&#xD;
      After the data collection, this will be analyzed and a comparative study of the costs of&#xD;
      surgical treatment and hospitalization between the two groups will be made. This data will be&#xD;
      obtained from the billing department of the Santa Marcelina - Itaquera hospital.&#xD;
&#xD;
      Continuous variables will be expressed as medians with deviations. Categorical variables will&#xD;
      be represented by absolute numbers and percentages. The Gaussian distribution of the&#xD;
      variables will be tested using Kolmogorov - Smirnov test. The comparison between medians will&#xD;
      be evaluated through the use of Student's T test. The comparison between categorical&#xD;
      variables will be carried out using Chi-square test. Possible risk factors that contribute to&#xD;
      an increase in the length of hospital stay and an increase in postoperative pain will be&#xD;
      traced through the use of logistic regressions.&#xD;
&#xD;
      The analysis of the data will be carried out using the software Statistical Package for the&#xD;
      Social Sciences (SPSS) 17.0 software (SPSS, Chicago, IL, USA)&#xD;
&#xD;
      PROSM Guidelines Description:&#xD;
&#xD;
      Selected patients who agree to participate in the present project and whose randomization&#xD;
      assign them to the intervention PROSM group will be submitted to the following guidelines.&#xD;
&#xD;
      Preoperative care: In addition to conventional preoperative care including cessation of&#xD;
      smoking and use of medications for comorbidities treatment, guidelines for preoperative&#xD;
      fasting, verification of preoperative exams and cardiovascular and pre-anesthetic&#xD;
      evaluations, the patient will receive guidelines for home exercises to perform daily walks&#xD;
      with thirty minutes duration until the day of surgery. This measure aims to create in the&#xD;
      patient the habit of moving daily. This will facilitate adherence to the proposed exercises&#xD;
      for postoperative recovery.&#xD;
&#xD;
      On the day of surgery, immediately before the patient is taken to the operating room, we will&#xD;
      administer 8 drops of chlorpromazine solution and 750 milligrams of paracetamol or 500&#xD;
      milligrams of dipyrone. The goal is to generate preemptive analgesia. Patients who admitted&#xD;
      to the surgical procedure exhibit evidence of abandonment of the preoperative guidelines will&#xD;
      be excluded from the study.&#xD;
&#xD;
      Anesthesia: The participant will be adequately monitored with pulse oximetry, cardioscopy,&#xD;
      capnography, noninvasive blood pressure, temperature monitoring, anesthetic depth monitoring&#xD;
      through the BIS method (bispectral index), delayed bladder catheter. The necessity or not of&#xD;
      central venous access and invasive blood pressure will be evaluated according to the&#xD;
      cardiovascular risks and the size of the surgery. For pulmonary resection operations we will&#xD;
      use selective orotracheal intubation as already agreed in the institution.&#xD;
&#xD;
      Anesthetic induction will be performed using short duration opioid (remifentanil), hypnotic&#xD;
      (propofol) and neuromuscular blocker with dose adjusted according to the patient's body&#xD;
      mass.3 Intraoperative analgesia will be obtained through paravertebral and incisional&#xD;
      intercostal block through the infiltration of a drug solution containing 500mililiters of&#xD;
      saline, 1 vial of 5milligrams / 20milliliters bupivacaine, 20milliliters of lidocaine 2%&#xD;
      without vasoconstrictor, 10milligrams of dexamethasone , 500milligrams of hydrocortisone,&#xD;
      75milligrams of clonidine, 5milligrams of ketamine and 40milliliters of sodium bicarbonate&#xD;
      8.4% solution). Investigators will use only the volume of solution sufficient to generate the&#xD;
      intercostal blocks of the spaces pertaining to the incision and the orifice of the pleural&#xD;
      drain and completely infiltrate the surgical wound. The surplus drug solution will be&#xD;
      discarded.4 The participants will not be submitted to epidural anesthesia, only to the block.&#xD;
&#xD;
      Intercostal block and infiltration of the surgical wound will be performed by the surgical&#xD;
