Surgical EducationSURGTEACHNCT06421584
Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy. SURGTEACH Trial
A study testing Surgical telementoring in people with Surgical Education and Surgical Telementoring, run by Nordlandssykehuset HF at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Surgical Education, Surgical Telementoring
- What is being tested?
- Surgical telementoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteNorway
- Study dates
- 20 Jan 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Surgical Education, Surgical Telementoring
- Being tested
- Surgical telementoring
- Keywords
- Competency based surgical education, Surgical telementoring, Laparoscopic cholecystectomy, Randomized controlled clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical telementoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Surgical telementoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
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.
Measured: 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 (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.
Measured: Each mentor and telementor will be given a satisfaction score form to fill out within 1 hour after each procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start20 Jan 2025 (estimated)
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Surgical EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordlandssykehuset HF
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Sponsor
- Investigators
- Petter Øien, PhD, Study director, Head of research department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421584
- Sponsor's protocol ID
- Nordlandssykehuset
- Acronym
- SURGTEACH
- Status last verified
- May 2024
- First submitted
- 11 Apr 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Video records of the procedures will be stripped for patient-ID and stored anonymously on a secured website. Each video will be given an URL-address. The study secretary will have the key enabling recognition of each video to the specific patient and performing surgeon. The anonymous video records will be made available for each of the 5 mentors/telementors after being edited and labelled with key-steps of the procedure. Blinded GOALS- and NOTSS-assessment by the mentors/telementors will be performed. The assessment results will be collected by the study secretary on a questback scheme handed out in advance to the evaluators. The study secretary possesses the key enabling recognition of the video records according to patient-ID and performing residents. An Excel file with the results will be constructed by the study secretary and the data analysis will be commenced. The video records and the Excel file, constituting the raw data, will be available as IPD for sharing.
Publications
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.
PubMed 25926323Vickers 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.
PubMed 18207316Zorn 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.
PubMed 19625032Strasberg 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.
PubMed 8000648Yun 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.
PubMed 14551654Ohinmaa 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.
PubMed 12396857Schulam 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.
PubMed 9381336Augestad 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.
PubMed 23117447Wood 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.
PubMed 21500973Hanna 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.
PubMed 33086313Vassiliou 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.
PubMed 15972181Mackenzie 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.
PubMed 24374538Manatakis 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.
PubMed 36474120Dindo 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.
PubMed 15273542
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Cholecystectomy - A Randomized Controlled Trial Evaluating The Role Of Surgical Telementoring In Acquisition of Surgical Skills
- ClinicalTrials.gov ID
- NCT06421584
- Acronym / sponsor ID
- SURGTEACH / Nordlandssykehuset
- Conditions
- Surgical Education, Surgical Telementoring
- Keywords
- Competency based surgical education, Surgical telementoring, Laparoscopic cholecystectomy, Randomized controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nordlandssykehuset HFUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Nov 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Surgical telementoringThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical telementoringThe 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. | Device | Interventional arm |
Primary outcome
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
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.
2 secondary outcomes
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 25926323Holmer 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.
- Background: PubMed 18207316Vickers 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.
- Background: PubMed 19625032Zorn 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.
- Background: PubMed 8000648Strasberg 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.
- BackgroundYun 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: PubMed 14551654Doarn CR. Telemedicine in tomorrow's operating room: a natural fit. Semin Laparosc Surg. 2003 Sep;10(3):121-6. doi: 10.1177/107155170301000305.
- Background: PubMed 12396857Ohinmaa 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.
- Background: PubMed 9381336Schulam 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.
- Background: PubMed 23117447Augestad 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.
- Background: PubMed 21500973Wood 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.
- Background: PubMed 33086313Hanna 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.
- Background: PubMed 15972181Vassiliou 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.
- Individual participant dataSharing planned: Yes. Video records of the procedures will be stripped for patient-ID and stored anonymously on a secured website. Each video will be given an URL-address. The study secretary will have the key enabling recognition of each video to the specific patient and performing surgeon. The anonymous video records will be made available for each of the 5 mentors/telementors after being edited and labelled with key-steps of the procedure. Blinded GOALS- and NOTSS-assessment by the mentors/telementors will be performed. The assessment results will be collected by the study secretary on a questback scheme handed out in advance to the evaluators. The study secretary possesses the key enabling recognition of the video records according to patient-ID and performing residents. An Excel file with the results will be constructed by the study secretary and the data analysis will be commenced. The video records and the Excel file, constituting the raw data, will be available as IPD for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter Øien, PhD study director
Head of research department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical telementoring in people with Surgical Education and Surgical Telementoring, run by Nordlandssykehuset HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khayam Butt, Medical doctor (004799560985, dr_khayam@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06421584, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.