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Trial · NCT06017141

Registered outcomes14

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

ListOutcomeTime frameDescription
PrimaryNeutrophil extracellular traps (NET) formationPost-operative day (POD) 1 to POD 6 months
The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.
SecondaryEarly post-operative recoveryPost-Operative Day 0 to post-operative discharge, approximately 2-4 days
The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero until the time you are discharged from the hospital.
SecondaryGlobal and post-operative recoveryPost-Operative Day 0 to 6 months post-operatively
The QoR-40 is a recovery-specific and patient-rated questionnaire that contains 40 items measuring five dimensions: the physical comfort (12 items), emotional state (nine items), physical independence (five items), psychological support (seven items) and pain (seven items). Recovery will be assessed starting at Post-Operative Day Zero, Day One Post-Operative, Day Three Post Operative, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.
SecondaryPost-operative nausea scoresPost-Operative Day 0 to post-operative discharge, approximately 2-4 days
The post operative nausea scores will be assessed using standardized nursing assessments captured in the patient's medical record. These scores will be evaluated starting at Post-Operative Day Zero until patient discharge from the hospital.
SecondaryNumber and cumulative amount of doses of anti-emeticsPost-Operative Day 0 to post-operative discharge, approximately 2-4 daysThe number and amount of doses of antiemetics will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
SecondaryTotal hospital opioid usePost-Operative Day 0 to post-operative discharge, approximately 2-4 daysThe patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
SecondaryPatient-reported pain scoresPost-Operative Day 0 to post-operative discharge, approximately 2-4 daysThe patient's total opioid use will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
SecondaryNumber of times a pro re nata (PRN) medication administeredPost-Operative Day 0 to post-operative discharge, approximately 2-4 days
The number of times a patient is administered medication PRN (as needed) will be assessed in the patient's medical record starting at Post-Operative Day Zero until the time they are discharged from the hospital.
SecondaryFirst post-op day when participant tolerates a regular diet (at the discretion of the surgical team)Post-Operative Day 0 to post-operative discharge, approximately 2-4 daysThe first day when the patient is able to tolerate a regular diet. This will occur between Post-Operative Day Zero and the time they are discharged from the hospital.
SecondaryTime from study entry and from surgery to disease recurrence, death, or loss to follow upPost-Operative Day 0 up to Five Years Post-Operation
The length of time the patient is on the study and the time from surgery to either the cancer returning, the patient passing away, or the loss contact with the patient starting at Post-Operative Day Zero through the duration on the study (up to five years) unless the patient's disease returns, they pass away, or the study team loses contact with them.
SecondaryPost-operative complicationsPost-Operative Day 0 to Three Months Post-Operatively
Complications will be assessed via the patients' medical record, and the Clavien-Dindo classification system which includes the comprehensive complication index. The Clavien-Dindo classification system consists of complication index consists of the of the following grades: I, II, IIIa, IIIb, IVa, IVb, V. Post-operative complications will be assessed Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative.
SecondaryPost-operative immune suppressionPost-Operative Day 1 to 6 months Post-Operatively
Will be assessed by the notes in the patients' medical records and the biomarkers collected in the research blood tests. Post-operative immune suppression will be evaluated Post-Operative Day Zero, Week Three Post-Operative, Week Six Post-Operative, Month Three Post-Operative, and Month Six Post-Operative.
SecondaryCirculating tumor deoxyribonucleic acid (ctDNA)Post-Operative Day 0 up to 5 years
Will be assessed by blood tests using commercially available, FDA approved, assays according to the standard practices of the University of Kansas Cancer Center (KUMC) Division of Medical Oncology GI Oncology Group. Differences between groups will be compared using regression based and/or non-parametric analyses as appropriate.
SecondaryChanges in gene expressionImmediately post-operativelyRNA sequencing of resected tumors will be used to investigate differences in gene expression by anesthesia type.

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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