Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001419257
Ethics application status
Approved
Date submitted
17/08/2018
Date registered
24/08/2018
Date last updated
16/06/2021
Date data sharing statement initially provided
26/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of warm humidified insufflation for reducing post-operative ileus.
Scientific title
Efficacy of warm humidified insufflation for reducing post-operative ileus in women undergoing open surgery for presumed advanced ovarian, tubal or peritoneal malignancy: A randomised single-blind controlled trial.
Secondary ID [1] 295833 0
Nil
Universal Trial Number (UTN)
U1111-1209-3391
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Presumed advanced ovarian malignancy 309277 0
Presumed advanced tubal malignancy 309350 0
Presumed advanced peritoneal malignancy 309351 0
Condition category
Condition code
Cancer 308152 308152 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fisher and Paykel HumiGard Surgical Humidification system. The HumiGard system allows insufflation of warm humidified CO2 into the open wound cavity at a flow rate of 10L/min. The conditioned gas is delivered via a PVC tube placed on the edge of the surgical wound. The gas fills the wound cavity for the duration of the surgery. The output temperature is ~37 degrees and relative humidity ~90%. The intervention will be set up by the research nurse and placed in the wound by the operating surgeon.
Intervention code [1] 312167 0
Treatment: Surgery
Comparator / control treatment
Standard of care, exposure of the surgical wound to ambient air in the operating room.
Control group
Active

Outcomes
Primary outcome [1] 307126 0
Recovery of bowel function as defined as tolerance of a solid diet (25% of their post-operative meal intake over 2 consecutive meals) and passage of stools.
Timepoint [1] 307126 0
Assessed 12 hourly by study investigator or by phone until tolerance of solid diet.,
Secondary outcome [1] 350767 0
Peritoneal inflammation of inflammation array (Over 90 genes that are targets for a range of inflammatory diseases) as measured by Real Time Quantitative Polymerase Chain Reaction.
Timepoint [1] 350767 0
After incision, 1 hour and 2 hours operatively

Eligibility
Key inclusion criteria
Age 18 or older
Consented for Open Debulking surgery for presumed advanced ovarian, tubal or peritoneal malignancy.
Primary, Interval (after initial chemotherapy), or recurrent setting
Able to give informed consent and understand risks and benefits of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Active inflammatory bowel disease
Moderate to severe renal impairment (eGFR<50mL/min/1.73m2)
Severe hepatic impairment (Child-Pugh C)
Pregnancy
Pre-existing gut motility disorder including endocrine, metabolic or neurological cause
Pre-operative malnutrition requiring parenteral nutrition
Inability to give consent or participate in post-operative assessments due to dementia, cognitive impairment, language difficulties, delirium

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous variables will be analysed using the independent samples t-test (reporting mean and standard deviation) and Mann Whitney U (reporting median and interquartile range) test for parametric and non-parametric data respectively. The Shapiro-Wilk test will be used to assess normality of data as well as assessment of the data histogram. A p-value of <0.05 will mean that the data are not normally distributed.
Multiple linear regression to adjust for covariate data including age, gender, type of operation, surgical technique (open/laparoscopic). Where data are not normally distributed for the primary outcome, continuous data will be log-transformed prior to regression analysis.
We will use SPSS version 24 to analyse all data and 2-sided p values of <0.05 will be deemed significant, and 95% confidence intervals presented where appropriate.
Categorical data will be analysed using the Chi-squared test or Fischer’s exact test where appropriate.

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Date of first participant enrolment
Anticipated
1/09/2018
Actual
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
226
Accrual to date
Final
Recruitment outside Australia
Country [1] 20786 0
New Zealand
State/province [1] 20786 0

Funding & Sponsors
Funding source category [1] 300428 0
Commercial sector/Industry
Name [1] 300428 0
Fisher and Paykel Healthcare
Country [1] 300428 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] 299890 0
None
Name [1] 299890 0
Address [1] 299890 0
Country [1] 299890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301232 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 301232 0
Ministry of Health
133 Molesworth Street
PO Box 2013
Wellington 6011
Ethics committee country [1] 301232 0
New Zealand
Date submitted for ethics approval [1] 301232 0
26/07/2018
Approval date [1] 301232 0
17/08/2018
Ethics approval number [1] 301232 0
18/STH/129

Summary
Brief summary
It is common after surgery to experience a delay in return to normal bowel function which may cause abdominal discomfort and delayed discharge from hospital. The purpose of this study is to investigate if the application of warm humidified carbon dioxide gas in your surgical site during your surgery helps to improve return to bowel function after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86314 0
Dr Cecile Bergzoll
Address 86314 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 2013
Country 86314 0
New Zealand
Phone 86314 0
006493670000
Fax 86314 0
Email 86314 0
[email protected]
Contact person for public queries
Name 86315 0
Miss Jennifer Mackie
Address 86315 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 2013
Country 86315 0
New Zealand
Phone 86315 0
006493670000
Fax 86315 0
Email 86315 0
[email protected]
Contact person for scientific queries
Name 86316 0
Miss Jennifer Mackie
Address 86316 0
Auckland City Hospital
2 Park Road
Grafton
Auckland 2013
Country 86316 0
New Zealand
Phone 86316 0
006493670000
Fax 86316 0
Email 86316 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
No data was collected


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.