      team while the other anesthetic procedures will be performed and accompanied by the&#xD;
      anesthesiologist. At any time during the procedure, the anesthesiologist may administer&#xD;
      additional anesthetic drugs or any other type of drug deemed necessary to ensure adequate&#xD;
      pain control and hemodynamic stability of the patient. Throughout the procedure there should&#xD;
      be dialogue and exchange of information between the surgical and anesthetic teams.&#xD;
&#xD;
      Anesthetic recovery: Post anesthetic recovery will commence immediately after the surgical&#xD;
      dressing. The participants will be placed in horizontal dorsal decubitus, the anesthetic&#xD;
      drugs will be switched off, the patient will receive intravenous antiemetic (ondansetron) and&#xD;
      intravenous non-steroidal anti-inflammatory drug (ketoprofen) before extubation to avoid&#xD;
      nausea and decrease postoperative pain. The patient will be extubated as soon as he is&#xD;
      recovering his consciousness and is able to maintain an effective spontaneous breath.&#xD;
&#xD;
      Immediately after the extubation, the surgeon will elevate the decubitus of the surgical&#xD;
      table to 45 degrees maintaining the constant observation of the blood pressure, heart rate&#xD;
      and pulse oximetry. It will remain elevated until the patient is well awake. If the patient&#xD;
      is unable to maintain a sufficient level of consciousness to understand and respond to verbal&#xD;
      commands within 50 minutes of extubation or if during awakening the patient develops postural&#xD;
      hypotension surgical team will abort the protocol and resume recovery by conventional&#xD;
      measures.5 These cases will be counted as failure to execute the method.&#xD;
&#xD;
      When the patient is conscious and able to understand sentences and respond to verbal&#xD;
      commands, investigators will begin the postoperative exercise program. Initially participant&#xD;
      will do breathing exercises with inspirations and forced exhalations followed by elevation&#xD;
      and lowering of the upper limbs.&#xD;
&#xD;
      While the participant is in the operating room, sequences of 10 exercises with a 1-minute&#xD;
      interval between sequences will be performed.5 From the moment the anesthesiologist&#xD;
      authorizes, the patient will be referred for anesthetic recovery room Upon reaching&#xD;
      anesthetic recovery room, the patient will receive water and diet. After feeding, will be&#xD;
      placed in an armchair, maintaining monitoring where will continue to do breathing exercises,&#xD;
      lifting and lowering exercises of the upper limbs and extension and flexion of lower limbs.&#xD;
      At this moment the participant will be accompanied by a doctor of the surgical team and a&#xD;
      physiotherapist who will guide him in relation to the movements. A family escort will be&#xD;
      allowed to remain with the patient helping to do the exercises. This phase of recovery will&#xD;
      last 2 hours.5, 6 After this period of time, the physician representing the surgical team&#xD;
      will put the patient on stand and watch the patient for 4 minutes in order to evaluate&#xD;
      possible postural hypotension and assess the patient's ability to support his or her own&#xD;
      weight. If the patient does not tolerate standing, participant will be placed back in the&#xD;
      armchair and will continue with the exercises. Otherwise, the physician and physiotherapist&#xD;
      will walk with the patient into the anesthetic recovery room for a period of 30 minutes with&#xD;
      rest breaks as needed.&#xD;
&#xD;
      Referral to the hospitalization unit: After anesthesia recovery, the participants will be&#xD;
      referred to the hospitalization units. In the hospitalization units the patient will do a 15&#xD;
      minute walk in the hallway every 60 minutes interval. During the intervals the patient will&#xD;
      be resting in an armchair doing the movements previously described.&#xD;
&#xD;
      Those patients at risk of postoperative cardiac arrhythmias who received intraoperative blood&#xD;
      products with a risk for hemorrhagic events using some type of vasoactive drug requiring&#xD;
      ventilatory support will be referred to the ICU where they will remain for at least 24 hours&#xD;
