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Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery (ABP-CS)

2026年6月27日 更新者：Jingyuan,Xu、Southeast University, China

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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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

研究类型

介入性

注册 (估计的)

150

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • Zhongda Hospital, Southeast University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Anti-Bloating Patch Group
Participants will receive anti-bloating patch treatment in addition to standard perioperative care after cardiac surgery.
其他：Anti-Bloating Patch
Participants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
其他：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.
有源比较器：Control Group
Participants will receive standard perioperative care after cardiac surgery without anti-bloating patch treatment.
其他：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Gastric Bubble Area on Postoperative Day 1
大体时间：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.
Postoperative Day 1

次要结果测量

结果测量
措施说明
大体时间
Gastric Bubble Area on Postoperative Day 1
大体时间：Postoperative Day 1
Absolute gastric bubble area measured on chest radiographs using ImageJ software.
Postoperative Day 1
Percentage Change in Gastric Bubble Area
大体时间：Postoperative Day 1
Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
Postoperative Day 1
Abdominal Distension Score
大体时间：Postoperative Day 1
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.
Postoperative Day 1
Time to First Flatus
大体时间：From surgery until first flatus, up to hospital discharge
Time from completion of surgery to first passage of flatus.
From surgery until first flatus, up to hospital discharge
Time to First Bowel Movement
大体时间：From surgery until first bowel movement, up to hospital discharge
Time from completion of surgery to first bowel movement.
From surgery until first bowel movement, up to hospital discharge
Gastric Drainage Volume
大体时间：Within 24 hours after surgery
Total gastric drainage volume recorded during the first 24 postoperative hours.
Within 24 hours after surgery
Time to Oral Feeding
大体时间：Through hospital discharge, an average of 10 days
Time from completion of surgery to first oral intake, measured in hours.
Through hospital discharge, an average of 10 days
Intensive Care Unit Length of Stay
大体时间：Through ICU discharge, an average of 3 days
Duration of stay in the intensive care unit, measured in hours or days.
Through ICU discharge, an average of 3 days
Postoperative Hospital Length of Stay
大体时间：Through hospital discharge, an average of 10 days
Duration of hospitalization after surgery, measured in days.
Through hospital discharge, an average of 10 days
Incidence of Patch-Related Adverse Events
大体时间：From patch application through hospital discharge, an average of 10 days
Incidence of adverse events related to anti-bloating patch application, including skin irritation, rash, itching, allergic reactions, or other treatment-related adverse events.
From patch application through hospital discharge, an average of 10 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Southeast University, China

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2027年6月1日

研究完成 (估计的)

2027年7月1日

研究注册日期

首次提交

2026年6月21日

首先提交符合 QC 标准的

2026年6月27日

首次发布 (实际的)

2026年6月30日

研究记录更新

最后更新发布 (实际的)

2026年6月30日

上次提交的符合 QC 标准的更新

2026年6月27日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2026ZDSYLL231-P01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the published results may be made available upon reasonable request to the corresponding investigator after publication of the primary study results, subject to institutional approval and applicable data protection regulations.

IPD 共享时间框架

De-identified individual participant data and supporting documents will be available beginning 6 months after publication of the primary study results and ending 5 years after publication.

IPD 共享访问标准

Access to de-identified individual participant data, study protocol, statistical analysis plan, and informed consent form will be provided to qualified researchers whose proposed use of the data has been approved by the principal investigator and the sponsoring institution. Requests should include a methodologically sound research proposal. Data will be shared for the purpose of achieving the aims outlined in the approved proposal and in accordance with applicable ethical and data protection requirements.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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