Morbidity and Mortality: Surgery and Standardized Transmission in Operating Room

NCT ID: NCT05440331

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-08

Study Completion Date

2026-10-31

Brief Summary

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The primary objective of the study is to evaluate the efficacy of standard handover with AnesList© between physician anesthesists in operating room, for a complete transmission for a patient, on the occurence of event as death, serious complications or rehospitalization in month of postoperative after major surgery.

Detailed Description

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The secondary objectives are:

* to analysis the impact of the transmission on:

1. the occurence of different events: re-hospitalization, serious complications, death at one month;
2. the duration of initial ICU stay and of hospitalization;
3. the duration of the transmission;
4. the quality of the transmission by the physician leaving operating room.
* to evaluate the condition of the transmission
* to study the persistence of the use of the AnesList© at 6 months after the end of inclusions in the center
* to evaluate the satisfaction on AnesList© and on the training with the tool and the obstacles of its utilization
* to evaluate the morbility-mortality in the centers of the centers before, during and 6 months after the beginning of the study.

Conditions

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Major Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental group

Experimental group with training after randomization immediately

Training with AnesList©

Intervention Type OTHER

Training with AnesList© as tool

Control group with delayed training

Control group with training: the training will delayed from time of randomization

Training with AnesList©

Intervention Type OTHER

Training with AnesList© as tool

Control group without training

Control group without training

No interventions assigned to this group

Interventions

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Training with AnesList©

Training with AnesList© as tool

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient aged \> 18 years;
* Patients with score ASA I-IV;
* Requiring urgent or planned surgery;
* Major surgery (duration of surgery \> 2 hours, requiring a hospital stay of at least 1 night): orthopedics, cardiac, vascular, thoracic, visceral, ENT, plastic surgery;
* Handover between two anesthesists defined as a definitive relay between one physician anaesthesist and another in operating room;
* Intensive care anesthesists and nurse anaesthetist working in investigator center during the study;
* Affiliated to a social security system;
* No-opposition to participating to the study.

Exclusion Criteria

* Transmission between physician anaesthesist and nurse anaesthetist;
* Medical transmission occurs out of anesthesia care out of operating room;
* Medical transmission occurs in transitory manner (for example: coffee time, lunch time);
* Patients enrolled in an another ongoing study of surgical intervention.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominique FLETCHER, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

Aicha KASSOUL, MD

Role: STUDY_DIRECTOR

Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

Locations

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Department of Anesthesia and Intensive Care - Ambroise Paré Hospital - APHP

Boulogne-Billancourt, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Dominique FLETCHER, MD, PhD

Role: CONTACT

+33 (0)661177035

Aicha KASSOUL, MD

Role: CONTACT

+ 33 (0)633855997

References

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Sedgwick P, Greenwood N. Understanding the Hawthorne effect. BMJ. 2015 Sep 4;351:h4672. doi: 10.1136/bmj.h4672. No abstract available.

Reference Type BACKGROUND
PMID: 26341898 (View on PubMed)

Jullia M, Tronet A, Fraumar F, Minville V, Fourcade O, Alacoque X, LeManach Y, Kurrek MM. Training in intraoperative handover and display of a checklist improve communication during transfer of care: An interventional cohort study of anaesthesia residents and nurse anaesthetists. Eur J Anaesthesiol. 2017 Jul;34(7):471-476. doi: 10.1097/EJA.0000000000000636.

Reference Type BACKGROUND
PMID: 28437261 (View on PubMed)

Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009 Jan 29;360(5):491-9. doi: 10.1056/NEJMsa0810119. Epub 2009 Jan 14.

Reference Type BACKGROUND
PMID: 19144931 (View on PubMed)

Other Identifiers

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2022-A01109-34

Identifier Type: REGISTRY

Identifier Source: secondary_id

APHP210992

Identifier Type: -

Identifier Source: org_study_id

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