Umbilical Hernia
Conditions
Keywords
Umbilical hernia, Taping, Observation, Medical tape, Strapping, Hernia strapping, Hernia taping, Hernia bracing
Brief summary
Umbilical hernias in infants are very common and in most cases disappear on their own by school age. If this does not happen, surgery may be necessary. Until then, the umbilical hernia is usually only observed and not treated. This approach is currently considered the medical standard. With this study, the investigators want to find out whether taping the umbilical hernia causes it to disappear more quickly. The investigators also want to know whether taping leads to less frequent protruding belly buttons (fewer "outies") and whether taping can cause a change in the quality of life of the parents. The investigatorsare therefore planning a study in which they will randomly divide patients into groups (observation versus taping) and examine the infants at 6 and 12 months of age. In addition to our physical examinations, the parents will each fill out a questionnaire about any stress they may be experiencing due to the umbilical hernia.
Interventions
PROCEDURETaping of the umbilical hernia
The study intervention is taping of the umbilical hernia. Patients parents of the treatment group shall be instructed by our physiotherapist on how to perform umbilical hernia taping. A parent information sheet on the standardized application of taping will be provided. Umbilical hernia taping involves reducing the prolapse beneath the level of the abdominal wall and applying multiple medical tapes to apply long-lasting and light pressure on the umbilicus as to prevent the hernia from protruding.
Sponsors
University Children's Hospital, Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Months to 3 Months
Healthy volunteers
No
Inclusion criteria
* Infants with protruding umbilical hernias with a visible protrusion above the level of the abdominal wall * Infants over 1 month of age and under 3 months of age * If the patient is born prematurely (\<37 0/7 weeks) it has to also be at least 4 weeks old AND over 32 weeks postmenstrual age (see below) and younger than 52 weeks postmenstrual age (i.e. 3 months of corrected age) * Legal custodian gives consent to participation in study
Exclusion criteria
* Umbilical abnormalities, such as stump still in place, continuing wet umbilicus or umbilical granuloma * Premature infants younger than 32 weeks of postmenstrual age * Patients with known underlying skin diseases in whom taping may cause extensive skin damage, such as Epidermolysis bullosa * Patients after suture-less closure of gastroschisis * Patients in whom the umbilical tapes cannot be positioned as per study protocol, e.g. in patients with intestinal ostomies.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical hernia closure rates at 6 months | at 6 months of age | The primary objective is to show that umbilical hernia closure rates at 6 months of age in infants with umbilical hernias undergoing umbilical taping are increased compared to the control group without taping. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical hernia closure rates at 12 months of age | At 12 months of age | — |
| Occurrence of complications of umbilical hernias within the first 12 months | Until 12 months of age | — |
| Diameter of umbilical fascial defect at all visits | Measured at each visit (first visit, at 6 months and at 12 months of age) | — |
| Parental health-related quality of life assessed by the Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module | Measured at each visit (first visit, at 6 months and at 12 months of age) | The Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module is scored from 0 to 100: * Highest score: 100 = better family functioning and less negative impact on the family. * Lowest score: 0 = worse family functioning and greater negative impact on the family. |
| Parental satisfaction of the appearance of the umbilicus after closure of the fascial ring assessed by the Infant Umbilical score | Measured only if and after umbilical fascial closure occurs at either 6 or 12 months | The Infant Umbilical Score is currently under validation and assesses six aspects, each scored from 1 to 5, giving a total score ranging from 6 to 30. Higher scores indicate greater reviewer satisfaction with the appearance of the infant umbilicus. |
| Blinded surgeons assessment of the appearance of the umbilicus after closure of the fascial ring assessed by the Infant Umbilical score | at 12 months of age | The Infant Umbilical Score is currently under validation and assesses six aspects, each scored from 1 to 5, giving a total score ranging from 6 to 30. Higher scores indicate greater reviewer satisfaction with the appearance of the infant umbilicus. |
Countries
Switzerland
Contacts
CONTACTHannah R Neeser, MD
STUDY_CHAIRUeli Möhrlen
University Children's Hospital of Zurich
Outcome results
None listed