EducationNCT04512560
Structured Remote Surgical Coaching to Improve Operative Performance in Laparoscopic Cholecystectomy
A study testing Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training and Surgical Training using Conventional Training Program in people with Education and Coaching, run by Dr. Boris Zevin at 1 site in Canada.
Trial summary
Surgical coaching, defined as a constructive relationship that provides objective feedback to individuals about a broad range of factors influencing operative performance, is a key strategy for integrating adult learning theory into the traditionally didactic arena of surgical education. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training and Surgical Training using Conventional Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2021to 30 Jul 2024
- 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
- General surgery residents (PGY 1-5) who routinely perform components of laparoscopic cholecystectomy as a primary surgeon (under supervision).
Who cannot join
- Individuals with injuries that preclude performance in the operating room will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Structured Remote Surgical Coaching to Improve Operative Performance in Laparoscopic Cholecystectomy: a Multicenter Randomized Control Trial
Surgical coaching, defined as a constructive relationship that provides objective feedback to individuals about a broad range of factors influencing operative performance, is a key strategy for integrating adult learning theory into the traditionally didactic arena of surgical education. It is gaining momentum as an area of potential growth and innovation, and may become a more meaningful method of ongoing professional development for practicing surgeons. Effective coaching interactions encourage discussion, provide feedback, affirm positive beliefs and challenge pre-existing assumptions. The effectiveness and uptake of coaching interventions in surgery can be influenced by the identity of the coach, and cultural or individual surgeon attitudes.
Surgical coaching has been linked to improvements in technical and procedural skills in both simulated and clinical environments. In 2015, a systematic review of surgical coaching showed a positive impact of surgical coaching interventions on learners' perceptions and attitudes, their technical and nontechnical skills, and their performance measures.
The investigators propose to conduct a multicenter randomized controlled trial of structured remote surgical coaching (SRSC) versus conventional surgical training for laparoscopic cholecystectomy performed by surgery residents at three institutions, in Canada and Australia, to not only provide additional evidence in support of validity and generalizability of a structured surgical coaching intervention for surgery trainees, but also to demonstrate improvement in accuracy of self-assessment of operative performance and the feasibility of remote coaching.
Read the detailed description
OBJECTIVES: To compare the effects of adding a structured remote surgical coaching (SRSC) program to conventional surgery training (CST) versus conventional surgery training (CST) alone on general surgery residents' (1) technical performance, (2) technical errors, and (3) accuracy of self-assessment for a laparoscopic cholecystectomy procedure. Feasibility of conducting remote coaching across different times zones and continents will also be explored.
Hypothesis 1: Participation in a SRSC program will result in superior technical skills and fewer technical errors committed during a laparoscopic cholecystectomy as compared to CST.
Hypothesis 2: Participation in a SRSC program will result in a more accurate self-assessment of participants' technical skills as compared to CST.
Hypothesis 3: It will be feasible to coach surgery residents remotely across different time zones and continents.
STUDY DESIGN AND SETTING:
The investigators will conduct a multicenter randomized controlled trial with study participants randomized 1:1 into intervention (SRSC+CST) and control groups (CST). The investigators will use blocked randomization with a block size of 4 and allocation ratio of 1:1 to ensure equal participant distribution over the 24 month continuous recruitment period.
STUDY PARTICIPANTS AND RECRUITMENT:
The investigators will recruit general surgery residents (PGY 1-5) as study participants. Any resident who routinely performs components of a laparoscopic cholecystectomy as a primary surgeon (under supervision) and is rotating on a general surgery service will be invited to participate.
STRUCTURED REMOTE SURGICAL COACHING (SRSC) PROGRAM (INTERVENTION):
Participants randomized to the intervention group will participate in a 3-month SRSC program in addition to CST. They will view a standardized 10-minute video presentation, which will explain the concept of surgical coaching and the purpose of the SRSC program. Surgical coaches will provide structured remote surgical coaching. Credentials and qualifications of each of the coaches are described below (Research Team). Zoom web-conferencing platform (https://zoom.us) will be used for remote coaching. Participants will be asked to provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon prior to the coaching session. Each coach will review the video recording and will identify key themes for discussion. Coaching sessions will be structured using the modified PRACTICE model, will be conducted outside of the clinical environment, and will employ facilitative coaching methods to encourage participants to define specific intra-operative problems and conceptually troubleshoot various solutions. Key observations and discussion points for each session will be recorded in a coaching template. Coaching sessions will be planned to be administered on a bi-weekly basis; however, variability may occur to accommodate residents operating schedule and exposure. The expectation is for each participant to complete three to four coaching sessions each lasting 30-45 minutes.
