<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/NCT03798951</url>
  </required_header>
  <id_info>
    <org_study_id>PRESS 152/INT/2018</org_study_id>
    <nct_id>NCT03798951</nct_id>
  </id_info>
  <brief_title>Prehabilitation in Esophageal Surgery (PRESS)</brief_title>
  <acronym>PRESS</acronym>
  <official_title>Evaluation of a Multimodal Program of Prehabilitation in Patients Undergoing Esophagectomy Within an ERAS Pathway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università Vita-Salute San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Stefano Turi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Luigi Beretta</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Paolo Parise</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Riccardo Rosati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Università Vita-Salute San Raffaele</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Despite important clinical improvements, esophageal cancer surgery is still associated to a&#xD;
      high rate of postoperative complications. Recent ERAS (Enhanced Recovery After Surgery)&#xD;
      Society guidelines underline the possible role of prehabilitations' programs in reducing&#xD;
      postoperative morbidity. In this trial, 200 patients, scheduled for esophageal cancer&#xD;
      resection, will be randomly assigned to two groups (100 patients for each group). In both&#xD;
      groups, patients will perform a basal evaluation with a physiotherapist, a nutritionist and a&#xD;
      psychologist. In the treatment group, each patient will receive a tailored prehabilitative&#xD;
      program and, during the 4 weeks before surgery, will be monitored constantly by each single&#xD;
      specialist. A preoperative revaluation (the day before surgery) and follow up visits at 3 and&#xD;
      6 months will be performed for all patients. The incidence of postoperative complications,&#xD;
      the length of hospital stay, and the reach of discharge criteria will be registered.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Multi-modal prehabilitation programs reported positive results in patients undergoing colonic&#xD;
      resection. These protocols are, generally, based on physiotherapist, nutritional and&#xD;
      psychological implementation programs. Nevertheless, the conflicting results obtained in&#xD;
      previous trials demonstrate how many elements have still to be clarified and that, probably,&#xD;
      the pre-habilitation interventions must be tailored, as much as possible, on the peculiar&#xD;
      characteristics of each single patient, modifying the approach as a function of the clinical&#xD;
      specific response. All these considerations suggest a strong basis for tailored interventions&#xD;
      in patients undergoing esophageal surgery, highlighting at the same time, as concluded in a&#xD;
      recent review, the need of further studies to better define specific peri-operative&#xD;
      strategies. This study will be a randomized, not blind, monocentric trial, that will be&#xD;
      conducted at Ospedale San Raffaele, Milano, Italia, between January 2018 and January 2021&#xD;
      (three years). 200 patients will be randomly assigned to two different groups. All the&#xD;
      patients, included in the study, will receive a preliminary evaluation performed by different&#xD;
      professional figures.&#xD;
&#xD;
      Physiotherapist evaluation:&#xD;
&#xD;
      All the patients of both groups will be classified according to specific tests in order to&#xD;
      establish their basal condition. Spirometry examination, 6-minute walking test, time up and&#xD;
      go test, steep ramp test&#xD;
&#xD;
      strength tests (target muscles will be the quadriceps and the handgrip muscles:&#xD;
&#xD;
      in both cases a specific dynamometer will be utilized) and Modified Iowa Level&#xD;
&#xD;
      of Assistance Scale (MILAS) evaluation will be performed.&#xD;
&#xD;
      The experimental group will follow a home-based prehabilitation program for four weeks; this&#xD;
      will be tailored on the patient on the bases of the first functional evaluation and the&#xD;
      identified needs. On day 1 the patients will attend a hospital session and will be instructed&#xD;
      by a physiotherapist on exercises and program to follow. The patients will then receive&#xD;
      instruction support in order to better follow and adjust the program at home. Patients will&#xD;
      also record what they do on a diary.&#xD;
&#xD;
      The physiotherapist will make phone calls in order to supervise patients' adherence to the&#xD;
      program and help them in adjusting it.&#xD;
&#xD;
      Prehabilitation program will comprise aerobic exercise (cyclette or treadmill, 3 times a&#xD;
      week) and IMT (inspiration muscle training, IMT respironics Philips, daily). In adjunction to&#xD;
      these ones, further exercises will be prescribed on the bases of the functional assessment&#xD;
      and the identification of deficits in any functional capacity assessed and will include two&#xD;
      of the following: airway clearance (two sessions 10' a day for 7 days a week), skeletal&#xD;
      muscles strengthening (3 days a week), stretching (three times a week), transfer and mobility&#xD;
      training.&#xD;
&#xD;
      The control group will follow the actual procedure usually administered prior to surgery:&#xD;
      this comprises inspiration exercises through a spirometer incentive without any monitoring&#xD;
      and some recommendations aimed at staying active during the preoperative period.&#xD;
&#xD;
      Nutritional evaluation:&#xD;
&#xD;
      All patients will undergo a comprehensive nutritional assessment at baseline, 4 weeks prior&#xD;
      to surgery, the day before or the day of surgery and 3 and 6 months after surgery. At&#xD;
