Trial Review

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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
Scientific title
Patient umbilical cleanliness prior to laparoscopic surgery: a pilot study to validate outcome assessments
Secondary ID [1] 300417 0
None
Universal Trial Number (UTN)
U1111-1247-6332
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Umbilical cleanliness 316074 0
Condition category
Condition code
Surgery 314346 314346 0 0
Other surgery

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 316713 0
Treatment: Other
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.

Control group
Active

Outcomes
Primary outcome [1] 322718 0
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.
Timepoint [1] 322718 0
16 weeks after study commencement
Primary outcome [2] 323029 0
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.
Timepoint [2] 323029 0
16 weeks after study commencement
Secondary outcome [1] 379408 0
The bacterial load of cleaned versus uncleaned participant umbilici, determined by analysing swabs of participant umbilici.
Timepoint [1] 379408 0
16 weeks after study commencement

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.

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

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)
Participant allocation will be concealed using sealed opaque envelopes.
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.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/03/2020
Actual
Date of last participant enrolment
Anticipated
4/05/2020
Actual
Date of last data collection
Anticipated
25/08/2020
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15739 0
Ballarat Health Services (Base Hospital) - Ballarat Central
Recruitment postcode(s) [1] 29168 0
3350 - Ballarat Central
Recruitment postcode(s) [2] 29169 0
3350 - Ballarat

Funding & Sponsors
Funding source category [1] 304839 0
Self funded/Unfunded
Name [1] 304839 0
Dr Carolyn E Vasey
Country [1] 304839 0
Australia
Funding source category [2] 305074 0
Commercial sector/Industry
Name [2] 305074 0
Anaeron Medical Supplies
Country [2] 305074 0
Australia
Primary sponsor type
Individual
Name
Dr Carolyn E Vasey
Address
Ballarat Health Services
1 Drummond St N
Ballarat Central
VIC 3350
Country
Australia
Secondary sponsor category [1] 305173 0
None
Name [1] 305173 0
Address [1] 305173 0
Country [1] 305173 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305249 0
The Ballarat Health Services (BHS) and St John of God Ballarat Hospital (SJGBH) Human Research Ethics Committee (HREC)
Ethics committee address [1] 305249 0
Ethics committee country [1] 305249 0
Australia
Date submitted for ethics approval [1] 305249 0
30/10/2019
Approval date [1] 305249 0
19/02/2020
Ethics approval number [1] 305249 0
HREC/59785/BHSSJOG-2020-202981
Ethics committee name [2] 305465 0
Ballarat Health Services and St John of God Healthcare Human Research Ethics Committee
Ethics committee address [2] 305465 0
Ethics committee country [2] 305465 0
Australia
Date submitted for ethics approval [2] 305465 0
30/10/2019
Approval date [2] 305465 0
19/02/2020
Ethics approval number [2] 305465 0
HREC/59785/BHSSJOG-2020-202981

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

Contacts
Principal investigator
Name 99762 0
Dr Carolyn E Vasey
Address 99762 0
Department of Surgery
Ballarat Health Services
1 Drummond St North
Ballarat Central
VIC 3350
Country 99762 0
Australia
Phone 99762 0
+61 438299530
Fax 99762 0
Email 99762 0
carolynvasey@hotmail.com
Contact person for public queries
Name 99763 0
Eleanor Watson
Address 99763 0
Department of Surgery
Ballarat Health Services
1 Drummond St North
Ballarat Central
VIC 3350
Country 99763 0
Australia
Phone 99763 0
+61400685091
Fax 99763 0
Email 99763 0
elliewatson@live.com.au
Contact person for scientific queries
Name 99764 0
Eleanor Watson
Address 99764 0
Department of Surgery
Ballarat Health Services
1 Drummond St North
Ballarat Central
VIC 3350
Country 99764 0
Australia
Phone 99764 0
+61400685091
Fax 99764 0
Email 99764 0
elliewatson@live.com.au

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
6713Ethical approval  howcleanisyourbellybutton@outlook.com
6714Informed consent form  howcleanisyourbellybutton@outlook.com
6715Clinical study report  howcleanisyourbellybutton@outlook.com



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.