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Trial registered on ANZCTR
Registration number
ACTRN12620000278932
Ethics application status
Approved
Date submitted
3/02/2020
Date registered
3/03/2020
Date last updated
3/03/2020
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered
Titles & IDs
Public title
Methods to assess belly button cleanliness prior to keyhole surgery
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Scientific title
Patient umbilical cleanliness prior to laparoscopic surgery: a pilot study to validate outcome assessments
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Secondary ID [1]
300417
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None
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Universal Trial Number (UTN)
U1111-1247-6332
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Umbilical cleanliness
316074
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Condition category
Condition code
Surgery
314346
314346
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0
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Other surgery
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants in the intervention group will be provided with materials and written instructions to clean their umbilicus. Cleaning will occur when participants present to hospital for laparoscopic surgery. Cleaning may occur at any time in the waiting period between patients' presentation to hospital and their operation, so long as the cleaning occurs on the same day as the operation. Cleaning will occur in the privacy of admission clinic rooms, and researchers, who are medical students or doctors, will be present in the clinic room to observe the cleaning routine. Cleaning the umbilicus is expected to take no longer than five minutes of participants’ time.
The cleaning materials will comprise ordinary household hygiene products to which participants have no known allergy, for example, soap, body wash and olive oil. All participants will continue to have their umbilici cleaned by surgeons prior to skin incision intraoperatively.
The cleaning of participant umbilici will be undertaken to facilitate validation of the Umbilical Cleanliness Scale (UCS). The UCS is a 5-point scale designed to enable a rapid visual assessment of umbilical cleanliness intraoperatively. The initial items on the UCS were devised by consultant surgeons who participate in abdominal surgery. These surgeons will not participate in the subsequent validation of the scale.
Departmental consultant and registrar surgeons will be asked to use the UCS to score photographs of clean and unclean patient umbilici. Researchers will photograph patient umbilici intraoperatively, just prior to anti-septic skin preparation. Photographs of patients will be of the abdomen only and will not be identifiable. Photographs will be printed on a hard-copy handout that will be provided to surgeons to record their scores. Each surgeon will score the same set of photographs on two separate occasions separated by at least two weeks. No patient-identifying information will be included on these handouts. The scoring of hand-outs is expected to take no longer than five minutes of surgeons’ time.
The bacterial load of participant umbilici will also be measured using a swab taken by researchers at the time the photographs are taken. Swabs (and their results) will be non-identifiable. The process of photographing and swabbing umbilici intraoperatively is expected to take no longer than two minutes per participant.
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Intervention code [1]
316713
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Treatment: Other
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Comparator / control treatment
Participants in the control group will not receive any cleaning instructions or materials and present for their operation as normal. These participants will also have their umbilici photographed and swabbed, as per the intervention group. All participants will continue to have their umbilici cleaned by surgeons prior to skin incision, in accordance with routine operating procedures.
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Control group
Active
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Outcomes
Primary outcome [1]
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The validity of the Umbilical Cleanliness Scale, which will be determined by calculating both the Scale's convergent validity and ability to differentiate between known groups. These calculations will be based on the scores assigned to photographs of participant umbilici and the bacterial load of swabs of participant umbilici.
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Assessment method [1]
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Timepoint [1]
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16 weeks after study commencement
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Primary outcome [2]
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The reliability of the Umbilical Cleanliness Scale, which will be determined by calculating both the test-retest reliability and inter-rater reliability of the Scale. These calculations will be based on the scores assigned to photographs of participant umbilici.
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Assessment method [2]
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Timepoint [2]
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16 weeks after study commencement
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Secondary outcome [1]
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The bacterial load of cleaned versus uncleaned participant umbilici, determined by analysing swabs of participant umbilici.
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Assessment method [1]
379408
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Timepoint [1]
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16 weeks after study commencement
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Eligibility
Key inclusion criteria
Eligible participants will be persons 18 years or older who are booked for elective laparoscopic abdominal surgery at Ballarat Health Services.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients will be excluded if they cannot understand English, have a health condition that impairs their ability to offer informed consent, have a known allergy to the proposed cleaning materials, or do not have an umbilicus.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participant allocation will be concealed using sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to control or intervention groups using random permuted blocks. Researchers recruiting participants will be blinded to the block sizes.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
To meet the primary objective of the study, the scores assigned to participant photographs will be used to determine the reliability and validity of the UCS using the following parameters for scale validation. The data will be analysed using SPSS software.
