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) (NOVICE)

Efficacy of Goal-directed Minimally Invasive Surgery Simulation Training With the Lübeck Toolbox-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)

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).

Study Overview

• Status: Unknown
• Conditions: Minimally Invasive Surgery Basic Skills
• Intervention / Treatment: Procedure: LTB-Curriculum; Procedure: Laparoscopic cholecystectomy

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Thomaschewski, MD; Phone Number: +491784007135; Email: Michael.Thomaschewski@uksh.de

Study Locations

• Germany
  • Schleswig-Holstein
    • Lubeck, Schleswig-Holstein, Germany, 23538
      • Recruiting
      • Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery
      • Contact: Michael Thomaschewski, MD; Phone Number: +491784007135; Email: Michael.Thomaschewski@uksh.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Procedure: 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.; Procedure: Laparoscopic cholecystectomy; Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS
ACTIVE_COMPARATOR: 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.	Procedure: Laparoscopic cholecystectomy; Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operation time	operation time of CHE I and CHE 2	8-12 weeks
percentage of the participants operating time in the total time of the CHE	percentage of participants operating time in the total time of the CHE I and CHE II	8-12 weeks
number of takeovers by the specialist assisting the CHE	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	8-12 weeks
potential conversion to laparotomy	potential conversion of the MIS CHE to open surgery	8-12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
sex of participant	sex of participant (male or female)	8-12 weeks
dominant hand of participant	dominant hand of participant (right or left)	8-12 weeks
age of participant	age of the participants	8-12 weeks
correlation with activities and hobbies	in particular playing an instrument, handicrafts and computer games	8-12 weeks
inter-rater reliability	possible differences and bias between video ratings by calculation	8-12 weeks

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein
• Investigators: Study Director: Claudia Benecke, MD, Medical University Center Schleswig-Holstein Campus Lübeck; Study Director: Tilman Laubert, MD, Medical University Center Schleswig-Holstein Campus Lübeck

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2017
• Primary Completion (ANTICIPATED): May 21, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: January 31, 2017
• First Posted (ESTIMATE): February 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: surgical education; laparoscopic; minimally invasive surgery; simulation training; video-based trainer
• Other Study ID Numbers: NOVICE trial

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No