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

NCT07819903 | Active Not Recruiting

• 1 other identifier: 26Anesthésie-Réa02
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergencies; Quality of Life; Postoperative Pain

Outcome Measures

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.

  3 months after index surgery (day 90 to day 120)

Secondary Outcomes (2)

• SF-36 Mental Component Summary (MCS) score at 3 months

  3 months after index surgery (day 90 to day 120)

• Persistent postsurgical pain at 3 months

  3 months after index surgery (day 90 to day 120)

Study Arms (2)

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

Usual-practice emergency-surgery triage OTHER

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.

Pre-implementation cohort

National surgical-emergency classification-based triage OTHER

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.

Post-implementation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Location

MeSH Terms

Conditions

Emergencies; Pain, Postoperative

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2026
• First Posted: September 15, 2026
• Study Start: March 9, 2026
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): July 20, 2027
• Last Updated: September 15, 2026

Record last verified: 2026-08

Locations

FR (1)