NCT07228767

Brief Summary

In May 2023, the French National Authority for Health published a solution for patient safety regarding tunnel vision. This concept, which is uncommon in the medical field, is defined as any situation in which a professional's attention is so focused on a goal that they do not hear or see warning signs that should prompt them to change their approach or even stop before an adverse event associated with care occurs. To better understand the causes of medical errors, the research will assess surgeons' mental fatigue and the factors associated with it. This fatigue, which occurs after or during prolonged periods of intense cognitive activity, is associated with a temporary inability to maintain optimal cognitive performance. Assessing mental fatigue is crucial in surgeons, as it can directly affect their ability to perform complex procedures and make critical decisions. The aim of this research is to examine the factors that may influence the level of mental fatigue and cognitive load in surgeons during surgical procedures.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Dec 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress39%
Dec 2025Jan 2027

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
21 days until next milestone

Study Start

First participant enrolled

December 5, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 5, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2027

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1.1 years

First QC Date

November 13, 2025

Last Update Submit

November 14, 2025

Conditions

Surgical Intervention

Outcome Measures

Primary Outcomes (1)

  • Measurement of surgeons' mental fatigue using visual analog scales from 0 (no fatigue, perfectly clear mind) to 100 (extreme fatigue, inability to maintain concentration).

    Before and after surgical procedures during 1 year

Study Arms (1)

Surgeons from the Digestive Surgery Department at the Vendée Departmental Hospital Center.

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgeons in the Digestive Surgery Department at CHD Vendée

You may qualify if:

  • Surgeon working in the digestive surgery department at CHD Vendée
  • Surgeon capable of understanding the protocol and willing to participate in the research

You may not qualify if:

  • Surgeon unable to be available for the entire duration of the research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, 85000, France

Location

Study Officials

  • Emeric ABET

    Centre Hospitalier Départemental Vendée

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chloé MOREAU

CONTACT

251446572promotion.urc@chd-vendee.fr

Study Design

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

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

December 5, 2025

Primary Completion (Estimated)

January 5, 2027

Study Completion (Estimated)

January 5, 2027

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)