LaparoscopyNCT04643314
Effect of Video-based Guided Self-reflection on Intraoperative Skills
A study testing Guided video-based self-evaluation in people with Laparoscopy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
While video-assisted structured feedback by expert surgeons significantly improves laparoscopic skill acquisition in surgical trainees, this method is resource intensive and may have limited feasibility outside of research settings. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopy
- What is being tested?
- Guided video-based self-evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2020to 30 Jul 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All residents involved at the McGill General Surgery Program (total of 35 residents on clinical rotations)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Saba Balvardi, MD contact
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H8N0C8
Liane S Feldman, MD, 514-934-8044, liane.feldman@mcgill.ca
About this study
Official title: Effect of Video-based Guided Self-reflection on Intraoperative Skills: a Pilot Randomized Controlled Trial
While video-assisted structured feedback by expert surgeons significantly improves laparoscopic skill acquisition in surgical trainees, this method is resource intensive and may have limited feasibility outside of research settings. Self-assessment and reflection are integral parts of medical experiential learning; however the value of video-based self-reflection in enhancing surgical skill acquisition remains to be determined.
The objective of the proposed pilot study is to investigate the feasibility of conducting a full-scale randomized controlled trial (RCT) aimed to evaluate the effectiveness of coached video-based self-reflection approach on surgical trainee performance of laparoscopic cholecystectomy.
Read the detailed description
The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial with participants (surgical trainees) individually allocated on a 1:1 ratio to intervention group (guided video-based self-evaluation in addition to traditional intraoperative teaching by faculty surgeons) and a control group (traditional intraoperative teaching alone).
All the trainees participating in this trial will be asked to submit intra-operative video-recordings of 5 consecutive laparoscopic cholecystectomies performed by them as the primary operator.
In this trial the intervention group participants will be asked to perform a guided self-assessment of their intra-operative skills by watching their operative video-recording. The trainee's self-assessment will be guided by validated intra-operative performance assessment tools. The control group will not have access to their recorded video submissions during the duration of this study.
Outcomes assessed will include trainee's intra-operative performance and time to completion of surgical procedure, Information generated from the pilot study will help inform a full-scale RCT by testing the study procedures. Feasibility outcomes will include number of trainees and surgeons approached, consented and randomized and adherence with intervention(surgeons: intra-operative assessments; trainees: video-based assessments). Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT.
- Conditions
- Laparoscopy
- Being tested
- Guided video-based self-evaluation
- Keywords
- laparoscopic surgical skills, self-reflection, operative recording, laparoscopic cholecystectomy, surgical education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided video-based self-evaluationOther
In addition to their usual residency training, participants randomized to this group will undergo the following interventions:
The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Guided video-based self-evaluation | Experimental | In addition to their usual residency training, participants randomized to this group will undergo the following interventions:
The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure. Receives: Other: Guided video-based self-evaluation |
| Traditional intraoperative teaching | No intervention | Subjects randomized to this group will undergo their usual residency training. The recordings of the 5 submitted consecutive laparoscopic cholecystectomy procedures performed by the participant as the primary operator will be stored. However participants in this arm of the study will not have access to the uploaded videos until the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Rate of recruitment (acceptability of the trial by trainees)
% of eligible residents who agree to participate in the study
Measured: 1 year
Feasibility: Rate of recruitment (acceptability of the trial by attending surgeons)
% of eligible attending surgeons who agree to participate in the study
Measured: 1 year
Feasibility: Adherence to intervention
% of adherence with intervention (surgeons: intra-operative assessments; trainees: video-based assessments)
Measured: 1 year
Feasibility: Rate of missing assessment data
% of missing responses
Measured: 1 year
Secondary outcomes (5)
Intraoperative performance- In-person: attending surgeon
Intra-operative performance will be assessed by the attending surgeon (present at time of the operation) after each operation (within 72 hours) using the following four tools:
The Global Operative Assessment of Laparoscopic Skills (GOALS) Score 5-25 with higher score signifying better skills Operative Performance Rating System (OPRS) Score 10-50 with higher score signifying better skills Eubanks checklist 0-100% with higher score signifying better skills The O-SCORE Entrustability Scale 1-5 with higher score signifying better skills
Measured: 1 year
Procedural times
Time to the following events:
- time to critical view of safety after completion of adhesiolysis,
- time to detachment of the gallbladder from the liver bed after division of the cystic artery and duct
- total procedure time (from insertion of first trocar to extraction of the gallbladder).
Measured: 1 year
Perceived usefulness
all participants will be asked to evaluate the perceived utility of video-based self-reflection at baseline. This will be repeated at the end of the trial for the intervention group. In addition, they will be queried about the ease of executing the intervention (recording, storage and retrieval of their procedures) at the end of trial.