      , maintaining the same lines of proposed postoperative exercises. Indication or not of ICU&#xD;
      postoperatively should be a consensus between surgical team and anesthetic team.7&#xD;
&#xD;
      Postoperative Prescription: The postoperative prescription should contain a general voluntary&#xD;
      diet, medications that the patient already use, prophylactic antibiotics in the first 24&#xD;
      hours of the postoperative period, dipyrone or paracetamol of schedule, ketoprofen of&#xD;
      schedule or toragesic, methadon 5milligrams per mouth if pain, antiemetics (ondansetron)&#xD;
      schedule, laxative once a day, chlorpromazine solution drops (from 8 to 10 drops) at nigth.&#xD;
      Investigators should not prescribe anticoagulants or antiplatelet agents until the patient&#xD;
      has 7 days postoperative. There is no need for prophylactic enoxaheparin because the patient&#xD;
      will be in continuous movement. Daily radiographs will be performed while the patient has a&#xD;
      thoracic drainage. Laboratory tests will be requested only if the patient shows some type of&#xD;
      abnormality on the physical examination that raises some suspicion of organic dysfunction or&#xD;
      if there is any indication for it based on the preoperative cardiovascular and anesthetic&#xD;
      evaluations.&#xD;
&#xD;
      Discharge: When the patient is in conditions for hospital discharge, this will be done&#xD;
      through some guidelines:&#xD;
&#xD;
        1. Return to the outpatient thoracic surgery in 7 days to continue postoperative follow-up.&#xD;
&#xD;
        2. Prescription of analgesics for home use.&#xD;
&#xD;
        3. Guidance on possible postoperative complications, making it very clear in which&#xD;
           circumstances the patient should return to the emergency room (fever, dyspnea, bleeding&#xD;
           or chest pain refractory to the use of medication).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">July 1, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2025</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>Randomized controlled Trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>It's impossible to mask the participants, care providers and investigators, because of the apparent differences in both techniques. For this reason the data analysis will be masked to avoid influences by the other participants during the analysis.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>length of hospitalization in days</measure>
    <time_frame>1825 days</time_frame>
    <description>To evaluate the impact of PROSM on the length of hospitalization in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital</description>
  </primary_outcome>
  <primary_outcome>
    <measure>postoperative pain using visual analog pain scale (VAS)</measure>
    <time_frame>1825 days</time_frame>
    <description>To evaluate the impact of PROSM on postoperative pain in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>costs of surgical treatment in US dollars</measure>
    <time_frame>1825 days</time_frame>
    <description>Evaluate the impacts of PROSM in reducing the costs of surgical treatment and hospitalization of these patients.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Postoperative Complications</condition>
  <condition>Postoperative Nausea</condition>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The participants of this arm will receive the convencional pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PROSM interventional</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants of this arm will receive the PROSM protocol pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROSM guidelines for preoperative, anesthesia and postoperative care for lung resections</intervention_name>
    <description>The PROSM guidelines is described previously in study description</description>
    <arm_group_label>PROSM interventional</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with elective pulmonary resections (segmentectomies, lobectomies or&#xD;
             pneumonectomies) to treat neoplastic lung diseases.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to read, understand and sign informed consent&#xD;
&#xD;
          -  patients with compromised performance status (ECOG greater than 2)&#xD;
