An observational study in Digestive System Neoplasms and Anxiety, sponsored by University Hospital, Rouen. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by University Hospital, Rouen · Observational
This prospective observational study aims to evaluate the association between preoperative anxiety and postoperative complications in patients undergoing major oncological digestive surgery. The study will assess whether preoperative anxiety is associated with the occurrence of major postoperative complications at 90 days, measured using the Comprehensive Complication Index (CCI).
316 studies on the registry are indexed under Digestive System Neoplasms; 84 are open to participants now.
This study's planned enrollment of 300 is above the median of 200 across 71 observational studies indexed under Digestive System Neoplasms.
Browse Digestive System Neoplasms studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 107 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults undergoing major oncological digestive surgery at the Digestive Surgery Department of Rouen University Hospital. Approximately 300 patients will be prospectively enrolled over a 24-month period and followed from the preoperative period through 90 days after surgery. The study will evaluate the association between preoperative anxiety and postoperative outcomes.
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Exclusion Criteria:
Patients undergoing major oncological digestive surgery who will be prospectively followed from the preoperative period through 90 days after surgery. Participants will subsequently be analyzed according to the presence or absence of preoperative anxiety.
Major postoperative complications at day 90 assessed using the Comprehensive Complication Index (CCI) (CCI)
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.
Time frame: day 90 after surgery
Postoperative complications according to the Clavien-Dindo classification
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.
Time frame: 30 days and 90 days after surgery
Prevalence of anxiety assessed using the State-Trait Anxiety Inventory, Form Y (STAI-Y), State scale
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.
Time frame: Preoperatively, and on Days 3, 7, 30 and 90 after surgery
Prevalence of anxiety assessed using the State-Trait Anxiety Inventory, Form Y (STAI-Y), Trait scale
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.
Time frame: Preoperatively, and on Days 3, 7, 30 and 90 after surgery
Prevalence of anxiety symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), Anxiety subscale
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.
Time frame: Preoperatively, and on Days 3, 7, 30 and 90 after surgery
Prevalence of depressive symptoms assessed using the Hospital Anxiety and Depression Scale (HADS), Depression subscale
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.
Time frame: Preoperatively, and on Days 3, 7, 30 and 90 after surgery
Patient activation assessed using the 13-item Patient Activation Measure (PAM-13)
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.
Time frame: Preoperatively, and on Days 7, 30 and 90 after surgery
Health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36)
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36).
Time frame: Preoperatively, and on Days 30 and 90 after surgery
Use of anxiolytic medications
Use of anxiolytic medications will be recorded from the medical record.
Time frame: Preoperatively, on postoperative Days 3 and 7
Use of hypnotic medications
Use of hypnotic medications will be recorded from the medical record.
Time frame: Preoperatively, on postoperative Days 3 and 7
Use of analgesic medications
Use of analgesic medications will be recorded from the medical record.
Time frame: Preoperatively, on postoperative Days 3 and 7
Postoperative pain intensity assessed using a visual analogue scale (VAS)
Postoperative pain intensity will be assessed using a visual analogue scale (VAS). Higher scores indicate greater pain intensity.(0-10)
Time frame: Postoperative Days 1, 3, 5 and 7
Use of psychological support during hospitalization
Use of psychological support will be recorded as a binary variable (yes/no).
Time frame: From the day of surgery until hospital discharge
Number of consultations with a psychologist during hospitalization
The number of consultations with a psychologist between the day of surgery and hospital discharge will be recorded.
Time frame: From the day of surgery until hospital discharge
Prealbumin concentration
Prealbumin concentration will be measured to assess the patient's nutritional status.
Time frame: Preoperatively
Albumin concentration
Albumin concentration will be measured to assess the patient's nutritional status.
Time frame: Preoperatively
Body weight
Body weight will be recorded to assess changes in the patient's physical and nutritional status.
Time frame: Preoperatively
Unplanned hospital readmission
The occurrence of unplanned hospital readmission after surgery will be recorded.
Time frame: Within 30 and 90 days after surgery
All-cause mortality
All-cause mortality will be assessed up to 90 days after surgery.
Time frame: Within 90 days after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Dec 2028, 27 months after the start.
Of 38 observational studies under Digestive System Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 102. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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