Remote Training in Laparoscopy

NCT ID: NCT04401306

Last Updated: 2021-02-12

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

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-08-31

Brief Summary

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The study is a prospective, randomized comparative study using a mixed methods design. The primary objective is to compare the effect of self-regulated simulation training (SRST) to instructor-regulated simulation training (IRST) in basic laparoscopic skills. The study population is first-year trainees in the specialties General Surgery, Urology and Obstetrics and Gynaecology within the postgraduate training region of northern Denmark. 46 first-year trainees will be randomized into two groups, one receiving SRST and one receiving IRST in basic laparoscopic skills.

Detailed Description

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Conditions

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Educational Problems Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Self-regulated simulation training

Group Type EXPERIMENTAL

Home-based self-regulated simulation training (SRST)

Intervention Type OTHER

Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.

Instructor-regulated simulation training

Group Type ACTIVE_COMPARATOR

Centralized instructor-regulated simulation training (IRST)

Intervention Type OTHER

Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.

Interventions

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Home-based self-regulated simulation training (SRST)

Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.

Intervention Type OTHER

Centralized instructor-regulated simulation training (IRST)

Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant is a medical doctor
* Participant is a first-year trainee in abdominal surgery, urology, or gynaecology and obstetrics.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria

* Performed \> 50 lap procedures prior to enrollment
* participated in training programs provided by the former course provider in the postgraduate training region of northern Denmark
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Denmark Region

OTHER

Sponsor Role collaborator

North Denmark Region

OTHER_GOV

Sponsor Role collaborator

KARL STORZ Endoscopy Denmark

UNKNOWN

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sigurd B Sloth, MD, PhD fellow

Role: PRINCIPAL_INVESTIGATOR

Centre for Health Sciences Education, Aarhus University, Denmark

Locations

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Centre for Health Sciences Education, Aarhus University

Aarhus, Danmark, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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sbs_au235143

Identifier Type: -

Identifier Source: org_study_id

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