Laparoscopic Surgery
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICESurroundScope
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.
Sponsors
270Surgical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to 18 2. Capable of giving informed consent 3. Scheduled for general or gynecology laparoscopic surgery or open procedure that in the surgeon's opinion can be performed laparoscopically with the 270System
Exclusion criteria
1. Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator) 2. Patients with contraindications to undergo surgery 3. Patients with ASA class\* \>3 4. Advanced cirrhosis with failure of hepatic function 5. Patients who have participated in another interventional clinical study in the last month 6. Pregnancy 7. Unable to consent (due to cultural, language or neurological barriers)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the need and potential benefits of the wide field of view | Day of surgery | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of the 270 Lenses clearance contribution to the procedure. | Day of surgery | 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. |
| A record of complications related to the SurroundScope | Day of surgery up to 2 weeks after the surgical procedure | The SurroundScope related operative complications, that require further clinical intervention |
Other
| Measure | Time frame | Description |
|---|---|---|
| Additional measurements - timing, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital. | day of surgery | Measuring time of laparoscopic procedure (lap inserted to final lap removal) |
| Additional measurements- Intraoperative events | day of surgery | Measurements include collecting a log of events that could have been missed with standard scope and were captured in the side screens |
| Additional measurements - lengs of stay, compared to retrospective data of matched anonymous 100 patients' data from the medical records of the hospital. | Up to two weeks | Number of days patients stayed at the hospital following the operation |
Countries
Israel
Contacts
Primary ContactGideon Sroka, MD
Outcome results
None listed