<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/NCT04505111</url>
  </required_header>
  <id_info>
    <org_study_id>08304219.8.0000.0072</org_study_id>
    <nct_id>NCT04505111</nct_id>
  </id_info>
  <brief_title>Prehabilitation Plus ERAS vs ERAS in Gynecological Surgery</brief_title>
  <official_title>Prehabilitation Plus Enhanced Recovery After Surgery Versus Enhanced Recovery After Surgery in Gynecological Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto Brasileiro de Controle do Cancer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Instituto Brasileiro de Controle do Cancer</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>
      Prospective, interventionist, controlled and randomized study to test the effectiveness of&#xD;
      multimodal prehabilitation protocol in patients who will undergo gynecological surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to the&#xD;
      multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the&#xD;
      effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or&#xD;
      suspicious gynaecological cancer, who will undergo gynaecological surgery.&#xD;
&#xD;
      The multidisciplinary prehabilitation program will be applied to the intervention group. For&#xD;
      the group participating in the prehabilitation and for the control group, the protocol and&#xD;
      specific recommendations for gynecological cancer defined by the Enhanced Recovery After&#xD;
      Surgery (ERAS®) guidelines will be applied.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Modification of the protocolo, new version was created. No patients were enrolled.&#xD;
  </why_stopped>
  <start_date type="Actual">July 23, 2020</start_date>
  <completion_date type="Actual">October 1, 2020</completion_date>
  <primary_completion_date type="Actual">October 1, 2020</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>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Single-Blind (surgeons and anesthesiologists)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative recovery time</measure>
    <time_frame>Up to 30 postoperative days</time_frame>
    <description>Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Up to 30 postoperative days</time_frame>
    <description>Clavien-Dindo Classification, Grades I-V</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmissions</measure>
    <time_frame>Up to 30 postoperative days</time_frame>
    <description>Readmission to the Hospital Facilities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive Care Unit admission rates</measure>
    <time_frame>Up to 30 postoperative days</time_frame>
    <description>Postoperative Intensive Care Unit admission and stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-related Quality of Life</measure>
    <time_frame>At Baseline, then at 30 and 60 days postoperatively</time_frame>
    <description>European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to the ERAS® program guidelines</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>Compliance to ERAS® protocol and implementation of the program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in anxiety and depression from baseline</measure>
    <time_frame>Baseline and postoperatively at 30 and 60 days</time_frame>
    <description>Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in functional capacity from baseline</measure>
    <time_frame>Baseline and postoperatively at 30 and 60 days</time_frame>
    <description>Patients will perform a 6-Minute Walk Test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in muscle strength</measure>
    <time_frame>Baseline and postoperatively at 30 and 60 days</time_frame>
    <description>Muscle strength is measured by using an dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in body mass</measure>
    <time_frame>Baseline and postoperatively at 30 and 60 days</time_frame>
    <description>Body mass is measured by using a bioelectrical impedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>Up to 30 days</time_frame>
    <description>Days from surgical procedure to hospital discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Gynecologic Surgical Procedures</condition>
  <condition>Enhanced Recovery After Surgery</condition>
  <arm_group>
    <arm_group_label>Prehabilitation + Enhanced Recovery After Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Enhanced Recovery After Surgery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prehabilitation Program + Enhanced Recovery After Surgery</intervention_name>
    <description>Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol</description>
    <arm_group_label>Prehabilitation + Enhanced Recovery After Surgery</arm_group_label>
    <other_name>Prehabilitation + ERAS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enhanced Recovery After Surgery</intervention_name>
    <description>ERAS protocol</description>
    <arm_group_label>Enhanced Recovery After Surgery</arm_group_label>
    <other_name>ERAS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who sign the Informed Consent Form, indicating that they understand the study&#xD;
             procedures and their purpose;&#xD;
&#xD;
          -  Women aged between 18 and 80 years old;&#xD;
&#xD;
          -  Gynecological surgery performed by laparotomy;&#xD;
&#xD;
          -  Patients with Eastern Cooperative Oncology Group Performance Status of at least 2&#xD;
             (ECOG ≤2);&#xD;
&#xD;
          -  Preoperative schedule that allows prehabilitation intervention for 2 to 3 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 or older than 80 years old;&#xD;
&#xD;
          -  ECOG ≥3;&#xD;
&#xD;
          -  Significant comorbidities, such as: neurological or musculoskeletal disorder, heart&#xD;
             disease and / or respiratory failure that prohibit physical exercise;&#xD;
&#xD;
          -  Limitation of locomotion preventing the patient to perform physical exercises;&#xD;
&#xD;
          -  Cognitive deterioration or patients with psychiatric disorder that prevents adherence&#xD;
             to the program;&#xD;
&#xD;
          -  Emergency or urgency surgeries;&#xD;
&#xD;
          -  Surgeries by minimally invasive approach (laparoscopy or robotics);&#xD;
&#xD;
          -  Vulvectomy or soft tissue surgery without abdominal approach;&#xD;
