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Evaluation in a Multimodal Structured Curriculum of Laparoscopic Surgery

NCT06579456 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2024-08-30

No results posted yet for this study

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.

Conditions

  • Medical Education
  • Laparoscopic Surgery

Interventions

OTHER

Surgical Training Intervention

Validation of a Formaldehyde-Free embalmed cadavers for recreate with more precision the experience of learning surgical endoscopy

OTHER

Positive Control

training in models that emulate the rigidity, structure, dimensions, and haptic feedback of the anatomical structures to be treated.

OTHER

Negative Control

Training proceeded in the rigid described skills acquisition platform, adding suture training using a perforable MMA-type woven fabric

Sponsors & Collaborators

  • University of Los Andes, Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-28
Primary Completion
2022-05-20
Completion
2022-09-20

Countries

  • Colombia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579456 on ClinicalTrials.gov