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.
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.
Study Type
OBSERVATIONAL
Enrollment
200
Blekinge County Hospital
Karlskrona, Blekinge County, Sweden
Kungsbacka Hospital
Kungsbacka, Sweden
Ljungby kirurgmottagningen
Ljungby, Sweden
Capio Gastro Center Skåne
Lund, Sweden
Change in questionnaire-reported Patient reported outcome measures pre-/post-umbilical hernia repar
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.
Time frame: From enrollment to 90 days after umbilical hernia repair.
Questionnaire comparison of primary preoperative patient reported outcome measure with surgeon reported outcome measure in patients with an umbilical hernia.
Through an electronic questionnaire (managed by REDCap), patients being evaluated for an umbilical hernia will be asked 8 questions regarding symptoms from an umbilical hernia. 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). Hernia surgeons, identified through the Swedish Hernia registry, will be invited to answer a similarly constructed questionnaire regarding which symptoms a typical patient with an umbilical hernia presents with (8 questions as described above). The dominating preoperative complaints will be compared between patients and surgeons.
Time frame: Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.