Measured: through study completion, an average of 1 year
Mindset
Dweck Mindset instrument, DMI
Measured: through study completion, an average of 1 year
Intraoperative performance-Video-based: blinded expert assessor
Intra-operative performance will be assessed by two expert assessors (MIS attending surgeons blinded to the case number or group allocation of the participants) using the following three tools:
The Global Operative Assessment of Laparoscopic Skills (GOALS) Score 5-25 with higher score signifying better skills Operative Performance Rating System (OPRS) Score 10-50 with higher score signifying better skills Eubanks checklist 0-100% with higher score signifying better skills
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Aug 2020
- Primary completion30 Jul 2021 (estimated)
- Study completion30 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Liane S. Feldman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Liane S Feldman, MD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04643314
- Sponsor's protocol ID
- 2020-6348
- Status last verified
- Nov 2020
- First submitted
- 24 Jun 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video-based Guided Self-reflection on Intraoperative Skills: a Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04643314
- Acronym / sponsor ID
- 2020-6348
- Conditions
- Laparoscopy
- Keywords
- laparoscopic surgical skills, self-reflection, operative recording, laparoscopic cholecystectomy, surgical education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Jul 2021 (estimated)
- Study completion
- 30 Jul 2021 (estimated)
- First posted
- 25 Nov 2020 (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.
While video-assisted structured feedback by expert surgeons significantly improves laparoscopic skill acquisition in surgical trainees, this method is resource intensive and may have limited feasibility outside of research settings. Self-assessment and reflection are integral parts of medical experiential learning; however the value of video-based self-reflection in enhancing surgical skill acquisition remains to be determined.
The objective of the proposed pilot study is to investigate the feasibility of conducting a full-scale randomized controlled trial (RCT) aimed to evaluate the effectiveness of coached video-based self-reflection approach on surgical trainee performance of laparoscopic cholecystectomy.
Detailed description
The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial with participants (surgical trainees) individually allocated on a 1:1 ratio to intervention group (guided video-based self-evaluation in addition to traditional intraoperative teaching by faculty surgeons) and a control group (traditional intraoperative teaching alone).
All the trainees participating in this trial will be asked to submit intra-operative video-recordings of 5 consecutive laparoscopic cholecystectomies performed by them as the primary operator.
In this trial the intervention group participants will be asked to perform a guided self-assessment of their intra-operative skills by watching their operative video-recording. The trainee's self-assessment will be guided by validated intra-operative performance assessment tools. The control group will not have access to their recorded video submissions during the duration of this study.
Outcomes assessed will include trainee's intra-operative performance and time to completion of surgical procedure, Information generated from the pilot study will help inform a full-scale RCT by testing the study procedures. Feasibility outcomes will include number of trainees and surgeons approached, consented and randomized and adherence with intervention(surgeons: intra-operative assessments; trainees: video-based assessments). Data from this pilot study will inform the calculation of sample size requirements for the full-scale RCT.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be a parallel, two-groups, assessor-blind, single-center, pilot randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Guided video-based self-evaluation | Experimental | Other: Guided video-based self-evaluationIn addition to their usual residency training, participants randomized to this group will undergo the following interventions: The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure. |
| Traditional intraoperative teaching | No intervention | –Subjects randomized to this group will undergo their usual residency training. The recordings of the 5 submitted consecutive laparoscopic cholecystectomy procedures performed by the participant as the primary operator will be stored. However participants in this arm of the study will not have access to the uploaded videos until the end of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All residents involved at the McGill General Surgery Program (total of 35 residents on clinical rotations)
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Guided video-based self-evaluationIn addition to their usual residency training, participants randomized to this group will undergo the following interventions: The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure. | Other | Guided video-based self-evaluation |
Primary outcome
Feasibility: Rate of recruitment (acceptability of the trial by trainees)
Time frame: 1 year
% of eligible residents who agree to participate in the study
Feasibility: Rate of recruitment (acceptability of the trial by attending surgeons)
Time frame: 1 year
% of eligible attending surgeons who agree to participate in the study
Feasibility: Adherence to intervention
Time frame: 1 year
% of adherence with intervention (surgeons: intra-operative assessments; trainees: video-based assessments)
Feasibility: Rate of missing assessment data
Time frame: 1 year
% of missing responses
5 secondary outcomes
Intraoperative performance- In-person: attending surgeon
Time frame: 1 year
Procedural times
Time frame: 1 year
Perceived usefulness
Time frame: through study completion, an average of 1 year
Mindset
Time frame: through study completion, an average of 1 year
Intraoperative performance-Video-based: blinded expert assessor
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be available to other researchers
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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.
Saba Balvardi, MD contact
Liane S Feldman, MD principal investigator
McGill University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided video-based self-evaluation in people with Laparoscopy, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 1 inclusion and 1 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 25 Nov 2020. 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 Canada. 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 Liane S Feldman, MD (5149341934 ext. 44004, liane.feldman@mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Rate of recruitment (acceptability of the trial by trainees) (time frame: 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2020.