Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy. SURGTEACH Trial
- Conditions
- Surgical EducationSurgical Telementoring
- Interventions
- Device: Surgical telementoring
- Registration Number
- NCT06421584
- Lead Sponsor
- Nordlandssykehuset HF
- Brief Summary
Surgical telementoring (ST) has the potential to become an integrated part of everyday surgical teaching practice. Its educational benefits require investigation.
This is a randomized controlled trial evaluating ST in a clinical setting. Laparoscopic cholecystectomy will be performed by eligible surgical residents randomized to the intervention group or the control group. The control group being guided by traditional onsite mentoring and the intervention group being telementored by a distantly located telementor during ongoing procedure. The primary outcome will be the video recorded GOALS-score (Global Operative Assessment of Laparoscopic Skills) and NOTSS-score (Non Technical Surgical Skills) assessment of each procedure while secondary outcomes will be satisfaction scores of the involved residents and mentors.
- Detailed Description
Background:
Developing surgical skills among residents takes time and resources. Surgical practice is increasingly driven by efficacy and hospital economics. Operating room surgical education might conflict with these goals. The identified factors need optimizing surgical resident training. Surgical telementoring (ST) seems natural in surgery. Some ST-systems are cost-effective and safe. Despite recent technical breakthroughs and growing experience with telemedicine in the health sector, data on educational outcomes is still being determined.
Objective:
ST will be evaluated for efficiency and safety as a skill development tool for laparoscopic cholecystectomy. In this randomized controlled trial, surgical residents will be randomly assigned in a 1:1 ratio to the intervention group (real-time telementoring and postoperative coaching) or the control group (traditional intraoperative hands-on teaching). The research follows CONSORT, SPIRIT 2013 statements and the intention to treat principle (ITT).
The study is approved by the Norwegian ethical committee (REK HELSE NORD 32592) and the data protection officer (PVO) at Nordland Hospital trust Bodø (NLSH Bodø).
Two groups of residents will be allocated. The control group will follow the traditional hands-on surgical training method. In the intervention group, an expert surgeon will telementor the surgical residents. General surgery trainees in years 1-6 who have completed more than five laparoscopic abdominal surgeries are eligible. Stratification according to previous experience of the mentee will be made. All residents must agree with the mentor on surgical communication. This model uses LapcoNor principles for intraoperative communication and the GROW-model as an educational model. The GOALS score is the primary trial outcome. It consists of a five-item global rating scale for laparoscopic surgical skills. Each item may be scored from 1 to 5, where 1 is the lowest and five is the highest. The max score is 25. We hypothesize that the intervention group will enhance clinical skills by 3-5 points on the GOALS score compared to the control group. To attain 0.8 statistical power, a p-value of less than 0.05, and a 20% dropout rate, 12 residents per group are needed.
In addition to the GOALS-score assessment of video records, the NOTSS-score evaluating non-surgical technical skills will be assessed. The NOTSS score is based on 4 categories where each category consists of 3 elements. Each element may be graded from 1 to 4 , where 1 is the lowest and 4 is the highest. The highest achievable score is 48.
The higher the score, the better the outcome for both scoring systems.
Results:
Lapco TT courses were given to all telementors and onsite consulting surgeons before the trial start. In December 2023, the Medprescence (c) telementoring system was installed in three local hospitals. Residents, consultant surgeons, and telementors learned Medprescence setup and use. Surgical residents will be recruited once this research protocol is evaluated and accepted for publication to accommodate any necessary changes before the study begins. Starting recruitment in spring 2024 is feasible. This would allow data analysis by end of 2024 and publication in an international peer-reviewed journal by spring 2025.
Conclusions:
The SURGTEACH trial is the first randomized trial of telementoring for surgical education. The surgical education system and surgeon supply are limited globally and locally. Due to geographical and educational barriers, the Norwegian healthcare system requires support in educating enough surgeons. Therefore, surgical education must evolve, and surgical telementoring may help solve these challenges. This research may give high quality evidence to improve surgical education, especially in rural hospitals.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interventional arm Surgical telementoring The residents randomized to the intervention arm will receive telementored guidance. This guidance is provided by telecommunication setup allowing the remotely located mentor to see the live footage of the laparoscopic procedure and to verbally communicate with the resident performing the surgical procedure.
- Primary Outcome Measures
Name Time Method GOALS-score (Global Operative Assessment of Laparoscopic Skills) Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days. GOALS-score is a validated scoring system for laparoscopic surgical skills. Each performed procedure in the control group and the intervention group will be divided into 5 key-steps and each step will be scored by the 5 involved mentors and telementors. The video records of the procedures will be edited by the main author into 5 key-steps. Each recorded procedure will not exceed 1hours duration. All five procedures by each resident will be edited and presented to 5 mentors/telementors for GOALS-score assessment. Total GOALS-score will be calculated by adding the scores of each key-step.
Every resident in each of the 2 groups will perform 5 consecutive procedures within 3-5 consecutive days. The GOALS-assessment will be required with 1 week after presenting the procedures to the 5 mentors/telementorsNOTSS-score (Non-technical surgical skills) Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days. Assessing non-surgical technical skills by assessment of 4 categories (Situation awareness, Decision making, Communication and teamwork and Leadership. Each category consists of 3 elements. Each category is rated from 1-4 and each of the 3 elements within each category is rated from 1-4. Each recorded and edited video record of the 5 consecutive laparoscopic procedures by the residents in both groups will be presented to mentors/telementors (5 members) for NOTSS-score assessment. The NOTSS-assessment will be required with 1 week after presenting the procedures to the 5 mentors/telementors.
- Secondary Outcome Measures
Name Time Method Satisfaction score of residents in the control group and the intervention group. 5 subsequent procedures will be performed by each resident within a periode of 3-5 days. Satisfaction score form will be asked for within 1 hour after each procedure. Each resident (both groups) will be given a predetermined form for self-reported satisfaction score. Resident satisfaction survey was based on a 5-point Likert scale. 7 statements are to be assessed with answers ranging from 1= strong disagreement with the statement and 5=strong agreement with the statement. 5 is the best outcome for each statement and 35 is the best overall result for the survey.
Satisfaction score of mentors (control group) and telementors (intervention group) Each mentor and telementor will be given a satisfaction score form to fill out within 1 hour after each procedure. Each mentor and telementor (both groups)will be given a predetermined form for self-reported satisfaction score. The mentor/telementor satisfaction survey was based on a 5-point Likert scale. 7 statements are to be assessed with answers ranging from 1= strong disagreement with the statement and 5=strong agreement with the statement. 5 is the best outcome for each statement and 35 is the best overall result for the survey.
Trial Locations
- Locations (1)
NordlandssykehusetHF
🇳🇴Bodø, Nordland, Norway