CONVENTIONAL SURGICAL TRAINING (CONTROL):
Participants randomized to the control group will continue of their usual general surgery residency training including attending scheduled teaching sessions, and continuing with assigned responsibilities on the ward and in the OR. Participants will be asked to record videos of 5 consecutive laparoscopic cholecystectomy procedures that they performed as a primary surgeon during a 3-month period to mimic the duration of exposure in the intervention group.
DEMOGRAPHIC DATA:
The investigators will collect age, sex, post-graduate year of training, handedness, number of basic, intermediate and advanced laparoscopic cases performed as a primary surgeon or assisted before and during the study.
PRIMARY OUTCOME MEASURES:
The investigators will measure technical performance during a laparoscopic cholecystectomy as the primary outcome. Two assessment scales will be used: the Global Operative Assessment of Laparoscopic Skills (GOALS) scale and the Generic Error Rating Tool (GERT) for errors in laparoscopic surgery.
SECONDARY OUTCOME MEASURES:
The investigators will explore, using a post-study questionnaire, the subjective perception of the usefulness of the SRSC program and challenges with remote coaching as the secondary outcome. The investigators will also collect feasibility data including duration of time spent on video review, preparation for the coaching session, and conduct of the session by the coach. Participant self-assessment data for their technical performance at baseline and upon the completion of the study will also be collected.
BASELINE AND POST-INTERVENTION ASSESSMENT:
The 1st and 5th submitted video recording for each study participant will be assessed by a trained rater, blinded to the group allocation and training level of participant, for technical skill and errors using GOALS and GERT scales, respectively. Participants will self-assess their technical performance with the GOALS scale.
SAMPLE SIZE:
Using clinically relevant effect size of 1.25 and 1:1 allocation ratio for groups, a minimum of 9 participants will be required per group to achieve a power of 0.8 and alpha of 0.05. The investigators will aim to recruit a total of 24 participants (12 per group) to account for possible participant dropout. An interim analysis will be performed once 9 participants have been recruited per group. Recruitment will continue until completion of the interim analysis.
DATA ANALYSIS:
The investigators will perform descriptive statistical analysis and will assess the normality of data distribution using the Shapiro-Wilk test. For continuous variables with normal distribution, the investigators will use a t-test for independent samples for between group comparisons, and a paired t-test for within group comparisons. For continuous variables with skewed distribution, the investigators will use the Mann-Whitney U test for between group comparisons, and the Wilcoxon rank sign tests for within group comparisons. The investigators will compare categorical data using the Fisher exact test. The investigators will use Spearman correlations to examine the correlation between self-assessment scores and blinded rater scores.
- Conditions
- Education, Coaching, Surgical, Laparoscopic, Cholecystectomy
- Being tested
- Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training, Surgical Training using Conventional Training Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical TrainingBehavioural
General surgery residents (PGY 1-5) will provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon. The coach will identify key moments or themes for discussion on how to improve technical skills and reduce intra-operative errors during five, 30-45 minute remote coaching sessions .
Surgical Training using Conventional Training ProgramBehavioural
General surgery residents (PGY 1-5) will continue their usual residency training.
| Study group | Role | What they receive |
|---|---|---|
| Structured Remote Surgical Coaching | Experimental | Participants randomized to the intervention group will participate in a 3-month SRSC program in addition to CST. Participants will be asked to provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon prior to the coaching session. Each coach will review the video recording and will identify key themes for discussion. Coaching sessions will be structured using the modified PRACTICE model, will be conducted outside of the clinical environment, and will employ facilitative coaching methods to encourage participants to define specific intra-operative problems and conceptually troubleshoot various solutions. Receives: Behavioral: Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training |
| Conventional Surgical Training | Active comparator | Participants randomized to the control group will continue of their usual general surgery residency training including attending scheduled teaching sessions, and continuing with assigned responsibilities on the ward and in the OR. Receives: Behavioral: Surgical Training using Conventional Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skill set during performance of a laparoscopic cholecystectomy in the operating room
Technical skills during a laparoscopic cholecystectomy in the operating room will be one of the primary outcomes for this study. The Global Operative Assessment of Laparoscopic Skills (GOALS) scale will be used to measure this outcome.
Measured: 90 days
Technical errors made during a laparoscopic cholecystectomy in the operating room
Technical errors during a laparoscopic cholecystectomy in the operating room will be one of the primary outcomes for this study. The Generic Error Rating Tool (GERT) will be used to measure this outcome.
Measured: 90 days
Secondary outcomes (2)
Subjective assessment of the usefulness of SRSC program
A post-study questionnaire will be administered to participants in the intervention group to assess their subjective perception of the usefulness of the SRSC program and challenges that they encountered with remote coaching.
A scale for Perception of Usefulness will be used in this post-study questionnaire with a minimum value of 1 indicating not useful at all and a maximum value of 10 indicating very useful.