      baseline, a complete medical and nutrition history will be collected, and physical&#xD;
      examination will be performed. Anthropometric parameters including body weight (kg) and&#xD;
      height (cm), waist and hip circumference will be measured, and body mass index (kg/m2)&#xD;
      calculated. The Malnutrition Universal Screening Tool (MUST) will be used to screen patients&#xD;
      for nutrition risk. Standard biochemical markers of malnutrition and inflammation, including&#xD;
      albumin, prealbumin, retinol-binding protein, total lymphocyte count, transferrin and&#xD;
      C-reactive protein will be measured in all patients. The Prognostic Nutritional Index (PNI)&#xD;
      will also be calculated using serum albumin concentration and total lymphocyte count. Single&#xD;
      frequency-bio-impedance analysis (SF-BIA) will be used to estimate total body water (TBW),&#xD;
      fat free mass (FFM) and BIA-derived phase angle. Basal energy expenditure (BEE) will be&#xD;
      estimated using the Harris-Benedict equation. Energy and protein needs (ranging from 1 to 1.5&#xD;
      g/kg/day) will be established according to age, BEE, disease and degree of protein depletion.&#xD;
      At baseline, all patients will receive nutrition counselling to help manage symptoms and&#xD;
      encourage the intake of energy-enriched foods and fluids that are better tolerated, as per&#xD;
      the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on nutrition in&#xD;
      cancer patients. Patients in the treatment group will be provided with a dietary plan based&#xD;
      on their energy and protein needs. Patients will be monitored by a follow-up phone call at&#xD;
      two weeks after the baseline visit. Furthermore, patients in the treatment group will receive&#xD;
      an immune-enhancing formula (7.6% protein, 18.9% carbohydrate, 3.9% fat) enriched with&#xD;
      arginine, RNA, ω3 fatty acids and soluble fibre (partially hydrolysed guar gum, PHGG) 5 days&#xD;
      before surgery (237 ml TID). Patients in the control group will receive nutritional&#xD;
      counselling at baseline and will be managed according to standard protocols in use at our&#xD;
      Institution.&#xD;
&#xD;
      Psychologist evaluation:&#xD;
&#xD;
      All the patients will perform a psychological interview and specific assessment tests to&#xD;
      define their: quality of life (SF-36 and EORTC), specific disorders anxiety and depression&#xD;
      Hads (Hospital anxiety and Depression Scale) and coping strategies (MAC mental Adjustment to&#xD;
      Cancer). The assessment test will be performed at the recruitment of the patients, the day&#xD;
      before surgery and 3 and 6 months after surgery. In the treatment group, periodical&#xD;
      re-evaluations, trough phone calls, will be performed to support patients in their adjustment&#xD;
      path to surgery. It will be, also, necessary to sustain them to accept possible changes and&#xD;
      pressures deriving from prehabilitative programs. Treated patients will also receive a&#xD;
      post-operative evaluation to define possible symptoms and adaptive reactions, developed to&#xD;
      overcome the physiologic and metabolic modifications deriving from surgery.&#xD;
&#xD;
      The intra and post-operative treatment will be developed according to the same principles of&#xD;
      ERAS in both groups. The authors will record all post-operative complications; the length of&#xD;
      hospital stays and the reach of the criteria for the discharge (free solid intake, adequate&#xD;
      pain control with oral analgesics, autonomous mobilization, restarting of bowel function and&#xD;
      no evidence of possible post-surgical complications). Postoperative complications will be&#xD;
      defined and registered according Calvien- Dindo classification criteria. The primary outcome&#xD;
      of our study will be the reduction of post-operative complications, from 70% to 50%.&#xD;
      Secondary outcomes will be a reduction in the length of hospital stay and a faster return to&#xD;
      the pre-operative physical conditions, through a comparison with the basal evaluation, in the&#xD;
      treatment group. Patients will be evaluated the day before surgery, during hospital stay and&#xD;
      trough a follow-up visit at 3 and 6 months after surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 5, 2019</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">January 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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post-operative complications</measure>
    <time_frame>Hospital discharge (10-15 days)</time_frame>
    <description>Reduction of incidence of post-operative complications, registered according to Clavien-Dindo's Classification criteria</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Esophageal Cancer Surgery</condition>
  <arm_group>
    <arm_group_label>Prehabilitation program</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient. The program will have a duration of, at least, 4 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The patients included in this group will, also, receive a basal evaluation by a physiotherapist, a nutritionist and a psychologist. These patients will not receive a tailored prehabilitation program and will be revaluated the day before surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prehabilitation</intervention_name>
    <description>The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient.&#xD;
The program will have a duration of, at least, 4 weeks.</description>
    <arm_group_label>Prehabilitation program</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent;&#xD;
&#xD;
          -  Patients scheduled for Esophageal cancer resection with Ivor-lewis technique;&#xD;
