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Active, not recruitingNCT07819903Updated Sep 15, 2026

Quality of Life and Persistent Pain 3 Months After Emergency Surgery Before and After a National Urgency Classification

An observational study in Emergencies, Quality of Life and Postoperative Pain, sponsored by Centre Hospitalier Universitaire de Nice. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Centre Hospitalier Universitaire de Nice · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Emergencies
  • Quality of Life
  • Postoperative Pain
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients over 18 years of age at Nice University Hospital (CHU de Nice) with a condition requiring emergency surgical management.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    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.

    Other: National surgical-emergency classification-based triage

Interventions

  • OtherUsual-practice emergency-surgery triage

    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.

  • OtherNational surgical-emergency classification-based triage

    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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 3 months after index surgery (day 90 to day 120)

Secondary outcomes

  1. 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.

    Time frame: 3 months after index surgery (day 90 to day 120)

  2. 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.

    Time frame: 3 months after index surgery (day 90 to day 120)

06

Study locations

1 site
  • CHU de Nice
    Nice, Alpes Maritimes 06000, France
07

Registry details

Key details

Study ID
NCT07819903
Lead sponsor
Centre Hospitalier Universitaire de Nice
Responsible party
Sponsor
First posted
Sep 15, 2026
Start date
Mar 9, 2026
Primary completion
Jul 20, 2027 (estimated)
Completion
Jul 20, 2027 (estimated)
Last update
Sep 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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