Hysterectomy for Abnormal Uterine BleedingNCT01916343
Laparoscopic Gynecology Curriculum for Residents
A study testing Study Laparoscopic Curriculum in people with Hysterectomy for Abnormal Uterine Bleeding, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Gynecologists are currently using laparoscopy to perform many surgeries traditionally approached by laparotomy. The technical skills required for laparoscopic surgery are different than the skills required for laparotomy, causing a prolonged learning curve. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hysterectomy for Abnormal Uterine Bleeding
- What is being tested?
- Study Laparoscopic Curriculum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Dec 2013
- 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
- Novice residents (defined as having performed less than 10 laparoscopic salpingectomies)
- Patients undergoing uncomplicated right-sided salpingectomies prophylactically at the time of laparoscopic hysterectomy, laparoscopic salpingo-ophorectomies, or laparoscopic-assisted vaginal hysterectomies.
Who cannot join
- Residents who have performed more than 10 laparoscopic salpingectomies
- Residents in PGY3 or higher
- Patients with multiple prior abdominal surgeries, high BMI, significant adnexal pathology, and extensive endometriosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents
Gynecologists are currently using laparoscopy to perform many surgeries traditionally approached by laparotomy. The technical skills required for laparoscopic surgery are different than the skills required for laparotomy, causing a prolonged learning curve. Currently there is no standardized laparoscopy curriculum for gynecology residents. This study aims to develop a specific evidence-based surgical skills gynecologic curriculum that could be instituted in residency programs at a national and international level. The investigators will then validate the curriculum using Obstetrics and Gynecology residents through a cognitive examination, a technical skills examination, and a video recording of performance in the operating room.
HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team training exercises. The investigators hypothesize that residents in the experimental curriculum-trained group will perform better than the residents in the traditional residency curriculum-trained group on a cognitive examination, a technical skills examination, and in the operating room. The operating room performance will be judged by blinded experts on a previously validated evaluation tool.
- Being tested
- Study Laparoscopic Curriculum
- Keywords
- Laparoscopy, Surgical skills, Team training, Obstetrics and Gynecology, Curriculum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study Laparoscopic CurriculumProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Study Laparoscopic Curriculum | Experimental | Residents will perform a salpingectomy in the operating room, which will be video-recorded through the laparoscopic camera. The residents in the intervention group will then complete the salpingectomy at the conclusion of the curriculum. Following the completion of the curriculum, residents in the intervention group will undergo a multiple-choice examination as well as a repeat skills examination. Receives: Procedure: Study Laparoscopic Curriculum |
| Standard Clinical Education | No intervention | Residents will perform a salpingectomy in the operating room, which will be video-recorded through the laparoscopic camera. The standard clinical education residents will perform the procedure as per standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical Performance Score
Technical performance score will be assessed via a previously validated tool known as the OSA-LS (Objective Structured Assessment of Laparoscopic Salpingectomy), with the score received on the OSA-LS being equivalent to their technical score. The OSA-LS is based on the OSATS9, along with a rating scale that has been modified for laparoscopic cholecystectomy. The latter was developed by the primary investigator, Dr. Teodor Grantcharov, and consists of both a reduced global rating scale (GRS) made suitable for laparoscopic surgery, along with a task-specific rating scale known as the operative component rating scale (OCRS). Previously in a pilot study, ten video recorded operations were assessed in order to standardize assessments and to make adjustments to the overall scale. Residents will be video recorded performing a salpingectomy in the operating room. These recordings will be then be scored as per the OSA-LS, by a blinded observer in order to generate an overall assessment.
Measured: 9 months
Secondary outcomes (2)
Cognitive Test Scores
The cognitive training component of the curriculum will consist of of self-directed reading and video-based learning. Participants will learn theoretical principals and management of post operative complications due to laparoscopic gynecologic surgery and watch videos of gynecologic procedures with an expert facilitator.
Measured: 5 months
Surgical Skills
To determine if the proposed laparoscopic curriculum will improve resident scores assessed by cognitive and technical skills examination.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hysterectomy for Abnormal Uterine BleedingStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teodor Grantcharov, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01916343
- Sponsor's protocol ID
- 12-159
- Status last verified
- Feb 2019
- First submitted
- 19 Jun 2013
- Last updated
- 22 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Larsen CR, Grantcharov T, Schouenborg L, Ottosen C, Soerensen JL, Ottesen B. Objective assessment of surgical competence in gynaecological laparoscopy: development and validation of a procedure-specific rating scale. BJOG. 2008 Jun;115(7):908-16. doi: 10.1111/j.1471-0528.2008.01732.x.