Test-retest reliability
To determine the extent to which individual surgeons’ scores for the same photographs remain consistent across two separate occasions, the intraclass correlation coefficient will be calculated using a 2-way random-effects model.
Inter-rater reliability
To determine the extent to which different surgeons assign the same score to the same photograph, Krippendorff’s alpha will be calculated.
Convergent validity
To determine the extent to which the scores correlate with the bacterial load of the umbilicus, a Spearman Rank Correlation will be calculated.
Differentiation by known groups
To determine whether the scores of umbilici that have and have not been cleaned differ, a Mann-Whitney U Test will be used.
To meet the secondary objective of the study, the difference in the bacterial load of the umbilici of participants in the control and intervention groups will be determined using an unpaired t-test (two-tailed hypothesis).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/03/2020
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Actual
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Date of last participant enrolment
Anticipated
4/05/2020
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Actual
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Date of last data collection
Anticipated
25/08/2020
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Ballarat Health Services (Base Hospital) - Ballarat Central
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Recruitment postcode(s) [1]
29168
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3350 - Ballarat Central
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Recruitment postcode(s) [2]
29169
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3350 - Ballarat
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Dr Carolyn E Vasey
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Address [1]
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Ballarat Health Services
1 Drummond St N
Ballarat Central
VIC 3350
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Country [1]
304839
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Australia
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Funding source category [2]
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Commercial sector/Industry
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Name [2]
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Anaeron Medical Supplies
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Address [2]
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Anaeron Pty Ltd
PO Box 22
Forestville NSW 2087
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Country [2]
305074
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Australia
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Primary sponsor type
Individual
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Name
Dr Carolyn E Vasey
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Address
Ballarat Health Services
1 Drummond St N
Ballarat Central
VIC 3350
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
305173
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Country [1]
305173
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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The Ballarat Health Services (BHS) and St John of God Ballarat Hospital (SJGBH) Human Research Ethics Committee (HREC)
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Ethics committee address [1]
305249
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Ballarat Health Services
1 Drummond St N
Ballarat Central
VIC 3350
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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30/10/2019
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Approval date [1]
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19/02/2020
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Ethics approval number [1]
305249
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HREC/59785/BHSSJOG-2020-202981
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Ethics committee name [2]
305465
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Ballarat Health Services and St John of God Healthcare Human Research Ethics Committee
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Ethics committee address [2]
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Ballarat Base Hospital
Drummond Street North
Ballarat, Victoria, 3353
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Ethics committee country [2]
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Australia
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Date submitted for ethics approval [2]
305465
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30/10/2019
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Approval date [2]
305465
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19/02/2020
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Ethics approval number [2]
305465
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HREC/59785/BHSSJOG-2020-202981
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Summary
Brief summary
In keyhole surgery, a cut is made through the belly button. Many patients do not realise this and present for their operation with unclean belly buttons. This makes it difficult for the surgeon to ensure that the skin is sterilised before making a cut and may increase the risk of an infection after the operation. Our overall aim is to determine whether providing written education to patients prior to keyhole surgery improves the cleanliness of the belly button. Before this research can occur, we first need to study a scale that enables surgeons to visually assess the cleanliness of belly buttons. To do this, surgeons will use the scale to score photographs of clean and unclean participant belly buttons. Swabs will also be used to measure the bacterial load in participant belly buttons. The scores and bacterial load will then be used to determine whether the scale is a valid and reliable measure of belly button cleanliness. This scale can then be used to determine whether education improves belly button cleanliness in subsequent research.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Carolyn E Vasey
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Address
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Department of Surgery
Ballarat Health Services
1 Drummond St North
Ballarat Central
VIC 3350
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Country
99762
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Australia
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Phone
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+61 438299530
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Eleanor Watson
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Address
99763
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Department of Surgery
Ballarat Health Services
1 Drummond St North
Ballarat Central
VIC 3350
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Country
99763
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Australia
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Phone
99763
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+61400685091
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Fax
99763
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Email
99763
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[email protected]
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Contact person for scientific queries
Name
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Ms Eleanor Watson
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Address
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Department of Surgery
Ballarat Health Services
1 Drummond St North
Ballarat Central
VIC 3350
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Country
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Australia
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Phone
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+61400685091
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Fax
99764
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Email
99764
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
6713
Ethical approval
[email protected]
6714
Informed consent form
[email protected]
6715
Clinical study report
[email protected]
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.
Download to PDF