Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery

Официальное название

Efficacy of an Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery: A Randomized Controlled Trial Using Quantitative Gastric Bubble Imaging Analysis

Обзор

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.

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

Вмешательства

• Другое Anti-Bloating Patch
  Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
• Другое Standard Perioperative Care
  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.

Первичные конечные точки

• Change in Gastric Bubble Area on Postoperative Day 1 [Срок оценки: Postoperative Day 1]

Вторичные конечные точки (10)

• Gastric Bubble Area on Postoperative Day 1 [Срок оценки: Postoperative Day 1]
• Percentage Change in Gastric Bubble Area [Срок оценки: Postoperative Day 1]
• Abdominal Distension Score [Срок оценки: Postoperative Day 1]
• Time to First Flatus [Срок оценки: From surgery until first flatus, up to hospital discharge]
• Time to First Bowel Movement [Срок оценки: From surgery until first bowel movement, up to hospital discharge]
• Gastric Drainage Volume [Срок оценки: Within 24 hours after surgery]
• Time to Oral Feeding [Срок оценки: Through hospital discharge, an average of 10 days]
• Intensive Care Unit Length of Stay [Срок оценки: Through ICU discharge, an average of 3 days]
• Postoperative Hospital Length of Stay [Срок оценки: Through hospital discharge, an average of 10 days]
• Incidence of Patch-Related Adverse Events [Срок оценки: From patch application through hospital discharge, an average of 10 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

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

Китай · 1 центр

• Zhongda Hospital, Southeast University — Нанкин

Идентификаторы

NCT: NCT07677423 · 2026ZDSYLL231-P01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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