Taping for Umbilical Hernia
ConditionUmbilical Hernia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorUniversity Children's Hospital, Zurich
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Taping of the umbilical hernia
Procedure/SurgeryThe 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.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Intervention / Taping GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Umbilical hernia closure rates at 6 months
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.
Time frame
at 6 months of ageSecondary outcomes
1
Umbilical hernia closure rates at 12 months of age
Time frame
At 12 months of age2
Occurrence of complications of umbilical hernias within the first 12 months
Time frame
Until 12 months of age3
Diameter of umbilical fascial defect at all visits
Time frame
Measured at each visit (first visit, at 6 months and at 12 months of age)4
Parental health-related quality of life assessed by the Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module
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.
Time frame
Measured at each visit (first visit, at 6 months and at 12 months of age)Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: