Robotic Hysterectomy (Benign Indications/Early-stage Cancer)NCT01969487
Effect of Preoperative Simulator Warmup on Intraoperative Robotic Surgical Skills
A study testing Preoperative warm-up on simulator in people with Robotic Hysterectomy (Benign Indications/Early-stage Cancer), run by Johns Hopkins University at 2 sites in United States.
Trial summary
Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room. Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Robotic Hysterectomy (Benign Indications/Early-stage Cancer)
- What is being tested?
- Preoperative warm-up on simulator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2012to Jun 2014
- 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
- Enrollment in the graduate (residency and fellowships) gynecology training program at the study institution;
- Participation as assistant surgeon in a robotic hysterectomy for benign indications for early stage uterine or cervical cancer.
Who cannot join
- Participation as assistant surgeon in a non-robotic hysterectomy or robotic hysterectomy for gynecologic cancer that has spread beyond the uterus based on preoperative imaging and biopsy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
Official title: Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes
Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room. Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed. Although an increasingly large number of patients are undergoing robotic hysterectomy and other robotic surgical procedures, little is known on how to ensure patient safety and treatment effectiveness when trainee surgeons participate in the operating room. Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery simulator by gynecologic surgical trainees on their intraoperative performance and on patient outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major academic medical center to either warm-up immediately before surgery on a robotic surgery simulator or to not warm-up. The attending surgeon supervising the trainee in the operating room is unaware of whether the trainee was assigned to warm-up or no warm-up. The investigators will compare standard robotic surgical skills assessments of the trainees by the supervising attending surgeons and patient outcomes in the two groups.
- Being tested
- Preoperative warm-up on simulator
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative warm-up on simulatorOther
| Study group | Role | What they receive |
|---|---|---|
| Preoperative warm-up on simulator | Experimental | Trainees perform standard practice tasks programmed into a robotic surgical simulator immediately before the surgery. Receives: Other: Preoperative warm-up on simulator |
| No preoperative warm-up | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global rating score - GEARS approach
Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills (OSATS) and the Global Evaluative Assessment of Robotic Surgery (GEARS).
Measured: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Global rating score - OSATS approach
Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills and the Global Evaluative Assessment of Robotic Surgery.
Measured: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Surgical skill metrics
Computed using surgical tool motion and/or video of procedure.
Measured: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Secondary outcomes (5)
Operative time
Measured: Intraoperative
Estimated blood loss
Measured: Intraoperative
Length of hospital stay
Measured: We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
Change in hematocrit
Measured: Postoperative days 1, 2, and 3
Readmission or emergency room visit
Measured: 6 weeks after discharge from hospital (following initial admission for surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Hysterectomy (Benign Indications/Early-stage Cancer)Studies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grace CC Chen, M.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969487
- Sponsor's protocol ID
- NA_00074621
- Other IDs
- WU_00074621
- Status last verified
- Nov 2020
- First submitted
- 25 Sep 2013
- Last updated
- 12 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Warmup on a Simulator by Trainee Surgeons on Intraoperative Robotic Surgical Skill and Postoperative Patient Outcomes
- ClinicalTrials.gov ID
- NCT01969487
- Acronym / sponsor ID
- NA_00074621
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Oct 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.
Surgical residents and fellows acquire operative knowledge and skills by assisting attending surgeons in the operating room. Previous research has shown that practising technical skills prior to operating on patients can improve how skillfully laparoscopic surgery can be performed. Although an increasingly large number of patients are undergoing robotic hysterectomy and other robotic surgical procedures, little is known on how to ensure patient safety and treatment effectiveness when trainee surgeons participate in the operating room. Our study aims to determine the impact of immediate preoperative warm-up on a robotic surgery simulator by gynecologic surgical trainees on their intraoperative performance and on patient outcomes. The investigators are randomly assigning gynecologic surgical trainees at a major academic medical center to either warm-up immediately before surgery on a robotic surgery simulator or to not warm-up. The attending surgeon supervising the trainee in the operating room is unaware of whether the trainee was assigned to warm-up or no warm-up. The investigators will compare standard robotic surgical skills assessments of the trainees by the supervising attending surgeons and patient outcomes in the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative warm-up on simulator | Experimental | Other: Preoperative warm-up on simulatorTrainees perform standard practice tasks programmed into a robotic surgical simulator immediately before the surgery. |
| No preoperative warm-up | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Enrollment in the graduate (residency and fellowships) gynecology training program at the study institution;
- Participation as assistant surgeon in a robotic hysterectomy for benign indications for early stage uterine or cervical cancer.
Key exclusion criteria (1 listed)
- Participation as assistant surgeon in a non-robotic hysterectomy or robotic hysterectomy for gynecologic cancer that has spread beyond the uterus based on preoperative imaging and biopsy.
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 |
|---|---|---|
| Preoperative warm-up on simulator | Other | Preoperative warm-up on simulator |
Primary outcome
Global rating score - GEARS approach
Time frame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills (OSATS) and the Global Evaluative Assessment of Robotic Surgery (GEARS).
Global rating score - OSATS approach
Time frame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Global rating scores assigned by the supervising surgeon immediately after each study surgical procedure. Global rating scores use two different approaches - the Objective Structured Assessment of Surgical Skills and the Global Evaluative Assessment of Robotic Surgery.
Surgical skill metrics
Time frame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)
Computed using surgical tool motion and/or video of procedure.
5 secondary outcomes
Operative time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Length of hospital stay
Time frame: We will follow patients in the study for the duration of their hospital stay; an anticipated average of about 5 days.
Change in hematocrit
Time frame: Postoperative days 1, 2, and 3
Readmission or emergency room visit
Time frame: 6 weeks after discharge from hospital (following initial admission for surgery)
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 12 Nov 2020.
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.
Grace CC Chen, M.D. principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative warm-up on simulator in people with Robotic Hysterectomy (Benign Indications/Early-stage Cancer), run by Johns Hopkins University at 2 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 2 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 12 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 2 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?
Global rating score - GEARS approach (time frame: Assessed during the surgery (scheduled immediately following warm-up/no warm-up)). The study lists 3 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 12 Nov 2020.