Anti-Bloating Patch for Postoperative Gastric Distension After Cardiac Surgery

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSoutheast University, China

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Anti-Bloating Patch
  • Standard Perioperative Care

Treatment groups

150 Participants
are divided into 2 treatment groups

Sponsors and collaborators