&#xD;
          -  body mass below 60 kg or greater than 120 kg&#xD;
&#xD;
          -  allergy to latex&#xD;
&#xD;
          -  patients with a history of allergy to any of the drugs used in anesthesia for PROSM&#xD;
&#xD;
          -  patients with renal dysfunction&#xD;
&#xD;
          -  liver dysfunction&#xD;
&#xD;
          -  severe cardiac dysfunction (cardiac failure)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fernando C Abrão, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Coordinating physician of the thoracic surgery team of Santa Marcelina de Itaquera Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Igor Renato LB de Abreu, M.D.</last_name>
    <phone>55(11)982035629</phone>
    <email>dr.igor.abreu@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fernando C Abrão, M.D.</last_name>
    <phone>55(11) 982255088</phone>
    <email>torax.santa.marcelina@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ambulatório de Nódulos e Massas Pulmonares H Santa Marcelina</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <zip>08270070</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Igor Renato LB Abreu, MD</last_name>
      <phone>55(11) 20706000</phone>
      <email>torax.santa.marcelina@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Dong Q, Zhang K, Cao S, Cui J. Fast-track surgery versus conventional perioperative management of lung cancer-associated pneumonectomy: a randomized controlled clinical trial. World J Surg Oncol. 2017 Jan 13;15(1):20. doi: 10.1186/s12957-016-1072-5.</citation>
    <PMID>28086896</PMID>
  </reference>
  <reference>
    <citation>Wolk S, Meissner T, Linke S, Mussle B, Wierick A, Bogner A, Sturm D, Rahbari NN, Distler M, Weitz J, Welsch T. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1.</citation>
    <PMID>28222805</PMID>
  </reference>
  <reference>
    <citation>Jones NL, Edmonds L, Ghosh S, Klein AA. A review of enhanced recovery for thoracic anaesthesia and surgery. Anaesthesia. 2013 Feb;68(2):179-89. doi: 10.1111/anae.12067. Epub 2012 Nov 5.</citation>
    <PMID>23121400</PMID>
  </reference>
  <reference>
    <citation>Komatsu T, Kino A, Inoue M, Sowa T, Takahashi K, Fujinaga T. Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery. Int J Surg. 2014;12(9):936-9. doi: 10.1016/j.ijsu.2014.07.272. Epub 2014 Aug 1.</citation>
    <PMID>25091399</PMID>
  </reference>
  <reference>
    <citation>Das-Neves-Pereira JC, Bagan P, Coimbra-Israel AP, Grimaillof-Junior A, Cesar-Lopez G, Milanez-de-Campos JR, Riquet M, Biscegli-Jatene F. Fast-track rehabilitation for lung cancer lobectomy: a five-year experience. Eur J Cardiothorac Surg. 2009 Aug;36(2):383-91; discussion 391-2. doi: 10.1016/j.ejcts.2009.02.020. Epub 2009 Mar 26.</citation>
    <PMID>19324571</PMID>
  </reference>
  <reference>
    <citation>Chen L, Sun L, Lang Y, Wu J, Yao L, Ning J, Zhang J, Xu S. Fast-track surgery improves postoperative clinical recovery and cellular and humoral immunity after esophagectomy for esophageal cancer. BMC Cancer. 2016 Jul 11;16:449. doi: 10.1186/s12885-016-2506-8.</citation>
    <PMID>27401305</PMID>
  </reference>
  <reference>
    <citation>Asteriou C, Lazopoulos A, Rallis T, Gogakos AS, Paliouras D, Barbetakis N. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study. J Minim Access Surg. 2016 Jul-Sep;12(3):209-13. doi: 10.4103/0972-9941.183483.</citation>
    <PMID>27279390</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>December 17, 2020</last_update_submitted>
  <last_update_submitted_qc>December 17, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hospital Santa Marcelina</investigator_affiliation>
    <investigator_full_name>Igor Renato Louro Bruno de Abreu</investigator_full_name>
    <investigator_title>Assistant physician of the thoracic surgery team of the Hospital Santa Marcelina de Itaquera</investigator_title>
  </responsible_party>
  <keyword>Fast Track surgical recovery</keyword>
  <keyword>Surgical recovery</keyword>
  <keyword>Thoracic surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We are planning to publish partial data analysis during the study period</ipd_description>
  </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/NCT03271749
org study id: 70142917.0.0000.0066
nct id: NCT03271749
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Introduction:

