Digestive System NeoplasmsEVAPOCNCT07897942
Evaluation of Preoperative Anxiety in Digestive Surgery
An observational study of Digestive System Neoplasms and Anxiety, run by University Hospital, Rouen at 1 site in France.
Trial summary
This prospective observational study aims to evaluate the association between preoperative anxiety and postoperative complications in patients undergoing major oncological digestive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Digestive System Neoplasms, Anxiety
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 3 Sep 2026to 3 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
LEBEDIEFF contact
France1 site, 1 recruiting
- Recruiting
Rouen, university hospital
Rouen, 76 031
AUDIEVRE, +33232888572, f.audievre@chu-rouen.fr
About this study
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).
- Conditions
- Digestive System Neoplasms, Anxiety
- Medical subject headings
- Digestive System Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing major oncological digestive surgery | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 90 after surgery
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Preoperatively, and on Days 30 and 90 after surgery
Use of anxiolytic medications
Use of anxiolytic medications will be recorded from the medical record.
Measured: Preoperatively, on postoperative Days 3 and 7
Use of hypnotic medications
Use of hypnotic medications will be recorded from the medical record.
Measured: Preoperatively, on postoperative Days 3 and 7
Use of analgesic medications
Use of analgesic medications will be recorded from the medical record.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: From the day of surgery until hospital discharge
Prealbumin concentration
Prealbumin concentration will be measured to assess the patient's nutritional status.
Measured: Preoperatively
Albumin concentration
Albumin concentration will be measured to assess the patient's nutritional status.
Measured: Preoperatively
Body weight
Body weight will be recorded to assess changes in the patient's physical and nutritional status.
Measured: Preoperatively
Unplanned hospital readmission
The occurrence of unplanned hospital readmission after surgery will be recorded.
Measured: Within 30 and 90 days after surgery
All-cause mortality
All-cause mortality will be assessed up to 90 days after surgery.
Measured: Within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start3 Sep 2026
- Primary completion3 Dec 2028 (estimated)
- Study completion3 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive System NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897942
- Sponsor's protocol ID
- 2025/0476/OB
- Acronym
- EVAPOC
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Preoperative Anxiety in Digestive Surgery
- ClinicalTrials.gov ID
- NCT07897942
- Acronym / sponsor ID
- EVAPOC / 2025/0476/OB
- Conditions
- Digestive System Neoplasms, Anxiety
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 3 Dec 2028 (estimated)
- Study completion
- 3 Dec 2028 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing major oncological digestive surgery | – | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Major postoperative complications at day 90 assessed using the Comprehensive Complication Index (CCI) (CCI)
Time frame: 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.
18 secondary outcomes
Postoperative complications according to the Clavien-Dindo classification
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
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
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
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
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)
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)
Time frame: Preoperatively, and on Days 30 and 90 after surgery
Use of anxiolytic medications
Time frame: Preoperatively, on postoperative Days 3 and 7
Use of hypnotic medications
Time frame: Preoperatively, on postoperative Days 3 and 7
Use of analgesic medications
Time frame: Preoperatively, on postoperative Days 3 and 7
Postoperative pain intensity assessed using a visual analogue scale (VAS)
Time frame: Postoperative Days 1, 3, 5 and 7
Use of psychological support during hospitalization
Time frame: From the day of surgery until hospital discharge
Number of consultations with a psychologist during hospitalization
Time frame: From the day of surgery until hospital discharge
Prealbumin concentration
Time frame: Preoperatively
Albumin concentration
Time frame: Preoperatively
Body weight
Time frame: Preoperatively
Unplanned hospital readmission
Time frame: Within 30 and 90 days after surgery
All-cause mortality
Time frame: Within 90 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Digestive System Neoplasms
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
LEBEDIEFF contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Digestive System Neoplasms and Anxiety, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanny AUDIEVRE, nurse (+33232888572, f.audievre@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major postoperative complications at day 90 assessed using the Comprehensive Complication Index (CCI) (CCI) (time frame: day 90 after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.