&#xD;
          -  Previous CT/RT neoadjuvant treatment;&#xD;
&#xD;
          -  Possibility to perform a prehabilitation treatment of, at least, 4 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Comorbid medical, physical, and mental conditions that contraindicate exercise or oral&#xD;
             nutrition.&#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_contact>
    <last_name>Riccardo Rosati, Prof</last_name>
    <phone>+39022643</phone>
    <phone_ext>2270</phone_ext>
    <email>rosati.riccardo@hsr.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Stefano Turi, MD</last_name>
    <phone>+39022643</phone>
    <phone_ext>2656</phone_ext>
    <email>turi.stefano@hsr.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>IRCCS San Raffaele Scientific Institute</name>
      <address>
        <city>Milan</city>
        <state>MI</state>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giovanni Landoni</last_name>
      <email>landoni.giovanni@hsr.it</email>
    </contact>
    <investigator>
      <last_name>Stefano Turi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Riccardo Rosati, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Low DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4.</citation>
    <PMID>30276441</PMID>
  </reference>
  <reference>
    <citation>Minnella EM, Awasthi R, Loiselle SE, Agnihotram RV, Ferri LE, Carli F. Effect of Exercise and Nutrition Prehabilitation on Functional Capacity in Esophagogastric Cancer Surgery: A Randomized Clinical Trial. JAMA Surg. 2018 Dec 1;153(12):1081-1089. doi: 10.1001/jamasurg.2018.1645.</citation>
    <PMID>30193337</PMID>
  </reference>
  <reference>
    <citation>Minnella EM, Carli F. Prehabilitation and functional recovery for colorectal cancer patients. Eur J Surg Oncol. 2018 Jul;44(7):919-926. doi: 10.1016/j.ejso.2018.04.016. Epub 2018 Apr 30.</citation>
    <PMID>29754828</PMID>
  </reference>
  <reference>
    <citation>Stratton RJ, Hackston A, Longmore D, Dixon R, Price S, Stroud M, King C, Elia M. Malnutrition in hospital outpatients and inpatients: prevalence, concurrent validity and ease of use of the 'malnutrition universal screening tool' ('MUST') for adults. Br J Nutr. 2004 Nov;92(5):799-808. doi: 10.1079/bjn20041258.</citation>
    <PMID>15533269</PMID>
  </reference>
  <reference>
    <citation>Mohri Y, Inoue Y, Tanaka K, Hiro J, Uchida K, Kusunoki M. Prognostic nutritional index predicts postoperative outcome in colorectal cancer. World J Surg. 2013 Nov;37(11):2688-92. doi: 10.1007/s00268-013-2156-9.</citation>
    <PMID>23884382</PMID>
  </reference>
  <reference>
    <citation>Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6.</citation>
    <PMID>27637832</PMID>
  </reference>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>December 23, 2022</last_update_submitted>
  <last_update_submitted_qc>December 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università Vita-Salute San Raffaele</investigator_affiliation>
    <investigator_full_name>Giovanni Landoni</investigator_full_name>
    <investigator_title>MD, Asociate Professor</investigator_title>
  </responsible_party>
  <keyword>Esophageal cancer surgery</keyword>
  <keyword>Prehabilitation</keyword>
  <keyword>Enhanced recovery after surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Esophageal Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT03798951
org study id: PRESS 152/INT/2018
nct id: NCT03798951
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Despite important clinical improvements, esophageal cancer surgery is still associated to a
      high rate of postoperative complications. Recent ERAS (Enhanced Recovery After Surgery)
      Society guidelines underline the possible role of prehabilitations' programs in reducing
      postoperative morbidity. In this trial, 200 patients, scheduled for esophageal cancer
      resection, will be randomly assigned to two groups (100 patients for each group). In both
      groups, patients will perform a basal evaluation with a physiotherapist, a nutritionist and a
      psychologist. In the treatment group, each patient will receive a tailored prehabilitative
      program and, during the 4 weeks before surgery, will be monitored constantly by each single
      specialist. A preoperative revaluation (the day before surgery) and follow up visits at 3 and
      6 months will be performed for all patients. The incidence of postoperative complications,
      the length of hospital stay, and the reach of discharge criteria will be registered.
Multi-modal prehabilitation programs reported positive results in patients undergoing colonic
      resection. These protocols are, generally, based on physiotherapist, nutritional and
      psychological implementation programs. Nevertheless, the conflicting results obtained in
      previous trials demonstrate how many elements have still to be clarified and that, probably,
      the pre-habilitation interventions must be tailored, as much as possible, on the peculiar
      characteristics of each single patient, modifying the approach as a function of the clinical
      specific response. All these considerations suggest a strong basis for tailored interventions
      in patients undergoing esophageal surgery, highlighting at the same time, as concluded in a
      recent review, the need of further studies to better define specific peri-operative
      strategies. This study will be a randomized, not blind, monocentric trial, that will be
      conducted at Ospedale San Raffaele, Milano, Italia, between January 2018 and January 2021
      (three years). 200 patients will be randomly assigned to two different groups. All the
      patients, included in the study, will receive a preliminary evaluation performed by different
      professional figures.

