Patient vs. Surgeon Defined Preoperative Patient-reported Outcome Measures (PROMs) in Patients With an Umbilical Hernia.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change in questionnaire-reported Patient reported outcome measures pre-/post-umbilical hernia repar
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •A recurrent hernia
- •Presence of other simultaneous hernias
- •An emergency repair
研究组 & 干预措施
Patients
Patients being examined for an umbilical hernia
Surgeons
Hernia surgeons reporting surgeon reported outcome measures
结局指标
主要结局
Change in questionnaire-reported Patient reported outcome measures pre-/post-umbilical hernia repar
时间窗: 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.
次要结局
- Questionnaire comparison of primary preoperative patient reported outcome measure with surgeon reported outcome measure in patients with an umbilical hernia.(Baseline)
研究者
Martin Frimand Rönnow
Licensed medical practitioner, Phd student
Blekinge County Council Hospital