Other Surgical ProceduresNCT01433029
Objective Assessment of Technical Skills in Cardiothoracic Surgery
An observational study of Other Surgical Procedures, run by M.D. Anderson Cancer Center at 6 sites in United States.
Trial summary
The goal of this research study is to develop a method of rating videos of CAB procedures that will produce a reliable assessment of a cardiothoracic surgical trainee's technical proficiency. In addition, researchers also want to learn if using a video manual to train raters can help improve rater reliability. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Other Surgical Procedures
- What is being tested?
- Surgical Video Assessments and Video Recording of CAB
- How many people
- 8 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Sep 2011to 22 Jan 2017
- Phase
- Observational
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training. Experienced faculty are cardiothoracic surgeons who regularly perform coronary artery bypass (CAB) procedures and have at least 10 years of post-training experience.
Who may be able to join
- The trainee must be a cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training and must be currently enrolled at any of the following institutions: U.T. Health Science Center in Houston, The Texas Heart Institute/Baylor College of Medicine, U.T. San Antonio, U. T. Southwestern, U.T. M.D. Anderson Cancer Center, and The Methodist Hospital.
- The trainee must provide an informed consent to participate.
- The experience faculty must be a cardiothoracic surgeon who regularly performs CAB procedures and has at least 10 years of post-training experience.
- The experienced faculty is currently operating at the same institutions listed in inclusion criterion 1.
- The experienced faculty must provide written informed consent to participate.
- The faculty rater must be a cardiothoracic surgeon who regularly performs CAB procedures, is practicing in an Adult Cardiothoracic Graduate Medical Evaluation (ACGME) approved CTS training program, and has practiced at least 5 years after certification by the American Board of Thoracic Surgery (ABTS). There is no restriction on geographic location.
- The expert CAB surgeon for Consensus Building must be a cardiothoracic surgeon who regularly performs CAB procedures, is practicing in an ACGME approved CTS training program, and has practiced at least 10 years after certification by the ABTS. There is no restriction on geographic location.
Who cannot join
- N/A
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
The University of Texas Southwestern Medical Center in Dallas
Dallas, Texas, 75390
Texas Heart Institute at St. Luke's Episcopal Hospital
Houston, Texas, 77030
The Methodist Hospital Research Institute
Houston, Texas, 77030
The University of Texas Medical School at Houston
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
The goal of this research study is to develop a method of rating videos of CAB procedures that will produce a reliable assessment of a cardiothoracic surgical trainee's technical proficiency. In addition, researchers also want to learn if using a video manual to train raters can help improve rater reliability.
Read the detailed description
Cardiothoracic Surgeon:
If you agree to take part in this study, you will receive a DVD containing multiple videos of different surgeons or surgical trainees performing CAB procedures. You will be trained by the Principal Investigator (PI) on how you should rate the performance of each surgeon/trainee. You will be randomly assigned to 1 of 2 groups:
- If you are in the Conventional Rater (CR) Group, you will receive conventional training from the PI about how to rate the videos.
- If you are in the Video Rater (VR) Group, you will receive conventional training from the PI about how to rate the videos. You will also receive a video rater training manual.
You will receive up to 38 different recorded procedures while you are on study. Each procedure should last about 15 minutes. You will record the identification code that appears at the beginning of each video, and the date and time that you viewed each video. You will watch each video and then rate the performance of the surgeon/trainee using a checklist and a Global Rating Scale. These rating documents will be given to you on a thumb drive that you will either fill out on your computer or print out and fill in by hand. You will be given more detailed instructions on how to fill out the checklist and rating scales by the Principal Investigator (PI).
Your identity will be coded and blinded throughout the study. No identifying information will be directly linked to your responses. Only the video identification numbers and your code number will be used to identify the assessment data. The code key will be stored in a separate computer or thumb drive.
Length of Study:
You will have 1 month to view and rate all videos. You will be contacted 1 time each week by the PI to monitor your progress.
After you have watched and rated all the videos, you will return the videos, your responses (either on the thumb drive or on printed hard-copies), and the video rater training manual (if you are in the VR group) in a pre-paid mailer.
Up to 20 raters may take part in this study.
Cardiothoracic Surgical Trainee:
If you agree to take part in this study, you will fill out a form that asks about your surgical experience. It will also ask about your age, sex, and initials, but these fields are optional.
You will then use the ProXennon Surgical Headlight Camera System (a small camera that is mounted in place directly over a high-intensity light that you wear on your head) to record yourself performing CAB procedures. The main principal investigator (PI) will be present when the system is being used to make sure that it is set up properly and to collect the videos when the procedures are complete. No audio will be recorded. Each video will begin when the dissection of a coronary artery has begun and will end when all manipulation of the anastomosis is complete. You will record at least 6 separate anastomoses, or at least 2-3 procedures.