      Aiming at reducing costs and optimizing the use of these financial resources, several
      postoperative recovery protocols have emerged that aim to reduce the length of hospital stay
      by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic
      scenario allied to the existing scientific knowledge on the subject , the investigators
      developed a protocol that aims to meet this need using resources already available and
      offered in brazilian public health system. The investigators called this protocol as Protocol
      of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of
      accelerated postoperative recovery already used in several European health services.

      Goals:

        1. To evaluate the impact of PROSM on the length of hospitalization in days and
           postoperative pain (visual analog pain scale - VAS) in patients submitted to surgical
           procedures performed by the thoracic surgery team of the Hospital Santa Marcelina de
           Itaquera.

        2. Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment
           and hospitalization of these patients.

      Materials and methods:

      A group of 200 patients with elective pulmonary resections (segmentectomies, lobectomies or
      pneumonectomies) to treat neoplastic lung diseases will be selected by the investigators.

      The participants will be randomized into two groups (rate of randomization 1/1).

      The first group will be submitted to the standard surgical treatment that is currently used
      in Santa Marcelina - Itaquera hospital. The second group will be submitted to treatment with
      the adoption of the PROSM guidelines, which will be detailed later.

      Investigators will evaluate in the two groups: surgical time in minutes, intraoperative
      complications: intraoperative bleeding in mililiters, need for transfusion of blood products,
      intraoperative clinical complications. Investigators will also evaluate the need for
      postoperative recovery in Intensive Care Unit (ICU), medications used to maintain the
      anesthetic plane during the procedure (amount of drugs in milligrams), medications used for
      postoperative analgesia, length of hospital stay in days, postoperative clinical
      complications, need for surgical re-boarding, immediate postoperative pain (VAS),
      postoperative pain at the time of discharge and the first outpatient return (VAS), the need
      for opioid analgesics at home after discharge.

      After the data collection, the investigators will analyze them and make a comparative study
      of the costs of surgical treatment and hospitalization between the two groups. This data will
      be obtained from the billing department of the Hospital Santa Marcelina de Itaquera.
Introduction:

      Patients submitted to surgical procedures for the treatment of thoracic diseases, whether
      benign or neoplastic, are exposed to potential complications.

      The main complications related to these procedures are primarily lung infections, followed by
      thrombotic events, cardiovascular events, and complications due to previous chronic diseases.

      Faced with the occurrence of complications, these patients require a longer hospitalization
      period, using high cost medications, generating additional unexpected costs.

      Aiming at reducing costs and optimizing the use of these financial resources, several
      postoperative recovery protocols have emerged that aim to reduce the length of hospital stay
      by accelerating surgical recovery.1,2 In view of the current Brazilian political and economic
      scenario allied to the existing scientific knowledge on the subject , the investigators
      developed a protocol that aims to meet this need using resources already available and
      offered in brazilian public health system. The investigators called this protocol as Protocol
      of Operative Recovery Santa Marcelina (PROSM) that had as inspiration the protocols of
      accelerated postoperative recovery already used in several European health services.

      Goals:

        1. To evaluate the impact of PROSM on the length of hospitalization in days and
           postoperative pain (visual analog pain scale - VAS) in patients submitted to surgical
           procedures performed by the thoracic surgery team of the Hospital Santa Marcelina de
           Itaquera.

        2. Evaluate the impacts of PROSM in reducing the costs (US dollars) of surgical treatment
           and hospitalization of these patients.

      Materials and methods:

      A group of 200 patients with elective pulmonary resections (segmentectomies, lobectomies or
      pneumonectomies) to treat neoplastic lung diseases will be selected by the investigators.

      Patients under the age of eighteen years old, unable to read, understand and sign informed
      consent, patients with compromised performance status (ECOG greater than 2), patients with a
      body mass below 60 kilograms or greater than 120 kilograms , patients with allergy to latex,
      patients with a history of allergy to any of the drugs used in anesthesia for PROSM, patients
      with renal dysfunction, liver dysfunction and severe cardiac dysfunction (cardiac failure),
      will be excluded from this study.

      The participants will be randomized into two groups (rate of randomization 1/1). The first
      group will be submitted to the standard surgical treatment that is currently used in Santa
      Marcelina - Itaquera hospital. The second group will be submitted to treatment with the
      adoption of the PROSM guidelines, which will be detailed later.

      Investigators will evaluate in the two groups: surgical time in minutes, intraoperative
      complications: intraoperative bleeding in mililiters, need for transfusion of blood products,
      intraoperative clinical complications. Investigators will also evaluate the need for
      postoperative recovery in Intensive Care Unit (ICU), medications used to maintain the
      anesthetic plane during the procedure (amount of drugs in milligrams), medications used for
      postoperative analgesia, length of hospital stay in days, postoperative clinical
      complications, need for surgical re-boarding, immediate postoperative pain (VAS),
      postoperative pain at the time of discharge and the first outpatient return (VAS), the need
      for opioid analgesics at home after discharge. The follow-up time of these patients for the
      purpose of collecting data for this study will be started with their agreement to participate
      in the project and with the signing of the free and informed consent term and will extend
      until the third postoperative return. After this period, the participants will be followed
      for assistance purposes only.

