Clinical trial NCT04585529: Surgical Emergency Flows and Delays in Admission to the Operating Room
Official title: Flows of Emergency Surgery and Delay in Admission to the Operating Room: a Multicenter Prospective Observational Study in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Emergencies
Postoperative Complications
Keywords: delay
organization
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Société Française d'Anesthésie et de Réanimation
First posted: 2020-10-14
Enrollment: 1149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged at least 18 years hospitalized and requiring non-elective surgery.

Non-elective means that the surgery must ideally be performed within 72 hours. Patients may be coming in via the emergency department or may already be hospitalized when requiring surgical intervention.

Anthony).

Brief summary: French hospitals treat non-elective surgery according to three organizational models: in a dedicated multi-specialty emergency operative room (OR), in a dedicated OR within a specialized surgical platform or in any available OR from a list of non-dedicated OR. Some triage algorithms for the classification of non-elective surgery have been described but are not routinely applied. The rate of delay in the management of non-elective surgery in France is not known. Reducing this delay decreased mortality and morbidity in urgent surgery (McIsaac D, et al., CMAJ 2017). Optimizing the flow of non-elective surgery represents a major challenge. The main objective of this study is to determine the rate of delay in admission to the OR in emergency surgery through a multicenter prospective observational study in France. All patients requiring urgent surgical management (\<72 hours) will be included. The ideal time for surgery was previously defined by surgeons according to the NEST classification (NEST 1: within minutes; NEST 2: \< 1 hour; NEST 3: \< 4 hours; NEST 4: \< 12 hours; NEST 5: \< 48 hours; NEST 6: \< 72 hours). For each patient, the ratio between the observed time (actual Time To Surgery \[aTTS\] ) and the ideal time (ideal Time To Surgery \[iTTS\]) will be determined. The delay is identified by aTTS/iTTS ratio \>1.


Eligibility criteria: Inclusion Criteria:

any patient meeting the Following two criteria

* at least 18 ys old
* decision for unplanned surgery (which should be performed within 72 hours according to the protocol)
* in one of the following hospitals: Lille University hospital, Grenoble University hospital, Strasbourg University hospital, Paris University hospitals (Européen Georges Pompidou, Beaujon, H. Mondor), Lyon University hospital (Hôpital E. Herriot, Lyon Sud), Angers University hospital, Anthony Private hospital).

Exclusion Criteria:

* obstetrics
* interventional radiology
* endoscopies

Primary outcomes:
measure: Incidence of OR admission delay (delay = aTTS / iTTS > 1)
timeFrame: 30 days
Secondary outcomes:
measure: OR Admission delay according to the three organizational model
timeFrame: 30 days
measure: OR Admission delay according to the period of work (day, night, and week-end)
timeFrame: 30 days
measure: OR Admission delay according to the NEST classification
timeFrame: 30 days
measure: delays related to organisational causes
timeFrame: 30 days
measure: delays related to material causes
timeFrame: 30 days
measure: delays related to human causes
timeFrame: 30 days
measure: Impact of the delay on ICU length of stay
timeFrame: 30 days
measure: Impact of the delay on hospital length of stay
timeFrame: 30 days
measure: Impact of the delay on mortality
timeFrame: 30 days
measure: Impact of the delay on morbidity
timeFrame: 30 days
Other outcomes:
Locations:
city: Angers
country: France
facility: University hospital
city: Antony
country: France
facility: Clinique
city: Clichy
country: France
facility: Beaujon Hospital
city: Créteil
country: France
facility: Henri Mondor Hospital
city: Grenoble
country: France
facility: University Hospital
city: Lille
country: France
facility: University hospital
city: Lyon
country: France
facility: Edouard Herriot Hospital
city: Lyon
country: France
facility: Hôpital sud
city: Paris
country: France
facility: HEGP
city: Strasbourg
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Lille, France
name: Delphine GARRIGUE, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Lille, France
name: Benoit TAVERNIER, MD, PhD
role: STUDY_CHAIR
References: