Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)

NCT ID: NCT03040544

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-22
• Study Completion Date: 2020-12-31

Brief Summary

Background: Laparoscopic surgical procedures have become increasingly established in operative medicine. They require special motor, haptic, and spatial-visual skills to perform the interventions safely and effectively. These minimally invasive surgery (MIS) basic skills are often learned in the operating room (OR) on the patient. This is economically inefficient and can be improved with regard to patient safety. Against the background of this problem, various simulators and video-box trainer have been developed in order to train laparoscopic basic skills outside the OR. The Lübecker Toolbox (LTB) curriculum is a video-based trainer including standardized and validated exercises with defined targets, based on the skills of experts MIS. Conducting MIS training outside the OR prior to performing the first MIS procedures on patients could be a sensible and valuable contribution to effective surgical education. An evidence of effectiveness in the practice transfer could have a considerable relevance with regard to the integration of MIS training programs into surgical education programs.

Aim of the study: The aim of the study is to investigate whether surgical residents without previous active experience in MIS are able to improve laparoscopic skills in MIS procedures in the OR, if they have successfully completed the LTB curriculum.

In the multicentric prospective study, will be conducted with surgical residents (SR) without prior active experience in MIS (n=14). After the SR have completed their first laparoscopic cholecystectomy (CHE), they will be randomized into two groups: 1) The intervention group will perform the LTB-Curriculum, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE. Improvements in operative performance (between CHE I and CHE II) will be evaluated according to the Global Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).

Conditions

Minimally Invasive Surgery Basic Skills

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LTB-Curriculum

First group/arm undergo MIS training according to the LTB curriculum after the first own laparoscopic cholecystectomy in the OR as a baseline. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using the Global Operational Assessment of Laparoscopic Skill (GOALS) score.

Group Type: EXPERIMENTAL

LTB-Curriculum

Intervention Type: PROCEDURE

The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS

no LTB-Curriculums

Second group/arm will not undergo any MIS trains after their first laparoscopic CHE in the OR. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using GOALS score.

Group Type: ACTIVE_COMPARATOR

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS

Interventions

LTB-Curriculum

The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy

Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• no motor or sensory restrictions when using surgical instruments surgical instruments.
• no previous performed MIS simulation training
• no previous performed MIS procedure ( any previous assisted MIS procedures are not an exclusion criterion)
• residents in surgical education for general or visceral surgery in Germany

Exclusion Criteria

• The participant are not allowed to perform any other MIS training programs during the study period
• Before the start of the study, participants are not allowed to have performed any prior MIS simulation training or any MIS procedure

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Schleswig-Holstein

OTHER

Sponsor Role: lead

Responsible Party

Michael Thomschewski

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Benecke, MD

Role: STUDY_DIRECTOR

Medical University Center Schleswig-Holstein Campus Lübeck

Tilman Laubert, MD

Role: STUDY_DIRECTOR

Medical University Center Schleswig-Holstein Campus Lübeck

Locations

Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery

Lübeck, Schleswig-Holstein, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Michael Thomaschewski, MD

Role: CONTACT

Michael.Thomaschewski@uksh.de

+491784007135

Facility Contacts

Michael Thomaschewski, MD

Role: primary

Michael.Thomaschewski@uksh.de

+491784007135

Other Identifiers

NOVICE trial

Identifier Type: -

Identifier Source: org_study_id