      After the data collection, this will be analyzed and a comparative study of the costs of
      surgical treatment and hospitalization between the two groups will be made. This data will be
      obtained from the billing department of the Santa Marcelina - Itaquera hospital.

      Continuous variables will be expressed as medians with deviations. Categorical variables will
      be represented by absolute numbers and percentages. The Gaussian distribution of the
      variables will be tested using Kolmogorov - Smirnov test. The comparison between medians will
      be evaluated through the use of Student's T test. The comparison between categorical
      variables will be carried out using Chi-square test. Possible risk factors that contribute to
      an increase in the length of hospital stay and an increase in postoperative pain will be
      traced through the use of logistic regressions.

      The analysis of the data will be carried out using the software Statistical Package for the
      Social Sciences (SPSS) 17.0 software (SPSS, Chicago, IL, USA)

      PROSM Guidelines Description:

      Selected patients who agree to participate in the present project and whose randomization
      assign them to the intervention PROSM group will be submitted to the following guidelines.

      Preoperative care: In addition to conventional preoperative care including cessation of
      smoking and use of medications for comorbidities treatment, guidelines for preoperative
      fasting, verification of preoperative exams and cardiovascular and pre-anesthetic
      evaluations, the patient will receive guidelines for home exercises to perform daily walks
      with thirty minutes duration until the day of surgery. This measure aims to create in the
      patient the habit of moving daily. This will facilitate adherence to the proposed exercises
      for postoperative recovery.

      On the day of surgery, immediately before the patient is taken to the operating room, we will
      administer 8 drops of chlorpromazine solution and 750 milligrams of paracetamol or 500
      milligrams of dipyrone. The goal is to generate preemptive analgesia. Patients who admitted
      to the surgical procedure exhibit evidence of abandonment of the preoperative guidelines will
      be excluded from the study.

      Anesthesia: The participant will be adequately monitored with pulse oximetry, cardioscopy,
      capnography, noninvasive blood pressure, temperature monitoring, anesthetic depth monitoring
      through the BIS method (bispectral index), delayed bladder catheter. The necessity or not of
      central venous access and invasive blood pressure will be evaluated according to the
      cardiovascular risks and the size of the surgery. For pulmonary resection operations we will
      use selective orotracheal intubation as already agreed in the institution.

      Anesthetic induction will be performed using short duration opioid (remifentanil), hypnotic
      (propofol) and neuromuscular blocker with dose adjusted according to the patient's body
      mass.3 Intraoperative analgesia will be obtained through paravertebral and incisional
      intercostal block through the infiltration of a drug solution containing 500mililiters of
      saline, 1 vial of 5milligrams / 20milliliters bupivacaine, 20milliliters of lidocaine 2%
      without vasoconstrictor, 10milligrams of dexamethasone , 500milligrams of hydrocortisone,
      75milligrams of clonidine, 5milligrams of ketamine and 40milliliters of sodium bicarbonate
      8.4% solution). Investigators will use only the volume of solution sufficient to generate the
      intercostal blocks of the spaces pertaining to the incision and the orifice of the pleural
      drain and completely infiltrate the surgical wound. The surplus drug solution will be
      discarded.4 The participants will not be submitted to epidural anesthesia, only to the block.

      Intercostal block and infiltration of the surgical wound will be performed by the surgical
      team while the other anesthetic procedures will be performed and accompanied by the
      anesthesiologist. At any time during the procedure, the anesthesiologist may administer
      additional anesthetic drugs or any other type of drug deemed necessary to ensure adequate
      pain control and hemodynamic stability of the patient. Throughout the procedure there should
      be dialogue and exchange of information between the surgical and anesthetic teams.

      Anesthetic recovery: Post anesthetic recovery will commence immediately after the surgical
      dressing. The participants will be placed in horizontal dorsal decubitus, the anesthetic
      drugs will be switched off, the patient will receive intravenous antiemetic (ondansetron) and
      intravenous non-steroidal anti-inflammatory drug (ketoprofen) before extubation to avoid
      nausea and decrease postoperative pain. The patient will be extubated as soon as he is
      recovering his consciousness and is able to maintain an effective spontaneous breath.