Measured: 90 days
Accuracy of self-assessment
Participants' self-assessment scores for technical skill will be compared to the scores assigned by a trained, blinded rater to determine if SRSC improves accuracy of self-assessment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Feb 2021
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Boris Zevin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Boris Zevin, Queen's University
- Investigators
- Boris Zevin, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04512560
- Sponsor's protocol ID
- SURG-497-20
- Status last verified
- Jul 2024
- First submitted
- 31 Mar 2020
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Structured Remote Surgical Coaching to Improve Operative Performance in Laparoscopic Cholecystectomy: a Multicenter Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04512560
- Acronym / sponsor ID
- SURG-497-20
- Conditions
- Education, Coaching, Surgical, Laparoscopic, Cholecystectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Boris ZevinUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 13 Aug 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.
Surgical coaching, defined as a constructive relationship that provides objective feedback to individuals about a broad range of factors influencing operative performance, is a key strategy for integrating adult learning theory into the traditionally didactic arena of surgical education. It is gaining momentum as an area of potential growth and innovation, and may become a more meaningful method of ongoing professional development for practicing surgeons. Effective coaching interactions encourage discussion, provide feedback, affirm positive beliefs and challenge pre-existing assumptions. The effectiveness and uptake of coaching interventions in surgery can be influenced by the identity of the coach, and cultural or individual surgeon attitudes.
Surgical coaching has been linked to improvements in technical and procedural skills in both simulated and clinical environments. In 2015, a systematic review of surgical coaching showed a positive impact of surgical coaching interventions on learners' perceptions and attitudes, their technical and nontechnical skills, and their performance measures.
The investigators propose to conduct a multicenter randomized controlled trial of structured remote surgical coaching (SRSC) versus conventional surgical training for laparoscopic cholecystectomy performed by surgery residents at three institutions, in Canada and Australia, to not only provide additional evidence in support of validity and generalizability of a structured surgical coaching intervention for surgery trainees, but also to demonstrate improvement in accuracy of self-assessment of operative performance and the feasibility of remote coaching.
Detailed description
OBJECTIVES: To compare the effects of adding a structured remote surgical coaching (SRSC) program to conventional surgery training (CST) versus conventional surgery training (CST) alone on general surgery residents' (1) technical performance, (2) technical errors, and (3) accuracy of self-assessment for a laparoscopic cholecystectomy procedure. Feasibility of conducting remote coaching across different times zones and continents will also be explored.
Hypothesis 1: Participation in a SRSC program will result in superior technical skills and fewer technical errors committed during a laparoscopic cholecystectomy as compared to CST.
Hypothesis 2: Participation in a SRSC program will result in a more accurate self-assessment of participants' technical skills as compared to CST.
Hypothesis 3: It will be feasible to coach surgery residents remotely across different time zones and continents.
STUDY DESIGN AND SETTING:
The investigators will conduct a multicenter randomized controlled trial with study participants randomized 1:1 into intervention (SRSC+CST) and control groups (CST). The investigators will use blocked randomization with a block size of 4 and allocation ratio of 1:1 to ensure equal participant distribution over the 24 month continuous recruitment period.
STUDY PARTICIPANTS AND RECRUITMENT:
The investigators will recruit general surgery residents (PGY 1-5) as study participants. Any resident who routinely performs components of a laparoscopic cholecystectomy as a primary surgeon (under supervision) and is rotating on a general surgery service will be invited to participate.
STRUCTURED REMOTE SURGICAL COACHING (SRSC) PROGRAM (INTERVENTION):
Participants randomized to the intervention group will participate in a 3-month SRSC program in addition to CST. They will view a standardized 10-minute video presentation, which will explain the concept of surgical coaching and the purpose of the SRSC program. Surgical coaches will provide structured remote surgical coaching. Credentials and qualifications of each of the coaches are described below (Research Team). Zoom web-conferencing platform (https://zoom.us) will be used for remote coaching. Participants will be asked to provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon prior to the coaching session. Each coach will review the video recording and will identify key themes for discussion. Coaching sessions will be structured using the modified PRACTICE model, will be conducted outside of the clinical environment, and will employ facilitative coaching methods to encourage participants to define specific intra-operative problems and conceptually troubleshoot various solutions. Key observations and discussion points for each session will be recorded in a coaching template. Coaching sessions will be planned to be administered on a bi-weekly basis; however, variability may occur to accommodate residents operating schedule and exposure. The expectation is for each participant to complete three to four coaching sessions each lasting 30-45 minutes.
CONVENTIONAL SURGICAL TRAINING (CONTROL):
Participants randomized to the control group will continue of their usual general surgery residency training including attending scheduled teaching sessions, and continuing with assigned responsibilities on the ward and in the OR. Participants will be asked to record videos of 5 consecutive laparoscopic cholecystectomy procedures that they performed as a primary surgeon during a 3-month period to mimic the duration of exposure in the intervention group.
