The (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open 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
- В протоколе указаны: Percutaneous Inguinal Ring Suturing (PIRS) technique.
- Кому может быть актуально
- Состояния в реестре: Inguinal Hernia. Базовые параметры: 0 лет — 16 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
- Нидерланды
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
'Hernia Endoscopic oR opeN Repair In chIldren Analysis": A Randomized Controlled Trial to Study the (Cost-) Effectiveness of Paediatric Laparoscopic Hernia Repair Compared to Open Hernia Repair
Обзор
This study assess the (cost-)effectiveness of open versus laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique for unilateral inguinal hernia repair in children aged 0-16 years.
Подробное описание
Research question Inguinal hernia repair is one of the most common operations in children. After open unilateral inguinal hernia repair, 6-8% of patients develops an inguinal hernia on the contralateral side. Laparoscopic inguinal hernia offers the opportunity to inspect the contralateral groin and repair an asymptomatic contralateral hernia, if present.
Main question: What is the most (cost-)effective treatment strategy for unilateral inguinal hernia repair in children aged 0-16 years: the open or laparoscopic Percutaneous Inguinal Ring Suturing (PIRS) technique?
Hypothesis The optimal treatment for children with an inguinal hernia is laparoscopic hernia repair, since the surgeon can inspect and possibly, repair, the contralateral groin. Laparoscopic inguinal hernia repair results in less operations and exposure to anaesthesia, less hospital admissions, lower costs and a better quality of life compared to open inguinal hernia repair.
Study design Multicentre randomized controlled trial.
Study population Children aged 0 - 16 years with a unilateral inguinal hernia.
Intervention Inguinal hernia repair with the laparoscopic PIRS technique.
Usual care/comparison Inguinal hernia repair with the open technique.
Outcome Measures Primary: Number of operations related to inguinal hernia repair and cost-effectiveness (social and healthcare related costs). Secondary: complications, total duration of surgery (including anaesthesia and total duration of operating room time), post-operative pain, length of hospital stay, time to normal daily activities, cosmetic appearance, health-related quality of life. All outcome measures will be assessed within two years after the primary inguinal hernia correction.
Sample size/data analysis 464 patients (power of 0.80, alpha 0.05). Cost-effectiveness analysis/budget impact analysis The economic evaluation will be assessed from a societal and health care perspective. Cost-effectiveness will be assessed in terms of QALYs and the primary and secondary outcomes. A budget impact analysis will be conducted using the "Budget Impact Analyse - leidraad en rekentool" of ZonMw. Missing data will be imputed.
Вмешательства
- Процедура Percutaneous Inguinal Ring Suturing (PIRS) technique
Percutaneous Inguinal Ring Suturing (PIRS) technique
Первичные конечные точки
- Re-operation rate [Срок оценки: within two years after the primary inguinal hernia repair]
Вторичные конечные точки (8)
- Complications [Срок оценки: Within two years after the primary inguinal hernia repair]
- Duration of Surgery [Срок оценки: Within two years after the primary inguinal hernia repair]
- Post-operative pain [Срок оценки: Within two years after the primary inguinal hernia repair]
- Length of hospital stay [Срок оценки: Within two years after the primary inguinal hernia repair]
- Time to normal daily activities [Срок оценки: Within two years after the primary inguinal hernia repair]
- Cosmetic appearance [Срок оценки: Within two years after the primary inguinal hernia repair]
- Health-related quality of life [Срок оценки: Within two years after the primary inguinal hernia repair]
- Cost-effectiveness [Срок оценки: Cost-effectiveness is measured qithin two years after the primary inguinal hernia repair]
Критерии участия
Критерии включения
1\. Infants aged 0 months to 16 years of age with a primary unilateral inguinal hernia undergoing hernia repair
Критерии исключения
- incarcerated inguinal hernia, which have to be operated immediately,
- recurrent hernia
- ventricular-peritoneal drain
- non-descended testis
- parents who are not able to understand the nature or consequences of the study.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Нидерланды · 9 центров
- Maxima Medisch Centrum — Veldhoven
- FlevoZiekenhuis — Almere
- Amsterdam UMC, locatie AMC and VUmc — Amsterdam
- Erasmus MC — Rotterdam
- MST — Enschede
- Alrijne Ziekenhuis — Leiderdorp
- UMCG — Groningen
- Maastricht UMC+ — Maastricht
- … и ещё 1 центр
Публикации
- Maat SC, de Vreeze LE, Eurlings R, Anema J, Van Baren R, Been JV, van den Broek F, Cakir H, van Dongen JM, Ferenschild F, C de Graaff J, Nijveldt R, Ottenhof A, Ploeg AJ, Rippen H, Ruiterkamp J, Twisk JWR, Vermeulen E, De Wit R, Zijp G, van Heurn ELW, Derikx JPM. HERNIIA-II trial (Hernia Endoscopic oR opeN repair In chIldren Analysis): a protocol of a multicentre randomised controlled trial to stu PMID 41344705
Идентификаторы
NCT: NCT06451432 · NL71765.029.20