      Immediately after the extubation, the surgeon will elevate the decubitus of the surgical
      table to 45 degrees maintaining the constant observation of the blood pressure, heart rate
      and pulse oximetry. It will remain elevated until the patient is well awake. If the patient
      is unable to maintain a sufficient level of consciousness to understand and respond to verbal
      commands within 50 minutes of extubation or if during awakening the patient develops postural
      hypotension surgical team will abort the protocol and resume recovery by conventional
      measures.5 These cases will be counted as failure to execute the method.

      When the patient is conscious and able to understand sentences and respond to verbal
      commands, investigators will begin the postoperative exercise program. Initially participant
      will do breathing exercises with inspirations and forced exhalations followed by elevation
      and lowering of the upper limbs.

      While the participant is in the operating room, sequences of 10 exercises with a 1-minute
      interval between sequences will be performed.5 From the moment the anesthesiologist
      authorizes, the patient will be referred for anesthetic recovery room Upon reaching
      anesthetic recovery room, the patient will receive water and diet. After feeding, will be
      placed in an armchair, maintaining monitoring where will continue to do breathing exercises,
      lifting and lowering exercises of the upper limbs and extension and flexion of lower limbs.
      At this moment the participant will be accompanied by a doctor of the surgical team and a
      physiotherapist who will guide him in relation to the movements. A family escort will be
      allowed to remain with the patient helping to do the exercises. This phase of recovery will
      last 2 hours.5, 6 After this period of time, the physician representing the surgical team
      will put the patient on stand and watch the patient for 4 minutes in order to evaluate
      possible postural hypotension and assess the patient's ability to support his or her own
      weight. If the patient does not tolerate standing, participant will be placed back in the
      armchair and will continue with the exercises. Otherwise, the physician and physiotherapist
      will walk with the patient into the anesthetic recovery room for a period of 30 minutes with
      rest breaks as needed.

      Referral to the hospitalization unit: After anesthesia recovery, the participants will be
      referred to the hospitalization units. In the hospitalization units the patient will do a 15
      minute walk in the hallway every 60 minutes interval. During the intervals the patient will
      be resting in an armchair doing the movements previously described.

      Those patients at risk of postoperative cardiac arrhythmias who received intraoperative blood
      products with a risk for hemorrhagic events using some type of vasoactive drug requiring
      ventilatory support will be referred to the ICU where they will remain for at least 24 hours
      , maintaining the same lines of proposed postoperative exercises. Indication or not of ICU
      postoperatively should be a consensus between surgical team and anesthetic team.7

      Postoperative Prescription: The postoperative prescription should contain a general voluntary
      diet, medications that the patient already use, prophylactic antibiotics in the first 24
      hours of the postoperative period, dipyrone or paracetamol of schedule, ketoprofen of
      schedule or toragesic, methadon 5milligrams per mouth if pain, antiemetics (ondansetron)
      schedule, laxative once a day, chlorpromazine solution drops (from 8 to 10 drops) at nigth.
      Investigators should not prescribe anticoagulants or antiplatelet agents until the patient
      has 7 days postoperative. There is no need for prophylactic enoxaheparin because the patient
      will be in continuous movement. Daily radiographs will be performed while the patient has a
      thoracic drainage. Laboratory tests will be requested only if the patient shows some type of
      abnormality on the physical examination that raises some suspicion of organic dysfunction or
      if there is any indication for it based on the preoperative cardiovascular and anesthetic
      evaluations.

      Discharge: When the patient is in conditions for hospital discharge, this will be done
      through some guidelines:

