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OpenTrials
Active, not recruiting

NCT Number: NCT07819903

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

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Emergencies Disease Attributes Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Quality of Life Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, Alpes Maritimes, 06000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 3 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.

  2. Persistent postsurgical pain at 3 months

    Time frame: 3 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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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