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Methods to assess belly button cleanliness prior to keyhole surgery

Patient umbilical cleanliness prior to laparoscopic surgery: a pilot study to validate outcome assessments

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000278932
Enrollment
62
Registered
2020-03-03
Start date
2020-08-01
Completion date
2020-10-01
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 docto

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.

Sponsors

Dr Carolyn E Vasey
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Eligible participants will be persons 18 years or older who are booked for elective laparoscopic abdominal surgery at Ballarat Health Services.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Jul 23, 2026