&#xD;
          -  Minor gynaecological surgeries such as conizations;&#xD;
&#xD;
          -  Surgeries performed together with other specialties, in which the gynecology team is&#xD;
             not primarily responsible for postoperative care;&#xD;
&#xD;
          -  Non-adherence of the patient in the intervention group to the preoperative&#xD;
             prehabilitation program.&#xD;
&#xD;
          -  If surgery is performed 21 days after the last day of the prehabilitation program, for&#xD;
             any reason&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andre Lopes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Doctor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IBCC - Instituto Brasileiro de Controle do Cancer</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <zip>03102-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.</citation>
    <PMID>25076007</PMID>
  </reference>
  <reference>
    <citation>Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.</citation>
    <PMID>24439570</PMID>
  </reference>
  <reference>
    <citation>Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.</citation>
    <PMID>28489682</PMID>
  </reference>
  <reference>
    <citation>Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.</citation>
    <PMID>26603969</PMID>
  </reference>
  <reference>
    <citation>Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.</citation>
    <PMID>26757238</PMID>
  </reference>
  <reference>
    <citation>Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.</citation>
    <PMID>30877144</PMID>
  </reference>
  <reference>
    <citation>Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.</citation>
    <PMID>14555665</PMID>
  </reference>
  <reference>
    <citation>Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.</citation>
    <PMID>25535730</PMID>
  </reference>
  <reference>
    <citation>Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.</citation>
    <PMID>31473663</PMID>
  </reference>
  <reference>
    <citation>Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.</citation>
    <PMID>15273542</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>April 2, 2022</last_update_submitted>
  <last_update_submitted_qc>April 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Instituto Brasileiro de Controle do Cancer</investigator_affiliation>
    <investigator_full_name>André Lopes</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Prehabilitation</keyword>
  <keyword>Gynecological Cancer</keyword>
  <keyword>ERAS - Enhanced Recovery After Surgery</keyword>
  <keyword>Gynecologic Surgery</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>After publication of the results</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>After study enrollment</ipd_time_frame>
    <ipd_access_criteria>Public</ipd_access_criteria>
  </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/NCT04505111
org study id: 08304219.8.0000.0072
nct id: NCT04505111
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Prospective, interventionist, controlled and randomized study to test the effectiveness of
      multimodal prehabilitation protocol in patients who will undergo gynecological surgery.
Prospective, interventionist and randomized controlled trial in a 1: 1 ratio, open to the
      multidisciplinary team but blind to surgeons and anaesthesiologists. The aim is to test the
      effectiveness of a multimodal prehabilitation protocol in patients with diagnosed or
      suspicious gynaecological cancer, who will undergo gynaecological surgery.

      The multidisciplinary prehabilitation program will be applied to the intervention group. For
      the group participating in the prehabilitation and for the control group, the protocol and
      specific recommendations for gynecological cancer defined by the Enhanced Recovery After
      Surgery (ERAS®) guidelines will be applied.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: Single-Blind (surgeons and anesthesiologists)
measure: Postoperative recovery time
time frame: Up to 30 postoperative days
description: Postoperative day patient is ready for discharge, defined as the day the patient has the ability to walk alone, take care of herself, and ingest at least 75% of the daily caloric needs
measure: Complications
time frame: Up to 30 postoperative days
description: Clavien-Dindo Classification, Grades I-V
measure: Readmissions
time frame: Up to 30 postoperative days
description: Readmission to the Hospital Facilities
measure: Intensive Care Unit admission rates
time frame: Up to 30 postoperative days
description: Postoperative Intensive Care Unit admission and stay
measure: Health-related Quality of Life
time frame: At Baseline, then at 30 and 60 days postoperatively
description: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
measure: Compliance to the ERAS® program guidelines
time frame: Through study completion, an average of 1 year
description: Compliance to ERAS® protocol and implementation of the program
measure: Changes in anxiety and depression from baseline
time frame: Baseline and postoperatively at 30 and 60 days
description: Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale. Scores for each sub scale (depression and anxiety) are summed-up and range from 0 to 21. Values from 0-7 indicate normal levels, 8-10 are border values and values from 11-21 are considered to be pathological.
measure: Changes in functional capacity from baseline
time frame: Baseline and postoperatively at 30 and 60 days
description: Patients will perform a 6-Minute Walk Test
measure: Change in muscle strength
time frame: Baseline and postoperatively at 30 and 60 days
description: Muscle strength is measured by using an dynamometer
measure: Change in body mass
time frame: Baseline and postoperatively at 30 and 60 days
description: Body mass is measured by using a bioelectrical impedance analysis
measure: Hospital stay
time frame: Up to 30 days
description: Days from surgical procedure to hospital discharge
arm group label: Prehabilitation + Enhanced Recovery After Surgery
arm group type: Experimental
description: Patients allocated to the intervention group will undergo prehabilitation protocol (nutrition + exercise + psychological counselling), with individualized monitoring by the multidisciplinary team.
arm group label: Enhanced Recovery After Surgery
arm group type: Active Comparator
description: Patients allocated to the control group will not undergo any pre-surgical intervention, except for preoperative counselling, already implicated in ERAS®.
intervention type: Other
intervention name: Prehabilitation Program + Enhanced Recovery After Surgery
description: Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
arm group label: Prehabilitation + Enhanced Recovery After Surgery
other name: Prehabilitation + ERAS
intervention type: Other
intervention name: Enhanced Recovery After Surgery
description: ERAS protocol
arm group label: Enhanced Recovery After Surgery
other name: ERAS
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andre Lopes, MD
role: Principal Investigator
affiliation: Doctor
facility: 
country: Brazil
citation: Gillis C, Li C, Lee L, Awasthi R, Augustin B, Gamsa A, Liberman AS, Stein B, Charlebois P, Feldman LS, Carli F. Prehabilitation versus rehabilitation: a randomized control trial in patients undergoing colorectal resection for cancer. Anesthesiology. 2014 Nov;121(5):937-47. doi: 10.1097/ALN.0000000000000393.
PMID: 25076007
citation: Santa Mina D, Clarke H, Ritvo P, Leung YW, Matthew AG, Katz J, Trachtenberg J, Alibhai SM. Effect of total-body prehabilitation on postoperative outcomes: a systematic review and meta-analysis. Physiotherapy. 2014 Sep;100(3):196-207. doi: 10.1016/j.physio.2013.08.008. Epub 2013 Nov 13.
PMID: 24439570
citation: Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293.
PMID: 28489682
citation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for pre- and intra-operative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part I. Gynecol Oncol. 2016 Feb;140(2):313-22. doi: 10.1016/j.ygyno.2015.11.015. Epub 2015 Nov 18. No abstract available.
PMID: 26603969
citation: Nelson G, Altman AD, Nick A, Meyer LA, Ramirez PT, Achtari C, Antrobus J, Huang J, Scott M, Wijk L, Acheson N, Ljungqvist O, Dowdy SC. Guidelines for postoperative care in gynecologic/oncology surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations--Part II. Gynecol Oncol. 2016 Feb;140(2):323-32. doi: 10.1016/j.ygyno.2015.12.019. Epub 2016 Jan 3. No abstract available.
PMID: 26757238
citation: Nelson G, Bakkum-Gamez J, Kalogera E, Glaser G, Altman A, Meyer LA, Taylor JS, Iniesta M, Lasala J, Mena G, Scott M, Gillis C, Elias K, Wijk L, Huang J, Nygren J, Ljungqvist O, Ramirez PT, Dowdy SC. Guidelines for perioperative care in gynecologic/oncology: Enhanced Recovery After Surgery (ERAS) Society recommendations-2019 update. Int J Gynecol Cancer. 2019 May;29(4):651-668. doi: 10.1136/ijgc-2019-000356. Epub 2019 Mar 15.
PMID: 30877144
citation: Lauretani F, Russo CR, Bandinelli S, Bartali B, Cavazzini C, Di Iorio A, Corsi AM, Rantanen T, Guralnik JM, Ferrucci L. Age-associated changes in skeletal muscles and their effect on mobility: an operational diagnosis of sarcopenia. J Appl Physiol (1985). 2003 Nov;95(5):1851-60. doi: 10.1152/japplphysiol.00246.2003.
PMID: 14555665
citation: Iyer R, Gentry-Maharaj A, Nordin A, Burnell M, Liston R, Manchanda R, Das N, Desai R, Gornall R, Beardmore-Gray A, Nevin J, Hillaby K, Leeson S, Linder A, Lopes A, Meechan D, Mould T, Varkey S, Olaitan A, Rufford B, Ryan A, Shanbhag S, Thackeray A, Wood N, Reynolds K, Menon U. Predictors of complications in gynaecological oncological surgery: a prospective multicentre study (UKGOSOC-UK gynaecological oncology surgical outcomes and complications). Br J Cancer. 2015 Feb 3;112(3):475-84. doi: 10.1038/bjc.2014.630. Epub 2014 Dec 23.
PMID: 25535730
citation: Miralpeix E, Mancebo G, Gayete S, Corcoy M, Sole-Sedeno JM. Role and impact of multimodal prehabilitation for gynecologic oncology patients in an Enhanced Recovery After Surgery (ERAS) program. Int J Gynecol Cancer. 2019 Oct;29(8):1235-1243. doi: 10.1136/ijgc-2019-000597. Epub 2019 Aug 30.
PMID: 31473663
citation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PMID: 15273542
responsible party type: Principal Investigator
investigator affiliation: Instituto Brasileiro de Controle do Cancer
investigator full name: André Lopes
investigator title: MD
sharing ipd: Yes
ipd description: After publication of the results
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: After study enrollment
ipd access criteria: Public