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)

Not Applicable

• Conditions: Minimally Invasive Surgery Basic Skills
• Interventions: Procedure: Laparoscopic cholecystectomy; Procedure: LTB-Curriculum

• Registration Number: NCT03040544
• Lead Sponsor: University Hospital Schleswig-Holstein

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-29
• Study First Submitted QC: 2017-01-31
• Study First Posted: 2017-02-02
• Study Start: 2017-05-22
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-14
• Primary Completion: 2020-05-21
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
no LTB-Curriculums	Laparoscopic cholecystectomy	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.
LTB-Curriculum	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.
LTB-Curriculum	Laparoscopic cholecystectomy	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.

Primary Outcome Measures

Name	Time	Method
Global Operative Assessment of Laparoscopic Skill (GOALS)-Score	end of inclusion of all participants	The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon

Secondary Outcome Measures

Name	Time	Method
number of takeovers by the specialist assisting the CHE	8-12 weeks	experienced consultant surgeon will assist the CHE. The specialist can take over the operation at any time and perform surgical steps independently, according to his/her judgement with regard to the individual situation
operation time	8-12 weeks	operation time of CHE I and CHE 2
potential conversion to laparotomy	8-12 weeks	potential conversion of the MIS CHE to open surgery
percentage of the participants operating time in the total time of the CHE	8-12 weeks	percentage of participants operating time in the total time of the CHE I and CHE II

Trial Locations

Locations (1)

Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery; 🇩🇪 Lubeck, Schleswig-Holstein, Germany