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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Anti-Bloating Patch
Other interventionParticipants will receive anti-bloating patch treatment according to the study protocol in addition to standard perioperative care after cardiac surgery.
Standard Perioperative Care
Other interventionStandard perioperative management following cardiac surgery, including routine monitoring, fluid management, nutritional support, pain control, gastrointestinal function assessment, and other standard treatments as clinically indicated.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Anti-Bloating Patch GroupExperimental treatment 2 interventions
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Gastric Bubble Area on 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.
Time frame
Postoperative Day 1Secondary outcomes
1
Gastric Bubble Area on Postoperative Day 1
Absolute gastric bubble area measured on chest radiographs using ImageJ software.
Time frame
Postoperative Day 12
Percentage Change in Gastric Bubble Area
Percentage change in gastric bubble area from the day of surgery to postoperative day 1.
Time frame
Postoperative Day 13
Abdominal Distension Score
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.
Time frame
Postoperative Day 14
Time to First Flatus
Time from completion of surgery to first passage of flatus.
Time frame
From surgery until first flatus, up to hospital dischargeSponsors and contacts
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Source ClinicalTrials.gov
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