NCT07533214

Brief Summary

Study Characteristics and Structure are as follows: All Left-handed cardiac surgeons and residents attending the 2024 EACTS annual meeting (october 2024) are invited to any of the 3-day 8-endoscopic sessions as part of this study trial. The Left-handed cardiac surgeons and residents may participte in any of the sessions which best fits their schedule. Time frame includes all three days of endoscopic simulation sessions as walk-ins according to the availability of each surgeon. The exclusion criteria will be experienced endoscopic left-handed surgeons who are already experts. Left-handed surgeons will be randomized to either the standard right-handed guided simulation training session or to a Left-handed tailored simulation session. Study Intervention: Left-handed surgeons and residents will be randomized to either a 2-hour Left-handed tailored-guided session (Group 1) or a standard right-handed guided 2-hour endoscopic simulation training session (Group 2). Setting: EACTS 2024 annual meeting (october 2024 - 3-day convention) Group 1 will be guided by a left-handed intructor using Left-handed endoscopic suture maps Group 2 will be guided by a right-handed intructor using Standard right-handed suture maps Pre-course tests will evaluate accuracy and time of endoscopic suture placement in comparison to post-course tests to assess improvements. Pre-session assessments will be carried out evaluating endoscopic suture placement accuracy and time to suture placement. These include:

  1. 1.Time to suture placement under \<60 seconds
  2. 2.Accuracy of suture placement considered to be between 2-8 mm
  3. 3.Suture placement locations will be both Anterior and Posterior annular placements

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Oct 2024Oct 2026

First Submitted

Initial submission to the registry

October 2, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

October 9, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 16, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2026

Expected
Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

October 2, 2024

Last Update Submit

April 14, 2026

Conditions

Keywords

cardiacleft-handsimulation

Outcome Measures

Primary Outcomes (2)

  • Delta time difference of suture placement

    Final study evaluations and delta time comparisons will be performed to determine if Left-handed surgeons guided by left-handed surgeons outperform or at least fair better then when guided by right-handed instructors. Study Objectives: Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors. Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training. We hypothesize that the pairing of same dexterity tailored training will improve endoscopic skill performance.

    From the randomisation (start of the training) to the end of two-hours training

  • improvement in seconds taken to perform mitral suturing

    time duration it takes to successfully place mitral annular sutures on simulators

    this will be performed during a two hour course

Study Arms (2)

Left-handed surgeons with left-handed instructors

ACTIVE COMPARATOR

Determine if during endoscopic simulation training the pairing of LH surgeons with LH instructors will outperform LH surgeons guided by right-handed intructors.

Procedure: Endoscopic annular suture placement guided by left handed instructor

Left-handed surgeons with right-handed instructor

NO INTERVENTION

Determine whether LH surgeons guided by right-handed instructors on simulation training fair worse against Right-handed to right handed simulation training.

Interventions

Endoscopic suture placement efficiency guided by left hamded instructors

Left-handed surgeons with left-handed instructors

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Left handed cardiac surgeons and residents

You may not qualify if:

  • experienced endoscopic left handed surgeons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

EACTS ANNUAL MEETING AT Lisbon convention center

Portugal, Portugal

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Left-handed surgeons trained by left -handed instructors
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiothoracic Surgeon

Study Record Dates

First Submitted

October 2, 2024

First Posted

April 16, 2026

Study Start

October 9, 2024

Primary Completion

October 12, 2025

Study Completion (Estimated)

October 12, 2026

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Participants will be anonymous

Locations