Laparoscopic Implantation of a Gastric Pacemaker in the Treatment of Gastroparesis
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Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Gastric pacemaker (Enterra system) implantation.
- Кому может быть актуально
- Состояния в реестре: Gastroparesis, Gastroparesis Postoperative, Gastroparesis Nondiabetic, Gastroparesis With Diabetes Mellitus. 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
- Германия
- 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
Laparoscopic Implantation of a Gastric Pacemaker is a Low-complication Alternative for Gastroparesis
Обзор
Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life. Aim of the investogators' registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.
Подробное описание
Gastroparesis is a burdensome condition that is caused by abnormal motor function of the stomach that results in delayed gastric emptying. It typically manifests with bloating, nausea, vomiting, abdominal pain, and even excessive weight loss and dehydration. The most common causes of gastroparesis are idiopathic, diabetic, medication-induced or iatrogenic (postsurgical) gastroparesis.
After ruling out mechanical obstruction as an underlying cause of gastroparesis using endoscopy or computed tomography, further assessment includes gastric emptying studies by scintigraphy to confirm the presence of delayed gastric emptying. Severity of symptoms and impact on health-related quality of life can be assessed using the Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Quality of Life Index (GIQLI).
Management of gastroparesis includes assessment of nutritional status, correction of fluid, electrolytes and nutritional deficiencies, symptomatic therapy, management of the underlying cause of gastroparesis, and improvement of gastric emptying. Implantation of a gastric neurostimulation device is a surgical option to improve gastric emptying in patients with medication-refractory gastroparesis. Enterra® system is a gastric electrical stimulation that sends mild pulses through leads implanted in the stomach wall that stimulate gastric smooth muscles and nerves in order to improve symptoms and quality of life.
Aim of this registry trial is to evaluate the feasibility and efficacy of laparoscopic gastric pacemaker implantation for electrical stimulation (Enterra® system). Primary endpoints of the study are symptom severity, health-related quality of life, and frequency of hospitalization before and after pacemaker implantation, perioperative complication rate, and cost effectiveness.
It is hypothesized that implantation of the Enterra systems leads to a significant improvement of symptoms as well as an increase in health-related quality of life in patients with gastroparesis.
Вмешательства
- Устройство Gastric pacemaker (Enterra system) implantation
Laparascopic implantation of a gastric pacemaker (Enterra system) for patients with therapy refractive gastroparesis
Первичные конечные точки
- Symptoms [Срок оценки: 5 years]
- Health-related quality of life [Срок оценки: 5 years]
Вторичные конечные точки (2)
- Hospital admission [Срок оценки: 5 years]
- Perioperative complication rate [Срок оценки: 1 year]
Критерии участия
Критерии включения
- Scintigraphically proven gastroparesis
- Failed conservative therapy
- Severe impairment of quality of life
- Written informed consent
- German language
Критерии исключения
- Age < 18 years
- Prior gastric resection
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Германия · 1 центр
- Department of Functional Upper GI Surgery — Cologne
Идентификаторы
NCT: NCT06661668 · Gastroparesis_Enterra