Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001094561
Ethics application status
Approved
Date submitted
15/08/2024
Date registered
11/09/2024
Date last updated
19/10/2024
Date data sharing statement initially provided
11/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Visual clarity using the Fisher and Paykel Laparoscopic Vision System – A Prospective Randomised Controlled Trial
Scientific title
Visual Clarity using the F&P Laparoscopic Vision System during Laparoscopic Anterior Resection and Right Hemicolectomy in Adults – A Prospective Randomised Controlled Trial
Secondary ID [1] 312765 0
Nil known
Universal Trial Number (UTN)
U1111-1311-7469
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparoscopic Surgery 334304 0
Loss of visual clarity 334895 0
Condition category
Condition code
Surgery 330960 330960 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328978 0
Treatment: Devices
Comparator / control treatment
For the control group, off-the-shelf visual clarity interventional tools or standard tools per hospital practices can be used, except for the F&P Laparoscopic Vision System. All other aspects of the surgery are to be conducted following the standard of care and hospital practice for the procedure.
Control group
Active

Outcomes
Primary outcome [1] 339068 0
Number of visual impairment events during the laparoscopic surgery.
Timepoint [1] 339068 0
Visual impairment events will be recorded by the research staff throughout the laparoscopic surgery. The study participation ends upon the completion of surgery.
Secondary outcome [1] 438462 0
The subjective impact of the visual impairment event had on the procedure as reported by the operating surgeon.
Timepoint [1] 438462 0
End of the surgical procedure

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment will be achieved using sealed opaque envelopes opened by the research team at the time of surgery setup
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the number of visual impairment events (primary outcome) and subjective assessment of visual clarity (secondary outcome), statistical difference between the two study groups will be analysed using independent t-tests for mean difference. Continuous variables, e.g. duration of visual impairment disruption, will be tested for normality using the D’Agostino-Pearson test. Non-parametric continuous variables will be analysed using Mann-Whitney U test. Basic demographic and other baseline characteristics will be collected and analysed for all participants. Summary statistics (mean, standard deviation, median, minimum and maximum for quantitative variables) will be presented for the total study population. The level of significance for all tests will be set at p< 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/10/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26918 0
Footscray Hospital - Footscray
Recruitment postcode(s) [1] 42982 0
3011 - Footscray

Funding & Sponsors
Funding source category [1] 316759 0
Commercial sector/Industry
Name [1] 316759 0
Fisher & Paykel Healthcare Healthcare Ltd.
Country [1] 316759 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare Pty Ltd.
Address
Country
Australia
Secondary sponsor category [1] 319442 0
None
Name [1] 319442 0
Address [1] 319442 0
Country [1] 319442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315527 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315527 0
Ethics committee country [1] 315527 0
Australia
Date submitted for ethics approval [1] 315527 0
31/07/2024
Approval date [1] 315527 0
10/10/2024
Ethics approval number [1] 315527 0
HREC Reference Number: HREC/109864/MH-2024

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134970 0
Prof Justin Yeung
Address 134970 0
Department of Colorectal Surgery, Footscray Hospital, Western Health, 160, Gordon Street, Footscray, Victoria 3011, Australia.
Country 134970 0
Australia
Phone 134970 0
+61 421 684 985
Fax 134970 0
Email 134970 0
[email protected]
Contact person for public queries
Name 134971 0
Smitha Nair
Address 134971 0
Fisher and Paykel Healthcare, 15 Maurice Paykel Place East Tamaki, Auckland 2013, New Zealand.
Country 134971 0
New Zealand
Phone 134971 0
+64 220123527
Fax 134971 0
Email 134971 0
[email protected]
Contact person for scientific queries
Name 134972 0
Smitha Nair
Address 134972 0
Fisher and Paykel Healthcare, 15 Maurice Paykel Place East Tamaki, Auckland 2013, New Zealand.
Country 134972 0
New Zealand
Phone 134972 0
+64 220123527
Fax 134972 0
Email 134972 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.