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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07819903
Enrollment
200
Registered
2026-09-15
Start date
2026-03-09
Completion date
2027-07-20
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emergencies, Postoperative Pain, Quality of Life

Brief 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.

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.

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
SF-36 Physical Component Summary (PCS) score at 3 months3 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.

Secondary

MeasureTime frameDescription
SF-36 Mental Component Summary (MCS) score at 3 months3 months after index surgery (day 90 to day 120)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.
Persistent postsurgical pain at 3 months3 months after index surgery (day 90 to day 120)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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026