Patient Reported Outcome Measures in Umbilical Hernia Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Umbilical Hernia Repair. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patient vs. Surgeon Defined Preoperative Patient-reported Outcome Measures (PROMs) in Patients With an Umbilical Hernia.
Overview
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.
Detailed description
Repair for a symptomatic umbilical hernia is a common minor standard surgical procedure. Over decades, long-term recurrence rates have been the main surgical outcome after elective incisional, umbilical and inguinal hernia repair. Mesh reinforcement repair has dramatically reduced the risk of recurrence after umbilical hernia repair to 2% - 10%. However, and despite being only a small surgical standard operation, there are still important unsolved surgical challenges in patients undergoing uncomplicated umbilical hernia repair.
Patient-reported outcome measures (PROMs) is increasingly used in patients undergoing umbilical (and other types of) hernia repair. The studies in patients undergoing umbilical hernia repair PROMs have so far been surgeon defined (S-PROMs) and not defined by the patients themselves (P-PROMs). There are no comparative studies of preoperative complaints defined the patients and by the surgeons. Therefore, the optimal postoperative monitoring using PROMs is not known. Furthermore, there is only weak evidence that S-PROMs improve following umbilical hernia repair. One explanation could hypothetically be important differences between surgeon-defined PROMs (S-PROMs) and patient-defined PROMs (P-PROMs.)
In summary, there is still several unsolved clinical challenges to optimize the clinical results after umbilical hernia repair. This study focuses on long-term outcomes by analyzing PROMs.
Primary outcome measures
- Change in questionnaire-reported Patient reported outcome measures pre-/post-umbilical hernia repar [Time frame: From enrollment to 90 days after umbilical hernia repair.]
Secondary outcome measures (1)
- Questionnaire comparison of primary preoperative patient reported outcome measure with surgeon reported outcome measure in patients with an umbilical hernia. [Time frame: Baseline]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 4 centers
- Blekinge County Hospital — Karlskrona
- Kungsbacka Hospital — Kungsbacka
- Ljungby kirurgmottagningen — Ljungby
- Capio Gastro Center Skåne — Lund
Identifiers
NCT: NCT07717021 · Dnr 2024-00310-01