DEMOGRAPHIC DATA:
The investigators will collect age, sex, post-graduate year of training, handedness, number of basic, intermediate and advanced laparoscopic cases performed as a primary surgeon or assisted before and during the study.
PRIMARY OUTCOME MEASURES:
The investigators will measure technical performance during a laparoscopic cholecystectomy as the primary outcome. Two assessment scales will be used: the Global Operative Assessment of Laparoscopic Skills (GOALS) scale and the Generic Error Rating Tool (GERT) for errors in laparoscopic surgery.
SECONDARY OUTCOME MEASURES:
The investigators will explore, using a post-study questionnaire, the subjective perception of the usefulness of the SRSC program and challenges with remote coaching as the secondary outcome. The investigators will also collect feasibility data including duration of time spent on video review, preparation for the coaching session, and conduct of the session by the coach. Participant self-assessment data for their technical performance at baseline and upon the completion of the study will also be collected.
BASELINE AND POST-INTERVENTION ASSESSMENT:
The 1st and 5th submitted video recording for each study participant will be assessed by a trained rater, blinded to the group allocation and training level of participant, for technical skill and errors using GOALS and GERT scales, respectively. Participants will self-assess their technical performance with the GOALS scale.
SAMPLE SIZE:
Using clinically relevant effect size of 1.25 and 1:1 allocation ratio for groups, a minimum of 9 participants will be required per group to achieve a power of 0.8 and alpha of 0.05. The investigators will aim to recruit a total of 24 participants (12 per group) to account for possible participant dropout. An interim analysis will be performed once 9 participants have been recruited per group. Recruitment will continue until completion of the interim analysis.
DATA ANALYSIS:
The investigators will perform descriptive statistical analysis and will assess the normality of data distribution using the Shapiro-Wilk test. For continuous variables with normal distribution, the investigators will use a t-test for independent samples for between group comparisons, and a paired t-test for within group comparisons. For continuous variables with skewed distribution, the investigators will use the Mann-Whitney U test for between group comparisons, and the Wilcoxon rank sign tests for within group comparisons. The investigators will compare categorical data using the Fisher exact test. The investigators will use Spearman correlations to examine the correlation between self-assessment scores and blinded rater scores.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Remote Surgical Coaching | Experimental | Behavioral: Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical TrainingParticipants randomized to the intervention group will participate in a 3-month SRSC program in addition to CST. Participants will be asked to provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon prior to the coaching session. Each coach will review the video recording and will identify key themes for discussion. Coaching sessions will be structured using the modified PRACTICE model, will be conducted outside of the clinical environment, and will employ facilitative coaching methods to encourage participants to define specific intra-operative problems and conceptually troubleshoot various solutions. |
| Conventional Surgical Training | Active comparator | Behavioral: Surgical Training using Conventional Training ProgramParticipants randomized to the control group will continue of their usual general surgery residency training including attending scheduled teaching sessions, and continuing with assigned responsibilities on the ward and in the OR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- General surgery residents (PGY 1-5) who routinely perform components of laparoscopic cholecystectomy as a primary surgeon (under supervision).
Key exclusion criteria (1 listed)
- Individuals with injuries that preclude performance in the operating room will be excluded.
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 Training using Structured Remote Surgical Coaching in addition to Conventional Surgical TrainingGeneral surgery residents (PGY 1-5) will provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon. The coach will identify key moments or themes for discussion on how to improve technical skills and reduce intra-operative errors during five, 30-45 minute remote coaching sessions . | Behavioural | Structured Remote Surgical Coaching |
| Surgical Training using Conventional Training ProgramGeneral surgery residents (PGY 1-5) will continue their usual residency training. | Behavioural | Conventional Surgical Training |
Primary outcome
Skill set during performance of a laparoscopic cholecystectomy in the operating room
Time frame: 90 days
Technical skills during a laparoscopic cholecystectomy in the operating room will be one of the primary outcomes for this study. The Global Operative Assessment of Laparoscopic Skills (GOALS) scale will be used to measure this outcome.
Technical errors made during a laparoscopic cholecystectomy in the operating room
Time frame: 90 days
Technical errors during a laparoscopic cholecystectomy in the operating room will be one of the primary outcomes for this study. The Generic Error Rating Tool (GERT) will be used to measure this outcome.
2 secondary outcomes
Subjective assessment of the usefulness of SRSC program
Time frame: 90 days
Accuracy of self-assessment
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Boris Zevin, MD principal investigator
Queen's 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 Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training and Surgical Training using Conventional Training Program in people with Education and Coaching, run by Dr. Boris Zevin 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: finished, as of the sponsor's last update on 17 Oct 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skill set during performance of a laparoscopic cholecystectomy in the operating room (time frame: 90 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?
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 17 Oct 2024.