Набор по приглашению NCT07717021

Patient Reported Outcome Measures in Umbilical Hernia Surgery

— Наблюдательное Umbilical Hernia Repair

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Umbilical Hernia Repair. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Швеция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

Change in questionnaire-reported Patient reported outcome measures pre-/post-umbilical hernia repar [Срок оценки: From enrollment to 90 days after umbilical hernia repair.]

Вторичные конечные точки (1)

Questionnaire comparison of primary preoperative patient reported outcome measure with surgeon reported outcome measure in patients with an umbilical hernia. [Срок оценки: Baseline]

Критерии участия

Критерии включения

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