Trial · NCT07897942
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Major postoperative complications at day 90 assessed using the Comprehensive Complication Index (CCI) (CCI) | day 90 after surgery | Major postoperative complications will be defined as a Comprehensive Complication Index (CCI) score ≥30 at Day 90 after surgery. The association between preoperative anxiety and major postoperative complications will be assessed. The CCI ranges from 0 to 100, with higher scores indicating greater postoperative morbidity. |
| Secondary | Postoperative complications according to the Clavien-Dindo classification | 30 days and 90 days after surgery | The occurrence and severity of postoperative complications will be assessed using the Clavien-Dindo classification, which grades complications from Grade I to Grade V, with higher grades indicating greater severity. |
| Secondary | Prevalence of anxiety assessed using the State-Trait Anxiety Inventory, Form Y (STAI-Y), State scale | Preoperatively, and on Days 3, 7, 30 and 90 after surgery | The prevalence of anxiety will be assessed using the State scale of the State-Trait Anxiety Inventory, Form Y (STAI-Y). The State scale consists of 20 items and yields a score ranging from 20 to 80. A score ≥46 will indicate anxiety symptoms. |
| Secondary | Prevalence of anxiety assessed using the State-Trait Anxiety Inventory, Form Y (STAI-Y), Trait scale | Preoperatively, and on Days 3, 7, 30 and 90 after surgery | The prevalence of anxiety will be assessed using the Trait scale of the State-Trait Anxiety Inventory, Form Y (STAI-Y). The Trait scale consists of 20 items and yields a score ranging from 20 to 80. A score ≥46 will indicate anxiety symptoms. |
| Secondary | Prevalence of anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), Anxiety subscale | Preoperatively, and on Days 3, 7, 30 and 90 after surgery | Anxiety symptoms will be assessed using the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS). The subscale consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21. A score ≥8 will indicate anxiety symptoms. |
| Secondary | Prevalence of depressive symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), Depression subscale | Preoperatively, and on Days 3, 7, 30 and 90 after surgery | Depressive symptoms will be assessed using the Depression subscale of the Hospital Anxiety and Depression Scale (HADS). The subscale consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21. A score ≥8 will indicate depressive symptoms. |
| Secondary | Patient activation assessed using the 13-item Patient Activation Measure (PAM-13) | Preoperatively, and on Days 7, 30 and 90 after surgery | Patient activation will be assessed using the 13-item Patient Activation Measure (PAM-13), which evaluates patients' knowledge, skills and confidence in managing their health. The evolution of patient activation over time and its association with anxiety and depressive symptoms will be evaluated. |
| Secondary | Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36) | Preoperatively, and on Days 30 and 90 after surgery | Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). |
| Secondary | Use of anxiolytic medications | Preoperatively, on postoperative Days 3 and 7 | Use of anxiolytic medications will be recorded from the medical record. |
| Secondary | Use of hypnotic medications | Preoperatively, on postoperative Days 3 and 7 | Use of hypnotic medications will be recorded from the medical record. |
| Secondary | Use of analgesic medications | Preoperatively, on postoperative Days 3 and 7 | Use of analgesic medications will be recorded from the medical record. |
| Secondary | Postoperative pain intensity assessed using a visual analogue scale (VAS) | Postoperative Days 1, 3, 5 and 7 | Postoperative pain intensity will be assessed using a visual analogue scale (VAS). Higher scores indicate greater pain intensity.(0-10) |
| Secondary | Use of psychological support during hospitalization | From the day of surgery until hospital discharge | Use of psychological support will be recorded as a binary variable (yes/no). |
| Secondary | Number of consultations with a psychologist during hospitalization | From the day of surgery until hospital discharge | The number of consultations with a psychologist between the day of surgery and hospital discharge will be recorded. |
| Secondary | Prealbumin concentration | Preoperatively | Prealbumin concentration will be measured to assess the patient's nutritional status. |
| Secondary | Albumin concentration | Preoperatively | Albumin concentration will be measured to assess the patient's nutritional status. |
| Secondary | Body weight | Preoperatively | Body weight will be recorded to assess changes in the patient's physical and nutritional status. |
| Secondary | Unplanned hospital readmission | Within 30 and 90 days after surgery | The occurrence of unplanned hospital readmission after surgery will be recorded. |
| Secondary | All-cause mortality | Within 90 days after surgery | All-cause mortality will be assessed up to 90 days after surgery. |
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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