Evaluation in a Multimodal Structured Curriculum of Laparoscopic Surgery

NCT06579456 | Completed DMC

• 1 other identifier: 2019102254
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laparoscopic Surgical Training; General Surgery; General Surgery Residents; Technical Skills

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The efficacy given by the progression through the different multimodal methods at OSATS Scale

  48 hours

• The efficacy given by the progression through the different multimodal methods at GOALS Scale

  48 hours

Study Arms (3)

- Negative control

ACTIVE COMPARATOR

participants who continued after the pre-test in this model (negative control group) proceeded with training in the described skills, adding suture training using a perforable MMA-type woven fabric

Other: Negative Control

- Positive control

ACTIVE COMPARATOR

simulation in silicone models was conducted using models that emulate the rigidity, structure, dimensions, and haptic feedback of the anatomical structures to be treated, specifically a hollow viscus for enterorrhaphy training. Each model was placed inside a Pelvitrainer for training, and the participants performed cutting and suturing exercises freely for the allotted time

Other: Positive Control

Intervention Group

EXPERIMENTAL

training in the cadaveric model was carried out using a complete human body preserved in formaldehyde-free solution. The cadaver was positioned and covered with surgical drapes in the supine position and a pneumoperitoneum was performed for training using a Mindray HD3 laparoscopy tower

Other: Surgical Training Intervention

Interventions

Surgical Training Intervention OTHER

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

Intervention Group

Positive Control OTHER

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

- Positive control

Negative Control OTHER

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

- Negative control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Los Andes, Columbia: lead

Study Sites (1)

Universidad de los Andes School of Medicine

Bogotá, Cundinamarca, 111711, Colombia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A single-center, single-blind, randomized educational intervention clinical trial was carried out to compare the use of formaldehyde free solution cadaver training in laparoscopic surgery with other traditional simulation surgery options. The trial was approved by our Institutional Research Board, prior to the beginning of the study (Act. No.201910224). Written informed consent was obtained from each participant and the CONSORT statement was followed.

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 30, 2024
• Study Start: January 28, 2022
• Primary Completion: May 20, 2022
• Study Completion: September 20, 2022
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)