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Recruiting Observational

Evaluation of Preoperative Anxiety in Digestive Surgery

NCT07897942 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-09-03
Last updated
2026-10-27

Condition(s) studied

Digestive System NeoplasmsAnxiety

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adults aged 18 years or older * French-speaking patients * Patients scheduled to undergo major oncological digestive surgery at the Digestive Surgery Department of Rouen University Hospital * American Society of Anesthesiologists (ASA) physical status classification ≤3 * Patients who have read and understood the study information letter and have not objected to participation in the study * Patients affiliated with a social security system Exclusion Criteria: * Contraindication to surgery * Long-term use of anxiolytic, hypnotic and/or antidepressant medication * Previous psychiatric or psychological disorder likely to prevent the participant from understanding the study requirements or from providing valid non-opposition to participation * Pregnant, parturient or breastfeeding women * Persons deprived of liberty by administrative or judicial decision * Persons under judicial protection, including safeguard of justice, guardianship or curatorship

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Rouen, university hospital Rouen France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07897942 on ClinicalTrials.gov ↗ ← All trials in France