      Physiotherapist evaluation:

      All the patients of both groups will be classified according to specific tests in order to
      establish their basal condition. Spirometry examination, 6-minute walking test, time up and
      go test, steep ramp test

      strength tests (target muscles will be the quadriceps and the handgrip muscles:

      in both cases a specific dynamometer will be utilized) and Modified Iowa Level

      of Assistance Scale (MILAS) evaluation will be performed.

      The experimental group will follow a home-based prehabilitation program for four weeks; this
      will be tailored on the patient on the bases of the first functional evaluation and the
      identified needs. On day 1 the patients will attend a hospital session and will be instructed
      by a physiotherapist on exercises and program to follow. The patients will then receive
      instruction support in order to better follow and adjust the program at home. Patients will
      also record what they do on a diary.

      The physiotherapist will make phone calls in order to supervise patients' adherence to the
      program and help them in adjusting it.

      Prehabilitation program will comprise aerobic exercise (cyclette or treadmill, 3 times a
      week) and IMT (inspiration muscle training, IMT respironics Philips, daily). In adjunction to
      these ones, further exercises will be prescribed on the bases of the functional assessment
      and the identification of deficits in any functional capacity assessed and will include two
      of the following: airway clearance (two sessions 10' a day for 7 days a week), skeletal
      muscles strengthening (3 days a week), stretching (three times a week), transfer and mobility
      training.

      The control group will follow the actual procedure usually administered prior to surgery:
      this comprises inspiration exercises through a spirometer incentive without any monitoring
      and some recommendations aimed at staying active during the preoperative period.

      Nutritional evaluation:

