Patient Reported Outcome Measures in Umbilical Hernia Surgery

NCT07717021 | Enrolling By Invitation

• 1 other identifier: Dnr 2024-00310-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Umbilical Hernia Repair

Keywords

long-term outcomes; PROM; chronic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to 90 days after umbilical hernia repair.

Secondary Outcomes (1)

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

  Baseline

Study Arms (2)

Patients

Patients being examined for an umbilical hernia

Surgeons

Hernia surgeons reporting surgeon reported outcome measures

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients referred to a surgical ambulatory ward for examination of an umbilical hernia.

You may qualify if:

• 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

You may not qualify if:

• A recurrent hernia
• Presence of other simultaneous hernias
• An emergency repair

Sponsors & Collaborators

• Blekinge County Council Hospital: lead

Study Sites (4)

Blekinge County Hospital

Karlskrona, Blekinge County, 37141, Sweden

Location

Kungsbacka Hospital

Kungsbacka, Sweden

Location

Ljungby kirurgmottagningen

Ljungby, Sweden

Location

Capio Gastro Center Skåne

Lund, Sweden

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claes Hjalmarsson, MD, phd

  Region Halland

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Licensed medical practitioner, Phd student

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 21, 2026
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)