Surgical Emergency Flows and Delays in Admission to the Operating Room

NCT04585529 | Completed

• 1 other identifier: NI2020/01
• Study Type: observational
• Target: 1,149
• Locations: 1 country
• Sites: 10

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.

Conditions

Surgery; Emergencies; Postoperative Complications

Keywords

delay; organization

Outcome Measures

Primary Outcomes (1)

• Incidence of OR admission delay (delay = aTTS / iTTS > 1)

  hours

  30 days

Secondary Outcomes (10)

• OR Admission delay according to the three organizational model

  30 days

• OR Admission delay according to the period of work (day, night, and week-end)

  30 days

• OR Admission delay according to the NEST classification

  30 days

• delays related to organisational causes

  30 days

• delays related to material causes

  30 days

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• obstetrics
• interventional radiology
• endoscopies

Sponsors & Collaborators

• University Hospital, Lille: lead
• Société Française d'Anesthésie et de Réanimation: collaborator

Study Sites (10)

University hospital

Angers, France

Location

Clinique

Antony, France

Location

Beaujon Hospital

Clichy, France

Location

Henri Mondor Hospital

Créteil, France

Location

University Hospital

Grenoble, France

Location

University hospital

Lille, France

Location

Edouard Herriot Hospital

Lyon, France

Location

Hôpital sud

Lyon, France

Location

HEGP

Paris, France

Location

University Hospital

Strasbourg, France

Location

MeSH Terms

Conditions

Emergencies; Postoperative Complications

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Delphine GARRIGUE, MD

  University Hospital, Lille, France

  PRINCIPAL INVESTIGATOR

• Benoit TAVERNIER, MD, PhD

  University Hospital, Lille, France

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 14, 2020
• Study Start: October 5, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Locations

FR (10)