- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06421584
Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy. SURGTEACH Trial (SURGTEACH)
Laparoscopic Cholecystectomy - A Randomized Controlled Trial Evaluating The Role Of Surgical Telementoring In Acquisition of Surgical Skills
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Khayam Butt, Medical doctor
- Phone Number: 004799560985
- Email: dr_khayam@hotmail.com
Study Contact Backup
- Name: Knut-Magne Augestad, Professor
- Phone Number: 004797499442
- Email: k.m.augestad@medisin.uio.no
Study Locations
-
-
Nordland
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Bodø, Nordland, Norway, 8004
- NordlandssykehusetHF
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria for residents in control- and intervention group:
- General surgery residents in years 1 to 6 of their specialty education having performed more than five laparoscopic procedures.
- Stratification according to experience will be made for the subject in the control arm and in the intervention arm.
- Having passed the prerequisite mandatory national course of general laparoscopic principles.
- All residents had to undergo agreement with the mentor about communication model during surgery. This model is derived from LapcoNor principals (11). Residents in the intervention group underwent an additional introduction to the principals of communication through telementoring at the OR. They were introduced to the telementoring equipment.
Inclusion criteria for on-site mentors (control group) and telementors (intervention group): • - Consultant surgeon with more than 3 years of experience with independently performing laparoscopic cholecystectomies.
- Having acquaintance with assessment of videos for GOALS-score (12)
- Both telementors and on-site mentors had to show certificate of having done the national LapCo-Nor "train the trainer" course and followed standardized norms of communication with the mentee during surgical mentoring thus diminishing bias of communicative difference.
Inclusion criteria for included patients:
- Gallstone disease without clinical history of cholecystitis
- BMI < 38
- No previous history of upper abdominal laparotomy
- No previous history of percutaneous gallbladder drainage
- Patient provided informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
The residents randomized to the control arm will receive traditional intra operative guidance by the mentor holding the laparoscopic camera during the procedure.
|
|
Experimental: Interventional arm
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.
|
The intervention group receives intraoperative guidance by telementoring.
The telementor is remotely located but able to see the real-time footage of the ongoing procedure and simultaneously verbally communicate with the operating resident wearing a headset during surgery.
Additionally, feedback by telestration may be given to the operating resident if required.
This involves graphic annotations on a still picture of the ongoing surgery which the telementor may design if required.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GOALS-score (Global Operative Assessment of Laparoscopic Skills)
Time Frame: 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/telementors |
Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days.
|
NOTSS-score (Non-technical surgical skills)
Time Frame: 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.
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Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction score of residents in the control group and the intervention group.
Time Frame: 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.
|
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.
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Satisfaction score of mentors (control group) and telementors (intervention group)
Time Frame: 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.
|
Each mentor and telementor will be given a satisfaction score form to fill out within 1 hour after each procedure.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Petter Øien, PhD, Head of research department
Publications and helpful links
General Publications
- Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
- Vassiliou MC, Feldman LS, Andrew CG, Bergman S, Leffondre K, Stanbridge D, Fried GM. A global assessment tool for evaluation of intraoperative laparoscopic skills. Am J Surg. 2005 Jul;190(1):107-13. doi: 10.1016/j.amjsurg.2005.04.004.
- Ohinmaa A, Vuolio S, Haukipuro K, Winblad I. A cost-minimization analysis of orthopaedic consultations using videoconferencing in comparison with conventional consulting. J Telemed Telecare. 2002;8(5):283-9. doi: 10.1177/1357633X0200800507.
- Strasberg SM, Hertl M, Soper NJ. An analysis of the problem of biliary injury during laparoscopic cholecystectomy. J Am Coll Surg. 1995 Jan;180(1):101-25. No abstract available.
- Hanna GB, Mackenzie H, Miskovic D, Ni M, Wyles S, Aylin P, Parvaiz A, Cecil T, Gudgeon A, Griffith J, Robinson JM, Selvasekar C, Rockall T, Acheson A, Maxwell-Armstrong C, Jenkins JT, Horgan A, Cunningham C, Lindsey I, Arulampalam T, Motson RW, Francis NK, Kennedy RH, Coleman MG; on behalfofLapco program. Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England. Ann Surg. 2022 Jun 1;275(6):1149-1155. doi: 10.1097/SLA.0000000000004584. Epub 2020 Oct 19.
- Holmer H, Lantz A, Kunjumen T, Finlayson S, Hoyler M, Siyam A, Montenegro H, Kelley ET, Campbell J, Cherian MN, Hagander L. Global distribution of surgeons, anaesthesiologists, and obstetricians. Lancet Glob Health. 2015 Apr 27;3 Suppl 2:S9-11. doi: 10.1016/S2214-109X(14)70349-3. No abstract available.
- Vickers AJ, Bianco FJ, Gonen M, Cronin AM, Eastham JA, Schrag D, Klein EA, Reuther AM, Kattan MW, Pontes JE, Scardino PT. Effects of pathologic stage on the learning curve for radical prostatectomy: evidence that recurrence in organ-confined cancer is largely related to inadequate surgical technique. Eur Urol. 2008 May;53(5):960-6. doi: 10.1016/j.eururo.2008.01.005. Epub 2008 Jan 14.
- Zorn KC, Gautam G, Shalhav AL, Clayman RV, Ahlering TE, Albala DM, Lee DI, Sundaram CP, Matin SF, Castle EP, Winfield HN, Gettman MT, Lee BR, Thomas R, Patel VR, Leveillee RJ, Wong C, Badlani GH, Rha KH, Eggener SE, Wiklund P, Mottrie A, Atug F, Kural AR, Joseph JV; Members of the Society of Urologic Robotic Surgeons. Training, credentialing, proctoring and medicolegal risks of robotic urological surgery: recommendations of the society of urologic robotic surgeons. J Urol. 2009 Sep;182(3):1126-32. doi: 10.1016/j.juro.2009.05.042. Epub 2009 Jul 21.
- Yun Kyung Jung et al: What is the safe training to educate the laparoscopic cholecystectomy for surgical residents in early learning curve ? J. Minim Invasive Surg 2016; 19(2): 70-74
- Doarn CR. Telemedicine in tomorrow's operating room: a natural fit. Semin Laparosc Surg. 2003 Sep;10(3):121-6. doi: 10.1177/107155170301000305.
- Schulam PG, Docimo SG, Saleh W, Breitenbach C, Moore RG, Kavoussi L. Telesurgical mentoring. Initial clinical experience. Surg Endosc. 1997 Oct;11(10):1001-5. doi: 10.1007/s004649900511.
- Augestad KM, Bellika JG, Budrionis A, Chomutare T, Lindsetmo RO, Patel H, Delaney C; Mobile Medical Mentor (M3) Project. Surgical telementoring in knowledge translation--clinical outcomes and educational benefits: a comprehensive review. Surg Innov. 2013 Jun;20(3):273-81. doi: 10.1177/1553350612465793. Epub 2012 Oct 30.
- Wood D. No surgeon should operate alone: how telementoring could change operations. Telemed J E Health. 2011 Apr;17(3):150-2. doi: 10.1089/tmj.2011.9986. No abstract available.
- Mackenzie H, Cuming T, Miskovic D, Wyles SM, Langsford L, Anderson J, Thomas-Gibson S, Valori R, Hanna GB, Coleman MG, Francis N. Design, delivery, and validation of a trainer curriculum for the national laparoscopic colorectal training program in England. Ann Surg. 2015 Jan;261(1):149-56. doi: 10.1097/SLA.0000000000000437.
- Manatakis DK, Antonopoulou MI, Tasis N, Agalianos C, Tsouknidas I, Korkolis DP, Dervenis C. Critical View of Safety in Laparoscopic Cholecystectomy: A Systematic Review of Current Evidence and Future Perspectives. World J Surg. 2023 Mar;47(3):640-648. doi: 10.1007/s00268-022-06842-0. Epub 2022 Dec 6.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Nordlandssykehuset
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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