Interruptions, Teamwork, Stress and Patient Outcomes in the Operating Room

NCT ID: NCT04226391

Last Updated: 2022-04-13

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

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-15

Study Completion Date

2021-10-30

Brief Summary

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The operating theatre (OR) in hospitals is a highly complex working environment and can withstand a variety of stresses and strains for the surgical team. So-called "Flow Disruption Events" (FDs) with a potential risk to patient safety occur very often.

The aim of the planned study project is to determine the effects of flow disruption events in the operating theatre on patients, the OR team and the duration of the surgery. The investigators plan an observational study at two university hospital in Southern Germany. The study population includes the entire surgical team during selected surgical procedures as well as the patients treated. The planned sample size is 82 surgical procedures. The investigators intend to collect data in two surgical specialties: Urology and traumatology.

Selected surgeries are evaluated by a trained observer and the interruptions and distractions in the course of the surgery are observed with a standardized tool. In addition, non-technical skills of the OR team are recorded: all members of the OR team will complete a short standardized questionnaire that measures mental workload and stress during the procedure. Additionally, post-operative patient outcomes are recorded.

Detailed Description

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Conditions

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Intraoperative Flow Disruptions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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RAS Partial Nephrectomy

No interventions assigned to this group

RAS Radical Prostatectomy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients: Written consent, completed case
* OR Team: Written consent, at least 3 months working experience in the clinic, present for the majority of the procedure duration

Exclusion Criteria

\- OR visitors \& students
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Matthias Weigl

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Urological Clinic and Outpatient Clinic, University hospital of the Ludwig-Maximilians-University (LMU) Munich

Munich, , Germany

Site Status

Countries

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Germany

References

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Koch A, Quartucci C, Buchner A, Schlenker B, Becker A, Catchpole K, Weigl M. Associations of flow disruptions with patient, staff, and process outcomes: a prospective observational study of robotic-assisted radical prostatectomies. Surg Endosc. 2023 Sep;37(9):6964-6974. doi: 10.1007/s00464-023-10162-2. Epub 2023 Jun 19.

Reference Type DERIVED
PMID: 37336845 (View on PubMed)

Other Identifiers

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FD&OUTCOME01

Identifier Type: -

Identifier Source: org_study_id

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