PubMed 18485171
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design of a Comprehensive Evidence-Based Laparoscopy Curriculum for Gynecology Residents
- ClinicalTrials.gov ID
- NCT01916343
- Acronym / sponsor ID
- 12-159
- Keywords
- Laparoscopy, Surgical skills, Team training, Obstetrics and Gynecology, Curriculum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 5 Aug 2013 (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.
Gynecologists are currently using laparoscopy to perform many surgeries traditionally approached by laparotomy. The technical skills required for laparoscopic surgery are different than the skills required for laparotomy, causing a prolonged learning curve. Currently there is no standardized laparoscopy curriculum for gynecology residents. This study aims to develop a specific evidence-based surgical skills gynecologic curriculum that could be instituted in residency programs at a national and international level. The investigators will then validate the curriculum using Obstetrics and Gynecology residents through a cognitive examination, a technical skills examination, and a video recording of performance in the operating room.
HYPOTHESIS: The investigators aim is to design a standardized evidence-based comprehensive laparoscopic curriculum that focuses on cognitive knowledge, surgical skills, and team training exercises. The investigators hypothesize that residents in the experimental curriculum-trained group will perform better than the residents in the traditional residency curriculum-trained group on a cognitive examination, a technical skills examination, and in the operating room. The operating room performance will be judged by blinded experts on a previously validated evaluation tool.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Laparoscopic Curriculum | Experimental | Procedure: Study Laparoscopic CurriculumResidents will perform a salpingectomy in the operating room, which will be video-recorded through the laparoscopic camera. The residents in the intervention group will then complete the salpingectomy at the conclusion of the curriculum. Following the completion of the curriculum, residents in the intervention group will undergo a multiple-choice examination as well as a repeat skills examination. |
| Standard Clinical Education | No intervention | –Residents will perform a salpingectomy in the operating room, which will be video-recorded through the laparoscopic camera. The standard clinical education residents will perform the procedure as per standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Novice residents (defined as having performed less than 10 laparoscopic salpingectomies)
- Patients undergoing uncomplicated right-sided salpingectomies prophylactically at the time of laparoscopic hysterectomy, laparoscopic salpingo-ophorectomies, or laparoscopic-assisted vaginal hysterectomies.
Key exclusion criteria (3 listed)
- Residents who have performed more than 10 laparoscopic salpingectomies
- Residents in PGY3 or higher
- Patients with multiple prior abdominal surgeries, high BMI, significant adnexal pathology, and extensive endometriosis
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 |
|---|---|---|
| Study Laparoscopic Curriculum | Procedure or surgery | Study Laparoscopic Curriculum |
Primary outcome
Technical Performance Score
Time frame: 9 months
Technical performance score will be assessed via a previously validated tool known as the OSA-LS (Objective Structured Assessment of Laparoscopic Salpingectomy), with the score received on the OSA-LS being equivalent to their technical score. The OSA-LS is based on the OSATS9, along with a rating scale that has been modified for laparoscopic cholecystectomy. The latter was developed by the primary investigator, Dr. Teodor Grantcharov, and consists of both a reduced global rating scale (GRS) made suitable for laparoscopic surgery, along with a task-specific rating scale known as the operative component rating scale (OCRS). Previously in a pilot study, ten video recorded operations were assessed in order to standardize assessments and to make adjustments to the overall scale. Residents will be video recorded performing a salpingectomy in the operating room. These recordings will be then be scored as per the OSA-LS, by a blinded observer in order to generate an overall assessment.
2 secondary outcomes
Cognitive Test Scores
Time frame: 5 months
Surgical Skills
Time frame: 5 months
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 22 Feb 2019.
- Background: PubMed 18485171Larsen CR, Grantcharov T, Schouenborg L, Ottosen C, Soerensen JL, Ottesen B. Objective assessment of surgical competence in gynaecological laparoscopy: development and validation of a procedure-specific rating scale. BJOG. 2008 Jun;115(7):908-16. doi: 10.1111/j.1471-0528.2008.01732.x.
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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.
Teodor Grantcharov, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Study Laparoscopic Curriculum in people with Hysterectomy for Abnormal Uterine Bleeding, run by Unity Health Toronto 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 2 inclusion and 3 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 22 Feb 2019. 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?
Technical Performance Score (time frame: 9 months). 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 NCT01916343, which also lists 1 linked publication.
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 22 Feb 2019.