Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000818235
Ethics application status
Approved
Date submitted
9/05/2018
Date registered
11/05/2018
Date last updated
8/08/2019
Date data sharing statement initially provided
8/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Warm Humidified Insufflation on Lens Fogging during Laparoscopic Cholecystectomy. A Single centre, superiority, blinded randomised controlled trial.
Scientific title
Effect of Warm Humidified Insufflation on Lens Fogging during Laparoscopic Cholecystectomy. A Single centre, superiority, blinded randomised controlled trial.
Secondary ID [1] 294576 0
None
Universal Trial Number (UTN)
U1111-1203-2641
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cholecystitis 307763 0
Condition category
Condition code
Surgery 306809 306809 0 0
Surgical techniques
Oral and Gastrointestinal 306840 306840 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible patients undergoing elective laparoscopic cholecystectomy at Auckland District Health Board will be approached to take part in the study. If the patient consents they will be randomised to either receive warmed and humidified CO2 insufflation using the Humigard device or standard CO2 insufflation during the procedure.

Intervention arm – Patients will receive humidified insufflation. This will be given by commercially available gas insufflation device. Connected to an insufflator, Humigard warms and humidifies the CO2 to 37oC and 100% relative humidity.

The images taken by the laparoscopic camera will be assessed during the procedure and the number of fogging events will be recorded by a research nurse. The images will be recorded and after the procedure they will be saved onto an external hard drive. Three experienced surgeons who are blinded to the treatment allocation will score the images and assess any fogging events.

There is no follow up for this study.
Intervention code [1] 301137 0
Treatment: Surgery
Intervention code [2] 301158 0
Treatment: Devices
Comparator / control treatment
Control arm – Patients will receive the same treatment for their cholecystitis and the camera will not be set up to receive Humigard.

The images taken by the laparoscope will be assessed during the procedure and the number of fogging events will be recorded by a research nurse. The images will be recorded and after the procedure they will be saved onto an external hard drive. Three experienced surgeons who are blinded to the treatment allocation will score the images and assess any fogging events.

A sub-set of de-identified, pooled video data will be shared with the engineering department of the sponsor, Fisher & Paykel Healthcare, to enable creation of an algorithm that is needed to analyse all caputured videos at completion of the study.

There is no follow up for this study.
Control group
Active

Outcomes
Primary outcome [1] 305810 0
Number of fogging events recorded onto the case report form by a research nurse at the time of surgery.
Timepoint [1] 305810 0
Throughout the surgical procedure by a research nurse and retrospectively based on review of laparoscopic recordings by a consultant.
Primary outcome [2] 305811 0
Duration of fogging measured by a research nurse using a stopwatch.
Timepoint [2] 305811 0
Throughout the surgical procedure by a research nurse and retrospectively based on review of laparoscopic recordings by a consultant.
Secondary outcome [1] 346656 0
The combined subjective effort fogging had on the procedure as reported by the operating surgeon, assistant surgeon and scrub nurse. This will be measured using a Likert-like scale.
Timepoint [1] 346656 0
Within one hour of completion of surgery.

Eligibility
Key inclusion criteria
1. Scheduled to undergo laparoscopic cholecystectomy
2. Able to give informed consent
3. Male or female 18 years of age or older.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Participant is pregnant

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients are randomised using random numbers obtained by a computer-based random number generator. Concealment will be achieved by the use of opaque envelopes opened at surgery by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size calculation - To calculate the number of patients to be include in the trial the standard power parameter of 0.8 and a test level of 0.05 will be used. A recent study scored lens fogging using a scientific model which evaluated fogging on a scales from 1 to 4 and measured differences with a SD of 1. To account for possible increased variation in patients we increased the SD to 1.5, Thus, we used the SD value of 1.5, and a mean separation of one on the ordinal scale to separate the groups for substantive significance and to estimate a samples size. This generated a required sample size of 37 per arm, totaling 74 patients. Allowing for a drop out rate of 10% per group the numbers should be expanded to 61 in each arm or 122 in total.

