CompletedNot Applicable

Evaluation in a Multimodal Structured Curriculum of Laparoscopic Surgery

Colombia37 participantsStarted 2022-01-28

Plain-language summary

Development of Laparoscopic surgery skills for general surgery residents are considered competencies of major importance. Different tools are used for this purpose, including synthetic models, virtual reality, animal models and human cadaveric specimens preserved by freezing.Cadaveric models share the anatomical similarity, however have some clear disadvantages including the biological risk and the alteration of the mechanical properties of the bodies preserved by this technique, such as tissue rigidness, lack of elasticity and consistency, and the impossibility of achieving adequate pneumoperitoneum. However, we previosly devoleped a formaldehyde free solution for anatomical preservation. Hence. we propose a a single-center, single-blind, randomized educational intervention clinical trial. Research participants who meet the inclusion criteria have a theoretical and practical module on the acquisition of skills in laparoscopy and take a pre-test focused on intracorporeal enterorrhaphy. Subsequently, they are randomized by blocks into three groups: Negative Control, Positive Control, and Intervention, continuing their training in skill acquisition models, silicone models, or Formaldehyde-free solution preserved corpses, respectively. Finally they are evaluated with a post-test. Two blind experts will evaluate participants using the GOALS and OSATS scales for laparoscopic surgery.

Who can participate

Sex

ALL

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Inclusion criteria

. Fourth, fifth or sixth year medical students over 18 years old who completed their general surgery rotations
. General Surgery residents over 18 years old at any level of training Over 18 years old.

Exclusion criteria

. Serious illnesses that affect the hability of the participant to safety and ability to complete the study.
. Participants who have known allergies to components of the interventions or have experienced severe adverse reactions in the past will be excluded from the study.
. Participants who cannot provide valid informed consent due to cognitive issues, mental impairment, or legal incapacity will be excluded from the study.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in Skills in Laparoscopic Surgery using global operative assessment of laparoscopic skills (GOALS) scale

Timeframe: 48 hours

Improvement in the Objective Structured Assessment of Technical Skills (OSATS) global rating scale

Timeframe: 48

Trial details

NCT IDNCT06579456

SponsorUniversity of Los Andes, Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-20

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