The time taken to set-up the recording equipment will be documented by the PI for each procedure. After each procedure, a questionnaire will be completed by the intra-operative personnel (nurses, anesthesiologist, perfusionist, operative surgeon, assistant surgeon) that contains questions about any interference from the recording equipment. Neither you nor the intra-operative personnel will be identified in this questionnaire.
The videos will be given a code number. The code key will be kept separately from the video recordings. No identifying information will be directly linked to your videos. Only the researcher in charge will have access to the code key. This is so the researcher will be able to link the videos to the form you filled out at the beginning of the study describing your surgical experience. All data will be presented in aggregate to protect participant identity.
Length of Study:
Your participation in this study will be over after you have submitted your last recording
This is an investigational study. The ProXennon Surgical Headlight Camera System is an approved, standard method of recording CAB procedures.
Up to 22 trainees and up to 8 experienced surgeons may take part in this study.
- Conditions
- Other Surgical Procedures
- Being tested
- Surgical Video Assessments, Video Recording of CAB
- Keywords
- Surgical Procedure, Assessment, Cardiothoracic Surgery, Coronary artery bypass, CAB, Video recordings, Global rating scale, GRS, Cardiothoracic surgeon, Surgical trainees
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Video AssessmentsOther
Rate performance of the surgeon/trainee in each CAB video performance (5 recorded procedures) using two rating scales, a checklist and the Global Rating Scale. Up to 38 different recorded procedures rated while on the study, each procedure lasting about 15 minutes.
Video Recording of CABOther
Each video begins when dissection of a coronary artery has begun and ends when all manipulation of anastomosis is complete. At least 6 separate anastomoses will be recorded, or at least 2-3 procedures. A ProXennon Surgical Headlight Camera System (a small camera that is mounted in place directly over a high-intensity light that is worn on the head) records the performance of the coronary artery bypass (CAB) procedures.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Rater (CR) | CR Group receives conventional training from PI about how to rate coronary artery bypass (CAB) videos. Receives: Other: Surgical Video Assessments | |
| Video Rater (VR) | VR Group receives conventional training from PI about how to rate CAB videos, along with a video rater training manual. Receives: Other: Surgical Video Assessments | |
| CAB Recording | CAB recording of performance cardiothoracic surgeon or surgical trainee in 1st, 2nd, or 3rd year of training. Receives: Other: Video Recording of CAB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Video Recordings of Cardiothoracic Surgery (CTS) Procedures
Assessing 5 recorded procedures with qualified raters using two rating scales; a checklist developed using a consensus building project and a global rating scale (GRS) adapted from an established surgical assessment tool. The GRS uses a 5 point scale and behavioral anchors are provided for 1, 3, and 5 (a score of 1 equals a novice, 3 equals a competent surgeon, and 5 equals an expert). Raters have 1 month to view videos.
Measured: 1 month for rating
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study start1 Sep 2011
- Primary completion22 Jan 2017
- Study completion22 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ara Vaporciyan, MD,BS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433029
- Sponsor's protocol ID
- 2010-0595
- Status last verified
- Jan 2017
- First submitted
- 8 Sep 2011
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Assessment of Technical Skills in Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT01433029
- Acronym / sponsor ID
- 2010-0595
- Conditions
- Other Surgical Procedures
- Keywords
- Surgical Procedure, Assessment, Cardiothoracic Surgery, Coronary artery bypass, CAB, Video recordings, Global rating scale, GRS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 1 Sep 2011 (actual)
- Primary completion
- 22 Jan 2017 (actual)
- Study completion
- 22 Jan 2017 (actual)
- First posted
- 13 Sep 2011 (estimated)
- 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.
The goal of this research study is to develop a method of rating videos of CAB procedures that will produce a reliable assessment of a cardiothoracic surgical trainee's technical proficiency. In addition, researchers also want to learn if using a video manual to train raters can help improve rater reliability.
Detailed description
Cardiothoracic Surgeon:
If you agree to take part in this study, you will receive a DVD containing multiple videos of different surgeons or surgical trainees performing CAB procedures. You will be trained by the Principal Investigator (PI) on how you should rate the performance of each surgeon/trainee. You will be randomly assigned to 1 of 2 groups:
- If you are in the Conventional Rater (CR) Group, you will receive conventional training from the PI about how to rate the videos.
- If you are in the Video Rater (VR) Group, you will receive conventional training from the PI about how to rate the videos. You will also receive a video rater training manual.
You will receive up to 38 different recorded procedures while you are on study. Each procedure should last about 15 minutes. You will record the identification code that appears at the beginning of each video, and the date and time that you viewed each video. You will watch each video and then rate the performance of the surgeon/trainee using a checklist and a Global Rating Scale. These rating documents will be given to you on a thumb drive that you will either fill out on your computer or print out and fill in by hand. You will be given more detailed instructions on how to fill out the checklist and rating scales by the Principal Investigator (PI).
Your identity will be coded and blinded throughout the study. No identifying information will be directly linked to your responses. Only the video identification numbers and your code number will be used to identify the assessment data. The code key will be stored in a separate computer or thumb drive.