        1. Return to the outpatient thoracic surgery in 7 days to continue postoperative follow-up.

        2. Prescription of analgesics for home use.

        3. Guidance on possible postoperative complications, making it very clear in which
           circumstances the patient should return to the emergency room (fever, dyspnea, bleeding
           or chest pain refractory to the use of medication).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled Trial
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: It's impossible to mask the participants, care providers and investigators, because of the apparent differences in both techniques. For this reason the data analysis will be masked to avoid influences by the other participants during the analysis.
measure: length of hospitalization in days
time frame: 1825 days
description: To evaluate the impact of PROSM on the length of hospitalization in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital
measure: postoperative pain using visual analog pain scale (VAS)
time frame: 1825 days
description: To evaluate the impact of PROSM on postoperative pain in patients submitted to surgical procedures by thoracic surgery team of the Santa Marcelina - Itaquera hospital
measure: costs of surgical treatment in US dollars
time frame: 1825 days
description: Evaluate the impacts of PROSM in reducing the costs of surgical treatment and hospitalization of these patients.
arm group label: Conventional
arm group type: No Intervention
description: The participants of this arm will receive the convencional pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms
arm group label: PROSM interventional
arm group type: Experimental
description: The participants of this arm will receive the PROSM protocol pre operative, anesthesia and postoperative care for lung resections for treatment of lung neoplasms
intervention type: Other
intervention name: PROSM guidelines for preoperative, anesthesia and postoperative care for lung resections
description: The PROSM guidelines is described previously in study description
arm group label: PROSM interventional
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Fernando C Abrão, M.D.
role: Study Chair
affiliation: Coordinating physician of the thoracic surgery team of Santa Marcelina de Itaquera Hospital
last name: Igor Renato LB de Abreu, M.D.
phone: 55(11)982035629
email: dr.igor.abreu@gmail.com
last name: Fernando C Abrão, M.D.
phone: 55(11) 982255088
email: torax.santa.marcelina@gmail.com
facility: 
contact: 
country: Brazil
citation: Dong Q, Zhang K, Cao S, Cui J. Fast-track surgery versus conventional perioperative management of lung cancer-associated pneumonectomy: a randomized controlled clinical trial. World J Surg Oncol. 2017 Jan 13;15(1):20. doi: 10.1186/s12957-016-1072-5.
PMID: 28086896
citation: Wolk S, Meissner T, Linke S, Mussle B, Wierick A, Bogner A, Sturm D, Rahbari NN, Distler M, Weitz J, Welsch T. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial. Trials. 2017 Feb 21;18(1):77. doi: 10.1186/s13063-017-1782-1.
PMID: 28222805
citation: Jones NL, Edmonds L, Ghosh S, Klein AA. A review of enhanced recovery for thoracic anaesthesia and surgery. Anaesthesia. 2013 Feb;68(2):179-89. doi: 10.1111/anae.12067. Epub 2012 Nov 5.
PMID: 23121400
citation: Komatsu T, Kino A, Inoue M, Sowa T, Takahashi K, Fujinaga T. Paravertebral block for video-assisted thoracoscopic surgery: analgesic effectiveness and role in fast-track surgery. Int J Surg. 2014;12(9):936-9. doi: 10.1016/j.ijsu.2014.07.272. Epub 2014 Aug 1.
PMID: 25091399
citation: Das-Neves-Pereira JC, Bagan P, Coimbra-Israel AP, Grimaillof-Junior A, Cesar-Lopez G, Milanez-de-Campos JR, Riquet M, Biscegli-Jatene F. Fast-track rehabilitation for lung cancer lobectomy: a five-year experience. Eur J Cardiothorac Surg. 2009 Aug;36(2):383-91; discussion 391-2. doi: 10.1016/j.ejcts.2009.02.020. Epub 2009 Mar 26.
PMID: 19324571
citation: Chen L, Sun L, Lang Y, Wu J, Yao L, Ning J, Zhang J, Xu S. Fast-track surgery improves postoperative clinical recovery and cellular and humoral immunity after esophagectomy for esophageal cancer. BMC Cancer. 2016 Jul 11;16:449. doi: 10.1186/s12885-016-2506-8.
PMID: 27401305
citation: Asteriou C, Lazopoulos A, Rallis T, Gogakos AS, Paliouras D, Barbetakis N. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study. J Minim Access Surg. 2016 Jul-Sep;12(3):209-13. doi: 10.4103/0972-9941.183483.
PMID: 27279390
responsible party type: Sponsor-Investigator
investigator affiliation: Hospital Santa Marcelina
investigator full name: Igor Renato Louro Bruno de Abreu
investigator title: Assistant physician of the thoracic surgery team of the Hospital Santa Marcelina de Itaquera
mesh term: Postoperative Complications
mesh term: Postoperative Nausea and Vomiting
mesh term: Anesthetics
sharing ipd: Undecided
ipd description: We are planning to publish partial data analysis during the study period