None listed
Conditions
Brief summary
Loss of visual clarity during laparoscopic surgery remains a major challenge for surgeons as this can contribute to the safety and outcomes of patients. Typically, a suboptimal display of surgical field can occur due to fogging on the front of the laparoscope lens, smoke generated during tissue cutting, and/or splatter of blood, bodily fluids, fat droplets or tissue etc. When the visual clarity is suboptimal, the surgical procedure will be disrupted or prolonged. Currently there are a number of products for restoring laparoscopic visual clarity. Multiple products are often needed in a surgery to tackle the visual clarity challenge. The frequent practice is still to remove the laparoscope from the abdomen for lens cleaning outside of the body. The F&P Laparoscopic Vision System is designed to remove smoke from the field of view of surgeons, enabling surgeons to continue with their work with better visual clarity and less interruption. Better visual clarity has been demonstrated in bench model and uses in patients. The aim of this prospective randomized study is to evaluate whether laparoscopic visual clarity can be improved by using the F&P Vision System compared to other available visual clarity products. Participants will be recruited and randomized to the intervention (where surgeons will use the F&P Laparoscopic Vision System during the surgery) or control group (where surgeons will use the off-the-shelf smoke filter plus other available visual clarity products during the surgery). All other aspects of the surgery are to be carried out as per standard of care and hospital practice. Study participation ends at the end of surgery.
Interventions
Eligible participants scheduled for laparoscopic anterior resection or right hemicolectomy procedure at Footscray Hospital - Western Health will be invited to participate in the study. Upon obtaining their consent, participants will be randomised to either of two groups:
Group 1 - Control group (operating surgeon will use standard-of-care products to improve laparoscopic lens clarity)
Group 2 - Interventional group (operating surgeon will use F&P Laparoscopic Vision System during the laparoscop
Eligible participants scheduled for laparoscopic anterior resection or right hemicolectomy procedure at Footscray Hospital - Western Health will be invited to participate in the study. Upon obtaining their consent, participants will be randomised to either of two groups: Group 1 - Control group (operating surgeon will use standard-of-care products to improve laparoscopic lens clarity) Group 2 - Interventional group (operating surgeon will use F&P Laparoscopic Vision System during the laparoscopic procedure) The F&P Laparoscopic Vision System consist of a laparoscopic sheath and a smoke filter. The system will be used throughout the laparoscopic surgery (approximately 2- 5 hours). During surgery, the laparoscopic sheath will be attached to the laparoscope and is used for insufflation of the abdominal cavity. The laparoscopic smoke filter will be connected to a laparoscopic port to filter and remove the smoke generated from the patient's abdominal cavity during tissue cutting, etc. This study assesses the laparoscopic visual impairments in both groups. Apart from the visual clarity interventions, all other aspects of the surgery are to be conducted as per the standard of care and hospital practices. Study participation ends at the end of laparoscopic surgery. There are no clinical or laboratory assessments in this study. F&P Laparoscopic Vision System is a single-use product, to be used only for laparoscopic procedures and is disposed of after the surgery. All staff members involved in the surgery including the operating surgeons, theatre staff and theatre technicians will be notified of the protocol requirements, Adherence will be maintained by the implementation of checklists. A research coordinator will be employed to ensure that all parties involved adhere to the protocol.
Sponsors
Fisher and Paykel Healthcare Pty Ltd.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participating individuals should be: - scheduled for a laparoscopic anterior resection or right hemicolectomy procedure to be performed by a participating surgeon at Footscray Hospital - Western Health - 18 years and older - can provide written informed consent The study does not have specific criteria for including surgeons, other than their willingness to assess the F&P Laparoscopic Vision system. After the surgery, participating surgeons in both study groups will subjectively evaluate the clarity of laparoscopic vision during the procedure.
Exclusion criteria
Individuals are excluded from participating in this study if: 1. Pregnant 2. American Society of Anesthesiologists (ASA) Class 4 or 5 3. Surgical procedure requires concomitant use of humidified insufflation during laparoscopy 4. Surgical procedure requires concomitant use of valveless insufflation system during laparoscopy 5. Surgical procedure requires Robotic-assisted laparoscopy The study does not have any specific criteria for the surgical team.
Outcome results
None listed