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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2D Laparoscopy | Active Comparator | The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy |
|
| 3D laparoscopy | Active Comparator | The Storz 3D Laparoscopy System is the intervention we are studying at the time of the total laparoscopic hysterectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Storz 3D Laparoscopy System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Start of vaginal cuff closure to end of vaginal cuff closure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of Procedure End |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon Einarsson, MD, PhD, MPH | Brigham and Women's Hospital | Principal Investigator |
| Sarah L Cohen, MD, MPH | Brigham and Women's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Odense University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16985832 | Background | Bhayani SB, Andriole GL. Three-Dimensional (3D) Vision: Does It Improve Laparoscopic Skills? An Assessment of a 3D Head-Mounted Visualization System. Rev Urol. 2005 Fall;7(4):211-4. | |
| 23072406 | Background | Tanagho YS, Andriole GL, Paradis AG, Madison KM, Sandhu GS, Varela JE, Benway BM. 2D versus 3D visualization: impact on laparoscopic proficiency using the fundamentals of laparoscopic surgery skill set. J Laparoendosc Adv Surg Tech A. 2012 Nov;22(9):865-70. doi: 10.1089/lap.2012.0220. Epub 2012 Oct 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 3D Laparoscopy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | minutes | Start of vaginal cuff closure to end of vaginal cuff closure |
|
Adverse event data was collected from the day of surgery to 8 weeks following the operation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ER visit | Skin and subcutaneous tissue disorders | Systematic Assessment | Subject presented to ER 5 days after discharge concerned about blood clot in hand where IV had been. Seen and prescribed warm compresses and discharged. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jon I. Einarsson | Brigham and Women's Hospital | 617-732-5500 | jeinarsson@partners.org |
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| ID | Term |
|---|---|
| D007889 | Leiomyoma |
| D008796 | Metrorrhagia |
| D017699 | Pelvic Pain |
| D062788 | Adenomyosis |
| ID | Term |
|---|---|
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 2D Laparoscopy | Device | The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy. |
|
| Odense |
| Denmark |
| Background | Einarsson JI, Wang KC, Cohen SL, Sandberg EM, Vree FEM, Jonsdottir GM, Gobern J, Brown DN. A Randomized Controlled Trial of Barbed versus Traditional Suture for Vaginal Cuff Closure at Time of Total Laparoscopic Hysterectomy: Preliminary Results. Abstracts/ Journal of Minimally Invasive Gynecology. 19 (2012); S36-70. |
| 31172324 | Derived | Ajao MO, Larsen CR, Manoucheri E, Goggins ER, Rask MT, Cox MKB, Mushinski A, Gu X, Cohen SL, Rudnicki M, Einarsson JI. Two-dimensional (2D) versus three-dimensional (3D) laparoscopy for vaginal cuff closure by surgeons-in-training: a randomized controlled trial. Surg Endosc. 2020 Mar;34(3):1237-1243. doi: 10.1007/s00464-019-06886-9. Epub 2019 Jun 6. |
| 3D equipment rep unable to join |
|
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| 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. |
|
|
| 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. | Posted | Mean | Standard Deviation | millileters | Time of Procedure End |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 3 |
| 29 |
| EG001 | 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. | 0 | 28 | 0 | 28 | 4 | 28 |
|
| Reoperation for vaginal cuff dehiscence | Surgical and medical procedures | Systematic Assessment | Subject presented to ER 18 days after surgery with abdominal pain. Rxed with dilaudid; required re-operation for cuff dehiscence. |
|
| Iritation around abdominal surgical incision site | Skin and subcutaneous tissue disorders | Systematic Assessment | Subject experienced some postoperative red/itching around incision sites - near smaller incisions like a rash; advised oral antihistamines and topical hydrocortisone for presumed dermabond reaction. Improved with treatment. |
|
| Incision cellulitis | Infections and infestations | Systematic Assessment | Subject was treated with antibiotics for postoperative incision cellulitis. |
|
| Yeast infection | Infections and infestations | Systematic Assessment | Subjected was treated with diflucan for postoperative yeast infection. |
|
| Intraoperative complication | Injury, poisoning and procedural complications | Systematic Assessment | Intraoperative cystotomy (bladder injury), repaired laparoscopically. Normal recovery. |
|
| Urinary retention | General disorders | Systematic Assessment | Subject had postoperative urinary retention with transient Foley catheter needed but returned to normal by post-operative follow up. |
|
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| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |