Patient Reported Outcome Measures in Umbilical Hernia Surgery

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.

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Key information

Conditions

Umbilical Hernia Repair Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Blekinge County Hospital, Karlskrona, Blekinge County, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Change in questionnaire-reported Patient reported outcome measures pre-/post-umbilical hernia repar

Time frame: 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.

Secondary outcomes

Questionnaire comparison of primary preoperative patient reported outcome measure with surgeon reported outcome measure in patients with an umbilical hernia.

Time frame: Baseline

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.

Sponsors and collaborators

Lead sponsor

Blekinge County Council Hospital

Other

Registry information

Official study title

Patient vs. Surgeon Defined Preoperative Patient-reported Outcome Measures (PROMs) in Patients With an Umbilical Hernia.

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2027
First posted: Jul 21, 2026
Registry last updated: Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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