      All patients will undergo a comprehensive nutritional assessment at baseline, 4 weeks prior
      to surgery, the day before or the day of surgery and 3 and 6 months after surgery. At
      baseline, a complete medical and nutrition history will be collected, and physical
      examination will be performed. Anthropometric parameters including body weight (kg) and
      height (cm), waist and hip circumference will be measured, and body mass index (kg/m2)
      calculated. The Malnutrition Universal Screening Tool (MUST) will be used to screen patients
      for nutrition risk. Standard biochemical markers of malnutrition and inflammation, including
      albumin, prealbumin, retinol-binding protein, total lymphocyte count, transferrin and
      C-reactive protein will be measured in all patients. The Prognostic Nutritional Index (PNI)
      will also be calculated using serum albumin concentration and total lymphocyte count. Single
      frequency-bio-impedance analysis (SF-BIA) will be used to estimate total body water (TBW),
      fat free mass (FFM) and BIA-derived phase angle. Basal energy expenditure (BEE) will be
      estimated using the Harris-Benedict equation. Energy and protein needs (ranging from 1 to 1.5
      g/kg/day) will be established according to age, BEE, disease and degree of protein depletion.
      At baseline, all patients will receive nutrition counselling to help manage symptoms and
      encourage the intake of energy-enriched foods and fluids that are better tolerated, as per
      the European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines on nutrition in
      cancer patients. Patients in the treatment group will be provided with a dietary plan based
      on their energy and protein needs. Patients will be monitored by a follow-up phone call at
      two weeks after the baseline visit. Furthermore, patients in the treatment group will receive
      an immune-enhancing formula (7.6% protein, 18.9% carbohydrate, 3.9% fat) enriched with
      arginine, RNA, ω3 fatty acids and soluble fibre (partially hydrolysed guar gum, PHGG) 5 days
      before surgery (237 ml TID). Patients in the control group will receive nutritional
      counselling at baseline and will be managed according to standard protocols in use at our
      Institution.

      Psychologist evaluation:

      All the patients will perform a psychological interview and specific assessment tests to
      define their: quality of life (SF-36 and EORTC), specific disorders anxiety and depression
      Hads (Hospital anxiety and Depression Scale) and coping strategies (MAC mental Adjustment to
      Cancer). The assessment test will be performed at the recruitment of the patients, the day
      before surgery and 3 and 6 months after surgery. In the treatment group, periodical
      re-evaluations, trough phone calls, will be performed to support patients in their adjustment
      path to surgery. It will be, also, necessary to sustain them to accept possible changes and
      pressures deriving from prehabilitative programs. Treated patients will also receive a
      post-operative evaluation to define possible symptoms and adaptive reactions, developed to
      overcome the physiologic and metabolic modifications deriving from surgery.

      The intra and post-operative treatment will be developed according to the same principles of
      ERAS in both groups. The authors will record all post-operative complications; the length of
      hospital stays and the reach of the criteria for the discharge (free solid intake, adequate
      pain control with oral analgesics, autonomous mobilization, restarting of bowel function and
      no evidence of possible post-surgical complications). Postoperative complications will be
      defined and registered according Calvien- Dindo classification criteria. The primary outcome
      of our study will be the reduction of post-operative complications, from 70% to 50%.
      Secondary outcomes will be a reduction in the length of hospital stay and a faster return to
      the pre-operative physical conditions, through a comparison with the basal evaluation, in the
      treatment group. Patients will be evaluated the day before surgery, during hospital stay and
      trough a follow-up visit at 3 and 6 months after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Post-operative complications
time frame: Hospital discharge (10-15 days)
description: Reduction of incidence of post-operative complications, registered according to Clavien-Dindo's Classification criteria
arm group label: Prehabilitation program
arm group type: Experimental
description: The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient. The program will have a duration of, at least, 4 weeks.
arm group label: Control
arm group type: No Intervention
description: The patients included in this group will, also, receive a basal evaluation by a physiotherapist, a nutritionist and a psychologist. These patients will not receive a tailored prehabilitation program and will be revaluated the day before surgery.
intervention type: Other
intervention name: Prehabilitation
description: The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient.
The program will have a duration of, at least, 4 weeks.
arm group label: Prehabilitation program
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Riccardo Rosati, Prof
phone: +39022643
phone ext: 2270
email: rosati.riccardo@hsr.it
last name: Stefano Turi, MD
phone: +39022643
phone ext: 2656
email: turi.stefano@hsr.it
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Italy
citation: Low DE, Allum W, De Manzoni G, Ferri L, Immanuel A, Kuppusamy M, Law S, Lindblad M, Maynard N, Neal J, Pramesh CS, Scott M, Mark Smithers B, Addor V, Ljungqvist O. Guidelines for Perioperative Care in Esophagectomy: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations. World J Surg. 2019 Feb;43(2):299-330. doi: 10.1007/s00268-018-4786-4.
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PMID: 27637832
responsible party type: Principal Investigator
investigator affiliation: Università Vita-Salute San Raffaele
investigator full name: Giovanni Landoni
investigator title: MD, Asociate Professor
mesh term: Esophageal Neoplasms
sharing ipd: No