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The aim of this study is to assess the need and potential benefits of the wide field of view during general and gynecology laparoscopic surgery.
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 evaluate standard laparoscopic surgery using the 270Surgical system; "The SurroundScope".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SurroundScope | Experimental | For laparoscopic camera system, the SurroundScope. 270-degree angle videoscope (270Surgical, Israel) was used |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SurroundScope | Device | The study will evaluate standard laparoscopic surgery using the 270Surgical system. The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the need and potential benefits of the wide field of view | 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). | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the 270 Lenses clearance contribution to the procedure. | Lenses clearance contribution will be assessed by: Rating of the visual impairment due to smoke using a likert-type scale of 1-5: 1=imperceptible, 2= perceptible but not interfering, 3=same as in standard procedure, 4=annoying, 5=Very annoying. | Day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Additional measurements - timing, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital. | Measuring time of laparoscopic procedure (lap inserted to final lap removal) | day of surgery |
| Additional measurements- Intraoperative events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gideon Sroka, MD | Contact | +97248359137 | 0 | Gideon.sroka@b-zion.org.il |
| Name | Affiliation | Role |
|---|---|---|
| Gideon Sroka, MD | Bnai Zion Medical Center, 47 Golomb St. Haifa, 31048, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnai Zion Medical Center | Recruiting | Haifa | 31048 | Israel |
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| Assessment of the 270 Lenses clearance contribution to the procedure. |
Lenses clearance contribution will be assessed by: Amount of removals and pauses for fog and smoke incidences using a scale of 1-5: 1=none, 2= less than in standard procedure, 3=same as in standard procedure, 4= more than in standard procedure, 5=much more than in standard procedure. |
| Day of surgery |
| A record of complications related to the SurroundScope | The SurroundScope related operative complications, that require further clinical intervention | Day of surgery up to 2 weeks after the surgical procedure |
Measurements include collecting a log of events that could have been missed with standard scope and were captured in the side screens |
| day of surgery |
| Additional measurements - lengs of stay, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital. | Number of days patients stayed at the hospital following the operation | Up to two weeks |