Evaluation in a Multimodal Structured Curriculum of Laparoscopic Surgery
NCT Number: NCT06579456
Acronym: EDU-SURGERY
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Medical Education|Laparoscopic Surgery
Interventions: OTHER: Surgical Training Intervention|OTHER: Positive Control|OTHER: Negative Control
Sponsor: University of Los Andes, Columbia
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 37
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: OTHER
Start Date: 2022-01-28
Completion Date: 2022-09-20
Locations: Universidad de los Andes School of Medicine, Bogotá, Cundinamarca, 111711, Colombia

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.

Primary Outcome Measures: Improvement in Skills in Laparoscopic Surgery using global operative assessment of laparoscopic skills (GOALS) scale, Pre- and post-intervention individual measures will be taken using the operative assessment of laparoscopic skills (GOALS) to compare the efficacy of the simulated program. The unit of measure are the points of GOALS Scale with a minum score of 5 and a maximum of 25 points. A higher score means a better outcome., 48 hours|Improvement in the Objective Structured Assessment of Technical Skills (OSATS) global rating scale, Pre- and post-intervention individual measures will be taken using the Objective Structured Assessment of Technical Skills (OSATS) Scale to compare the efficacy of the simulated program. The unit of measure are the points of OSATS Scale with a minum score of 4 points and a maximum of 20 points. A higher score means a better outcome., 48
Secondary Outcome Measures: The efficacy given by the progression through the different multimodal methods at OSATS Scale, The results of the 3 arms will be compared. The unit of measure are the points of OSATS Scale, with a minimum of 4 points and a maximum of 20 points. A higher score means a better outcome., 48 hours|The efficacy given by the progression through the different multimodal methods at GOALS Scale, The results of the 3 arms will be compared. The unit of measure are the points of GOALS Scale, with a minimum of 5 points and a maximum of 25 points. A higher score means a better outcome., 48 hours