Efficacy of an Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery: A Randomized Controlled Trial Using Quantitative Gastric Bubble Imaging Analysis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in Gastric Bubble Area on Postoperative Day 1
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Participants and investigators are aware of group assignments. Outcome assessment of gastric bubble area will be performed using standardized imaging analysis procedures.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Gastric Bubble Area on Postoperative Day 1
时间窗: 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.
次要结局
- Gastric Bubble Area on Postoperative Day 1(Postoperative Day 1)
- Percentage Change in Gastric Bubble Area(Postoperative Day 1)
- Abdominal Distension Score(Postoperative Day 1)
- Time to First Flatus(From surgery until first flatus, up to hospital discharge)
- Time to First Bowel Movement(From surgery until first bowel movement, up to hospital discharge)
- Gastric Drainage Volume(Within 24 hours after surgery)
- Time to Oral Feeding(Through hospital discharge, an average of 10 days)
- Intensive Care Unit Length of Stay(Through ICU discharge, an average of 3 days)
- Postoperative Hospital Length of Stay(Through hospital discharge, an average of 10 days)
- Incidence of Patch-Related Adverse Events(From patch application through hospital discharge, an average of 10 days)
研究者
Jingyuan,Xu
Director
Southeast University, China