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Trial · NCT06030804

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProgression-free survival after surgeryUp to 3 years after surgery of the last enrolled patient.Time interval from index surgery to cancer recurrence/metastasis/progression or all-cause death, whichever comes first.
SecondaryIncidence of postoperative delirium.During the first 4 postoperative days.Delirium will be assessed with the 3D-Confusion Assessment Method (3D-CAM) or CAM for the Intensive Care Unit (CAM-ICU) twice daily during the first 4 postoperative days.
SecondaryIncidence of cognitive dysfunction at 6 months and 1 year postoperatively.At 6 months and 1 year postoperatively.
Cognitive function will be assessed with the Telephone Montreal Cognitive Assessment (T-MoCA; scores range from 0 to 22, with higher score indicating better function) before surgery and at 6 months and 12 months after surgery. A T-MoCA score reduction of 1 standard deviation (SD) or more from baseline will be considered occurrence of cognitive dysfunction.
OtherRate of intensive care unit (ICU) admission after surgery.Up to 30 days after surgery.Percentage of patients who required ICU admission within 30 days after surgery.
OtherIntensity of pain after surgery.Two hours after surgery and during the first 4 postoperative days.Intensity of pain will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=no pain and 10=the worst pain) twice daily during the first 4 postoperative days.
OtherSubjective sleep quality after surgery.During the first 4 postoperative days.Subjective sleep quality will be assessed with the Numeric Rating Scale (NRS; an 11-point scale where 0=the best sleep and 10=the worst sleep) once daily during the first 4 postoperative days.
OtherLength of stay in hospital after surgery.Up to 30 days after surgery.Length of stay in hospital after surgery.
OtherIncidence of postoperative complications within 30 days.Up to 30 days after surgery.
Postoperative complications are defined as new-onset medical events other than delirium that are deemed harmful and require therapeutic intervention, that is grade II or higher on the Clavien-Dindo classification.
OtherOverall survival after surgeryUp to 3 years after surgery of the last enrolled patient.Time interval from index surgery to all-cause death.
OtherCancer-specific survival after surgeryUp to 3 years after surgery of the last enrolled patient.
Time interval from index surgery to cancer-specific death, with deaths from other causes being censored at the time of death. Cancer-specific death is defined as death fully attributable to the cancer for which the index surgery is performed and usually involves cancer recurrence/metastasis/progression after exclusion of other causes such as stroke and myocardial infarction.
OtherEvent-free survival after surgeryUp to 3 years after surgery of the last enrolled patient.Time interval from index surgery to cancer recurrence/metastasis/progression, new-onset cancer, new-onset serious illness (requiring hospitalization), or all-cause death, whichever comes first.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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