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A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v27

  2. Notable

    Primary and study completion dates: Oct 30, 2025 to Oct 30, 2028

    Study Statusv26

  3. Minor

    2 amendments

    2 re-verifications since 2025-01-14, no change to tracked fields

    v24-v25

  4. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Primary and study completion dates: Oct 2019 to Oct 30, 2025; Start date: Oct 2005 to Oct 30, 2005; Eligibility criteria shortened, about 37 words; and 2 more

    Show all 6 changes in this update
    • Notable Trial status: Active, Not Recruiting to Recruiting
    • Notable Primary and study completion dates: Oct 2019 to Oct 30, 2025
    • Minor Start date: Oct 2005 to Oct 30, 2005
    • Minor Eligibility criteria shortened, about 37 words
      Show what changed
      Inclusion Criteria: PatientParticipants 18 years of age or older. Patients scheduled for elective major intrabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cystectomy, radical transabdominal debulkingParticipants with ornewly withoutdiagnosed intrabdominalesophageal hyperthermicand perfusionlung cancer undergoing neoadjuvant chemotherapy, pelvicradiation exenteration, retroperitoneal lymph node dissectionstherapy, and/or low anterior resection)immunotherapy. PatientsParticipants who have signed the consent form to participate in the stu [...] [...]
    • Minor Study description shortened, about 264 words
      Show what changed
      ParticipantsPrimary Objective: • To characterize the effects of neoadjuvant therapy (chemotherapy, radiation therapy, and/or immunotherapy) on functional capacity in thisesophageal studyand are already scheduled to have major abdominal or pelviclung cancer surgery. Ifparticipants youas agreemeasured toby takegas partexchange inparameters this(%predicted studyAT, you%predicted will exercise on a stationary bicycleP-VO2, while breathing through a mouthpiece and wearing a nose clip, before your surgery. You will be asked to pedalVO2 at 60AT revolutions& per minute as the resistance to pedaling gr [...] [...]
    • Minor Site details revised

    Study Status, Study Description, Eligibility, Contacts/Locationsv23

  5. Minor

    2 amendments

    2 re-verifications since 2019-01-11, no change to tracked fields

    v21-v22

Show 19 earlier versions

  1. Notable

    Primary completion date: Oct 2018 to Oct 2019

    Completion date: Oct 2019

    Study Status, Oversightv20

  2. Notable

    Primary completion date: Oct 2016 to Oct 2018

    Study Statusv19

  3. Notable

    Primary endpoint revised

    Show what changed: Primary endpoints
    Patient Perioperative Risk + Postoperative Morbidity

    Study Status, Outcome Measures, Contacts/Locationsv18

  4. Notable

    Primary completion date: Oct 2015 to Oct 2016

    Study site revised

    Show what changed: Study sites
    UTUniversity of Texas MD Anderson Cancer Center

    Study Status, Contacts/Locations, Referencesv17

  5. Minor

    Study Status

    Re-verified, no change to tracked fields

    v16

  6. Notable

    Primary completion date: Oct 2014 to Oct 2015

    Study Statusv15

  7. Notable

    Primary completion date: Oct 2013 to Oct 2014

    Study Statusv14

  8. Notable

    Primary completion date: Oct 2012 to Oct 2013

    Study Statusv13

  9. Minor

    Study Status, Sponsor/Collaborators

    Re-verified, no change to tracked fields

    v12

  10. Notable

    Primary completion date: Oct 2011 to Oct 2012

    Study Statusv11

  11. Minor

    Eligibility criteria revised

    Show what changed: Eligibility criteria
    Inclusion Criteria: Patient 18 years of age or older. Patients scheduled for elective major intraabdominalintrabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, es [...] ystectomy, radical transabdominal debulking with or without intraabdominalintrabdominal hyperthermic perfusion, pelvic exenteration, retroperitonea [...]

    Study Status, Eligibilityv10

  12. Notable

    Primary completion date: Oct 2010 to Oct 2011

    Study Statusv9

  13. Notable

    Enrollment target: 600 to 200

    Study site revised

    Show what changed: Study sites
    U.T.M.D.UT MD Anderson Cancer Center

    Study Status, Study Design, Contacts/Locationsv8

  14. Notable

    Primary completion date: Dec 2009 to Oct 2010

    Primary endpoint revised

    Show what changed: Primary endpoints
    ToPatient studyPerioperative ifRisk cardiopulmonary+ exercisePostoperative testing (CPET) is a more accurate method than what is currently being used to predict the outcome of surgical patients who are scheduled for major abdominal or pelvic cancer surgery.Morbidity

    Study Status, Arms and Interventions, Outcome Measuresv7

  15. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv6

  16. Notable

    Primary endpoint revised

    Primary completion date: Oct 2009 to Dec 2009

    Show what changed: Primary endpoints
    To seestudy if cardiopulmonary exercise testing (CPET) is a more accura [...]

    Study Status, Study Description, Outcome Measures, Eligibilityv5

  17. Notable

    Primary completion date: Oct 2008 to Oct 2009

    Primary endpoint revised; Interventions: Cardiopulmonary Exercise Testing (CPET) (Other), optional blood sample (Procedure) to Cardiopulmonary Exercise Testing (CPET) (Other); Secondary endpoints shortened, about 13 words

    Show what changed: Primary endpoints
    MeasureTo preoperativesee energyif reservecardiopulmonary capacityexercise testing (fitnessCPET) is a more accurate method than what is currently being used to predict the outcome of surgical patients who are scheduled for major abdominal or pelvic cancer surgery.
    Show what changed: Secondary endpoints
    Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism.

    Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Referencesv4

  18. Minor

    Completion date: Oct 2008 to not stated

    Study description shortened, about 45 words; Study title expanded, about 3 words

    Show what changed: Study description
    [...] estionnaire, your participation in this study will be over. You will be given a parking voucher on the day of your exercise testing study visit. The parking voucher has a $10.00 value and can be used at M.D. Anderson parking garages #2 and #10. This is an investigational study. There will be no cost to participants in this study. Between 180-200 patients per surgical group will take part in this study. All will be enrolled at M. D. Anderson.
    Show what changed: Study title
    DeterminingA Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes

    Study Identification, Study Status, Study Description, Eligibilityv3

  19. Minor

    Primary and study completion dates: Oct 2008

    Interventions: Cardiopulmonary Exercise Testing (CPET) (Behavioral) to Cardiopulmonary Exercise Testing (CPET) (Other), optional blood sample (Procedure); Eligibility criteria expanded, about 1 word; Study title revised; and 1 more

    Show all 5 changes in this update
    • Minor Primary and study completion dates: Oct 2008
    • Minor Interventions: Cardiopulmonary Exercise Testing (CPET) (Behavioral) to Cardiopulmonary Exercise Testing (CPET) (Other), optional blood sample (Procedure)
    • Minor Eligibility criteria expanded, about 1 word
      Show what changed
      [...] r elective major intraabdominal surgery or pelvic surgeries surgeries (e.g. gastrectomy, esophagectomy, pancreatectomy, radical cy [...]
    • Minor Study title revised
      Show what changed
      ADetermining Study CorrelatingWhether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
    • Minor Study arms: 0 to 1

    Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibilityv2

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
To validate a new method for assessing perioperative risk in the cancer patient undergoing major cancer surgery. In this proposed study researchers will: 1. Measure preoperative energy reserve capacity (fitness) 2. Determine if postoperative morbidity is a function of perioperative cardiopulmonary gas exchange metabolism
Trial Details
NCT Number NCT00493688
Lead Sponsor M.D. Anderson Cancer Center
Conditions Abdominal Cancer, Pelvic Cancer
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov