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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
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The EndoWrist One Vessel Sealer is a bipolar electrosurgical instrument for use with the da Vinci Si robotic surgical system. It is intended for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit within the jaws of the instrument. Their use in this study will be to perform tissue transection during PLND such that the intended use is within the FDA-approved domain for this instrument. Investigators intend to identify whether its use for PLND reduces lymphoceles given that the device is known to seal vessels up to 7 mm, which is much larger than lymphatic vessels encountered during PLND. Because the instrument is new and has been FDA approved for less than one year, there is no published literature regarding its use to date.
Our hypothesis is that using the Vessel Sealer on a single side of the pelvis will reduce the incidence of screening detected lymphoceles on that side. Investigators propose a total sample size of 120 patients.
Investigators propose a prospective, randomized, single-blinded study of patients diagnosed with pelvic cancer who are electing to undergo robotic surgery with PLND. The patients in our trial will be pelvic cancer patients at risk for lymphocele after PLND. Given the safe nature of the product and the patient's risk for lymphocele after PLND and subsequent potential morbidity, there is justification to give patients the option for inclusion in the study. Investigators intend to determine whether the rate of lymphocele formation after PLND at the time of robotic pelvic cancer surgery can be reduced by using the robotic Vessel Sealer unilaterally for the lymph node dissection. The side of the pelvis of each patient will be randomly selected by Excel's® random number function "RAND()" to receive the Vessel Sealer dissection. Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control and eliminate patient specific confounding variables such as BMI, and surgeon specific factors such as degree and method of hemostasis utilized by each surgeon. In addition, Dr. Abaza will be the only surgeon performing these procedures, eliminating variation in technique between surgeons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intuitive Vessel Sealer | Active Comparator | Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. |
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| Maryland Bipolar Cautery | Active Comparator | Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intuitive Vessel Sealer | Device | Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Lymphoceles | Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Surgical Complications | Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2). | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronney Abaza, MD, FACS | OhioHealth | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dublin Methodist Hospital | Columbus | Ohio | 43016 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34677080 | Derived | Abaza R, Henderson SJ, Martinez O. Robotic Vessel Sealer Device for Lymphocele Prevention After Pelvic Lymphadenectomy: Results of a Randomized Trial. J Laparoendosc Adv Surg Tech A. 2022 Jul;32(7):721-726. doi: 10.1089/lap.2021.0531. Epub 2021 Oct 22. |
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Participants must be eligible for robotic procedures.
Prostatectomy patients were recruited from a single robotic urologists office, between 1/15/13 and 5/12/14. The final followup visit was completed on 12/18/14.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intuitive Vessel Sealer | Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intuitive Vessel Sealer | Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Incidence of Lymphoceles | Identify whether the use of the Vessel Sealer for PLND reduces the incidence of screening detected lymphoceles via CT scan of the pelvis by comparing the Vessel Sealer side of the pelvis with the control side of the pelvis. | Lymphoceles were identified by CT scan at 3 months post surgery. | Posted | Number | participants | 4 months |
|
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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 | Study Participants | Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rehospitalization | General disorders | Systematic Assessment | Rehospitalization due to fever and back pain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ronney Abaza | OhioHealth | 614-544-8104 | ronney.abaza@ohiohealth.com |
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| ID | Term |
|---|---|
| D008210 | Lymphocele |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D003560 | Cysts |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side. |
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| Secondary | Surgical Complications | Evaluate perioperative and postoperative surgical outcomes at 4 months after surgery. Possible outcomes include "no complications" (0), "minor complications" (1), and "major complications" (2). | Posted | Number | participants | 4 months |
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| 3 |
| 114 |
| 0 |
| 114 |
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| Bilateral Pulmonary Embolisms | Blood and lymphatic system disorders | Systematic Assessment | Shortness of breath. ER visit-CT angioplasty with thrombolysis and IVC filter placement with extended hospital (2 day) stay. |
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| Prolonged existing hospitalization | General disorders | Systematic Assessment | Post-operative course complicated by syncope (likely vasovagal in context of pain), SOB, Ileus. |
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| D005834 |
| Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |