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The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope
The tremendous popularity of the laparoscopic surgeries is balanced with its tradeoffs - the needs for an excellent intracavitary visualization along with a surgeon skill set capable of performing these, often more technically challenging procedures. Image quality has improved, but there are still various restrictions to images captured by the lens at the tip of a long tubular laparoscope. 270Surgical developed a 270 degree angle scope to overcome these unmet needs and improve the image quantity and extent during laparoscopy. The study will compare the use of the 270Surgical system (The "SurroundScope") to standard laparoscope during partial nephrectomy and nephrectomy urological surgeries;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SurroundScope | Experimental | For laparoscopic camera system, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used |
|
| Standard laparoscope | Active Comparator | For laparoscopic camera system, the Standard laparoscope that is in a standard use at the medical center is used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SurroundScope | Device | The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of the efficient work time with the standard scope and the SurroundScope - Time of surgery | Data collected include - skin to skin time of surgery | During the surgery - Since the first incision performed till the last incision is closed |
| Analysis of the efficient work time with the standard scope and the SurroundScope - tools and ports Visibility time | Data collected include - Visibility time of tools and ports in the Field of view | During the surgery - Since the first incision performed till the last incision is closed |
| Analysis of the efficient work time with the standard scope and the SurroundScope - time of scope removals | Data collected include - Time of scope removals during the case to clear smoke or fog | During the surgery - Since the first incision performed till the last incision is closed |
| Measure | Description | Time Frame |
|---|---|---|
| Time of defined surgical tasks - port placement time | Time to complete port placement will be measured | During the defined surgical task |
| Time of defined surgical tasks - transection time | Time to transection of renal artery & Vein with stapler will be measured |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Amount of intraoperative adverse event | During the surgery - Since the first incision performed till the last incision is closed |
| Length of stay | Length of stay at the hospital following the surgery in days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrew Nado, MD | Contact | +972 (0)547228500 | nadua@clalit.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Andrew Nado, MD | Rabin Medical Center, 39 Jabotinski St., Petah Tikva 49100 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | 49100 | Israel |
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For laparoscopic camera system to be used in urological surgeries, the SurroundScope, 270-degree angle videoscope (270Surgical, Israel) is used. This will be compared to the standard laparoscopic system use.
The study will evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope. The procedure will be performed according to the institution's standard of care, using the SurroundScope or the standard scope for visualization. Each surgery will be captured on video.
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Patients are not aware of the laparoscopic system that will be used during the operation.
| Standard Laparoscope | Device | The procedure will be performed according to the institution's standard of care, using the Standard laparoscope for visualization. |
|
| During the defined surgical task |
| Time of defined surgical tasks - clamp time | Clamp time during partial nephrectomy will be measured | During the defined surgical task |
| Since the surgery completion to discharge from the medical center |
| Surgeon's perception 270surgical | Surgeon's perception of the 270surgical System - Assessed by a multi-question subjective questionnaire completed in the OR, immediately after the case, by the surgeon and the camera person and constructed on a Likert-type, 5-point scale (1=Strongly disagree, 2=Disagree, 3=Neither agree or disagree, 4=Agree, 5=Strongly agree). | Immediately following the surgery is completed |