Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy. SURGTEACH Trial

NCT06421584 | Not Yet Recruiting DMC

• 1 other identifier: Nordlandssykehuset
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Education; Surgical Telementoring

Keywords

Competency based surgical education; Surgical telementoring; Laparoscopic cholecystectomy; Randomized controlled clinical trial

Outcome Measures

Primary Outcomes (2)

• GOALS-score (Global Operative Assessment of Laparoscopic Skills)

  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)

  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.

  Each resident in both the intervention group and the control group will be scheduled to perform 5 consecutive laparoscopic cholecystectomies within 3-5 days.

Secondary Outcomes (2)

• 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.

• 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.

Study Arms (2)

Control group

NO INTERVENTION

The residents randomized to the control arm will receive traditional intra operative guidance by the mentor holding the laparoscopic camera during the procedure.

Interventional arm

EXPERIMENTAL

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.

Device: Surgical telementoring

Interventions

Surgical telementoring DEVICE

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.

Interventional arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Nordlandssykehuset HF: lead
• Olympus: collaborator

Study Sites (1)

NordlandssykehusetHF

Bodø, Nordland, 8004, Norway

Location

Related Publications (15)

• 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.

  PMID: 25926323 BACKGROUND

• 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.

  PMID: 18207316 BACKGROUND

• 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.

  PMID: 19625032 BACKGROUND

• 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.

  PMID: 8000648 BACKGROUND

• 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

  BACKGROUND

• Doarn CR. Telemedicine in tomorrow's operating room: a natural fit. Semin Laparosc Surg. 2003 Sep;10(3):121-6. doi: 10.1177/107155170301000305.

  PMID: 14551654 BACKGROUND

• 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.

  PMID: 12396857 BACKGROUND

• 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.

  PMID: 9381336 BACKGROUND

• 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.

  PMID: 23117447 BACKGROUND

• 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.

  PMID: 21500973 BACKGROUND

• 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.

  PMID: 33086313 BACKGROUND

• 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.

  PMID: 15972181 BACKGROUND

• 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.

  PMID: 24374538 BACKGROUND

• 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.

  PMID: 36474120 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

Study Officials

• Petter Øien, PhD

  Head of research department

  STUDY DIRECTOR

Central Study Contacts

Khayam Butt, Medical doctor

CONTACT

004799560985; dr_khayam@hotmail.com

Knut-Magne Augestad, Professor

CONTACT

004797499442; k.m.augestad@medisin.uio.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Mentors and telementors performing the GOALS-assessment of the video records are blinded to the temporal order of the performed procedures by the residents in both groups.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized controlled trial (RCT) was designed as a superiority trial to demonstrate the superiority of telementored resident skill learning in the operating room (OR) compared to standard training methods.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: May 20, 2024
• Study Start: January 20, 2025
• Primary Completion: October 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available as it is collected. Videorecords of the procedures by the residents are planned to be finished by end of November 2024. The video records will be stored continuously and the website will be availabe at the starting point. The GOALS-scores and NOTSS-scores will be collected continuously as the video records are edited and presented to the mentors (control arm) and the telementors (intervention arm)
• Access Criteria: All raw data will be shared on request.

Locations

NO (1)