Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421584
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-11
Brief Title:
Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy SURGTEACH Trial
Sponsor:
Nordlandssykehuset HF
Organization:
Nordlandssykehuset HF
Study Overview
Official Title:
Laparoscopic Cholecystectomy - A Randomized Controlled Trial Evaluating The Role Of Surgical Telementoring In Acquisition of Surgical Skills
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SURGTEACH
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
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 11 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 08 statistical power a p-value of less than 005 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
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 11 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 08 statistical power a p-value of less than 005 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None