Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery (ABP-CS)
Efficacy of an Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery: A Randomized Controlled Trial Using Quantitative Gastric Bubble Imaging Analysis
Postoperative gastric distension is a common gastrointestinal complication after cardiac surgery and may delay recovery, prolong intensive care unit (ICU) stay, and reduce patient comfort. Anti-bloating patches are widely used in clinical practice to promote gastrointestinal function recovery; however, high-quality evidence regarding their effectiveness in cardiac surgical patients remains limited.
This randomized controlled trial aims to evaluate the efficacy and safety of an anti-bloating patch in reducing postoperative gastric distension after cardiac surgery. Adult patients undergoing cardiac surgery will be randomly assigned to receive either standard perioperative care alone or standard perioperative care plus anti-bloating patch therapy. Gastric bubble area will be quantitatively measured using chest radiographs and image analysis software.
The primary outcome is the change in gastric bubble area on postoperative day 1 compared with baseline. Secondary outcomes include gastric bubble area on postoperative day 1, percentage change in gastric bubble area, abdominal distension score, time to first flatus, time to first bowel movement, gastric drainage volume, time to oral feeding, ICU length of stay, postoperative hospital length of stay, and patch-related adverse events.
The results of this study may provide evidence for the use of anti-bloating patches as an adjunctive intervention to enhance postoperative gastrointestinal recovery in patients undergoing cardiac surgery.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Background Postoperative gastrointestinal dysfunction is frequently observed after cardiac surgery because of surgical stress, cardiopulmonary bypass, anesthesia, opioid administration, and prolonged bed rest. Gastric distension may contribute to patient discomfort, delayed gastrointestinal recovery, prolonged hospitalization, and increased healthcare utilization. Although anti-bloating patches are commonly used as a complementary intervention in perioperative care, evidence regarding their efficacy in cardiac surgery patients remains insufficient.
Objective To evaluate the clinical efficacy and safety of anti-bloating patch therapy for postoperative gastric distension in patients undergoing cardiac surgery and to establish an objective imaging-based method for quantitative assessment of gastric bubble area.
Methods This is a prospective, randomized, controlled, single-center clinical trial. A total of 150 adult patients undergoing elective cardiac surgery will be enrolled and randomly assigned in a 1:1 ratio to either an anti-bloating patch group or a control group.
Participants in the control group will receive standard perioperative management. Participants in the intervention group will receive anti-bloating patch therapy in addition to standard perioperative management.
Chest radiographs obtained on the day of surgery and on postoperative day 1 will be analyzed using ImageJ software. Gastric bubble area will be independently measured by trained investigators according to a predefined protocol
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Xu Jingyuan, Director
- Номер телефона: 025-83262550
- Электронная почта: zhongdacq804@126.com
Места учебы
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Jiangsu
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Nanjing, Jiangsu, Китай
- Zhongda Hospital, Southeast University
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Контакт:
- Xu Jingyuan, MD
- Номер телефона: 025-83262550
- Электронная почта: zhongdacq804@126.com
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
Inclusion Criteria:
- Age ≥18 years
- Undergoing elective cardiac surgery
- Postoperative chest radiographs available for gastric bubble area assessment
- Able to provide written informed consent or have consent provided by a legally authorized representative
- Expected postoperative intensive care unit admission
Exclusion Criteria:
- Previous major gastrointestinal surgery affecting gastric anatomy or motility
- Known gastrointestinal obstruction, perforation, or severe gastrointestinal disease
- Severe hepatic or renal dysfunction judged unsuitable by the investigators
- Known allergy or hypersensitivity to components of the anti-bloating patch
- Participation in another interventional clinical trial within the previous 30 days
- Pregnancy or lactation
- Inability to complete study assessments or follow study procedures
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Anti-Bloating Patch Group
Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery.
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Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
Standard perioperative management following cardiac surgery, including routine monitoring, fluid management, nutritional support, pain control, gastrointestinal function assessment, and other standard treatments as clinically indicated.
|
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Активный компаратор: Control Group
Participants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment.
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Standard perioperative management following cardiac surgery, including routine monitoring, fluid management, nutritional support, pain control, gastrointestinal function assessment, and other standard treatments as clinically indicated.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Gastric Bubble Area on Postoperative Day 1
Временное ограничение: Postoperative Day 1
|
Change in gastric bubble area measured on chest radiographs from the day of surgery to postoperative day 1.
Gastric bubble area will be quantified using ImageJ software and calculated as: postoperative day 1 gastric bubble area minus baseline gastric bubble area measured on the day of surgery.
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Postoperative Day 1
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Gastric Bubble Area on Postoperative Day 1
Временное ограничение: Postoperative Day 1
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Absolute gastric bubble area measured on chest radiographs using ImageJ software.
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Postoperative Day 1
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Percentage Change in Gastric Bubble Area
Временное ограничение: Postoperative Day 1
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Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
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Postoperative Day 1
|
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Abdominal Distension Score
Временное ограничение: Postoperative Day 1
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Patient-reported abdominal distension severity assessed using a Numerical Rating Scale (NRS) ranging from 0 to 10, where 0 indicates no abdominal distension and 10 indicates the worst imaginable abdominal distension.
Higher scores indicate more severe abdominal distension.
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Postoperative Day 1
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Time to First Flatus
Временное ограничение: From surgery until first flatus, up to hospital discharge
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Time from completion of surgery to first passage of flatus.
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From surgery until first flatus, up to hospital discharge
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Time to First Bowel Movement
Временное ограничение: From surgery until first bowel movement, up to hospital discharge
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Time from completion of surgery to first bowel movement.
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From surgery until first bowel movement, up to hospital discharge
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Gastric Drainage Volume
Временное ограничение: Within 24 hours after surgery
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Total gastric drainage volume recorded during the first 24 postoperative hours.
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Within 24 hours after surgery
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Time to Oral Feeding
Временное ограничение: Through hospital discharge, an average of 10 days
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Time from completion of surgery to first oral intake, measured in hours.
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Through hospital discharge, an average of 10 days
|
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Intensive Care Unit Length of Stay
Временное ограничение: Through ICU discharge, an average of 3 days
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Duration of stay in the intensive care unit, measured in hours or days.
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Through ICU discharge, an average of 3 days
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Postoperative Hospital Length of Stay
Временное ограничение: Through hospital discharge, an average of 10 days
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Duration of hospitalization after surgery, measured in days.
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Through hospital discharge, an average of 10 days
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Incidence of Patch-Related Adverse Events
Временное ограничение: From patch application through hospital discharge, an average of 10 days
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Incidence of adverse events related to anti-bloating patch application, including skin irritation, rash, itching, allergic reactions, or other treatment-related adverse events.
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From patch application through hospital discharge, an average of 10 days
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2026ZDSYLL231-P01
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Сроки обмена IPD
Критерии совместного доступа к IPD
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
- МКФ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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