Abnormal Uterine Bleeding, Adenomyosis, Pelvic Pain, Uterine Fibroids
Conditions
Keywords
Laparoscopy, 3D Visual System, Total Hysterectomy
Brief summary
The objective aim is to evaluate whether the use of 3D laparoscopy facilitates the vaginal cuff closure of the vaginal cuff during a total laparoscopic hysterectomy among novice laparoscopists (PGY 2-4, Fellow). This is a randomized single blinded controlled trial comparing the difference in 2D vs. 3D in regards to vaginal cuff closure time stratified by residents and fellows. Patients will undergo a total laparoscopic hysterectomy and will be randomized to either 2D versus 3D.
Detailed description
This is a randomized single blinded controlled trial investigating 3D laparoscopy in the clinical setting. Based on previous studies indicating 3D laparoscopy has improved skills of novice surgeons in the simulation lab, there has been no reports to date investigating the role of 3D laparoscopy in the operating room. Our study will evaluate the facility of 3D laparoscopy in the novice surgeon, mainly residents and fellow. Patients who present for a scheduled total laparoscopic hysterectomy will be randomized to either the standard 2D laparoscopy system or 3D laparoscopy system. Stratifying residents versus fellow, we will compare the time to close the vaginal cuff comparing both systems.
Interventions
DEVICEStorz 3D Laparoscopy System
The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
DEVICE2D Laparoscopy
The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Women with benign conditions such as uterine fibroids, menorrhagia, adenomyosis, pelvic pain, abnormal uterine bleeding
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal Cuff Closure Times | Start of vaginal cuff closure to end of vaginal cuff closure | The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy | Time of Procedure End | The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy. |
Countries
Denmark, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 2D Laparoscopy The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy
2D Laparoscopy: The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy. | 29 |
| 3D Laparoscopy The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy.
Storz 3D Laparoscopy System: The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system. | 28 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 3D equipment rep unable to join | 0 | 1 |
| Overall Study | Physician Decision | 1 | 2 |
| Overall Study | surgery type was changed | 1 | 1 |
Baseline characteristics
| Characteristic | 2D Laparoscopy | 3D Laparoscopy | Total |
|---|---|---|---|
| Age, Continuous | 27.5 years STANDARD_DEVIATION 5.2 | 43.9 years STANDARD_DEVIATION 8.2 | 42.7 years STANDARD_DEVIATION 7.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 26 Participants | 25 Participants | 51 Participants |
| Region of Enrollment Denmark | 11 participants | 10 participants | 21 participants |
| Region of Enrollment United States | 18 participants | 18 participants | 36 participants |
| Sex: Female, Male Female | 29 Participants | 28 Participants | 57 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 3 / 29 | 4 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
Primary
Vaginal Cuff Closure Times
The primary endpoint is the vaginal cuff closure time at the time of a total laparoscopic hysterectomy. As the 2D laparoscopy system is standard during laparoscopic cases, our objective is to assess if there is a difference in vaginal cuff closure time when a 3D laparoscopy system is used instead. At time of the surgery, that patient will be randomized to either system. A resident or fellow will close the vaginal cuff and time to close the vaginal cuff will be recorded.
Time frame: Start of vaginal cuff closure to end of vaginal cuff closure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2D Laparoscopy | Vaginal Cuff Closure Times | 10.17 minutes | Standard Deviation 5.98 |
| 3D Laparoscopy | Vaginal Cuff Closure Times | 12.54 minutes | Standard Deviation 6.99 |
Secondary
Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy
The secondary endpoint is the surgeon estimated blood loss at the time of a total laparoscopic hysterectomy.
Time frame: Time of Procedure End
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 2D Laparoscopy | Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy | 55.74 millileters | Standard Deviation 39.36 |
| 3D Laparoscopy | Estimated Blood Loss at the Time of Total Laparoscopic Hysterectomy | 60.83 millileters | Standard Deviation 62.32 |