EmergenciesNCT07819903
Quality of Life and Persistent Pain 3 Months After Emergency Surgery Before and After a National Urgency Classification
An observational study of Emergencies and Quality of Life, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The aim of this study is to evaluate the impact of implementing a national surgical emergency classification system in the emergency operating room in Nice on patients' quality of life and persistent pain 3 months after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emergencies, Quality of Life, Postoperative Pain
- What is being tested?
- Usual-practice emergency-surgery triage and National surgical-emergency classification-based triage
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Mar 2026to 20 Jul 2027
- 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: Patients over 18 years of age at Nice University Hospital (CHU de Nice) with a condition requiring emergency surgical management.
Who may be able to join
- Patient locally enrolled in CLASSE trial
- Patient aged >18 years
- Patient receiving initial care
- Patient having a diagnosis
- Patient with valid contact information
- Patient with no objection to ancillary follow-up
- Patient able to participate in a telephone interview in French.
Who cannot join
- Major cognitive impairment.
- Persistent inability to understand French
- Hearing or speech impairment incompatible with a standardized telephone interview
- Explicit refusal at the time of the call.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Implementing a National Surgical Emergency Classification on Quality of Life and Persistent Pain at 3 Months: A Single-Center Prospective Before-and-After Observational Study
The aim of this study is to evaluate the impact of implementing a national surgical emergency classification system in the emergency operating room in Nice on patients' quality of life and persistent pain 3 months after surgery.
This work is a local ancillary study of the CLASSE trial conducted by the French Society of Anaesthesia and Intensive Care Medicine (SFAR). The primary hypothesis is that implementing a decision-support tool incorporating recommended time-to-surgery targets will improve patients' health status 3 months after surgery, as reflected by higher SF-36 Physical Component Summary (PCS) scores, a lower incidence of persistent and neuropathic pain, and greater patient satisfaction.
- Conditions
- Emergencies, Quality of Life, Postoperative Pain
- Being tested
- Usual-practice emergency-surgery triage, National surgical-emergency classification-based triage
- Medical subject headings
- Emergencies, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual-practice emergency-surgery triageOther
Participants were included locally in CLASSES at CHU de Nice from March 9 to March 22, 2026, when emergency surgical cases were triaged according to usual local practice. No exposure was assigned by the investigators.
National surgical-emergency classification-based triageOther
Participants are included during the corresponding weeks of March 2027, after local implementation of the national surgical-emergency classification and its recommended time-to-surgery targets. No individual exposure is assigned by the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation cohort | Participants were included locally in CLASSES at CHU de Nice from March 9 to March 22, 2026, when emergency surgical cases were triaged according to usual local practice. No exposure was assigned by the investigators. Receives: Other: Usual-practice emergency-surgery triage | |
| Post-implementation cohort | Participants are included during the corresponding weeks of March 2027, after local implementation of the national surgical-emergency classification and its recommended time-to-surgery targets. No individual exposure is assigned by the investigators. Receives: Other: National surgical-emergency classification-based triage |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 Physical Component Summary (PCS) score at 3 months
PCS calculated from SF-36 responses using the validated scoring algorithm prespecified in the analysis plan. Higher scores indicate better physical health-related quality of life.
Measured: 3 months after index surgery (day 90 to day 120)
Secondary outcomes (2)
SF-36 Mental Component Summary (MCS) score at 3 months
MCS calculated from SF-36 responses using the validated scoring algorithm prespecified in the analysis plan. Higher scores indicate better mental health-related quality of life.
Measured: 3 months after index surgery (day 90 to day 120)
Persistent postsurgical pain at 3 months
Proportion of participants reporting current pain in or around the operated area or relevant territory that was absent before surgery or was clearly worsened or changed after surgery.
Measured: 3 months after index surgery (day 90 to day 120)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start9 Mar 2026
- Primary completion20 Jul 2027 (estimated)
- Study completion20 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmergenciesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819903
- Sponsor's protocol ID
- 26Anesthésie-Réa02
- Status last verified
- Aug 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Implementing a National Surgical Emergency Classification on Quality of Life and Persistent Pain at 3 Months: A Single-Center Prospective Before-and-After Observational Study
- ClinicalTrials.gov ID
- NCT07819903
- Acronym / sponsor ID
- 26Anesthésie-Réa02
- Conditions
- Emergencies, Quality of Life, Postoperative Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 20 Jul 2027 (estimated)
- Study completion
- 20 Jul 2027 (estimated)
- First posted
- 15 Sep 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.
The aim of this study is to evaluate the impact of implementing a national surgical emergency classification system in the emergency operating room in Nice on patients' quality of life and persistent pain 3 months after surgery.
This work is a local ancillary study of the CLASSE trial conducted by the French Society of Anaesthesia and Intensive Care Medicine (SFAR). The primary hypothesis is that implementing a decision-support tool incorporating recommended time-to-surgery targets will improve patients' health status 3 months after surgery, as reflected by higher SF-36 Physical Component Summary (PCS) scores, a lower incidence of persistent and neuropathic pain, and greater patient satisfaction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation cohort | – | Other: Usual-practice emergency-surgery triageParticipants were included locally in CLASSES at CHU de Nice from March 9 to March 22, 2026, when emergency surgical cases were triaged according to usual local practice. No exposure was assigned by the investigators. |
| Post-implementation cohort | – | Other: National surgical-emergency classification-based triageParticipants are included during the corresponding weeks of March 2027, after local implementation of the national surgical-emergency classification and its recommended time-to-surgery targets. No individual exposure is assigned by the investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age at Nice University Hospital (CHU de Nice) with a condition requiring emergency surgical management.
Key inclusion criteria (7 listed)
- Patient locally enrolled in CLASSE trial
- Patient aged >18 years
- Patient receiving initial care
- Patient having a diagnosis
- Patient with valid contact information
Key exclusion criteria (4 listed)
- Major cognitive impairment.
- Persistent inability to understand French
- Hearing or speech impairment incompatible with a standardized telephone interview
- Explicit refusal at the time of the call.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual-practice emergency-surgery triageParticipants were included locally in CLASSES at CHU de Nice from March 9 to March 22, 2026, when emergency surgical cases were triaged according to usual local practice. No exposure was assigned by the investigators. | Other | Pre-implementation cohort |
| National surgical-emergency classification-based triageParticipants are included during the corresponding weeks of March 2027, after local implementation of the national surgical-emergency classification and its recommended time-to-surgery targets. No individual exposure is assigned by the investigators. | Other | Post-implementation cohort |
Primary outcome
SF-36 Physical Component Summary (PCS) score at 3 months
Time frame: 3 months after index surgery (day 90 to day 120)
PCS calculated from SF-36 responses using the validated scoring algorithm prespecified in the analysis plan. Higher scores indicate better physical health-related quality of life.
2 secondary outcomes
SF-36 Mental Component Summary (MCS) score at 3 months
Time frame: 3 months after index surgery (day 90 to day 120)
Persistent postsurgical pain at 3 months
Time frame: 3 months after index surgery (day 90 to day 120)
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 15 Sep 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Emergencies and Quality of Life, run by Centre Hospitalier Universitaire de Nice 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 7 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SF-36 Physical Component Summary (PCS) score at 3 months (time frame: 3 months after index surgery (day 90 to day 120)). 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 15 Sep 2026.