Length of Study:
You will have 1 month to view and rate all videos. You will be contacted 1 time each week by the PI to monitor your progress.
After you have watched and rated all the videos, you will return the videos, your responses (either on the thumb drive or on printed hard-copies), and the video rater training manual (if you are in the VR group) in a pre-paid mailer.
Up to 20 raters may take part in this study.
Cardiothoracic Surgical Trainee:
If you agree to take part in this study, you will fill out a form that asks about your surgical experience. It will also ask about your age, sex, and initials, but these fields are optional.
You will then use the ProXennon Surgical Headlight Camera System (a small camera that is mounted in place directly over a high-intensity light that you wear on your head) to record yourself performing CAB procedures. The main principal investigator (PI) will be present when the system is being used to make sure that it is set up properly and to collect the videos when the procedures are complete. No audio will be recorded. Each video will begin when the dissection of a coronary artery has begun and will end when all manipulation of the anastomosis is complete. You will record at least 6 separate anastomoses, or at least 2-3 procedures.
The time taken to set-up the recording equipment will be documented by the PI for each procedure. After each procedure, a questionnaire will be completed by the intra-operative personnel (nurses, anesthesiologist, perfusionist, operative surgeon, assistant surgeon) that contains questions about any interference from the recording equipment. Neither you nor the intra-operative personnel will be identified in this questionnaire.
The videos will be given a code number. The code key will be kept separately from the video recordings. No identifying information will be directly linked to your videos. Only the researcher in charge will have access to the code key. This is so the researcher will be able to link the videos to the form you filled out at the beginning of the study describing your surgical experience. All data will be presented in aggregate to protect participant identity.
Length of Study:
Your participation in this study will be over after you have submitted your last recording
This is an investigational study. The ProXennon Surgical Headlight Camera System is an approved, standard method of recording CAB procedures.
Up to 22 trainees and up to 8 experienced surgeons may take part in this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Rater (CR) | – | Other: Surgical Video AssessmentsCR Group receives conventional training from PI about how to rate coronary artery bypass (CAB) videos. |
| Video Rater (VR) | – | Other: Surgical Video AssessmentsVR Group receives conventional training from PI about how to rate CAB videos, along with a video rater training manual. |
| CAB Recording | – | Other: Video Recording of CABCAB recording of performance cardiothoracic surgeon or surgical trainee in 1st, 2nd, or 3rd year of training. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training. Experienced faculty are cardiothoracic surgeons who regularly perform coronary artery bypass (CAB) procedures and have at least 10 years of post-training experience.
Key inclusion criteria (7 listed)
- The trainee must be a cardiothoracic surgical trainee in their 1st, 2nd, or 3rd year of training and must be currently enrolled at any of the following institutions: U.T. Health Science Center in Houston, The Texas Heart Institute/Baylor College of Medicine, U.T. San Antonio, U. T. Southwestern, U.T. M.D. Anderson Cancer Center, and The Methodist Hospital.
- The trainee must provide an informed consent to participate.
- The experience faculty must be a cardiothoracic surgeon who regularly performs CAB procedures and has at least 10 years of post-training experience.
- The experienced faculty is currently operating at the same institutions listed in inclusion criterion 1.
- The experienced faculty must provide written informed consent to participate.
Key exclusion criteria (1 listed)
- N/A
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 Video AssessmentsRate performance of the surgeon/trainee in each CAB video performance (5 recorded procedures) using two rating scales, a checklist and the Global Rating Scale. Up to 38 different recorded procedures rated while on the study, each procedure lasting about 15 minutes. | Other | Conventional Rater (CR), Video Rater (VR) |
| Video Recording of CABEach video begins when dissection of a coronary artery has begun and ends when all manipulation of anastomosis is complete. At least 6 separate anastomoses will be recorded, or at least 2-3 procedures. A ProXennon Surgical Headlight Camera System (a small camera that is mounted in place directly over a high-intensity light that is worn on the head) records the performance of the coronary artery bypass (CAB) procedures. | Other | CAB Recording |
Primary outcome
Feasibility of Video Recordings of Cardiothoracic Surgery (CTS) Procedures
Time frame: 1 month for rating
Assessing 5 recorded procedures with qualified raters using two rating scales; a checklist developed using a consensus building project and a global rating scale (GRS) adapted from an established surgical assessment tool. The GRS uses a 5 point scale and behavioral anchors are provided for 1, 3, and 5 (a score of 1 equals a novice, 3 equals a competent surgeon, and 5 equals an expert). Raters have 1 month to view videos.
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 30 Jan 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Ara Vaporciyan, MD,BS principal investigator
M.D. Anderson Cancer Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Other Surgical Procedures, run by M.D. Anderson Cancer Center at 6 sites in United States.
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 7 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 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Feasibility of Video Recordings of Cardiothoracic Surgery (CTS) Procedures (time frame: 1 month for rating). 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 30 Jan 2017.