Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia
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: Laparoscopic hiatal hernia repair.
- Кому может быть актуально
- Состояния в реестре: Large Hiatal Hernia. Базовые параметры: от 18 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
- Франция
- 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
Onlay Synthetic Bioabsorbable Mesh Herniorrhaphy Versus Herniorrhaphy Only in the Primary Treatment of Large Hiatal Hernia: a Multicenter, Randomized, Parallel-group, Evaluator Blinded, Phase III Clinical Trial
Обзор
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date. Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications. The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.
Подробное описание
The large hiatal hernia (LHH) now represents approximately 50% of laparoscopic antireflux surgical practice. Aging of the population and improvement of perioperative management may suggest that the number of these interventions will increase in the next few years. However, recurrence is common and has been described in up to 30% of patients who have undergone laparoscopic repair after a median follow up of 24 months.
The use of mesh reinforcement has been suggested to help preventing recurrence after LHH repair with non-absorbable and absorbable mesh.
In a non-comparative retrospective study of 399 patients operated for LHH with onlay patch of a bioprosthetic absorbable (Gore® Bio-A® HH0710) mesh with a mean follow-up of 44 months, 16% had a symptomatic recurrence with 7,9% requiring reoperation, one patient had oesophageal stenosis. No comparative effectiveness data exist to date.
Hypothesis: the incidence of postoperative hiatus hernia would be reduced by the addition of biosynthetic absorbable mesh reinforcement to a standardized suture repair technique, as compared to laparoscopic repair without mesh, without increasing the risk of complications.
The main objective is to compare the radiologic recurrence rate at 2 years between standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair versus standardized herniorrhaphy with no mesh in symptomatic LHH.
The secondary objectives are :
* To compare the improvement of specific symptoms between two arms; * To compare the Quality of life; * To compare the complication rate and thecomplication severity according to the Clavien-Dindo classification; * To assess the cost-effectiveness of standardized herniorrhaphy with onlay biosynthetic absorbable mesh repair as compared to standardized herniorrhaphy with no mesh, in symptomatic LHH, at 2 years, from the French Healthcare system point of view.
The expected benefits are :
* for the patient the diminution of LHH recurrence rate, quality of life improvement * for Public health: * Reducing the rate of reoperation for LHH; * Reduction of healthcare costs due to a decrease in proton pump consumption and surgical re-interventions; * The use of a synthetic bioprosthesis in laparoscopic surgery could be largely recommended and reimbursed either through the tariff related to the hospital stay (DRG tariff) or in additionto this tariff; * Long term follow-up up to 5 years, could be obtained thanks to the use of French health insurance databases.
Вмешательства
- Процедура Laparoscopic hiatal hernia repair
laparoscopic hiatal hernia repair has replaced the traditional laparotomic or thoracotomic approach, and has resulted in a reduction of length of hospital stay and morbidity, and increased patients' acceptance
Первичные конечные точки
- Number of Large Hiatal Hernia recurrence [Срок оценки: Month 24]
Вторичные конечные точки (12)
- Evaluation of Quality of life (QoL) by GIQLI, [Срок оценки: Day 0]
- Evaluation of Quality of life (QoL) by GIQLI, [Срок оценки: Month 1]
- Evaluation of Quality of life (QoL) by GIQLI, [Срок оценки: Month 6]
- Evaluation of Quality of life (QoL) by GIQLI, [Срок оценки: Month 12]
- Evaluation of Quality of life (QoL) by GIQLI, [Срок оценки: Month 24]
- Evaluation of Quality of life (QoL) by SF36 questionnaire [Срок оценки: Day 0]
- Evaluation of Quality of life (QoL) by SF36 questionnaire [Срок оценки: Month 1]
- Evaluation of Quality of life (QoL) by SF36 questionnaire [Срок оценки: Month 6]
- Evaluation of Quality of life (QoL) by SF36 questionnaire [Срок оценки: Month 12]
- Evaluation of Quality of life (QoL) by SF36 questionnaire [Срок оценки: Month 24]
- Evaluation of Quality of life (QoL) by EQ-5D-5L [Срок оценки: Day 0]
- Evaluation of Quality of life (QoL) by EQ-5D-5L [Срок оценки: Month 1]
Критерии участия
Критерии включения
- Patient undergoing laparoscopic primary repair for symptomatic LHH. LHH is defined as a hiatal hernia larger than 5 cm in axial length as diagnosed at barium series and/or CT-scan with contrast swallow and/or CT-scan with contrast injection with axial reconstruction.
- Symptomatic hiatal hernia: heartburn and/or regurgitation and/or epigastric pain and/or dysphagia and/or anemia (if exclusion of other origin);
- Patient aged ≥ 18 years;
- Patient affiliated to a social security system or beneficiary of the same;
- Free written informed consent signed by the participant and the investigator (no later than the inclusion day and before performing any examination required for the study).
Критерии исключения
- Patient undergoing reoperation for recurrent LHH repair;
- Emergency presentation needing an operation in a delay <6 hours;
- Asymptomatic hiatal hernia;
- American anesthesiologist score >3;
- Recurrent hiatal hernia and previous surgical interventions involving gastroesophageal junction;
- Brachyesophagus defined as the impossibility to achieve an intraabdominal length of the esophagus of at least 3cm after reduction of hernia contents and complete dissection and resection of the hernia sac;
- Previous major upper gastrointestinal surgery;
- Inability to perform primary closure of the crura;
- Pregnant or breast-feeding woman;
- Persons deprived of liberty or under guardianship or incapable of giving consent;
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator.
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
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Франция · 26 центров
- CH de la Côte Basque — Bayonne
- Hôpital Jean Minjoz, CHRU de Besançon — Besançon
- Hôpital Cavale blanche, CHRU de Brest — Brest
- Hôpital Côte de nacre, CHU Caen Normandie — Caen
- Hôpital Estang — Clermont-Ferrand
- Hôpital Louis-Mourier, AP-HP — Colombes
- Hôpital Nord, CHU de Grenoble — La Tronche
- Hôpital Claude Huriez, CHRU de Lille — Lille
- … и ещё 18 центров
Идентификаторы
NCT: NCT05867225 · CHUBX 2021/23