Statistical analyses - Statistical difference between the two groups will be sought using independent sample t-tests for mean difference and Pearson’s chi-square tests for proportional differences. Odds ratios for effect size to be calculated along with confidence intervals. An alpha level of 0.05 to be used for all statistical tests. Analyses of effect of surgeon to be compared using independent sample t-tests and Cohen’s effect size. For demographic variables, an alpha test level of 0.05 under standard assumptions. Multivariable logistic regression for factors such as surgeon experience, operating centre etc. Kappa tests for reviewer agreement.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
18/06/2018
Actual
8/06/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
122
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 10386 0
New Zealand
State/province [1] 10386 0
Auckland

Funding & Sponsors
Funding source category [1] 299193 0
Commercial sector/Industry
Name [1] 299193 0
Fisher and Paykel Healthcare
Country [1] 299193 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country
New Zealand
Secondary sponsor category [1] 298717 0
None
Name [1] 298717 0
Address [1] 298717 0
Country [1] 298717 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300118 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 300118 0
Ministry of Health
133 Molesworth Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 300118 0
New Zealand
Date submitted for ethics approval [1] 300118 0
26/03/2018
Approval date [1] 300118 0
14/05/2018
Ethics approval number [1] 300118 0
18/STH/71

Summary
Brief summary
This study is a medical device study on the effect of warm humidified carbon dioxide on optical clarity in laparoscopic cholecystectomy surgery. The medical device being used is called HumiGard and is approved for use in humans and is in routine medical use in several countries. It is manufactured by Fisher and Paykel Healthcare Ltd. Fisher and Paykel Healthcare (referred to as ‘FPH’) is a New Zealand owned medical device company and is the sponsor of this trial.

Loss of optical clarity during laparoscopic surgery remains a major concern for surgeons. Clear vision in surgery is important not only for safety by preventing accidental injury, but also to improve precision and reduce operative time. The condensation that leads to “fogging” occurs when the temperature of the camera lens is at or below the temperature of the air surrounding the object and this study aims at investigating whether a new surgical humidifier can reduce lens fogging by warming and humidifying the carbon dioxide gas used during laparoscopic cholecystectomies.

Participants undergoing laparoscopic cholecystectomy surgery at Auckland Hospital or Greenlane Hospital who meet the inclusion and exclusion criteria will be offered the opportunity to participate in the pilot study.

To measure the number of fogging events that occur during a routine procedure, the video feed of the laparoscopic camera will be recorded and analysed post-operatively. This camera and its recordings are nearly entirely internal and so there will be no way to identity participants from the video. In addition to the laparoscopic camera, a camera will be placed directly about the external surgical area as to capture all events that occur outside of the abdomen (not recorded by the laparoscopic camera).

During surgery, investigators or a research nurse will also take record of other measurements that will be monitored as part of standard of care. The measurements will include data such as core body temperature and the length of the procedure.

Video/image analysis of laparoscopic camera will be done at a later time point by medical professionals.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82622 0
Prof John Windsor
Address 82622 0
Building 599, level 12
ACH Support Building
Park Road
Grafton
Auckland 1142
Country 82622 0
New Zealand
Phone 82622 0
+64 9 373 7599
Fax 82622 0
Email 82622 0
[email protected]
Contact person for public queries
Name 82623 0
Sheryl Fenwick
Address 82623 0
Building 599, level 12
ACH Support Building
Park Road
Grafton
Auckland 1142
Country 82623 0
New Zealand
Phone 82623 0
+64 9 923 1908
Fax 82623 0
Email 82623 0
[email protected]
Contact person for scientific queries
Name 82624 0
Lotte van den Heuij
Address 82624 0
Fisher and Paykel Healthcare
15 Maurice Paykel Place
East Tamaki
Auckland
2013
Country 82624 0
New Zealand
Phone 82624 0
+64 9 574 0123
Fax 82624 0
Email 82624 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3512Clinical study report    This will be decided upon completion of the study.



Results publications and other study-related documents

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