Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery

NCT07677423 · tracked via the Priya Life Science China tracker

Sponsor

Southeast University, China

Phase

Not applicable

Started

2026-07-01

Last updated

2026-06-30

Condition(s) studied

Postoperative Gastric DistensionPostoperative Gastrointestinal DysfunctionCardiac Surgery

Investigational drug(s) / intervention(s)

Anti-Bloating PatchStandard Perioperative Care

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

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.

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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

Primary outcome measure(s)

Change in Gastric Bubble Area on Postoperative Day 1 — 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.

Trial sites (1)

Facility	City	Region	Status
Zhongda Hospital, Southeast University	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07677423 on ClinicalTrials.gov ↗ ← All trials in China