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Clinical Trials in Sweden / NCT07717021
Enrolling by invitation Observational

Patient Reported Outcome Measures in Umbilical Hernia Surgery

NCT07717021 · tracked via the Priya Life Science Sweden tracker
Sponsor
Blekinge County Council Hospital
Phase
Observational
Started
2024-09-01
Last updated
2026-07-22

Condition(s) studied

Umbilical Hernia Repair

Study summary

This study collects information on symptoms before and after elective umbilical hernia repair. Enrollment in the study does not alter the planned surgery. The goal is to better understand so called patient-reported outcome measures in umbilical hernia patients and actual patient reported outcomes will be compared to perceived hernia surgeon reported outcomes through an electronic questionnaire.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: * Patients eligible for an elective repair of a primary umbilical hernia with a clinically palpable and/or CT- or ultrasound (when in doubt) scanned defect of ≤4 cm * Age 18 - 75 * A body mass index (BMI) of 19 - 35 Exclusion Criteria: * A recurrent hernia * Presence of other simultaneous hernias * An emergency repair

Primary outcome measure(s)

  • Change in questionnaire-reported Patient reported outcome measures pre-/post-umbilical hernia repar — From enrollment to 90 days after umbilical hernia repair.
    Through an electronic questionnaire (managed by REDCap), 8 questions regarding symptoms from an umbilical hernia will be recorded. The first question, asks the patient to state a self-determined hernia-related dominating complaint (defined as P-PROM). Hereafter, 7 questions concerning pain, discomfort, cosmesis, bulge movement, skin sensibility complaints, size increase, and incarceration (based on the literature and the authors experience) will be collected and rated on a ten-point numeric rating scale (NRS, 1 = no and 10 = severe) as well as on a verbal rating scale (VRS, no, little, moderate, severe). 3 months after hernia repair, the patient will be asked to answer the questionnaire again, blinded to the primary responses.

Trial sites (4)

FacilityCityRegionStatus
Blekinge County Hospital Karlskrona Blekinge County
Kungsbacka Hospital Kungsbacka Sweden
Ljungby kirurgmottagningen Ljungby Sweden
Capio Gastro Center Skåne Lund Sweden

More Blekinge County Council Hospital trials in Sweden

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Screening for Pregnancy Related Pelvic Girdle Pain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07717021 on ClinicalTrials.gov ↗ ← All trials in Sweden