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NCT07677423
Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery
Conditions: Postoperative Gastric Distension, Postoperative Gastrointestinal Dysfunction, Cardiac Surgery
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 150
Sponsor: Southeast University, China
Location: Zhongda Hospital, Southeast University Nanjing Jiangsu
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07677423). StuddyBuddy aggregates publicly available trial information.