Laparoscopy Clinical Trial
Official title:
Assessment of the SurroundScope in Urologic Surgical Procedures
The aim of this study is to evaluate standard urological surgeries using the 270Surgical system vs same procedures using the standard scope
Status | Not yet recruiting |
Enrollment | 100 |
Est. completion date | December 2022 |
Est. primary completion date | December 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age greater than or equal to 18 - Capable of giving informed consent. - Scheduled for laparoscopic urologic surgery: Partial nephrectomy, Nephrectomy Exclusion Criteria: - Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator) - Patients with contraindications to undergo laparoscopic surgery. - Patients with American Society of Anesthesiology (ASA) class* >3 - Advanced cirrhosis with failure of hepatic function - Patients who have participated in another interventional clinical study in the last month. - Pregnancy - Unable to consent (due to cultural, language or neurological barriers) |
Country | Name | City | State |
---|---|---|---|
Israel | Rabin Medical Center | Petah Tikva |
Lead Sponsor | Collaborator |
---|---|
270Surgical |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse events | Amount of intraoperative adverse event | During the surgery - Since the first incision performed till the last incision is closed | |
Other | Length of stay | Length of stay at the hospital following the surgery in days | Since the surgery completion to discharge from the medical center | |
Other | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Secondary | Time of defined surgical tasks - port placement time | Time to complete port placement will be measured | During the defined surgical task | |
Secondary | Time of defined surgical tasks - transection time | Time to transection of renal artery & Vein with stapler will be measured | During the defined surgical task | |
Secondary | Time of defined surgical tasks - clamp time | Clamp time during partial nephrectomy will be measured | During the defined surgical task |
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